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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.

Validity Of Cost-effectiveness Models Based On Randomized Clinical Trials

Cost-effectiveness studies are widely used to guide prescribing policy in many countries, as part of health technology assessment programmes...

Chembio Awarded Three-Year $3MM NIH SBIR Phase II Grant To Complete DPP(R) Test For Human Leptospirosis

Chembio Diagnostic Systems, Inc. (a wholly-owned subsidiary of Chembio Diagnostics, Inc.) (OTCBB: CEMI) has been awarded a three-year $3 million Small Business Innovative Research (SBIR) Phase II grant from the United States National Institutes of Health (NIH) to fully develop, validate, and commercialize a rapid diagnostic test for leptospirosis for general use worldwide.

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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Clarifying Conflict Of Interest Disclosures In Clinical Trials

When enrolling patients in a clinical trial, researchers should disclose relevant financial relationships that might affect a patient's decision about participation, such as owning stock in the company that funds the study, or having a patent on the device being tested. It's a process many believe builds trust and fulfills a patient's right to know about financial conflicts of interest.

The Emergence Of A New Class Of Brain-Protecting Drugs

Researchers have identified a compound that mimics one of the brain's own growth factors and can protect brain cells against damage in several animal models of neurological disease. 7,8-dihydroxyflavone is a member of the flavonoid family of chemicals, which are abundant in fruits and vegetables...

More Than 200 Abstracts At ASH And SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current And Pipeline Therapies

More than 200 abstracts from therapies across the Novartis Oncology portfolio will be presented at two December medical congresses, providing new data and profiling potential patient benefits from ongoing collaboration with the oncology community.

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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BioElectronics Provides Clinical Study Data; Company To File Comprehensive FDA Application For OTC Clearance For Musculoskeletal Complaints

BioElectronics Corp. (PINKSHEETS: BIEL), the maker of inexpensive, disposable drug-free anti-inflammatory devices, held a conference call yesterday morning, a replay of which is available by dialing (888) 203-1112 and entering passcode 4461002. "We were once again able to exceed our wildest expectations relative to investor attendance with nearly 1,200 dialing in to hear the presentations.

Medifacts International Drives Innovation In Telemedicine For Clinical Trials

Medifacts International, Inc., one of the largest global providers of noninvasive cardiovascular diagnostic services, announced that they are once again leading the Cardiovascular Safety Services marketplace in innovation, expertise, and execution - this time with new innovations in the use of telemedicine, T-SMBP (Telemonitoring Self Measured Blood Pressure), in clinical trials...

Stiefel Laboratories Reaps First Fruits Of Barrier Acquisition With Completion Of Pivotal Phase III Clinical Trial For 200 Mg Hyphanox(TM)

Stiefel Laboratories, Inc. announced the completion and analysis of a pivotal phase III clinical trial for Hyphanox(TM) (itraconazole) tablet. The 200 mg itraconazole tablet formulation was developed using the proprietary Meltrex(R) technology. This trial is the largest randomized controlled clinical study in onychomycosis ever undertaken.

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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Karolinska Development: EMEA Recommends Orphan Drug Designation For Acute Myeloid Leukemia Treatment

The European Medicines Agency (EMEA) recommends orphan drug status for Aprea's treatment of acute myeloid leukemia (AML). The treatment is currently undergoing a Phase I clinical study and a final decision from the European Commission regarding status is expected in a few weeks. Aprea is part of the Karolinska Development portfolio...

Letters To The Editor Address Recent Editorial Related To Black Parents' Reluctance To Enroll Their Children Into Clinical Trials

In an editorial earlier this month, the Pittsburgh Post-Gazette responded to a recent study that found that 67% of black parents, compared with 50% of white parents, mistrust medical research. In addition, the study found that 40% of black parents, compared with 28% of white parents, "suspect doctors of experimenting on their children with risky medicines.

Esperion Therapeutics Initiates Phase I Clinical Study For ETC-1002

Esperion Therapeutics, a privately held biotechnology company working to discover, develop and commercialize treatments for cardiovascular and metabolic diseases, announced that the company has initiated a Phase I clinical study for ETC-1002, the company's novel small molecule compound designed to beneficially regulate the levels of plasma lipids and lipoproteins.

