Articles - History

Arena Pharmaceuticals Announces Initiation By Merck Of Phase 2 Clinical Trial Of Niacin Receptor Agonist

Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced the initiation of a Phase 2 clinical trial of an orally administered niacin receptor agonist drug candidate being developed by Merck & Co., Inc., under its collaboration with Arena to treat atherosclerosis. Agonists of the niacin receptor have the potential to regulate plasma lipid profiles, including HDL, or the "good" cholesterol, similar to the therapeutic action of niacin.

NOVAVAX Reports Positive Clinical Results From Pivotal Study Of H1N1 Influenza Vaccine In Mexico

Novavax, Inc. (Nasdaq: NVAX) reported favorable initial results from the first stage of a two-stage pivotal Phase II study evaluating the safety and immunogenicity of the company's 2009 H1N1 virus-like particle (VLP) pandemic influenza vaccine...

Identification Of Mechanism, Possible Drug Treatment For Tumors In Neurofibromatosis

Researchers studying neurofibromatosis type 1 - a rare disease in which tumors grow within nerves - have found that the tumors are triggered by crosstalk between cells in the nerves and cells in the blood. The researchers, who were funded by the National Institutes of Health (NIH) and the Department of Defense (DOD), also found that a drug on the market for treating certain kinds of blood cancer curbs tumor growth in a mouse model of neurofibromatosis type 1.

Anestvise Inc. is Delivering Quality and Enabling Technology

Anestvice Inc. www.anestvice.com sponsors clinical trials towards manufacture of new medical devices. They work with medical professionals to design better equipment to meet their needs.We envision a modernization of the development and regulation processes for new medical devices. This ...
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Is Esomeprazole The Best Choice For Reflux Esophagitis Patients?

In patients with gastroesophageal reflux disease (GERD), esomeprazole, has demonstrated pharmacological and clinical benefits beyond those seen with the other proton pump inhibitors( PPIs ). However it has not hitherto been fully determined whether differences in the onset of antisecreatary activity may affect the speed of symptom relief with different PPI. Dr. Ri-Nan Zheng from China addresses this question.

Research Reveals How Popular Skin Filler Works At The Molecular Level To Stimulate Collagen Production In Sun-Damaged Skin

In the U.S. and around the world, the popularity of minimally invasive cosmetic procedures continues to increase. Soft tissue injectables, also known as dermal fillers, are popular procedures that improve the appearance of aging and sun-damaged skin by restoring lost volume and filling lines...

Multidisciplinary Team Researching Gene Therapy For Human Degenerative Retinal Diseases

A Canadian and American research group including the team of Dr. Robert Koenekoop from the Research Institute at the Montreal Children's Hospital of the MUHC has just been awarded $2.4 million from the Canadian Institutes of Health Research (CIHR) and the Foundation Fighting Blindness Canada (FFB). This five-year grant will fund an ambitious research project to develop innovative gene therapies for a number of human degenerative retinal diseases.

Injury to myelinated axons in the CNS often has a devastating outcome in terms of neuronal loss, with accompanying loss of function.

Damage to the nervous system may result from traumatic injury, such as penetrating or blunt trauma, stroke, or neurodegenerative disorders such as Alzheimer's disease, Parkinson's disease, Huntington's disease, amyotrophic lateral sclerosis (ALS), diabetic neuropathy or senile dementia. ...
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Positive Results Of Phase 2 Osteoporosis Study - ZP-PTH Patch Shows Increase In Lumbar Spine And Hip Bone Mineral Density

Zosano Pharma, Inc., a privately held pharmaceutical company developing a novel transdermal delivery technology, today announced positive results from its phase 2, randomized, multi-center, double-blind, multi-dose study designed to determine safety and efficacy of its ZP-PTH rapid delivery patch for the treatment of osteoporosis. The product delivers PTH 1-34, teriparatide (PTH), a compound that has been proven to stimulate formation of new bone and reduce the risk of fractures.

Schering-Plough Announces U.S. Filing Of Mometasone Furoate/Formoterol Fumarate Combination For The Maintenance Treatment Of Asthma

Schering-Plough announced that a New Drug Application (NDA) for a fixed-dose combination of mometasone furoate and formoterol fumarate has been filed in the United States and accepted for review by the U.S. Food and Drug Administration (FDA). Schering-Plough is seeking marketing approval from the FDA of the mometasone furoate/formoterol fumarate combination for the maintenance treatment of asthma in patients 12 years of age and older.

Rexahn Completes Patient Enrollment In Phase IIa Clinical Trial Of ZoraxelTM To Treat Erectile Dysfunction

Rexahn Pharmaceuticals, Inc. (NYSE Alternext US: RNN), a leader in development of innovative therapeutics for life-threatening and life-debilitating diseases, announced the completion of enrollment in its Phase IIa clinical trial evaluating ZoraxelTM for treatment of Erectile Dysfunction (ED). The Company expects to have preliminary study results in March 2009.

Pharmalef Developments introduces several new products in Rheumatology, Immunology and Respiratory Diseases.

With a focus on familiar, everyday health problems, Pharmalef Developments . www.pharmalef.com aims to develop and deliver products that meet the individual’s health care needs, developing a wide range of products.In addition to its established range of highly effective and ...
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New Study Published In The New England Journal Of Medicine Shows Superiority Of CareFusion ChloraPrep(R) Compared To Povidone Iodine

Data published in The New England Journal of Medicine demonstrates that use of CareFusion's patient preoperative skin preparation ChloraPrep® (2 percent chlorhexidine gluconate and 70 percent isopropyl alcohol) reduced total surgical site infections (SSIs) by 41 percent, from 16.1 percent to 9...

Ferring Pharmaceuticals Launches Phase IIIB Trial Of Degarelix As Intermittent Therapy

Ferring Pharmaceuticals announced the launch of a Phase IIIB clinical trial of degarelix for injection, a new injectable gonadotropin-releasing hormone (GnRH) receptor antagonist approved by the U.S. Food and Drug Administration (FDA) for the treatment of hormone sensitive advanced prostate cancer. The announcement was made at the 2009 American Urological Association Annual Meeting in Chicago, IL.

FDA Licenses New Influenza Vaccine Designed Specifically For People 65 Years Of Age And Older

Sanofi Pasteur, the vaccines division of the sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), announced that the U.S. Food and Drug Administration (FDA) has approved the company's supplemental biologics license application (sBLA) for licensure of Fluzone® High-Dose (Influenza Virus Vaccine)...

Kriger Courses Are Indispensable To Break Into The Biopharmaceutical And Clinical Research Industry.

From what many of our students have said, Kriger www.kriger.com and their professional development courses are not only inspiring but also indispensable when trying to start a career in the biopharmaceutical and clinical research industry. These courses provide the necessary detailed ...
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New Pneumonia, Meningitis Vaccine Approved In U.S.; Pfizer, GAVI Will Lower Price In Developing Countries

The FDA approved Prevnar 13 - a "new version of a blockbuster vaccine that fights pneumonia, meningitis and other infections" - for use in children up to age 5 in the U.S., Reuters reports (Richwine, 2/24). Such infections cause the deaths of an estimated one million children in developing countries and "dozens of deaths" in the U.S...

Synvista Therapeutics Announces First Dosing Of SYI-2074 In Clinical Trial For Psoriasis

Synvista Therapeutics, Inc. (NYSE Alternext US: SYI) has dosed the first patient in a 30-patient Phase 2 clinical trial of its proprietary topical GPx-mimetic, SYI-2074, in patients with psoriasis. The trial is planned to be a 28-day multi-center, randomized, double-blind, placebo controlled study to assess the efficacy of topical SYI-2074, applied twice daily, for the treatment of chronic, mild-to-moderate plaque psoriasis in adults. The trial is being conducted in three centers in Israel.

Supporting Strategic Autism Research: NIH Will Use $60 Million In Recovery Act Funds

The National Institutes of Health (NIH) will commit roughly $60 million from American Recovery and Reinvestment Act (ARRA) to support autism research and meet objectives set forth earlier this year by a federal advisory committee. The Request for Applications is the largest funding opportunity for research on autism spectrum disorders (ASD) to date and combined with other ARRA initiatives represents a surge in NIH's commitment to finding the causes and treatments for autism.

