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Delcath Phase III Trial Results Exceed Primary Endpoint Expectations

Delcath Systems, Inc...

Tibotec Conducts Two Pivotal Phase III Clinical Trials Studying TMC278 In Treatment-Naive Adults With HIV

Tibotec Pharmaceuticals Ltd. announced that two major phase III efficacy trials examining TMC278, its investigational non-nucleoside reverse transcriptase inhibitor (NNRTI), in treatment-naive adults with HIV-1, are now recruiting patients.

Optical Coherence Tomography Shows Promise As Future Pancreatic Cancer Diagnostic Tool

A team of researchers from four Boston-area institutions led by Nicusor Iftimia from Physical Sciences, Inc...

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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New Study Finds "it's Never Too Late To Stop Drinking"

Where there is life there is hope and it is never too late to stop drinking, even with the most severe case of alcohol-related liver disease, according to new research from the University of Southampton. However, the downside is that up a quarter of people with alcohol-related cirrhosis die before they get the chance to stop drinking. Alcohol-related cirrhosis develops silently but usually presents with an episode of internal bleeding or jaundice - which is often fatal.

Tobira Therapeutics Initiates Phase IIb Trial Of Cenicriviroc, A Novel CCR5/CCR2 Antagonist For The Treatment Of HIV Infection

Tobira Therapeutics, Inc., a biopharmaceutical company focused on the development and commercialization of innovative therapies for HIV, announced today that it has initiated a Phase IIb clinical trial for the CCR5/CCR2 inhibitor cenicriviroc (TBR-652)...

New Analysis Estimates Numbers Of Older U.S. Adults Who May Benefit From Statin Therapy

Study highlights: A new analysis estimates more than 11 million older Americans could be newly eligible for statin therapy if findings from the JUPITER trial are adopted into guidelines. That could take the number of older adults eligible for statin therapy to over 44 million, or 80 percent of that population.

The paramount responsibility of Kriger Research Group International CRA-s is to ensure timely subjects recruitment, patient rights, safety and data integrity.

The paramount responsibility of Kriger Research Group International CRA-s is to ensure timely subjects recruitment, patient rights, safety and data integrity. In addition to on-site responsibilities each CRA is responsible for site management documentation and follow-up activities ...
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Popular Breast Cancer Drug Used With Certain Antidepressants Puts New Jersey Women At Risk

A new analysis finds that women in New Jersey who take the breast cancer drug tamoxifen in conjunction with certain popular antidepressants may be at a higher risk for a breast cancer recurrence. In May, Medco Health Solutions, Inc.

DeCODE Discovers Common Genetic Variations Contributing To Low Bone Mineral Density And Risk Of Osteoporosis

Scientists from deCODE genetics (Nasdaq: DCGN) and colleagues from Australia and Denmark report the discovery of common single-letter variations (SNPs) in the human genome linked to low bone mineral density (BMD), the clinical measurement used to diagnose osteoporosis. deCODE had previously identified five sites in the genome harboring SNPs with influence on BMD, and today's study has added four more.

Treatment Of Anemia With Erythropoietin May Benefit Heart Failure Patients

Heart failure patients may benefit from treatment of anaemia similarly to those with chronic kidney disease (CKD) or cancer. Anaemia is common to many diseases (chronic kidney disease, cancer, chronic heart failure) as well as a consequence of treatment for diseases such as cancer, specifically with chemotherapeutic agents. Anaemia may contribute to lethargy, reduced exercise tolerance and poor quality of life.

Clinical outsourcing and current trends: How are they affecting business?

The clinical research industries growth is skyrocketing, the portion of the market outsourced to CROs is said to have grown from US$1 billion dollars in the early 1990’s to over US$17 billion in 2007. Analysts predict that by the year 2010 the industry could see numbers well into and over ...
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Farletuzumab Data Presented On Phase II Clinical Trial In First-Relapsed Ovarian Cancer Subjects

Morphotek(R), Inc., a subsidiary of Eisai Corporation of North America, announced preliminary data from a Phase II trial evaluating the safety and efficacy of farletuzumab in platinum-sensitive epithelial ovarian cancer subjects experiencing their first relapse. Farletuzumab (MORAb-003) is a humanized monoclonal antibody that targets the Folate Receptor Alpha (FRA).