Over the past few years, CROs have received the lion's share of outsourced clinical research revenue.

CROs were first organized as outsourcing service companies that provided only clinical trial management. Today, many CROs have expanded their scope of services to provide comprehensive management of the complex drug trial processes for their client companies, as well as providing access to ...
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Bayer Starts Phase III Trial With Florbetaben

Bayer Schering Pharma AG, Germany, is progressing with the development of florbetaben to support Alzheimer diagnosis...

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,

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...

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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NeuroVive: NeuroVive Doses Last Patient In Clinical Trial Of Cremophor(R)- Free Cyclosporine I.v. NeuroSTAT(R)

NeuroVive Pharmaceutical AB, of Lund, Sweden, announced that on November 3, 2009 it completed the clinical phase of its study investigating tolerability and pharmacokinetics of the cremophor-free cyclosporine i.v. formula NeuroSTAT. CEO Eskil Elmér comments that "This study in 52 healthy subjects is a direct comparison of NeuroVive's injectable cyclosporine product NeuroSTAT with Novartis's product Sandimmune Injection.

Medtronic's Third-Generation Endeavor Resolute Drug-Eluting Stent Maintains Strong Efficacy And Safety Profile At Two Years

Of those treated with the Endeavor Resolute drug-eluting stent (DES) from Medtronic, Inc. (NYSE: MDT), in the RESOLUTE IDE trial only two patients required repeat procedures - a remarkably low 1.5 percent rate of target lesion revascularization (TLR) - at two years following implant, according to data released today at the Transcatheter Cardiovascular Therapeutics (TCT) meeting.

New Promising Obesity Drug May Have Huge Potential

According to trials, a new obesity drug, Tesofensine, which may be launched on the world market in a few years, can produce weight loss twice that of currently approved obesity drugs. The Danish company Neurosearch and a number of researchers at the Faculty of Life Sciences at University of Copenhagen are behind the promising findings. Tesofensine can produce weight loss twice that of currently approved obesity drugs, and should be studied in phase III trials.

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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TenX Biopharma To Conduct Clinical Study With The National Cancer Institute

TenX Biopharma, Inc., announced it has signed a Clinical Trial Agreement with the National Cancer Institute (NCI) to conduct an investigator sponsored Phase II clinical trial. For this study, the NCI's Surgery Branch Chief, Dr. Steven A...

Bristol-Myers Squibb Announces Acceptance Of Submission For Belatacept Biologic License Application

Bristol-Myers Squibb Company (NYSE:BMY) announced today that the U.S. Food and Drug Administration (FDA) has accepted, for filing and review, the company's submission of a biologic license application for belatacept, which is in ongoing phase III development for use in kidney transplantation. The Prescription Drug User Fee Act (PDUFA) goal date for the FDA is May 1, 2010.

Berlin Heart's EXCOR(R) Pediatric Receives Unconditional Investigational Device Exemption (IDE) Approval

Berlin Heart Inc. announced its EXCOR(R) Pediatric ventricular assist device (VAD) has received unconditional approval for the ongoing IDE clinical trial in the United States of America. The U.S Food and Drug Administration (FDA) has fully approved the Investigational Plan for the IDE study of the device.

ClinQua Inc. : The overall cost of clinical trials depends on an array of factors

In a progressive global market of supply and demand, it remains unthinkable to engage in practices that are ambitiously over-priced when there are endless opportunities to utilize more cost-efficient methods which would yield the same results. As per Mr. David Mills former ClinQua Clinical ...
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Why Some Monkeys Don't Get AIDS

Two studies published this month in the Journal of Clinical Investigation provide a significant advance in understanding how some species of monkeys such as sooty mangabeys and African green monkeys avoid AIDS when infected with SIV, the simian equivalent of HIV...

Ovarian Tumor Growth Slowed By Nanoparticle-Delivered 'Suicide' Genes

Nanoparticle delivery of diphtheria toxin-encoding DNA selectively expressed in ovarian cancer cells reduced the burden of ovarian tumors in mice, and researchers expect this therapy could be tested in humans within 18 to 24 months, according to a report in Cancer Research, a journal of the American Association for Cancer Research.