Understanding the Importance of ICH GCP is Vital to the Continued Safety of Clinical Patients.

Several Kriger www.krigerinternational.com course sessions are dedicated to understanding concepts and principles that have helped mold the industry into what it is today. This gives each student the opportunity to understand how the industry is progressing, so that when they take their place ...
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New Data Support Role For Monitoring Of Cell-Mediated Immunity In Adult Patients Following Renal Transplantation

A recently published article by Sanchez-Velasco et al. in Clinical Transplantation has expanded our understanding of the clinical potential of monitoring cell-mediated immunity in adult patients at risk for organ rejection or infection subsequent to kidney transplantation.

Cornerstone Pharmaceuticals Announces $6 Million Financing To Further Advance Clinical Trials In Cancer Patients

Cornerstone Pharmaceuticals, Inc., a privately-held pharmaceutical company focused on developing drugs in the emerging field of cancer bioenergetics, announced recently that it has raised a minimum of $6 million from a private investor group.

Torax Medical Launches Pivotal Clinical Study Of New Acid Reflux Treatment

Torax Medical Inc., a medical device company focused on the minimally invasive treatment of gastroesophageal reflux disease (GERD) has commenced a pivotal clinical trial of its LINX(TM) Reflux Management System. The trial, which is being conducted at 15 leading academic and private medical centers in the U.S. and Europe, will evaluate the safety and effectiveness of the LINX System in patients suffering from GERD despite medical therapy.

Ground breaking companies within the CRO industry

With over 1200 companies within the CRO industry Limdato www.limdato.com is one who is able to utilize cutting edge technology and innovations to ensure complete success for your clinical trial. During the 1970’s the industry was extremely limited to the services it could provide for ...
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Autism Study Finds Significant Benefit With Hyperbaric Treatment

In a medical world that tells parents of autistic children to "accept" the condition of their child, a new study brings not only hope, but actual help, to these families. Lead physician and researcher, Daniel Rossignol, M.D., treats children with autism. Seeing his patients improve with hyperbaric oxygen treatment led him to conduct the first large scale, double-blind, controlled study to examine its effectiveness. And, the results of this study demonstrate positive improvements.

Alkermes Initiates Clinical Trial For ALKS 33, A Novel Oral Molecule With Potential Benefits In Addiction And Other CNS Disorders

Alkermes, Inc. (NASDAQ: ALKS) today announced the initiation of a phase 1 study of ALKS 33, an oral opioid modulator for the potential treatment of addiction and other central nervous system (CNS) disorders. ALKS 33 is the company's first novel, small molecule drug candidate to enter the clinic. The molecule builds on Alkermes' scientific expertise in brain reward pathways as well as the company's clinical and commercial knowledge in the field of addiction.

Lives Of Patients With HER2-Positive Breast Cancer Prolonged By Targeted Therapy

Lapatinib plus trastuzumab are significantly better than lapatinib alone in extending the lives of breast cancer patients whose tumors are HER2-positive, according to Kimberly Blackwell, M.D., associate professor of medicine at Duke University Medical Center. Blackwell presented the findings at the CTRC-AACR San Antonio Breast Cancer Symposium...

Professor Esther Shohami has joined the board of advisors of Cereprotec Incorporated

Professor Esther Shohami has joined the board of advisors of Cereprotec Incorporated. Her research interests include: Pathophysiology of brain injury - mediators of delayed neuronal damage e.g., prostaglandins, reactive oxygen species, cytokines, cannabinoids, and the cholinergic system in ...
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Resverlogix Commences Phase 2 Atherosclerosis Clinical Trial

Resverlogix Corp. ("Resverlogix" or the "Company") (TSX:RVX) announced that it has begun dosing patients in its US Phase 2 clinical trial lead by Cleveland Clinic. This trial will examine RVX-208, Resverlogix's oral small molecule therapy for the treatment of atherosclerosis, in patients with stable coronary artery disease (CAD). This study is chaired by Dr...

Can Blood Samples Predict Arthritic Rheumatism?

Levels of inflammatory proteins, so-called cytokines, are elevated in the blood even before the onset of arthritic rheumatism...

Alimera Announces Positive Results From The Two Phase 3 FAME(TM) Trials Of Iluvien(R) In Patients With Diabetic Macular Edema

Alimera Sciences, Inc., a privately held biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, reported top-line results from the month 24 readout of the FAME Study...

Anestvise Inc will Create New Jobs at New Manufacturing Facility in Eastern Europe

Anestvice Inc. www.anestvice.com , whose customers include major pharmaceutical industry players, specializes in manufacturing of medical devices. The company’s long-term plans call for it’s new facility to serve as a device manufacturing center, using advanced technology in ...
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Traumatic Brain Injury Collaboration Between Arbor Vita And WRAIR

The U.S. Department of Applied Neurobiology at the Walter Reed Army Institute of Research (WRAIR) and Arbor Vita Corporation (AVC) have signed a Cooperative Research and Development Agreement (CRADA) for research and development of treatments for traumatic brain injury (TBI). The alliance is based on discoveries made from a collaborative effort between AVC and NoNO Inc.

Clinical Tests Begin On Medication To Correct Fragile X Defect

NIH-supported scientists at Seaside Therapeutics in Cambridge, Mass., are beginning a clinical trial of a potential medication designed to correct a central neurochemical defect underlying Fragile X syndrome, the most common inherited cause of intellectual disability. There has to date been no medication that could alter the disorder's neurologic abnormalities. The study will evaluate safety, tolerability, and optimal dosage in healthy volunteers.

Solvents May Cause Brain Disorders, But Rehabilitation Is Possible

There is little experience with the (neuro) psychological treatment of patients with solvent-induced chronic toxic encephalopathy (CSE). This randomised controlled trial evaluates a treatment programme based on previous outcome studies of patients with chronic fatigue, whiplash and traumatic brain damage.

Volunteers Respect Accurate and Personalized Information From Study Results

Many CRO’s and investigators believe that even though volunteer patients in clinical trials expose themselves to a great deal of risk, there is no legal mandate for investigators to inform them of study results. However, Clinproxy, www.clinproxy.com as well as many investigators have ...
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D-Pharm Receives FDA Clearance To Commence A Phase III Trial Of DP-b99 In Acute Stroke Patients

D-Pharm announced today that its Investigational New Drug (IND) application for a pivotal Phase III clinical trial of DP-b99 in acute ischemic stroke patients has been approved by the US Food and Drug Administration (FDA). D-Pharm plans to initiate the trial in the coming months, in over 100 clinical sites in North America, Europe, South Africa and Israel.

Deep Brain Stimulation May Be Effective Treatment For Tourette Syndrome

Deep brain stimulation may be a safe and effective treatment for Tourette syndrome, according to research published in the October 27, 2009, print issue of Neurology®, the medical journal of the American Academy of Neurology. "Our findings hold promise for helping people with severe Tourette syndrome, who are in need of new treatment options to improve their quality of life," said study author Andrea Cavanna, MD, of the University of Birmingham, in the United Kingdom.

GeoVax Labs, Inc. Provides Clinical Studies Update

GeoVax Labs, Inc. (OTC Bulletin Board: GOVX), an Atlanta-based HIV/AIDS vaccine development company announced updates on its ongoing and planned human clinical trials. "We have two main areas of focus for our HIV/AIDS vaccine - preventative and therapeutic," stated Robert McNally, Ph.D., Chief Executive Officer and President of GeoVax Labs, Inc.

Kriger Research Group International provides clinical research services on a truly global scale.

Kriger Research Group International www.krigerclinical.com provides clinical research services for pharmaceutical and biotechnology product development from phase II through phase IV for US, Canadian, European and multinational pharmaceutical companies. KRGI is your way to high quality ...
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Rapid Viral Diagnosis Tests In Emergency Rooms Show Promising Results

Rapid viral diagnosis tests for respiratory diseases in children who arrive in emergency departments have the potential to reduce pressures on health systems by enabling doctors to reach a quicker diagnosis, according to Cochrane Researchers. However, they say larger trials are needed to confirm this finding.