Appendicitis Blood-based Test - AspenBio Pharma Reports Preliminary Results Of AppyScore(TM) Clinical Study

AspenBio Pharma, Inc. (NASDAQ: APPY), an emerging bio-pharmaceutical company dedicated to the development of novel drugs and diagnostics for humans and animals, reported initial preliminary data from its Food and Drug Administration ("FDA") clinical trial for AppyScore(TM), the world's first blood-based test as an aid in the diagnosis of human appendicitis and an update on planned steps for pursuing FDA market authorization in the U.S.

Clinical Data For Carl Zeiss Meditec's INTRABEAM Targeted Intraoperative Radiotherapy System For Breast Cancer To Be Presented At ASCO 2010

Carl Zeiss Meditec announced that the TARGIT-A (TARGeted Intra-operative radiation Therapy) multicenter clinical trial that used the INTRABEAM® device, will be the subject of a late-breaking presentation at the American Society of Clinical Oncology's (ASCO's) 46th Annual Meeting in Chicago, IL...

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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Acupuncture Effective For Headaches, But 'Faked' Treatments Work Almost As Well

Headache sufferers can benefit from acupuncture, even though how and where acupuncture needles are inserted may not be important. Two separate systematic reviews by Cochrane Researchers show that acupuncture is an effective treatment for prevention of headaches and migraines. But the results also suggest that faked procedures, in which needles are incorrectly inserted, can be just as effective.

Amicus Therapeutics Presents Positive Data Update From Phase 2 Extension Study Of Amigal(TM) For Fabry Disease

Amicus Therapeutics (Nasdaq: FOLD) announced additional positive preliminary data from its ongoing Phase 2 extension study of its investigational drug Amigal™ (migalastat HCl) for Fabry disease at the Lysosomal Disease Network WORLD Symposium in Miami, Florida...

Oramed Pharmaceuticals Launches Phase 1A Trials Of Its Insulin Suppository

Oramed Pharmaceuticals, Inc. (OTCBB: ORMP.OB), a developer of alternative drug delivery systems, announced today that it has received approval from the South Africa Medicines Control Council (MCC) to begin conducting Phase 1A trials on eight healthy human volunteers for ORMD 0802, the company's newly developed insulin suppository.

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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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.

Delcath Systems Granted Orphan-Drug Designations For Cutaneous And Ocular Melanoma

Delcath Systems, Inc. (Nasdaq: DCTH), a medical technology company testing its proprietary liver cancer treatment for melanoma metastatic to the liver, announced that the United States Food and Drug Administration ("FDA") granted to Delcath two orphan-drug applications for the drug melphalan. Delcath was granted designations of the drug melphalan for the treatment of patients with cutaneous as well as ocular melanoma.

Sinovac Submits Clinical Trial Application For Mumps Vaccine To SFDA

Sinovac Biotech Ltd. (Nasdaq: SVA), a leading China-based vaccine manufacturer, announced today that its 30%-owned joint venture, Sinovac Dalian, has submitted an application to China's State Food and Drug Administration (SFDA) to commence human clinical trials for its mumps vaccine...

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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Drug That Attacks Blood Supply Of Fat Cells Causes Weight Loss In Obese Monkeys

Obese rhesus monkeys lost on average 11 percent of their body weight after four weeks of treatment with an experimental drug that selectively destroys the blood supply of fat tissue, a research team led by scientists at The University of Texas MD Anderson Cancer Center reports in Science Translational Medicine...

HIV - Avexa Completes Recruitment For First Component Of ATC Phase III Trial

Australian biotechnology company Avexa (ASX:AVX) today announced that it has completed recruitment of the first 160 patients for the two-dose component of its Phase III trial for apricitabine (ATC), with over 300 patients in the screening or dosing stages of the trial. The trial is ongoing with over 130 specialist HIV centres in 15 countries and results from this component of the trial are expected in the second quarter of 2009.

Tobira Therapeutics Inc. Announces Phase I Data Demonstrating Pharmacokinetic Properties Of TAK-652 For The Treatment Of HIV

Tobira Therapeutics Inc., a clinical stage biotechnology company committed to research and product discovery for the treatment of life-threatening and life-altering infectious diseases, today announced pharmacokinetic data and results from two Phase I pharmacokinetic studies for TAK-652, an investigational compound being developed for the treatment of HIV.