Endourology - Clinical Trials Evaluating The Role Of Alpha Blockers In Patients With Ureteral Calculi

ORLANDO, FL (UroToday.com) - (Annual Meeting of the American Urological Association) There were several clinical trials evaluating the role of alpha blockers in patients with Ureteral calculi. Alpha blockers did not seem beneficial for patients with untreated Ureteral calculi. However, alpha blockers did improve stone passage in patients who had ureteroscopic manipulation/laser therapy of the Ureteral stone.

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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ChemoCentryx's Traficet-EN(TM) Phase II/III Induction Phase Data In Crohn's Disease To Be Featured In Oral Presentation At 2009 Digestive Disease Week

ChemoCentryx, Inc., announced that data from the company's PROTECT-1 (the Prospective Randomized Oral Therapy Evaluation in Crohn's disease Trial) Phase II/III clinical trial of Traficet-EN(TM) (CCX282-B) in patients with moderate-to-severe Crohn's disease will be presented in an oral session at the upcoming 2009 Digestive Disease Week (DDW) meeting.

Study To Examine Effects Of Minimal Weight Gain During Pregnancy For Obese Women

An upcoming four-year trial called the Healthy Moms study will attempt to keep obese women from gaining any weight during their pregnancies to determine whether restricting weight gain can improve pregnancy outcomes, the New York Times reports. According to the Times, one-fifth of pregnant women in the U.S. are obese...

Poniard Pharmaceuticals Announces Pivotal Phase 3 SPEAR Trial Of Picoplatin In Small Cell Lung Cancer Did Not Meet Primary Endpoint

Poniard Pharmaceuticals, Inc. (Nasdaq: PARD) announced that its pivotal Phase 3 SPEAR (Study of Picoplatin Efficacy After Relapse) trial of picoplatin in the second-line treatment of small cell lung cancer (SCLC) did not meet its primary endpoint of overall survival. The analysis, based on 320 evaluable events (patient deaths), showed a hazard ratio of 0.82 with a p value of 0.089. "We are disappointed that the trial did not meet the primary endpoint.

The Best CROs bring a “big picture” Perspective

The key benefit of having a full service CRO is their ability to asses and expand risk management and to encompass a broader range of risk issues. The best CROS tend to have the communication skills required to influence the board, managers and employees responsible for making the day to day ...
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Heart Valves Implanted Without Open-Heart Surgery

An innovative approach for implanting a new aortic heart valve without open-heart surgery is being offered to patients at NewYork-Presbyterian Hospital/Columbia University Medical Center. Known as the PARTNER (Placement of AoRTic traNscathetER valves) trial, this Phase 3 multicenter study is being led by national co-principal investigators Dr. Martin Leon and Dr.

MAQUET Cardiovascular Announces Long-Term Follow-Up Data From Landmark 'SMART' Study Reinforce Positive Results For Patients Undergoing OPCAB

MAQUET Cardiovascular LLC, a leading provider of cardiovascular technologies, announced that long-term results from the landmark SMART (Surgical Management of Arterial Revascularization) study will be presented tomorrow to attendees of the Society of Thoracic Surgeons's 46th Annual Meeting by John Puskas, M.D...

Roche, Genentech And Biogen Idec Announce Positive Results From First Phase III Trial Of Ocrelizumab In Rheumatoid Arthritis

Roche (SIX: RO, ROG; OTCQX: RHHBY), Genentech, Inc...

ClinQua Inc. : The overall cost of clinical trials depends on an array of factors

In a progressive global market of supply and demand, it remains unthinkable to engage in practices that are ambitiously over-priced when there are endless opportunities to utilize more cost-efficient methods which would yield the same results. As per Mr. David Mills former ClinQua Clinical ...
(613) 686-5745 Cerepotec Pharmalef

Cerimon Pharmaceuticals Initiates Phase III Clinical Studies To Evaluate Its Topical Diclofenac Sodium Patch For Mild-to-Moderate Pain

Cerimon Pharmaceuticals, Inc., announced the Company has enrolled its first subjects in its once-daily topical diclofenac sodium patch Phase III program. The program consists of three randomized, double-blind, placebo-controlled Phase III clinical studies with Cerimon's diclofenac patch.

