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VaxInnate Reports Positive Results From Preclinical Testing Of Swine Flu Vaccine Developed Using Novel Technology

VaxInnate Corporation today reported positive preclinical results for a recombinant swine flu vaccine it developed in less than three weeks, making it one of the first companies in the world to begin testing a vaccine that could help halt the spread of the swine flu pandemic. Preclinical studies in mice suggest that VaxInnate's recombinant swine flu vaccine could provide protection against the pandemic H1N1 influenza A swine flu strain,

New HIV Study Shows That Large Numbers Of Women And People Of Color Can Be Successfully Enrolled In U.S. HIV Clinical Studies

Data from a historic HIV study demonstrate that it is possible to recruit large numbers of women, African Americans and Latinos into U.S.-based HIV-1 treatment studies. The study, known as GRACE, is the largest study to date in treatment-experienced adult women with HIV-1 to examine gender and race differences in response to an HIV-1 therapy -- PREZISTA(R) (darunavir) coadministered with ritonavir as part of combination therapy.

Ipsen's Partner Roche Announces That Taspoglutide Meets Its Primary Endpoint In The First Phase III Clinical Trial

Ipsen (Paris:IPN), an innovation-driven global specialty pharmaceutical group, announced that its partner Roche has disclosed the results of a first phase III clinical study using Taspoglutide, the first human once weekly glucagon-like peptide-1 (GLP-1) analogue originating from Ipsen's Research.

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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The Journal Of Urology Reports Treatments After Prostate Surgery

Although primary prostate surgery or radiotherapy is successful in many cases of prostate cancer, some patients will suffer a recurrence of the disease, which is most often first detected by a measurable PSA blood test. This so-called biochemical recurrence affects 30% to 40% of patients after surgery. One risk factor for recurrence, the presence of cancer potentially outside the prostate after surgery, will affect about a third of men.

Drug Developers Looking To Learn As Much As Possible In Phase I Trials, According To Tufts Center For The Study Of Drug Development

Under pressure to develop new medicines more quickly and at lower cost, drug sponsors are looking to answer as many questions as possible in Phase I, including those relating to efficacy as well as safety, according to the Tufts Center for the Study of Drug Development.

ERT Launches 'Centralized Cardiac Safety 2.0': A Revolutionary New Approach To ECG Management In Clinical Trials

ERT (Nasdaq: ERES), a leading provider of centralized services to the biopharmaceutical, medical device and related industries, announced the launch of Centralized Cardiac Safety 2.0, a portfolio of new solutions that enable a significant new approach to cardiac safety in clinical trials. These new solutions overcome many of the perceived barriers to centralizing all ECGs in clinical trials...

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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LegalView Blog Announces Recruitment Of Mesothelioma Victims For New Clinical Trial Combining Chemotherapy And Radiation Treatments

LegalView, the most comprehensive legal resource available on the Web, released details of a newly advertised clinical trial that will target radiation and chemotherapy treatments rather than surgery for mesothelioma patients. The study is for individuals suffering from malignant pleural mesothelioma, which is often considered the most deadly form of mesothelioma cancer.

After A Heart Attack, Also The State Of The Brain Matters

A new study published in the current issue of Psychotherapy and Psychosmatics has examined brain activity after a heart attack.This study provides the first evidence that persistent depressive symptoms after acute coronary syndrome are associated with vascular brain changes. Longitudinal studies are needed to determine whether depressive symptoms precede these changes or vice versa...

Anxious Older Adults May Benefit From Antidepressants

Many older adults worry a lot. Almost one in 10 Americans over age 60 suffer from an anxiety disorder that causes them to worry excessively about normal things like health, finances, disability and family. Although antidepressant drugs known as selective serotonin reuptake inhibitors (SSRIs) can improve anxiety symptoms in younger adults, little has been known about their effects in older people.

Understanding Your Liability and Confidentiality in Clinical Trials

Clinproxy, www.clinproxy.com fully understands the issues, laws risks and best practices relating to disclosures of confidential information about clinical trials. Early information about a clinical trial is extremely valuable. The information can be indiscreetly passed on to many people ...
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Keryx Receives FDA Fast Track Designation For KRX-0401 (Perifosine) For The Treatment Of Refractory Advanced Colorectal Cancer

Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for KRX-0401 (perifosine), the Company's novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, for the treatment of refractory advanced colorectal cancer...