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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Otonomy Receives FDA Clearance To Initiate Clinical Trial In Patients With Meniere's Disease

Otonomy, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted clearance of the company's Investigational New Drug (IND) application for the clinical trial of OTO-104 in patients with Meniere's disease, a debilitating disorder of the inner ear affecting balance and hearing...

Regeneron Announces EYLEA™ (aflibercept Ophthalmic Solution) Receives Unanimous Recommendation For Approval For Treatment Of Wet AMD From FDA

Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) announced that the Dermatologic and Ophthalmic Drugs Advisory Committee of the U.S...

Intervention Program Helps Breast Cancer Patients Live Longer After Recurrence

A psychological intervention program designed for breast cancer patients reduces the risk of dying if the cancer recurs, new research shows. The study is the latest in a series at Ohio State University that have shown that an intervention program that teaches patients how to cope with the disease can boost their health, well-being and even their chances of survival...

The concept of outsourcing should not be new to pharmaceutical companies

The idea of outsourcing clinical trials took a dramatic increase two decades ago and continues to increase at a rapid pace. It is estimated that by 2006 close to 45% of all drug development finances will be allocated to outsourcing to such companies as Limdato, www.limdato.com. Prior to the ...
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pSivida Reports Presentation Of Additional Positive 24-Month Data From Iluvien(R) Phase 3 FAME™ Study For Diabetic Macular Edema At Angiogenesis

pSivida Corp...

HeartWare Receives Second Patient Allotment Under Continued Access Protocol For Pivotal U.S. Bridge-To-Transplant Clinical Trial

HeartWare International, Inc. (Nasdaq: HTWR; ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that the U.S...

New Data Indicate Effectiveness Of Clarient's Pulmotax(TM) Test For Lung Cancer

Clarient, Inc. (Nasdaq: CLRT), a premier technology and services resource for pathologists, oncologists and the pharmaceutical industry, announced that data from a new study suggest that the Clarient Insight® Dx Pulmotax™ assay may effectively predict which lung cancer patients will respond favorably to chemotherapy...

EBRecruiters has a well established database of over 60,000 candidates all over the world

EBRecruiters www.ebrecruiters.com consultants have a wealth of knowledge and experience in Clinical Research, Data Management, Quality Assurance, Regulatory Affairs and all aspects of Information Technology and Office Support. EBRecruiters has a well established database of ...
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Brain Injuries Tied To Trouble Sleeping

People with brain injuries may produce low amounts of melatonin, which affects their sleep, according to a study published in the May 25, 2010, print issue of Neurology®, the medical journal of the American Academy of Neurology...

BHR Pharma Enrolls First Patient In Phase 3 SyNAPSe Traumatic Brain Injury Trial

BHR Pharma, LLC (BHR) announced that the first patient has been enrolled in its SyNAPSe study , a global, Phase 3, pivotal trial to evaluate the safety and effectiveness of its intravenous progesterone infusion product (BHR-100) as a neuroprotective agent for treating severe (Glasgow Coma Scale scores of 4-8) traumatic brain injury (TBI) patients...

GlaxoSmithKline And Genmab Announce Positive Top-line Results In Ofatumumab Chronic Lymphocytic Leukaemia Pivotal Study

GlaxoSmithKline (LSE and NYSE: GSK) and Genmab A/S (OMX: GEN) announced today positive top-line results from an interim analysis of the Phase III pivotal study evaluating ofatumumab (HuMax-CD20®) in two difficult to treat groups of patients with chronic lymphocytic leukaemia (CLL). At the interim analysis, the study met the primary endpoint in both populations and the results from the secondary endpoints also support the primary endpoint.

Why Clinical Research Companies Cannot Hire CRA’s Without Experience?

As per Bruce Kriger, CEO of Kriger Research Group International www.kriger.com , leading training institution and clinical research organization, there are three main reasons that actual experience is essential:Theoretical knowledge of GCP and CRA functions does not ensure the ...
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Papworth Hospital Trial New 'Airway Bypass' For Emphysema Sufferers, England

Papworth Hospital NHS Foundation Trust is pleased to announce on World COPD Day (Chronic Obstructive Pulmonary Disease) its participation in a trial of a new treatment for severe emphysema. Papworth is one of 45 hospitals in the world and only 2 in the UK participating in a worldwide trial to evaluate the effectiveness of the airway bypass procedure to relieve breathlessness in patients with advanced widespread 'homogeneous' emphysema.