COPPERTONE(R) Solar Research Center Unveils Studies On Efficacy Of Topical Antioxidants In Sunscreens At 2010 Annual Meeting

Schering-Plough HealthCare Products, Inc., the consumer healthcare division of Merck & Co., Inc., the makers of COPPERTONE®, announced at the 2010 Annual Meeting of the American Academy of Dermatology the results of studies demonstrating the efficacy of topical antioxidants in broad spectrum sunscreens...

Journal Of Clinical Oncology Article Highlights CellSearchT Circulating Tumor Cell Test In Treatment Of Metastatic Colorectal Cancer

An international, prospective clinical trial found the number of circulating tumor cells (CTCs) is a strong indicator of progression-free and overall survival among metastatic colorectal cancer patients, according to a report published in the July 1 issue of the Journal of Clinical Oncology.

Clinqua Inc. has embraced the concept that cooperation with other aspiring companies is the key to unlocking success in the clinical and biopharmaceutical research industry.

Clinqua is a Contract Research Organization www.clinqua.com that is attempting to change the age old notions that plagued the Clinical and Biopharmaceutical Industry, where in the past it was believed that for a company to survive it had to exist in competition with all others.

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Study Suggests New Treatment Approach May Be Needed For Management Of Depression In Some People With Bipolar Disorder

In a study published in The American Journal of Psychiatry, a team of researchers led by Mayo Clinic psychiatrist Mark Frye, M.D., attempted to identify what factors make some people with bipolar depression more likely to experience treatment-emergent mania (TEM). Bipolar disorder, also known as manic-depressive illness, is a mental illness characterized by severe mood instability that can be serious and disabling.

Pneumococcal Conjugate Vaccines Effective At Preventing Child Deaths

A study published in The Cochrane Review this month concludes that pneumococcal conjugate vaccines (PCV), already known to prevent invasive pneumococcal disease (IPD) and x-ray defined pneumonia, was also effective against child deaths. The findings were based on a systematic review of the results of 6 randomized and controlled trials conducted in the US, Africa, Philippines, and Finland.

A Year Into Blindness Trial, Vision Researchers See Unexpected Gain

Scientists have discovered that even in adults born with extremely impaired sight, the brain can rewire itself to recognize sections of the retina that have been restored by gene therapy. The discovery of the brain's surprising adaptability comes a year after three blind volunteers received doses of corrective genes to selected areas of their retinas at Shands at the University of Florida medical center.

What the Title of Home-based Clinical Research Associate Really Means

The title of Clinical Research Associate is deceiving to some degree. Many people think of “associate” as a secondary low paying job. “Clinical Monitor” is a title that better describes what CRA job entails. A clinical research associate does not, in fact, assist anyone; the associate ...
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Three New Studies Give Clear Guidance On How To Better Recruit Volunteers For Alzheimer's Clinical Studies

Partnering with local physicians, working with local clinics, conducting educational seminars and health fairs were found to be the most effective tools in recruiting people for clinical studies 'Clinical trials are very important. Not only do they drive forward dementia research but people who participate in clinical trials often experience positive benefits. Despite this a very small number of people are given the opportunity to participate in a dementia research trial.

Global Health Ventures To Initiate Human Clinical Trials In Europe For X-Excite, Its Male Sexual Enhancement Drug

Global Health Ventures Inc. (OTCBB:GHLV), or the "Company", is pleased to announce that it has engaged Clinical Investigations Ltd. of United Kingdom to design and carry out the human clinical trials for X-Excite in Europe under the European Regulatory Guidelines (EMEA)...

Personalized Anti-Cancer Vaccine Pivotal Phase III Results To Be Presented At ASCO Plenary Session

Biovest International, Inc. (Other OTC:BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (Other OTC:ABPIQ), announced that BiovaxID®, Biovest's personalized anti-cancer vaccine targeting B-cell blood cancers, will be featured in an oral presentation during the Plenary Session at the American Society of Clinical Oncology (ASCO) Annual Meeting on Sunday, May 31st, 2009 in Orlando, Florida. Stephen J. Schuster, M.D.

Successful Techniques for Monitoring Medical Devices

Limdato, www.limdato.com knows that you will never see effective monitoring results unless you know the “red flag” issues in your trial. Most monitors do not focus their monitoring efforts where they are needed most. Clinical Trial Monitors need to quickly distinguish between ...
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MabCure Launches Clinical Trial To Diagnose Ovarian Cancer

MabCure, N.V. ("MabCure") a wholly-owned subsidiary of MabCure Inc. (OTCBB: MBCI) , a biotech company that has developed a series of highly specific monoclonal antibodies (MAbs) to combat various types of cancers, has signed a clinical research agreement with the Ramathibodi Hospital, Mahidol University in Bangkok, Thailand...

Northwestern Memorial First To Trial Smallest Full Support Heart Assist Device

Northwestern Memorial Hospital's Bluhm Cardiovascular Institute is the first center in Illinois and among the first in the country to implant a new experimental left ventricular assist device (LVAD) into subjects with advanced heart failure, a condition where the heart cannot pump enough blood to the body's organs. The HeartWare® Ventricular Assist System (

Kinex Pharmaceuticals Initiates A Phase 2 Clinical Trial Of KX2-391 In Patients With Prostate Cancer

Kinex Pharmaceuticals opened a Phase 2 clinical trial to evaluate the safety and efficacy of KX2-391 in patients with bone-metastatic, castrate-resistant prostate cancer (CRPC) who have not had prior chemotherapy...

Kriger Research Group International joins TrialStat's CROFIRST Program

July 9, 2008, OTTAWA, ON - TrialStat Corporation, the industry's first clinical data solutions on demand company, today added Kriger Research Group International (KRC), a worldwide CRO specializing in the bio-medical field, to its CROFirst Program. The enhancements of TrialStat's CRO channel ...
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Cognitive Testing, Gender And Brain Lesions May Predict MS Disease Progression Risk

Cognitive testing may help people with inactive or benign multiple sclerosis (MS) better predict their future with the disease, according to a study published in the July 29, 2009, online issue of Neurology®, the medical journal of the American Academy of Neurology. Gender and brain lesions may also determine the risk of progression of MS years after diagnosis.

Adult Stem Cell Injections May Reduce Pain And Improve Walking In Severe Angina Patients

Preliminary data presented on March 28 as a late-breaking abstract at the American College of Cardiology's 58th annual scientific session from the largest CD34+ adult stem cell study for heart disease has shown the first evidence that delivering a potent form of autologous (from the patient) adult stem cells into the heart muscle of patients with severe angina may result in less pain and improved exercise tolerance.

Device Uses Human Liver Cells To Assist Organ's Functions

The first artificial organ for liver patients that uses immortalized human liver cells, the Extracorporeal Liver Assist Device, or ELAD®, is a bedside system that treats blood plasma, metabolizing toxins and synthesizing proteins just like a real liver does. NewYork-Presbyterian Hospital/Columbia University Medical Center is currently one of only a small number of hospitals in the U.S. offering this therapy to acute liver failure patients as part of ongoing clinical trials.

Outsourcing is not a new concept to pharmaceutical companies

Outsourcing is not a new concept to pharmaceutical companies; however, its use increased dramatically in the mid-1990s, and it is expected to continue to increase going forward. It is estimated by 2004 nearly 42% of all pharmaceutical drug development expenditures will be committed to ...
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Millennium Announces First Clinical Data For TAK-700 Prostate Molecule At ASCO GU

Millennium: The Takeda Oncology Company today announced the presentation of safety, pharmacokinetic and efficacy data from the Phase I portion of a Phase I/II clinical trial evaluating TAK-700 in patients with metastatic castration resistant prostate cancer (mCRPC)...

Curemark Receives Investigational New Drug Clearance For CM-AT For Autism

Curemark, LLC, a drug research and development company focused on the treatment of neurological diseases, announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application to initiate its pivotal Phase III clinical trial of CM-AT for the treatment of autism. The company expects to begin Phase III clinical trials at multiple sites across the US in the second quarter of 2009.