DURECT Reports Positive Phase IIb Data From POSIDUR(TM) Clinical Program

DURECT Corporation (Nasdaq: DRRX) announced positive results from a 60 patient Phase IIb clinical trial of POSIDUR(TM), a proprietary product under development for the treatment of post-surgical pain...

GE Healthcare Presents Positive Phase 2 Data With Flutemetamol - Phase 3 Program Now Underway

GE Healthcare will today present results from its multicenter phase 2 study of flutemetamol at the 4th annual Human Amyloid Imaging (HAI) Meeting in Toronto, Canada. Flutemetamol is a positron emission tomography (PET) imaging agent in development by GE Healthcare, in the field of brain imaging...

Anestvice Pressure Controller (APC), is build to maintain the pre-set constant pressure in the cuff throughout the surgery despite of the factors influencing and/or altering this parameter.

Anestvice (www.anestvice.com ) Pressure Controller (APC) is designed for massive use for improvement of patient safety during all kinds of surgical procedures with the use of Laryngeal Mask (LM) and Endotracheal Tube (ETT) . Use of this device doesn’t require any specific knowledge or ...
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Vitamin E May Decrease And Increase Mortality Of Male Smokers With High Dietary Vitamin C Intake

Six-year vitamin E supplementation decreased mortality by 41% in elderly male smokers who had high dietary vitamin C intake, but increased mortality by 19% in middle-aged smokers who had high vitamin C intake, according to a study published in the American Journal of Epidemiology. Large-scale controlled trials have not found any overall effects of vitamin E supplementation on the mortality of participants.

FDA Grants Priority Review Of Pirfenidone NDA For The Treatment Of Patients With IPF

InterMune, Inc. (Nasdaq: ITMN) announced that the U.S. Food and Drug Administration (FDA) has accepted for review and granted Priority Review designation for the company's New Drug Application (NDA) for pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis (IPF)...

New Updates To AHA/ACC/SCAI Clinical Guidelines Recommend Treatment With Effient(R) For Patients With Acute Coronary Syndromes Managed With PCI

Effient(R) (prasugrel) tablets, a new antiplatelet medicine, was added as a treatment option in two clinical guideline updates: one for patients receiving percutaneous coronary intervention (PCI) and a second one for patients with ST elevation myocardial infarction (STEMI), or severe heart attack.

Anestvice Pressure Controller (APC) – device for maintaining of precisely set pressure in the cuff of Laryngeal Mask (LM) and Endotracheal Tube (ETT) during the surgery

Anestvice ( www.anestvice.com )Pressure Controller (APC) – device for maintaining of precisely set pressure in the cuff of Laryngeal Mask (LM) and Endotracheal Tube (ETT) during the surgery. During the surgery pressure in the cuff may fluctuate, thereby endangering the patient. Currently ...
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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...

Vertex Pharmaceuticals Highlights Cystic Fibrosis Program Targeting The CFTR Protein Responsible For Cystic Fibrosis

VX-770 Based on data presented to date, Vertex intends to work with global regulatory authorities on the design of a registration program for VX-770 which, if agreed upon, could begin in the first half of 2009.

Cannabis Science Moves Its FDA Clinical Trial Process Forward

Cannabis Science Inc. (NASD OTCBB: CBIS), a pharmaceutical cannabis company, is pleased to report to their shareholders that the choice of our initial cannabis-based pharmaceutical for FDA clinical trials has been made. The Company has reported several possible drugs for FDA clinical trials...

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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Key Insights Into Locally Advanced Breast Cancer Offered By I-SPY Trial

Scientists are reporting two findings that could influence the way researchers screen for, treat and assess prognosis for women with locally advanced breast cancer, an aggressive form of the disease. One finding offers a critical message regarding treatment strategy, they say.

MAP Pharmaceuticals Announces Phase 3 Study Of Unit Dose Budesonide In Children With Asthma Did Not Meet Primary Endpoints

MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) announced results of its initial Phase 3 clinical trial of Unit Dose Budesonide (UDB) for the potential treatment of children with asthma. The Company announced that the clinical trial did not meet its co-primary endpoints, asthma control as assessed by changes from baseline in nighttime and daytime composite symptom scores, in either of the doses evaluated, when compared with placebo.