Three Phase II Ipilimumab Studies Showed Almost Half Of Previously Treated Metastatic Melanoma Patients Alive Beyond One Year

Bristol-Myers Squibb announced updated survival data from three Phase II studies of ipilimumab in patients with advanced metastatic melanoma (Stage III or IV), which showed that approximately half of previously-treated patients who received ipilimumab (10 mg/kg) remained alive beyond one year.

Strativa Pharmaceuticals' Development Partner, BioAlliance Pharma, Presents Phase III Study Results Of Miconazole Lauriad(R)

Strativa Pharmaceuticals, the proprietary products division of Par Pharmaceutical Companies, Inc. (NYSE: PRX), announced that its development partner BioAlliance Pharma SA presented Phase III study results for miconazole Lauriad(R) mucoadhesive buccal tablets (MBT) that demonstrate noninferiority to clotrimazole troches for oropharyngeal candidiasis (OPC), an opportunistic infection of the mouth and throat.

The Cerebroprotective Properties of Cereprotex (2,4,6,8-tetramethyl-2,4,6,8-tetraazabicyclo[3.3.0]-octane-3,7-dione) after traumatic and hypoxic brain injury

The cerebroprotective effect of Cereprotex (Patent pending – Cereprotec Inc. www.cereprotec.com ) (2,4,6,8-tetramethyl-2,4,6,8-tetraazabicyclo[3.3.0]-octane-3,7-dione) , previously known as (CombiCNS1), was assessed in a model of closed head injury in mice. This type of trauma produces ...
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Gilead Initiates Phase II Clinical Trial Of Cicletanine For The Treatment Of Pulmonary Arterial Hypertension

Gilead Sciences, Inc. (Nasdaq: GILD) announced that it has begun enrolling patients in a Phase II clinical trial of cicletanine hydrochloride (cicletanine), an oral agent in development for the treatment of pulmonary arterial hypertension (PAH). The study is designed to compare the efficacy, safety and tolerability of cicletanine to placebo in patients with PAH and will enroll 160 patients at approximately 60 investigational sites worldwide.

Second Pivotal Phase III Study Of Gilead's Darusentan For Resistant Hypertension Misses Primary Endpoints

Gilead Sciences, Inc...

Affymax And Takeda Report Phase 2 Analyses Of Hematide™/peginesatide In Hemodialysis Patients

Affymax, Inc. (Nasdaq: AFFY) and Takeda Global Research & Development Center, Inc., U.S., today announced data from several post hoc analyses of Phase 2 clinical trials that evaluated Hematide/peginesatide in dialysis patients with anemia in chronic kidney disease (CKD). The data provide hypotheses for further investigation of this agent in anemia management in this patient population...

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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Significant Long Term Benefit For Low Back Pain Revealed By Major Study

A major study led by a Southampton researcher has found significant evidence that the Alexander Technique can provide long-term benefit for people with chronic or recurrent low back pain. The study, one of the first of its kind, is being published online today by the BMJ at BMJ.com.

Bone Drug Suppresses Wandering Tumor Cells In Breast Cancer Patients

The bone-strengthening drug zoledronic acid (Zometa) can help fight metastatic breast cancer when given before surgery, suggests research at Washington University School of Medicine in St. Louis. When the drug was given along with chemotherapy for three months before breast cancer surgery, it reduced the number of women who had tumor cells in their bone marrow at the time of surgery...

UF Doctors Test Targets For Parkinson Surgery

Doctors may be able to tailor a specialized form of brain surgery to more closely match the needs of Parkinson patients, according to results from the first large-scale effort to compare the two current target areas of deep brain stimulation surgery, or DBS. Called the COMPARE Trial, the National Institutes of Health-funded study conducted at the University of Florida evaluated 45 patients for mood and cognitive changes related to DBS.

Outsourcing of R&D functions is reshaping the drug development services industry.