Patient Enrollment Complete For Phase I/II Clinical Trial For GALNS For Morquio A Syndrome

BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced that patient enrollment has been completed for the Phase I/II clinical trial for BMN-110 or N-acetylgalactosamine 6-sulfatase (GALNS), intended for the treatment of the lysosomal storage disorder Mucopolysaccharidosis Type IVA (MPS IVA), or Morquio A Syndrome. The company expects to report initial results in the first half of 2010.

Clinproxy is a CRO with a focus on the Investigator with aspects essential for validating a drug’s remedial benefits.

Clinproxy, www.clinproxy.com is a CRO (Contract Research Organizations), who specializes in evaluating the burden of the trial and eliminating surplus protocols by focusing the Investigator on aspects critical for validating the drug’s remedial benefits. Efficiency is all about resource ...
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Aerovance Initiates Phase IIb Clinical Trial With Aerovant(TM) For The Treatment Of Uncontrolled Asthma

Aerovance Inc. announced that it has received clearance from the U.S. Food and Drug Administration (FDA) and the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to initiate Aerovance's Phase IIb clinical trial, AeroTrial(TM), of inhaled dry powder Aerovant in patients with uncontrolled asthma. Study initiation begins today in the United States for AeroTrial, a double-blind, randomized, placebo-controlled, Phase IIb dose-ranging study.

Fibromyalgia Patients Show Decreases In Gray Matter Intensity

Previous studies have shown that fibromyalgia is associated with reductions in gray matter in parts of the brain, but the exact cause is not known. Using sophisticated brain imaging techniques, researchers from Louisiana State University, writing in The Journal of Pain, found that alterations in levels of the neurotransmitter dopamine might be responsible for gray matter reductions.

Geron Presents Interim Clinical Data On Its Telomerase Inhibitor Drug At AACR-NCI-EORTC

Geron Corporation (Nasdaq:GERN) announced the presentation of interim data from its ongoing trial of imetelstat (GRN163L), a telomerase inhibitor drug, in patients with refractory, advanced solid cancers at the 2009 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston.

Kriger Research Group International joins TrialStat's CROFIRST Program

July 9, 2008, OTTAWA, ON - TrialStat Corporation, the industry's first clinical data solutions on demand company, today added Kriger Research Group International (KRC), a worldwide CRO specializing in the bio-medical field, to its CROFirst Program. The enhancements of TrialStat's CRO channel ...
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Joining Forces Against Cancer

In cancer therapy, the best results are often achieved by combining treatments such as chemotherapy, radiotherapy and surgery. This multidisciplinary approach is the focus of special symposia at the meetings of the European Society for Medical Oncology (ESMO) and the European Society for Therapeutic Radiology (ESTRO) taking place in Sweden this month. "We are at a crucial moment in our fight against cancer," said ESMO President Prof. Jose Baselga.

13th World Conference On Lung Cancer Focuses On Advanced Targeted Therapies Effective As First-Line Treatment

The world's top lung cancer specialists, medical professionals and researchers are convening this week in San Francisco, CA for the 13th World Conference on Lung Cancer (WCLC), organized by the International Association for the Study of Lung Cancer (IASLC). According to a series of studies presented today at the WCLC, targeted therapies, as first-line treatment, have the potential to slow cancer growth and improve patient outcomes.

Boehringer Ingelheim Announces Pivotal Phase III Data Of Flibanserin In Pre-Menopausal Women With Hypoactive Sexual Desire Disorder

Data from pivotal Phase III clinical trials demonstrate that flibanserin 100mg increased the number of satisfying sexual events (SSE) and sexual desire (the co-primary endpoints) while decreasing the distress associated with Hypoactive Sexual Desire Disorder (HSDD). Flibanserin is an investigational compound being developed by Boehringer Ingelheim for the treatment of HSDD in pre-menopausal women.

Compliance in Developing countries is a balancing act

Clinproxy’s, www.clinproxy.com global spread continues to acknowledge to issues with regards to developing countries and the compliance required for clinical trials. Compliance is a balancing act between home-country regulations, international guidelines, and local rules and customs. ...
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Horizon Therapeutics Announces Two Pivotal HZT-501 Phase 3 Trials Meet Primary Endpoints

Horizon Therapeutics, Inc., a privately held biopharmaceutical company, announced that two pivotal Phase 3 trials evaluating its lead investigational product candidate, HZT-501, met all primary endpoints.

Assisted Reproduction Has No Effect On Birthing Process Or The Baby's Outcome

Whether a women gets pregnant the "traditional" way or by assisted reproduction has no effect on the birthing process itself or the baby, researchers at the Norwegian University of Science and Technology (NTNU) have found. Gynaecologist and medical researcher Liv Bente Romundstad and colleagues from NTNU and St Olav's University Hospital in Trondheim looked at the pregnancies of more than 1...

Synvista Therapeutics Receives Approval To Begin Phase 2 Trial Of Topical SYI-2074 In Psoriasis

Synvista Therapeutics, Inc. (Amex: SYI) announces that it has received approval from the Israeli Ministry of Health to begin a Phase 2 trial of a topical formulation of SYI-2074 in mild-to-moderate plaque psoriasis. The trial is expected to begin enrollment in the fourth quarter of 2008 at three sites in Israel, and is designed to enroll a total of 30 patients in a randomized, placebo-controlled study.

Outsourcing is not a new concept to pharmaceutical companies

Outsourcing is not a new concept to pharmaceutical companies; however, its use increased dramatically in the mid-1990s, and it is expected to continue to increase going forward. It is estimated by 2004 nearly 42% of all pharmaceutical drug development expenditures will be committed to ...
(613) 686-5745 Cerepotec Pharmalef

Children With Newly Diagnosed Epilepsy At Risk For Cognitive Problems

Children who have normal IQs before they experience a first seizure may also have problems with language, memory, learning and other cognitive skills, according to a study published in the August 12, 2009, online issue of Neurology®, the medical journal of the American Academy of Neurology.

Foresight Biotherapeutics Announces Initiation Of Viral Conjunctivitis Clinical Trial

Foresight Biotherapeutics announced that the first patient has been dosed in a viral conjunctivitis clinical trial. Foresight's proprietary lead compound, FST-100, will be tested in a placebo-controlled, masked, and randomized multicenter clinical study throughout the United States. The primary endpoint of the study is the resolution of clinical signs and symptoms of acute conjunctivitis.

Spiration Announces The Participation Of Several New Sites In U.S. Pivotal Trial Of Minimally Invasive Treatment For Severe Emphysema

Spiration, Inc., a developer of novel medical devices designed to benefit patients with acute and chronic conditions of the lung, announced today that several new clinical sites are now actively recruiting patients for participation in a pivotal trial of the company's minimally invasive treatment for severe emphysema. These sites include Akron General Medical Center in Akron, Ohio; Medical College of Wisconsin in Milwaukee, Wis.; National Jewish Health in Denver, Colo.

Limdato’s Grasp On Streamlining Clinical Trials

Limdato, www.limdato.com understands that executing a successful clinical trial requires a seamless coordination and communication with all individuals involved on levels on the trial. On average clinical trials in Phases 1,2,3 go beyond deadlines by 30%. These delays cost the ...
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A Surprise "Spark" For Pre-Cancerous Colon Polyps

Researchers at the Huntsman Cancer Institute (HCI) at the University of Utah studied the events leading to colon cancer and found that an unexpected protein serves as the "spark" that triggers formation of colon polyps, the precursors to cancerous tumors. "Our findings will certainly raise some eyebrows," says oncological sciences graduate student Reid Phelps, first author of the study, which will be published Friday, May 15 in the journal Cell.

Computer Based Model Helps Radiologists Diagnose Breast Cancer

Radiologists have developed a computer based model that aids them in discriminating between benign and malignant breast lesions, according to a study performed at the University Of Wisconsin School of Medicine, Madison, WI. The model was developed by a multidisciplinary group, including radiologists and industrial engineers, led by Elizabeth S. Burnside, MD, Oguzhan Alagoz, PhD, and Jagpreet Chhatwal, PhD.