Cumberland Pharmaceuticals Announces Presentation Of Caldolor Data At American Academy Of Pain Management Meeting

Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) announced that data from two key clinical trials for Caldolor®, an intravenous formulation of ibuprofen approved for treatment of pain and fever in adults, will be presented at the American Academy of Pain Management's (AAPM) 20th Annual Clinical Meeting to be held in Phoenix, Ariz., on October 8-11, 2009.

NeurogesX Announces FDA Acceptance To Review New Drug Application For NGX-4010 To Treat Post Herpetic Neuralgia

NeurogesX, Inc. (Nasdaq: NGSX), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) to review its investigational product candidate, NGX-4010, for the management of pain due to post-herpetic neuralgia (PHN).

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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Series Of Cognitive Tests That May Aid In Better Understanding And Treating Of Down Syndrome

Neuroscientists in the Down Syndrome Research Group at the University of Arizona have created a battery of tests that quickly aid in the assessment of the cognitive abilities of persons with Down syndrome. The UA collaborated on the development of the tests with colleagues at Johns Hopkins University and Emory University...

New Way To Predict Breast Cancer Survival And Enhance Effectiveness Of Treatment

A team of researchers at the University of California, San Francisco has discovered a new way to predict breast cancer survival based on an "immune profile" - the relative levels of three types of immune cells within a tumor. Knowing a patient's profile may one day help guide treatment. Moreover, the UCSF team showed that they could use drugs to alter this immune profile in mice...

ImmunoCellular Therapeutics Selects Averion International Corp. To Conduct Phase II Glioblastoma Study

ImmunoCellular Therapeutics, Ltd. (OTCBB: IMUC), a biotechnology company focused on the development of novel immune-based cancer therapies (the "Company"), has announced that it has contracted with the clinical research organization (CRO) Averion International Corp...

Clinproxy recommends that sponsors use their expertise in creating a budget within their means.

It is a reality that the development of pharmaceutical drugs is a very expensive task. Yet, these costs are necessary due to the substantial investment of both resources and time of the companies in question. If a company is willing to invest millions of dollars it is a given they would seek ...
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Sinapis Pharma Completes Phase I Trial

Sinapis Pharma, Inc. is pleased to announce that it has completed its first clinical trial in the development of its lead drug for the treatment of stroke and traumatic brain injury...

Hospira's Precedex® Phase IV Study Published In The Journal Of The American Medical Association

The Journal of the American Medical Association (JAMA) has published study results demonstrating Hospira, Inc.'s (NYSE: HSP) alpha-2 agonist Precedex (dexmedetomidine hydrochloride) for intravenous sedation provides comparable effectiveness to commonly used gamma-aminobutyric acid (GABA)-agonist midazolam for greater-than-24-hour sedation of mechanically ventilated patients in the intensive care unit (ICU).

Final Patient Completes Treatment In Boehringer Ingelheim's RE-LY(R) Study, The Largest Atrial Fibrillation Outcomes Trial To Date

Boehringer Ingelheim announced that the last patient has completed treatment in the Phase III Randomized Evaluation of Long term Anticoagulant therapy (RE-LY(R)) study. This study compared the long-term efficacy and safety of the oral direct thrombin inhibitor dabigatran etexilate with the current standard therapy, warfarin (target international normalized ratio, INR, 2-3) for the prevention of stroke and non-CNS systemic embolism in patients with atrial fibrillation (AF).

EBRecruiters has a well established database of over 60,000 candidates all over the world

EBRecruiters www.ebrecruiters.com consultants have a wealth of knowledge and experience in Clinical Research, Data Management, Quality Assurance, Regulatory Affairs and all aspects of Information Technology and Office Support. EBRecruiters has a well established database of ...
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Boehringer Ingelheim Initiates First Phase III Clinical Trial In Ovarian Cancer

Boehringer Ingelheim announced the initiation of a new phase III clinical trial to evaluate one of its two late-stage oncology pipeline compounds for the treatment of patients with advanced ovarian cancer...

ChemoCentryx Reports Positive Results And Completion Of Phase I Clinical Studies Of Novel CCR2 Antagonist, CCX140

ChemoCentryx, Inc., announced that it reported positive preclinical and Phase I study results at the European Association for the Study of Diabetes (EASD)...