As per Esploron www.esploron.com executive management the cost of drug development has soared during the past ten years compelling pharmaceutical and biotechnology companies to look for new, smarter ways of conducting clinical research. Driven by mounting market pressures, ...
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Trial To Test Whether Behavioral Therapy Can Reduce Anxiety In Young Adolescents With Autism

The USF Health Rothman Center for Neuropsychiatry in St. Petersburg, FL, is conducting a two-year federal trial testing the effectiveness of behavioral psychotherapy in treating anxiety among young adolescents with autism. The University of South Florida is one three sites for the $1-million study, sponsored by the National Institute of Child Health and Development (NICHD) through the American Recovery and Reinvestment Act.

New Studies Show Popular Heartburn Medications Moderate The Effect Of Taking Widely Prescribed Heart Drug

Four of the most commonly prescribed heartburn medications reduce the benefit associated with clopidogrel, a widely used antiplatelet medication also known by its brand name, Plavix. These findings by researchers at Medco Health Solutions, Inc. (NYSE: MHS) and the Indiana University School of Medicine were presented at the annual scientific meeting of the Society for Cardiovascular Angiography and Interventions (SCAI).

Schering Plough Announces European Launch Of BRIDION(R) (Sugammadex)

Schering-Plough Corporation (NYSE: SGP) announced that the European launch of BRIDION(R) (sugammadex) injection has begun with its introduction this week in Sweden, and that the product is expected to be available soon in the United Kingdom and Germany, with several other European markets to follow by the end of the year and in early 2009.

The Cerebroprotective Properties of Cereprotex (2,4,6,8-tetramethyl-2,4,6,8-tetraazabicyclo[3.3.0]-octane-3,7-dione) after traumatic and hypoxic brain injury

The cerebroprotective effect of Cereprotex (Patent pending – Cereprotec Inc. www.cereprotec.com ) (2,4,6,8-tetramethyl-2,4,6,8-tetraazabicyclo[3.3.0]-octane-3,7-dione) , previously known as (CombiCNS1), was assessed in a model of closed head injury in mice. This type of trauma produces ...
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NMT Medical Completes Enrollment In Landmark PFO/Stroke Clinical Trial

NMT Medical, Inc. (NASDAQ: NMTI) announced today that the Company has completed patient enrollment in its pivotal patent foramen ovale (PFO) /stroke clinical trial,

Zelos Therapeutics Initiates Dosing In A Phase 1 Clinical Study Of Nasal Spray Teriparatide

Zelos Therapeutics, Inc. has initiated dosing in a seven day clinical study of a nasal spray formulation of ZT-034 (teriparatide) that is being developed in collaboration with development partner Aegis Therapeutics, LLC...

No Benefit To Quality Of Life From Extra 'STICH' In Bypass

A surgical procedure to resize an enlarged, weakened heart muscle during coronary bypass surgery for heart failure adds cost and risk but doesn't offer patients any additional benefit when compared with those who received bypass procedure alone, according to researchers from the Duke Clinical Research Institute (DCRI).

It is recommended that sponsor companies should first check what budget they can allocate, and then seek Clinqua Inc. expertise in achieving their goal.

It is an undesirable reality, but the development of pharmaceutical drugs is a costly undertaking. Yet, these costs are necessitated by the substantial investment of both time and resources of the companies in question. It stands to reason that if a company is willing to invest millions of ...
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pSivida Corp: Enrollment Complete In BrachySilT Dose Ranging Study

pSivida Corp. (NASDAQ:PSDV)(ASX:PVA)(FF:PSI), a leading drug delivery company today announced the completion of enrollment of the BrachySilT (P32 BioSiliconT) dose ranging clinical trial. Dr Paul Ashton, President and CEO of pSivida Corp. said, "We are very pleased to be progressing BrachySilT as a potential new treatment for pancreatic cancer, a devastating disease for patients and their families.

Age Of Colon Cancer Patients Affects Chemotherapy Combination Outcomes

The combination of chemotherapies 5FU and oxaliplatin compared to 5FU alone after surgery for colon cancer decreases colon cancer recurrence and promotes longer survival for patients under 70 -- but not for those who are older, according to Mayo Clinic and Dana-Farber Cancer Institute scientists who presented their findings at the American Society of Clinical Oncology's (ASCO) annual meeting in Orlando, Fla.