Health Minister Approves To Start Leading Edge Live Cell Therapy Clinical Trial In New Zealand For Diabetics

Living Cell Technologies Limited (ASX: LCT; OTCQX: LVCLY) today announced that New Zealand Health Minister, the Honorable David Cunliffe, has approved an application from the company to conduct in New Zealand a Phase I/IIa clinical trial of DiabeCell®, LCT's lead product candidate for the treatment of insulin dependent (Type 1) diabetes.

Cereprotec Inc. and Institute of Applied Chemistry at Hebrew University are working together to synthesise new Glycoluril Derivatives with Possible Neuroprotection Effects.

According to report of Institute of Applied Chemistry they have performed the third step as it appears in the synthesis route scheme. This took much longer than the other steps, after all, this reaction doesn't appear in any literature and in the end only took two and half weeks. This ...
(613) 686-5745 Cerepotec Pharmalef

ImVisioN Therapeutics Starts Phase I Clinical Trial Of IVN201 Against Cat Dander Allergy And Raises CHF 4.6 M

ImVisioN Therapeutics AG., a biopharmaceutical company pioneering intralymphatic immunotherapy (ILITT), announced that it has enrolled the first patient for a Phase I clinical study of its lead product IVN201, an immunotherapeutic product for cat dander allergy. The Company also announced the closing of a Series A Financing round of CHF 4.6 M, allowing the clinical development of IVN201.

PAION Announces Successful Completion Of Phase I Study With The Sedative/Anaesthetic CNS 7056

The biopharmaceutical company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange, Prime Standard: PA8; London AIM: PAI) today announces that it has successfully completed a Phase I study with its intravenous sedative/anaesthetic CNS 7056. The study was completed ahead of schedule because the target criterion, more than 50% of the volunteers reaching loss of consciousness for more than 5 minutes, was reached in the 9th of the 10 planned cohorts.

Does Adding Simehicone To Sodium Phosphate Bowel Preparation Benefit Colonscopy

Bowel preparation has been reported inadequate in 10%-75% of colonoscopic examinations. None of the preparations reached all the requirements of safety, acceptance to patients with negligible discomfort, and rapid cleansing. Polyethyleneglycol is considered as the gold standard for colonoscopic bowel preparation (Grade IA), and aqueous sodium phosphate was an alternative regimen to PEG solution (Grade IA).

Streamlining the process of Clinical Trials

The process of clinical trials can be costly to say the least. Clinical affairs consumes an average of 37% of R&D budgets. Despite decades of practice, sponsors continue to underestimate the time required to complete 80% of studies, with the average Phase 1 study running over by 42%, ...
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Internet-Based Study Of Cognitive Behavioral Therapy For Bulimia To Be Conducted By UNC, WPIC

The University of North Carolina at Chapel Hill is leading a novel clinical trial to compare the effectiveness of online cognitive behavioral therapy, delivered through a Web site and augmented with therapist-moderated, weekly online chat sessions, to face-to-face group therapy for the treatment of bulimia nervosa.

Juvaris BioTherapeutics' Universal Influenza Vaccine Protects From Lethal H1N1 And H3N2 Challenges In Pre-Clinical Studies

Juvaris BioTherapeutics, Inc., a biotechnology company developing adjuvanted vaccines and immunotherapeutics for infectious diseases and cancer, announced results demonstrating that its universal influenza vaccine produces robust antibody responses and complete protection in H1N1 and H3N2 pre-clinical challenge models.

Sosei And NeuroSolutions Present Further Data On NSL-043/SD118 At The Society For Neuroscience 38th Annual Meeting

NeuroDiscovery Ltd (ASX: NDL), a specialty neuroscience service provider and drug development Company, and Sosei Group Corporation ("Sosei"; TSE Mothers Index: 4565), a leading international biopharmaceutical company, announce that NeuroSolutions is presenting further pivotal pre-clinical efficacy data for NSL-043/SD118. This investigational drug is a potential therapy for neuropathic pain and has successfully completed Phase I clinical studies and is now ready for Phase II studies.

Anestvise Inc. is Delivering Quality and Enabling Technology

Anestvice Inc. www.anestvice.com sponsors clinical trials towards manufacture of new medical devices. They work with medical professionals to design better equipment to meet their needs.We envision a modernization of the development and regulation processes for new medical devices. This ...
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Abbott's Kaletra(R) Tablet Dosed Once-Daily Or Twice-Daily Demonstrated Similar Clinical Results Across Race And Gender Lines

Initial treatment regimens containing once-daily or twice-daily dosing of Abbott's (NYSE: ABT) protease inhibitor Kaletra(R) (lopinavir/ritonavir) tablet provided similar results for controlling the virus (reducing the amount of HIV-1) and improving the immune system

Women Over 55 Underestimate Risk Of Fracture

Most women who are likely to have a bone fracture do not think they are at greater risk, said a leading Italian rheumatologist at a European conference today. This could help to explain why many women do not adhere to preventive treatment. Professor Silvano Adami from the University of Verona presented results from the GLOW trial, a multinational study involving 60393 women over 55 years in 10 countries in North America, Australia and Europe.

New Published Study Shows Masimo Rainbow SET(R) Pulse CO-Oximetry(TM) Reliably Determines Carbon Monoxide Levels In The Blood

Masimo (Nasdaq: MASI), the inventor of Pulse CO-Oximetry(TM) and Measure-Through Motion and Low-Perfusion pulse oximetry, announced that a new peer-reviewed clinical study published in this month's Inhalation Toxicology demonstrates that Masimo Rainbow SET® Pulse CO-Oximetry (SpCO) provides reliable measurements of carbon monoxide (CO) in the blood that facilitate fast, accurate diagnosis of CO poisoning in pre-hospital emergency and rescue environments.

The Birth of the Profession of Clinical Research Associate

According to the ICH Good Clinical Practice Guidelines, clinical research should be monitored by professionals—Clinical Research Associates, also known as Clinical Monitors. We asked Bruce Kriger, CEO of Kriger Research Group International www.kriger.com , leading training institution and ...
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Arena Pharmaceuticals Submits New Drug Application To FDA For Lorcaserin For Weight Management

Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for lorcaserin, Arena's internally discovered and developed drug candidate for weight management, including weight loss and maintenance of weight loss...

SciClone Announces First Patient Enrolled In Phase 2 Clinical Trial Using SCV-07 To Prevent Oral Mucositis

SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today announced the enrollment of its first patient in its phase 2, multi-center, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of SCV-07 for prevention of oral mucositis (OM) in patients receiving radio-chemotherapy for the treatment of head and neck cancer.

Head-to-Head Study Demonstrates Focalin(R) XR Offers Faster And Better Symptom Control Than Concerta(R)1 In Early Part Of ADHD Patients' Day

A head-to-head study, published in the June Journal of Child and Adolescent Psychopharmacology, confirms that Focalin(R) XR (dexmethylphenidate HCl) extended-release capsules offer greater improvements in managing symptoms of Attention Deficit/Hyperactivity Disorder compared with Concerta(R) (d,l- methylphenidate HCl) extended-release tablets at two hours post-dose, the primary study endpoint.

Limdato: Patient recruitment is essential to the accelerated success of a clinical trial.

Often one of the biggest burdens facing clinical trials is patient recruitment. The act of recruiting patients for a trail can be tedious at the best of times and often results in missed deadlines and an incredible hit to the sponsor’s budget. Limdato www.limdato.com along with its team of ...
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Results Further Support The Benefits Of TYSABRI For Multiple Sclerosis Patients

Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) have announced six-month results of an ongoing, one-year longitudinal, observational, patient-reported outcomes study showing multiple sclerosis (MS) patients taking TYSABRI® (natalizumab) experienced an improvement in both their physical function and psychological well-being. Findings from the study, which was performed in conjunction with HealthCore Inc.