BioSante Pharmaceuticals Reports Positive LibiGel Safety Data In Phase III Program

BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), announced positive safety data yesterday in its ongoing LibiGel Phase III clinical development program. BioSante reported that with over 1,250 women enrolled and almost 825 women-years of exposure in its LibiGel Phase III clinical development program, there have been no deaths and only five cardiovascular events. This analysis of blinded data indicates a very low cardiovascular event rate has occurred thus far.

Over the past few years, CROs have received the lion's share of outsourced clinical research revenue.

CROs were first organized as outsourcing service companies that provided only clinical trial management. Today, many CROs have expanded their scope of services to provide comprehensive management of the complex drug trial processes for their client companies, as well as providing access to ...
(613) 686-5745 Cerepotec Pharmalef

Mesoblast Limited (ASX:MSB) Gains US FDA Clearance For Phase 2 Trial Of NeoFuse In Minimally Invasive Lumbar Spinal Fusion Surgery

Australian regenerative medicine company, Mesoblast Limited (ASX:MSB)(PINK:MBLTY), announced that it has received clearance from the United States Food and Drug Administration (US FDA) for a Phase 2 clinical trial of its allogeneic or "off-the-shelf" adult stem cells in minimally invasive lumbar spinal fusion surgery.

Ariad Presents Preclinical Data On Deforolimus And Bicalutamide In Androgen-Independent Prostate Cancer

ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today presented preclinical data on the investigational mTOR inhibitor, deforolimus, alone or in combination with the anti-androgen agent, bicalutamide, in models of prostate cancer. This investigational study shows that the combination inhibits the growth of prostate cancer cell lines in various model systems.

IU Simon Cancer Center Researchers' Breast Cancer Trials Offer Recognized Potential To Improve Treatment, Survival

Two breast cancer clinical trials led by Indiana University Melvin and Bren Simon Cancer Center researchers are among 13 selected by a national panel as having the greatest potential to improve treatment and survival. The Coalition of Cancer Cooperative Groups (CCCG) recently convened a panel of breast cancer experts who included clinical trials led by Kathy Miller, M.D., and Victoria Champion, R.N., D.N.S., among the 13 promising phase III breast cancer research studies.

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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Sorafenib Treatment Appears To Benefit Older Renal Cancer Patients

Older and younger patients with renal cancer derive similar benefit from sorafenib therapy and tolerate the drug equally well, according to a study published online October 7 in the Journal of the National Cancer Institute. Although the risk of being diagnosed with cancer increases with age, relatively few older patients participate in clinical trials.

Cancer Drug Development Could Benefit From Improved Rodent Trials

Better design of rodent trials could reduce the cost and time required for cancer drug development, according to a commentary in the October 28 online issue of the Journal of the National Cancer Institute. Cancer drug development is a multistep process that involves in vitro tests, animal studies - often with rodent models of disease - and human clinical trials. Inadequately designed rodent studies have led to missteps and delays in previous drug development programs.

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.

Clinproxy is on the leading edge of adaptive clinical trials.

Clinproxy, www.clinproxy.com believes that adaptive clinical trials can drastically reduce the cost, time and subject drug exposure of clinical development. Classical clinical trials are planned with extreme dutiful details but once initiated fails to acknowledge that changes often need to be ...
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ONGLYZAT Significant Improvements Across Key Measures Of Glucose Control When Added To A Sulfonylurea Or Thiazolidinedione

Results from two 24-week Phase III studies presented at the 44th European Association for the Study of Diabetes Annual Meeting demonstrated that ONGLYZAT (saxagliptin), an investigational selective inhibitor with extended binding to the dipeptidyl peptidase-4 (DPP-4) enzyme in development b

New IDEAL IMPLANT Is The Next Breast Thing, Combining Natural Results And Safety Of Saline

Like many women, Teri did her research before making the decision to undergo breast augmentation. As a health-conscious mother seeking a better fit in her clothes, she was dissatisfied with the current breast implant choices of saline for safety or silicone gel for a more natural look, yet with bothersome potential risks.


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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