Falling In Old Age Linked To Altered Blood Flow In Brain

A new study shows that altered blood flow in the brain due to high blood pressure and other conditions may lead to falls in elderly people. The research will be published in the May 18, 2010, issue of Neurology®, the medical journal of the American Academy of Neurology. Each year, unintentional falls in the United States account for more than 16,000 deaths and 1...

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 ...
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Merrimack Pharmaceuticals Initiates Enrollment In A Phase 1/2 Combination Study Of MM-121 And Tarceva(R) In Patients With Non-Small Cell Lung Cancer

Merrimack Pharmaceuticals, Inc. announced that the first patient has received an initial dose in a Phase 1/2 clinical study combining MM-121 with Tarceva® (erlotinib) in patients with non-small cell lung cancer (NSCLC). This is the first of multiple trials that Merrimack and sanofi-aventis expect to initiate in 2010 as part of a broad Phase 2 clinical development program for MM-121...

Drug Combination Improves Outcome For Advanced Non-Small Cell Lung Cancer

A new, international study found that the combination of two drugs delays disease progression for patients with advanced non-small cell lung cancer (NSCLC). Results from the Phase III "ATLAS" trial were presented today by Dr. Vincent Miller of Memorial Sloan-Kettering Cancer Center (MSKCC) at the American Society of Clinical Oncology Annual Meeting.

Repligen Reports Phase 3 Clinical Trial Results Of RG1068 In Pancreatic Imaging

Repligen Corporation (Nasdaq: RGEN) reported top-line results from a Phase 3 clinical trial to evaluate the safety and efficacy of RG1068, synthetic human secretin, to improve magnetic resonance imaging (MRI) of the pancreas in patients with a history of pancreatitis...

Kriger Graduates Have Come To Realize Their Potential Within The Industry And Have Gone On To Successful Careers.

Kriger www.krigerinternational.com has maintained it's status within the industry because these training courses lead to the creation of highly trained individuals, due to the rigorous tasks that each student must perform in the projects. It results in individuals who are motivated to make the ...
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Synexus Continues To Expand Clinical Trials Activities In Poland

Synexus, the world's largest multi-national company dedicated to the recruitment and running of clinical trials is expanding its operations in Gdynia, Poland when it moves to new premises later this year. It has also recently increased the capacity of its original centre in Wroclaw by several hundred square metres...

ViroPharma Announces Initiation Of Phase 2 Study Of Cinryze(TM) (C1 Estersase Inhibitor [Human]) In Pediatric Patients

ViroPharma Incorporated (Nasdaq: VPHM) announced that it has initiated an open-label, single-dose Phase 2 study to evaluate doses of Cinryze™ (C1 esterase inhibitor [human)] for treatment of acute angioedema attacks in children less than 12 years of age with hereditary angioedema (HAE). Cinryze was approved by the U.S...

Experimental Drug That Targets BRAF Cancer Gene Shows Promise Against Metastatic Melanoma

A phase 1 clinical trial using a new formulation of an experimental drug that targets the BRAF cancer gene, has shown early promise in treating melanoma in patients with a mutated form of the gene and whose skin cancer has progressed to the metastatic stage. A paper on the trial appears in the 26 August issue of the New England Journal of Medicine, NEJM...

Contract Research Organizations Facing New Challenges

The biggest challenge facing CROs in the current industry are strict regulatory requirements. Global regulatory bodies increasingly require more detailed safety control of drug candidates to ensure safety and to avoid product recalls. In order to comply with these regulations CROs must ...
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Cardiologist Urges People To Get Informed About Angioplasty

A report broadcast during the CBS Evening News on June 8 noted that one in 200 patients die during elective coronary angioplasty procedures and suggested that patients may be safest at institutions where surgical backup is readily available when complications occur. The report also noted that as many as 40 percent of the angioplasties performed may be unnecessary because patients could experience the same benefits from drug therapies.