Pharmacokinetic/Pharmacodynamic Data Support Further Development Of Tobira's Next-Generation CCR5 Receptor Antagonist

Pharmacokinetic/pharmacodynamic (PK/PD) data for TBR-652, which is being developed by Tobira Therapeutics for the treatment of HIV infection, show a strong relationship between drug exposure and viral suppression with this next-generation CCR5 receptor antagonist. These data were presented here today at the 17th Conference on Retroviruses and Opportunistic Infections (CROI)...

Featured Clinical Trials To Be Presented At Transcatheter Cardiovascular Therapeutics 2009 In San Francisco

Special presentations will be made Sept. 24, 2-6 p.m. WHAT: A series of Featured Clinical Trials will be presented at Transcatheter Cardiovascular Therapeutics (TCT), in addition to late-breaking clinical trials. These featured clinical trials represent groundbreaking research and will yield data and insight that will further the field of interventional cardiology. WHEN: The TCT Featured Clinical Trials will be presented on September 24, 2009 from 2:00 - 6:00 pm.

Pharmalef Developments is a home for team-oriented professionals

Pharmalef Developments www.pharmalef.com is a home for team-oriented professionals and their aim is to be the first choice in the industry for licensing and academic collaborations that bring mutual benefits to each party.They entered into many collaborations with leading ...
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Duska Therapeutics Applies For Phase 3 Special Protocol Assessment

Duska Therapeutics, Inc., (OTC Bulletin Board: DSKA), announced that it has submitted its pivotal Phase 3 ATPace clinical trial protocol for review under a Special Protocol Assessment (SPA) procedure with the U.S. Food and Drug Administration (FDA). Subject to securing an agreement with the FDA, Duska intends to initiate a single, prospective, double-blind, placebo-controlled and randomized Phase 3 clinical trial with its lead product ATPace.

Folic Acid Treatment May Help Allergies, Asthma

Folic acid, or vitamin B9, essential for red blood cell health and long known to reduce the risk of spinal birth defects, may also suppress allergic reactions and lessen the severity of allergy and asthma symptoms, according to new research from the Johns Hopkins Children's Center.

Inclinix Releases Next Generation Critical Population Research(R) (CPR) For Clinical Trial Investigator Site Selection And Patient Recruitment

Inclinix, Inc., a clinical trial enrollment solutions provider, announces the release of its next generation Critical Population Research(R) (CPR) system. A proprietary technology that integrates numerous public and private databases, CPR analyzes each investigator site for multiple criteria to identify the optimal sites for clinical trials.

Accurate Data Management can be the make or break for the success of the clinical trial.

It is widely known throughout the clinical research industry that the accurate and precise collection of data is crucial to the success of any trial. Limdato www.limdato.com along with its partners have created a software system dedicated to compiling all data collected in a precise and user ...
(613) 686-5745 Cerepotec Pharmalef

Merrimack Pharmaceuticals Initiates Enrollment In A Phase 1 Study Of MM-121, An ErbB3 Antagonist

Merrimack Pharmaceuticals, Inc. announced that the first patient has received an initial dose in a Phase 1 clinical study of the Company's first oncology product, MM-121, a fully human monoclonal antibody and a first-in-class therapeutic designed to block signaling of the ErbB3 receptor. ErbB3 is a receptor in the ErbB family, a pathway that plays a critical role in cancer signaling.

Probiotics Prevent IgE Associated Allergy Until Age 5 In Cesarean Delivered Children But Not In Total Cohort

According to a recent study from the University and the University Central Hospital of Helsinki, Finland, no allergy-preventive effect is extended to age 5 years by perinatal supplementation with probiotics in babies at risk for developing allergies; protection is conferred only to Cesarean section babies Childhood allergies have increased significantly in industrialized countries during the past few decades.

I3 Launches New Web-Based Technology To Simplify And Accelerate The Clinical Trial Process

Pharmaceutical services company i3 launched its innovative, web-based i3CubeTM clinical trial and data management technology. i3Cube leverages i3's services and proprietary data to accelerate the clinical trial process through automation and connectivity, so that customers can make more rapid, informed decisions about their products throughout development and commercialization.

The World Is Getting Better!

According to Bruce Kriger, CEO of Kriger Research Group International www.kriger.com, leading training institution and clinical research organization, the world is getting better, no matter what critics say. Today’s life expectancy is the highest in human history. In Western countries, we ...
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BioMarin Initiates Phase 1/2 Clinical Trial For GALNS For Morquio A Syndrome

BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced the initiation of a Phase 1/2 clinical trial for BMN-110 or N-acetylgalactosamine 6-sulfatase (GALNS), intended for the treatment of the lysosomal storage disorder Mucopolysaccharidosis Type IVA (MPS IVA), or Morquio A Syndrome. The company expects to report initial results in the first half of 2010.

Internet-Based Therapy Effective In Treating Depression

In a discovery that could lead to new treatment approaches for depression, researchers from the University of New South Wales (UNSW) have shown that internet-based therapy programs are as effective as face-to-face therapies in combating the illness. Patients in a clinician-assisted internet-based treatment program experienced rates of recovery similar to those achieved by face-to-face therapy, the research found.

Caldolor(R) (Ibuprofen) Injection Demonstrates Significant Fever Reduction In Hospitalized Burn Patients

Cumberland Pharmaceuticals Inc. ( CPIX) announced positive new top-line results from a study evaluating the safety and efficacy of Caldolor (ibuprofen) Injection in treating fever in hospitalized burn patients. Statistical significance was achieved for the primary endpoint of reducing fever in burn patients over the first 24 hours of treatment.

Pharmalef Developments plays a vital role in proper documenting the drug development process.

New drugs are the lifeblood of the pharmaceutical industry. Yet strict testing and documentation requirements mean only one in many drug candidates make it to market. Pharmalef Developments www.pharmalef.com can play a vital role in documenting the drug development process. By ...
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Wii™ Video Games May Help Stroke Patients Improve Motor Function

Virtual reality game technology using Wii™ may help recovering stroke patients improve their motor function, according to research presented as a late breaking poster at the American Stroke Association's International Stroke Conference 2010. The study found the virtual reality gaming system was safe and feasible strategy to improve motor function after stroke...

Human Genome Sciences Reports Positive Long-Term Data For BENLYSTA(TM) (Formerly LymphoStat-B(R)) In Patients With Active Systemic Lupus Erythematosus

Human Genome Sciences, Inc.

Barr's BLA For Adenovirus Type 4 And 7 Live Oral Vaccines Accepted For Filing By FDA

Barr Pharmaceuticals, Inc. (NYSE: BRL) announced that the U.S. Food and Drug Administration (FDA) has accepted for review Duramed Pharmaceuticals, Inc.'s Adenovirus Types 4 and 7 Live Oral Vaccines Biologics License Application (BLA). These oral vaccines represent Barr's first in-house biologics development initiative and demonstrate the Company's ability to develop, manufacture and conduct clinical trials for biologic products.

Kriger Research Group International joins TrialStat's CROFIRST Program

July 9, 2008, OTTAWA, ON - TrialStat Corporation, the industry's first clinical data solutions on demand company, today added Kriger Research Group International (KRC), a worldwide CRO specializing in the bio-medical field, to its CROFirst Program. The enhancements of TrialStat's CRO channel ...
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Biocon And Abraxis BioScience Launch ABRAXANE In India For Treatment Of Breast Cancer

Biocon Limited, India's pioneering biotechnology company, and Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated biotechnology company, announced the launch of ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in India for the treatment of breast cancer after failure of combination therapy for metastatic disease or relapse within six months of adjuvant chemotherapy.

Evidence-Based Treatment For Childhood Epilepsy

The first comprehensive comparative effectiveness clinical trial of three widely used anti-seizure drugs for childhood absence epilepsy the most common form of epilepsy in kids has established an evidence-based approach for initial drug therapy...

Neurologix Completes All Surgical Procedures In Its Clinical Trial For Parkinson's Disease

Neurologix, Inc. (OTCBB:NRGX), a biotechnology company engaged in the development of innovative therapies for the brain and central nervous system, announced the completion of all planned surgeries in an ongoing Phase 2 clinical trial of the company's gene transfer approach to the treatment of advanced Parkinson's disease...