KiobrinaTM Shows Positive Phase II Results In Preterm Infants

Biovitrum AB (STO: BVT) today announced that the first of two clinical phase II studies, designed to together show proof of concept of Kiobrina™ (rhBSSL) in preterm infants, has been completed. The results show statistically significant improvement in the growth velocity in preterm infants when Kiobrina™ was added to infant formula compared to placebo. The safety profile was comparable to that of placebo and no drug related serious adverse events were reported.

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 ...
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Moffitt Cancer Center Chief Participates In Clinical Trial Resulting In FDA Approval Of New Label For Myelodysplastic Therapy VIDAZA

The Moffitt Cancer Center announced that Dr. Alan List, Physician-in-Chief, was one of the key investigators in a VIDAZA (azacitidine) clinical trial (AZA-001) whose results the U.S. Food & Drug Administration (FDA) has approved to add to the drug's label. In May 2004, VIDAZA was the first drug approved by the FDA for the treatment of MDS. The AZA-001 study is the largest ever phase III; multi-center randomized trial involving higher-risk MDS patients.

Study Suggests Treatment With Paliperidone ER Significantly Improves Symptoms Of Schizoaffective Disorder

Patients with schizoaffective disorder who received paliperidone extended release tablets (paliperidone ER) for six weeks showed significant improvement in a broad range of schizoaffective symptoms, according to a new study presented at the 12th International Congress on Schizophrenia Research (ICOSR) in San Diego, Calif.(1) The findings of the study provide additional evidence for symptomatic improvement of schizoaffective disorder following therapy with paliperidone ER.

Large Studies Needed To Further Confirm Prostate Cancer Drug Abiraterone

Larger trials are needed to further examine and confirm the early findings on the experimental drug abiraterone acetate (CB7630). Researcher Dr. Johann de Bono, from the Institute of Cancer Research and the Royal Marsden NHS Foundation Trust in the UK, who led two ongoing clinical trials of CB7630, said larger studies are necessary to find out the efficacy of the drug.

The concept of outsourcing should not be new to pharmaceutical companies

The idea of outsourcing clinical trials took a dramatic increase two decades ago and continues to increase at a rapid pace. It is estimated that by 2006 close to 45% of all drug development finances will be allocated to outsourcing to such companies as Limdato, www.limdato.com. Prior to the ...
(613) 686-5745 Cerepotec Pharmalef

Waterpipe Tobacco Smokers Inhale Same Toxicants As Cigarette Smokers

Smoking tobacco through a waterpipe exposes the user to the same toxicants carbon monoxide and nicotine as puffing on a cigarette, which could lead to nicotine addiction and heart disease, according to a study led by a Virginia Commonwealth University researcher published in the December issue of the American Journal of Preventive Medicine...

88.7% Of Ulcerative Colitis Patients In Remission Remained Relapse-Free At 12 Months With Once Daily Mezavant(R) XL (MMX Mesalazine)

Shire Limited, the global specialty biopharmaceutical company, announces that data published in Gut show that 64.4% of patients with mild to moderate ulcerative colitis (UC) who achieved clinical and endoscopic remission maintained this at 12 months when given two mesalazine 1200mg gastro-resistant, prolonged release tablets (Mezavant XL) once a day as a maintenance therapy.

New Computer Algorithm Helps Physicians Determine And Monitor Breast Density

A new computerized assessment has been developed that can help physicians objectively assess a patient's breast density and monitor it over time to detect any alarming changes that may suggest cancer, according to a study evaluating this technology that was performed at the University of Maryland School of Medicine, Baltimore, MD. A new computer algorithm assessment was developed that estimates mammographic breast density.

Skyrocketing growth of the CRO market

The combination of the growing trend by pharmaceutical companies to outsource a wider range of services, and the need to pass products through the testing and regulatory process in a rapid, cost-effective manner, has lead to skyrocketing growth of the CRO market. The CRO market grew from $1 ...
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Sorrento Therapeutics Announces Antibody Discovery And Development Alliance For The Prevention And Treatment Of MRSA Infections

Sorrento Therapeutics, Inc. (OTC Bulletin Board: SRNE) announced an antibody discovery and development collaboration with The Scripps Research Institute, La Jolla, CA...

Merck Receives CHMP Positive Opinion For New Fertility Treatment, ELONVA(R)

Merck & Co., Inc. announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has recommended approval of ELONVA® (corifollitropin alfa injection) as a treatment in controlled ovarian stimulation (COS) in combination with a GnRH antagonist for the development of multiple follicles in women participating in an assisted reproductive technology (ART) program.


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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