Enobia Pharma Receives FDA Orphan Drug Designation For Hypophosphatasia Product Candidate ENB-0040

Enobia Pharma, an emerging biotech company focused on developing novel therapeutics for serious bone disorders, announced that it has received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for ENB-0040, its enzyme replacement therapy (ERT) for hypophosphatasia, a rare, life-threatening genetic bone disease. In August 2008, Enobia dosed the first patient in a Phase I clinical trial of ENB-0040.

AFFiRiS AG: Interim Analysis Of Clinical Phase I Data Triggered Decision To Move Alzheimer's Vaccine Candidate AD02 Into Clinical Phase II Testing

AFFiRiS AG will focus its Alzheimer's vaccine program on one product candidate at an unexpectedly early stage of development: the vaccine candidate AD02 is planned to enter into Phase II clinical trial early in 2010. This decision by the company immediately follows the completion of two Phase I trials with the candidates AD01 and AD02. The company based its fast decision on the first interim analysis of the secondary endpoints at the six month time point.

ClinQua Inc. is one of CRO's focusing the Investigator on aspects critical for validating the drugs' therapeutic benefits.

ClinQua Inc. www.clinqua.com is one of CRO's (Contract Research Organizations), who specialize in evaluating the demands of the trial and eliminating redundant protocols and focusing the Investigator on aspects critical for validating the drugs' therapeutic benefits. Common sense would ...
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Pivotal Data Show Bronchial Thermoplasty Can Improve Quality Of Life And Reduce Asthma Attacks And Emergency Room Visits For Adults With Severe Asthma

Results of the Asthma Intervention Research 2 (AIR2) Trial of the Alair(R) Bronchial Thermoplasty System, developed by Asthmatx, Inc., were announced at ATS 2009, the International Conference of the American Thoracic Society, in San Diego, Calif.

New Clinical Research Study Focuses On New Treatment Option For Hard-to-Diagnose Painful Bladder Syndrome

A clinical research study is being conducted for patients with Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS), a chronic bladder disorder characterized by intense pelvic pain, urinary frequency-urgency, and pain during sexual intimacy. It is estimated that as many as 1.3 million people in the U.S. have been diagnosed with this disease and many more remain undiagnosed...

VIVUS Announces FDA Acceptance Of Qnexa(R) New Drug Application For Treatment Of Obesity

VIVUS, Inc. (Nasdaq: VVUS) announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company's new drug application (NDA) for its investigational drug, Qnexa®, for the treatment of obesity. The target date for the FDA to complete its review of the Qnexa NDA is October 28, 2010...

Pharmaceutical companies are relying on outsourcing strategies

It is imperative that pharmaceutical and biotechnology companies pass their product through the testing and regulatory process in a rapid, cost-effective manner. To accomplish this goal, pharmaceutical companies are relying on outsourcing strategies to provide the services that can ...
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Advanced Ovarian Cancer Patient Enrollment Phase 2 Study Of IMC-1121B Commences

ImClone Systems Incorporated (NASDAQ: IMCL), a global leader in the development and commercialization of novel antibodies to treat cancer, today announced that the first patient has been treated in its disease-directed Phase 2 clinical trial of IMC-1121B in patients with advanced ovarian cancer. IMC-1121B is ImClone's proprietary fully human, IgG1 anti-vascular growth factor receptor-2 (VEGFR-2) monoclonal antibody.

Phase 2 Data For Ultra-Long-Acting Insulin Degludec Shows The Potential To Effectively Lower Blood Sugar, Including When Used Three Times A Week

Novo Nordisk presented phase 2 proof-of-concept data for its investigational insulin degludec, an ultra-long-acting basal insulin, which demonstrated the potential to help achieve target glycemic control when used once daily or three times weekly. These data were presented at the 70th Scientific Sessions of the American Diabetes Association (ADA)...

Cordex Pharma Submits To The FDA An Amended Special Protocol Assessment For ATPace

Cordex Pharma, Inc. (OTC Bulletin Board: CDXP) announced that it has submitted to the U.S. Food and Drug Administration (FDA) an amended Phase 3 protocol for ATPace to be reviewed as a Special Protocol Assessment (SPA). The amendment addresses written comments recently received from the FDA in response to the Company's initial SPA submission to the FDA on November 20, 2008.

Use of the Cereprotex prior to and after the CABG procedures to substantially reduce or eliminate the effects of neuro-impairment.