Volunteers Respect Accurate and Personalized Information From Study Results

Many CRO’s and investigators believe that even though volunteer patients in clinical trials expose themselves to a great deal of risk, there is no legal mandate for investigators to inform them of study results. However, Clinproxy, www.clinproxy.com as well as many investigators have ...
(613) 686-5745 Cerepotec Pharmalef

Chemotherapy-related White Blood Cell Depletion - Application For Phase I, Open-Label, Single-Ascending-Dose, Safety Study Of HYC750

Orcrist Bio Inc. (ORC) a biotech company developing stem cell-mobilizing pharmaceuticals, announced today that it has filed with the European Competent Authority in Seville, Spain, a Phase I, open-label, single-ascending-dose, safety study of HYC750 in healthy male volunteers. The goal of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics (induction of hematopoiesis) of HYC750, a patent-protected formulation of hyaluronan.

Oncolytics Biotech Inc. Announces Decision To Pursue Phase II/III Pivotal Clinical Trial

Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) announced that it has made a decision to pursue a pivotal (Phase II/III) randomized trial using the combination of REOLYSIN(R) with paclitaxel/carboplatin in refractory patients with head and neck cancers. The decision was made following a review of results by the Company's Board of Directors from the Company's ongoing U.K.

Amgen Receives CHMP Positive Opinion For Prolia(TM) (Denosumab) In The European Union

Amgen Inc...

Clinproxy is a CRO with a focus on the Investigator with aspects essential for validating a drug’s remedial benefits.

Clinproxy, www.clinproxy.com is a CRO (Contract Research Organizations), who specializes in evaluating the burden of the trial and eliminating surplus protocols by focusing the Investigator on aspects critical for validating the drug’s remedial benefits. Efficiency is all about resource ...
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Data From Enzo Therapeutics' Phase II Study Of Crohn's Disease Presented At Prestigious Gastroenterology Conference

Enzo Biochem, Inc. (NYSE: ENZ), a biotechnology company specializing in gene identification and genetic and immune regulation technologies for diagnostic and therapeutic applications and laboratory services, announced that data from a Phase II clinical trial was presented today at Digestive Disease Week, the largest international gathering of academic researchers and practicing physicians in gastrointestinal medicine, held this year in Chicago.

CrystalGenomics Announces Positive Phase IIa Results For Osteoarthritis Study Of CG100649

CrystalGenomics, Inc. (Seoul, Korea) and CG Pharmaceuticals, Inc. (Emeryville, CA) announced positive results from a Phase IIa osteoarthritis (OA) study of the efficacy and safety of a next-generation NSAID, CG100649. The CG100649 treatment group met the primary efficacy endpoint by demonstrating a clinically and statistically significant change in the WOMAC(TM) OA score from baseline to Day 21 (p=0.010) compared to placebo.

Combating Weight Gain Caused By Antipsychotic Treatments

Antipsychotic drugs, such as olanzapine (Zyprexa), risperidone (Risperdal) and quetiapine (Seroquel), are commonly used to treat psychotic disorders like schizophrenia, but also bipolar disorder and even behavioral problems related to dementia. Unfortunately, the weight gain commonly experienced with antipsychotic treatment is an important side effect for many patients, and causes many patients to discontinue their use leading to even further problems.

Accurate Data Management can be the make or break for the success of the clinical trial.

It is widely known throughout the clinical research industry that the accurate and precise collection of data is crucial to the success of any trial. Limdato www.limdato.com along with its partners have created a software system dedicated to compiling all data collected in a precise and user ...
(613) 686-5745 Cerepotec Pharmalef

Promising Results From Two Trials Highlighting Developmental Oral IMiDS(R) Compound Pomalidomide Presented At The ASH

Celgene International Sarl (Nasdaq: CELG) today announced that its next IMiDs compound, pomalidomide, has shown promising activity with manageable safety and tolerability for the treatment of relapsed/refractory multiple myeloma (MM) and myelofibrosis. The data were presented at the 50th Annual American Society of Hematology meeting in San Francisco, CA.

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Cereprotec Inc. and Institute of Applied Chemistry at Hebrew University are working together to synthesise new Glycoluril Derivatives with Possible Neuroprotection Effects.According to report of Institute of Applied Chemistry they have performed the third step as it appears in the synthesis route scheme. This took much longer than the other steps, after all, this reaction doesn't appear in any literature and in the end only took two and half weeks. This research is fully sponsored by Cereprotec Incorporated www.cereprotec.com a US company that already runs clinical tests of their first drug Cereprotex .<br />In the reaction between compound II and III, one gets two main products, three additional compounds in small quantities plus unreacted starting materials and one main side product. All together there were 8 compounds in the reaction mixture. <br /><br />One of the main materials precipitated out from the mixture and was removed via filtration from the reaction mixture. This material was cleaned up via crystallization but turned out not to be the desired compound. <br />The second main material was separated via silica gel column chromatography. Unfortunately, this main material came off at the same Rf value as another material. They tested out several solvents and found that ethyl acetate was able to crystallize out the main material. <br /><br />Using NMR and elemental analysis, Institute of Applied Chemistry were able to prove that the crystallized out material is indeed Compound III. Yield was 17%. Two grams of material was obtained, enough to try out Stage IV. <br /><br />This step can be repeated in the future in order to produce more of compound III. <br />Cereprotec Inc. Phase II clinical study of efficacy and safety of Cereprotex as preventive treatment of cognitive dysfunction as a complication of coronary artery bypass graft (CABG) surgery.Cerebral dysfunction is a significant complication of coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass (CPB).While overt neurological dysfunction occurs in 3% of patients, cognitive dysfunction is detectable in most patients early after CABG and in up to half of patients at six months.<br /><br />Cereprotec Inc. www.cereprotec.com proposes to use Cereprotex prior to and after CABG procedures in order to minimize or eliminate entirely the effects of neuro-impairment. Based on the successful animal trials Cereprotec Inc. believes that the human trials will show significant reduction in neuro-impairment. <br /><br />At this moment Cereprotec Inc. www.cereprotec.com is prepared to start clinical trials and is actively seeking serious investors.<br />Cereprotec Inc: Cerebral dysfunction is a significant complication of coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass (CPB). Cerebral dysfunction is a significant complication of coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass (CPB). Cognitive dysfunction is detectable in up to 70% of patients.<br /><br />In Phase II Cereprotec Inc. www.cereprotec.com study patients will undergo a standard battery of 10 cognitive tests performed by one examiner before surgery and at 7 and one month after CABG. Four tests (auditory verbal learning test (AVLT), adult memory and information processing battery (AMIBP), trail-making test B (TMTB), and verbal fluency test (VFT)) will be used to calculate a composite cognitive index.<br />US Patent Application No.11/723,011 to be assigned to CEREPROTEC INC. Method for Neuroprotection with Glycoluril DerivativesCereprotec Incorporated www.cereprotec.com is a US company involved in the development of neuroprotective drug Cereprotex. <br /><br />This company is also developing a family of other promising novel chemical compounds. <br /><br />Proof of efficacy of these compounds has been obtained in three animal studies including hypoxia in both mice and rats and brain trauma in mice. The proof of neuroprotection concept has been shown not only for prevention (hypoxia model), but also for the treatment paradigm post brain trauma which reflects a potential realistic situation in humans. <br />Professor Esther Shohami has joined the board of advisors of Cereprotec IncorporatedProfessor Esther Shohami has joined the board of advisors of Cereprotec Incorporated. Her research interests include: Pathophysiology of brain injury - mediators of delayed neuronal damage e.g., prostaglandins, reactive oxygen species, cytokines, cannabinoids, and the cholinergic system in rat and mouse models of injury (closed head injury, CHI). Evaluation of potential therapeutic strategies. CHI as a risk factor for delayed onset of Alzheimer's disease. Genetic manipulations (cytokines or apoE knockouts, acetylcholine-esterase transgenics, and more) as tools for investigating the role of specific mediators in traumatic brain injury. Interrelationship between traumatic brain injury and bone remodeling. Role of endocannabinoids in blood-brain barrier function and in bone remodeling after brain trauma. Mechanisms of neuroprotection induced by pre-conditioning (ischemic or heat acclimation). In vitro model for stretch injury that simulates traumatic conditions in astrocytes.<br /><br />Dr. Roman Kamburg CEO of Cereprotec and the registered owner of 1125 shares in CEREPROTEC Incorporated (the "Corporation") www.cereprotec.com a corporation incorporated in and under the laws of the State of Delaware, having its registered office at 108 West 13th Street, Wilmington, Delaware, transfered to Dr. Esther Shohami 40 Shares of Common Stock, for no consideration, to be held by the Transferee, her administrators and assignees, subject to all the terms and conditions on which such shares were held by the Transferor, and Transferee agreed to receive such shares.<br />Pharmalef Inc. is starting collaboration in development of new oral delivery platformPharmalef Inc. www.pharmalef.com is starting collaboration in development of new oral delivery platform offers pharmaceutical companies the ability to extend the shelf life and stability of medicinal compounds.<br /><br />Moreover, oral delivery improves patient compliance, improves treatment, reduces patient inconvenience, and reduces treatment costs.<br /><br />Our partners have completed proof of concept and development of a proliposomal formulation for the model drug, calcitonin, which is used in the treatment of osteoporosis and thyroid cancer. <br /><br />Clinical trials are expected to begin at a number of centers across the United States, Canada and European Union. <br />Pharmalef Developments introduces several new products in Rheumatology, Immunology and Respiratory Diseases.With a focus on familiar, everyday health problems, Pharmalef Developments . www.pharmalef.com aims to develop and deliver products that meet the individual’s health care needs, developing a wide range of products.<br /><br />In addition to its established range of highly effective and distinctive products Pharmalef Developments will introduce several new products in new fields, including Rheumatology, Immunology and Respiratory Diseases.<br />Pharmalef Developments plays a vital role in proper documenting the drug development process.New drugs are the lifeblood of the pharmaceutical industry. Yet strict testing and documentation requirements mean only one in many drug candidates make it to market. <br /><br />Pharmalef Developments www.pharmalef.com can play a vital role in documenting the drug development process. By leveraging our expertise in business process management and the latest technologies, we can also help you develop a documentation process for clinical trials that is easy and efficient, while satisfying strict government requirements and regulations. <br />Pharmalef Developments is a home for team-oriented professionalsPharmalef Developments www.pharmalef.com is a home for team-oriented professionals and their aim is to be the first choice in the industry for licensing and academic collaborations that bring mutual benefits to each party.<br /><br />They entered into many collaborations with leading academic centers, CRO-s and biotechnology companies to complement our in-house R&D capabilities. <br /><br />They are always interested in forming new partnerships covering early-stage research, novel compounds or technologies and implementation of clinical trials.<br />CEREPROTEC Method for Neuroprotection with Glycoluril Derivatives Patent Application has been Published September 18, 2008<br /><br />A method for prevention, inhibition or treatment of neuronal degeneration caused by injury, disease, disorder or condition in the central nervous system (CNS) comprises administering a glycoluril derivative to an individual in need thereof. View document here: http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=/netahtml/PTO/srchnum.html&r=1&f=G&l=50&s1=20080227838.PGNR.&OS=DN/20080227838&RS=DN/20080227838<br /><br />1. A method for prevention, inhibition or treatment of neuronal degeneration caused by injury, disease, disorder or condition in the central nervous system (CNS), comprising administering to an individual in need thereof an amount effective to treat said injury, disease, disorder or condition, of a compound of the formula I:whereinR.sub.1, R.sub.2 and R.sub.3, the same or different, each is H or (C.sub.1-C.sub.6) alkyl;R.sub.4 is selected from the group consisting of (C.sub.1-C.sub.6) alkyl, --R.sub.5--COOR, --R.sub.5--OH, --R.sub.5--NH--CO--R and --R.sub.5--CO--NH--(CH.sub.2).sub.n--COOR;R.sub.5 is (C.sub.1-C.sub.6) alkylene;R is H or (C.sub.1-C.sub.3) alkyl;n is an integer of 1 to 6; or an enantiomer thereof or a pharmaceutically acceptable salt thereof.<br /><br />2. The method according to claim 1 wherein R.sub.1 to R.sub.3 each is H or (C.sub.1-C.sub.6) alkyl and R.sub.4 is (C.sub.1-C.sub.6) alkyl.<br /><br />3. The method according to claim 2, wherein R.sub.1 to R.sub.4 each is methyl.<br /><br />4. The method according to claim 1, wherein R.sub.1 to R.sub.3 each is H or (C.sub.1-C.sub.6) alkyl, R.sub.4 is --R.sub.5---COOR, R.sub.5 is (C.sub.1-C.sub.6) alkylene and R is H or (C.sub.1-C.sub.3) alkyl.<br /><br />5. The method according to claim 1, wherein R.sub.1 and R.sub.3 each is methyl, R.sub.2 is H and R.sub.4 is --(CH.sub.2).sub.3COOH.<br /><br />6. The method according to claim 1, wherein said injury, disease, disorder or condition is selected from the group consisting of: (i) a neurological injury: (ii) brain damage caused by a cardiovascular event; (iii) a cerebrovascular disorder or disease; (iv) a neurodegenerative disease or disorder; and (v) a dementia.<br /><br />7. The method according to claim 6, wherein said injury is a neurological traumatic injury selected from the group consisting of head trauma injury and spinal cord injury.<br /><br />8. The method according to claim 7, wherein said head trauma injury is selected from the group consisting of blunt trauma, closed head injury and penetrating trauma injury.<br /><br />9. The method according to claim 8, wherein said head trauma injury is closed head injury.<br /><br />10. The method according to claim 6, wherein said injury, disease, disorder or condition is brain damage caused by a cardiovascular event.<br /><br />11. The method according to claim 10, wherein said cardiovascular event is cardiac arrest or cardiac surgery.<br /><br />12. The method according to claim 6, wherein said injury, disease, disorder or condition is a cerebrovascular disorder or disease.<br /><br />13. The method according to claim 12, wherein said cerebrovascular disorder is brain ischemia or stroke.<br /><br />14. The method according to claim 6, wherein said injury, disease, disorder or condition is a neurodegenerative disease or disorder.<br /><br />15. The method according to claim 14, wherein said neurodegenerative disease or disorder is selected from the group consisting of Alzheimer's disease, Parkinson's disease, facial nerve (Bell's) palsy, multiple sclerosis, glaucoma, Huntington's chorea, amyotrophic lateral sclerosis and macular degeneration.<br /><br />16. The method according to claim 6, wherein said injury, disease, disorder or condition is dementia.<br /><br />17. The method according to claim 16, wherein said dementia is Alzheimer's disease or a non-Alzheimer's dementia selected from the group consisting of senile dementia, Lewy body dementia, vascular dementia and a dementia caused by Parkinson's disease, Huntington's chorea, Creutzfeld-Jacob disease or HIV infection.<br /><br />18. A method for conferring neuroprotection to an individual afflicted with a neurological injury, which comprises administering to said individual a compound of formula I in claim 1 or an enantiomer or a pharmaceutically acceptable salt thereof in an amount effective to ameliorate the neurodegeneration associated with said neurological injury.<br /><br />19. The method according to claim 18, wherein said neurological injury is selected from the group consisting of head trauma injury and spinal cord injury.<br /><br />20. A method for conferring neuroprotection to an individual suffering from a neurological or neurodegenerative disease or disorder, which comprises administering to said individual a compound of formula I in claim 1 or an enantiomer or a pharmaceutically acceptable salt thereof in an amount effective to ameliorate the neurodegeneration associated with said neurological or neurodegenerative disease or disorder.<br /><br />21. The method according to claim 20, wherein said neurological or neurodegenerative disease or disorder is selected from the group consisting of Alzheimer's disease, Parkinson's disease, facial nerve (Bell's) palsy, multiple sclerosis, glaucoma, Huntington's chorea, amyotrophic lateral sclerosis, macular degeneration and dementia.
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