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 ...
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HIV/AIDS Preventive Vaccine Of Mymetics: Green Light From EU To Start Phase I Human Clinical Study

Mymetics Corporation (OTCBB: MYMX) announces the confirmed success of its preventive vaccine against HIV/AIDS. To this day, these results are the most promising and advanced in the world. They confirm a decisive breakthrough in the HIV/AIDS prevention. To such an extent that European authorities have just authorized the launch of the Phase I human clinical study.

ZaBeCor Pharmaceuticals Begins Phase II Clinical Trial In Asthma Patients Following Positive Phase I Results

ZaBeCor Pharmaceuticals ("ZaBeCor" or the "Company") announced the initiation of a Phase II clinical trial for its asthma drug candidate Excellair™, following the successful results of the Company's Phase I clinical trials. ZaBeCor is one of the first companies to deliver siRNA to the lung and one of the first to target asthma with siRNA. "The advancement of Excellair™ into a Phase II clinical trial for asthma is a significant milestone for our company," said Alan D.

Long Term Ozone Exposure Raises The Risk Of Dying From Lung Disease

Long-term exposure to elevated levels of ground ozone a major constituent of smog significantly raises the risk of dying from lung disease, according to a new nationwide study of cities that evaluated the impact of ozone on respiratory health over an 18-year period. The study found that the risk of dying from respiratory disease is more than 30 percent greater in metropolitan areas with the highest ozone concentrations than in those with the lowest ozone concentrations.

Clinical Trials Do Not Need To Be Expensive!

Many CRO Directors will argue that the foreseeable burden of clinical investigation is cost and the weight of that burden falls onto clients. The clinical climate has seen extraordinary escalation in federal regulations to make sure that the integrity of the products that are ...
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Osteotech Initiates Pivotal Clinical Trial For DuraTech(TM) BioRegeneration Matrix

Osteotech, Inc. (Nasdaq: OSTE), a leader in the emerging field of biologic products for regenerative healing, announced that it has initiated a pivotal clinical trial for its DuraTech(TM) BioRegeneration Matrix. The first five patients in this 60-patient trial have already been enrolled.

New Studies Presented At European Society Of Anaesthesia Further Validate Masimo PVI(TM) For Noninvasive And Continuous Fluid Monitoring

Masimo (Nasdaq: MASI), the inventor of Pulse CO-Oximetry(TM) and Measure-Through Motion and Low-Perfusion pulse oximetry, announced that three new independent studies demonstrating the clinical accuracy and utility of Masimo PVI as a noninvasive and continuous measure of patient fluid status and responsiveness were presented this week at the European Society of Anaesthesiology (ESA) Annual Congress in Milan, Italy.

Physicians Sharing Their Notes With Patients

Patients across the country are voicing a growing desire for greater engagement in, and control over, their own medical care. A new study led by Beth Israel Deaconess Medical Center (BIDMC) will examine the impact of adding new layer of openness to a traditionally one-sided element of the doctor-patient relationship - the notes from patients' doctors' visits. Funded through a $1.

Clinical Trials Do Not Need To Be Expensive!

Many CRO Directors will argue that the foreseeable burden of clinical investigation is cost and the weight of that burden falls onto clients. The clinical climate has seen extraordinary escalation in federal regulations to make sure that the integrity of the products that are ...
(613) 686-5745 Cerepotec Pharmalef

Medication Plus Parent Training Improves Behavioral Problems In Children With PDD

Treatment that includes medication plus a structured training program for parents reduces serious behavioral problems in children with autism and related conditions, according to a study funded by the National Institute of Mental Health (NIMH). The study, which was part of the NIMH Research Units on Pediatric Psychopharmacology (RUPP) Autism Network, was published in the December 2009 issue of the Journal of the American Academy of Child and Adolescent Psychiatry.

The Daily Consumption Of Cannabis Predisposes To The Appearance Of Psychosis And Schizophrenia, According To A Study

The daily consumption of cannabis predisposes to the appearance of psychosis and schizophrenia, and those episodes of psychosis which are fruit of this substance present certain specific characteristics, both before their appearance and in the clinical presentation of the psychosis.


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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