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Indevus Announces Initiation Of Phase III Clinical Trial Of Octreotide Implant For Acromegaly

Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV) announced the initiation of a Phase III clinical trial of the Company's novel octreotide implant for acromegaly. This trial is designed to test the efficacy, safety and tolerability of the octreotide implant in patients with acromegaly. The implant utilizes the Company's patented HYDRON(R) Polymer Technology to deliver effective levels of octreotide for six months.

Orexigen(R) Therapeutics Presents Data On Its Proprietary Formulation Of Naltrexone Sustained Release (SR) Used In Contrave(R)

Orexigen Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity and other central nervous system-related disorders, presented data showing the investigational drug, Contrave(R) (naltrexone SR / bupropion SR), successfully achieved key objectives (lowered naltrexone Cmax, increased Tmax, comparable AUC) in two Phase 1 clinical trials.

Anavex Presents Neuroprotective Effects Of Anavex 1-41 At The International Conference On Alzheimer's Disease 2008

ANAVEX Life Sciences Corp. (OTCBB: AVXL), a biopharmaceutical company engaged in the discovery and development of novel therapeutics to treat Central Nervous System (CNS) diseases and cancer, presented data from the company's novel compound, ANAVEX 1-41, targeting Alzheimer's disease, at the International Conference on Alzheimer's Disease (ICAD) 2008, Chicago, USA, July 26 to 31, 2008.

ClinQua Inc: Regulatory Agencies Do Not Require Clinical Trials To Be Expensive!

Mr. David Mills former ClinQua Clinical Trials Inc. www.clinqua.com executive argues that the inevitable burden of clinical investigation is cost, and unfortunately, the weight of that burden falls onto consumers...
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Prasugrel Significantly Reduced New Or Recurrent Heart Attacks In Both Acute And Longer-Term Settings Following PCI, Compared With Clopidogrel

A sub-analysis of the TRITON-TIMI 38 clinical trial showed that treatment with prasugrel compared with clopidogrel significantly reduced the risk of new or recurrent heart attacks (7.4 percent vs. 9.7 percent, p

Innocoll Receives Fast Track Designation For Gentamicin Surgical Implant

Innocoll, Inc., a privately-held biopharmaceutical company, announced that the FDA has designated Gentamicin SURGICAL Implant as a Fast Track development program. GENTAMICIN SURGICAL IMPLANT is currently being evaluated in two phase III clinical trials as an adjunct to systemic antibiotic administration for the prevention of surgical site infections in patients who are at higher risk of developing surgical site infections.

Springer Launches Content Solutions For Industry

Springer Science+Business Media has announced the release of Springer Content Solutions for Industry, which features customized collections of professional, scientific, technical and medical books, journals, reference works and protocols specifically organized for the needs of companies heavily active in research, development and marketing activities.

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 dollars that they would seek individuals and companies that had the professionals, resources, and capacity to minimize overhead costs and the time needed to bring a drug to the market.
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Getting To Grips With The Complexity Of Disease Proteins

Drug molecules seldom act simply on one protein but on protein complexes and networks. A deeper understanding of these 'cooperative assemblies' should lead to better targeting of drugs New research into how proteins in human cells interact and 'talk' to each other is leading to a better understanding of how drug molecules work and should result in more effective therapies, according to a leading European scientist.

CMS Behind In Medicare Pricing Audits That Help Federal Government Prevent Pricing Fraud, GAO Report Finds

CMS has not completed the majority of its scheduled audits of 2006 drug pricing information, which could hinder the government in recognizing and preventing pricing fraud in the Medicare prescription drug benefit, according to a Government Accountability Office report released on Friday, CongressDaily reports.

Oxford Researchers Give Protein Production More Precision

Oxford researchers have developed a new technique to prepare proteins for use as therapeutic drugs. The technology, which represents a significant step forward from current production methods, will enable the development of purer and more effective protein-based drugs. Therapeutic proteins are currently prescribed for the treatment of cancer, heart attacks, cystic fibrosis, strokes, diabetes, anaemia and haemophilia.

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

Kriger Research Group International www.krigerclinical.com provides clinical research services for pharmaceutical and biotechnology product development from phase II through phase IV for US, Canadian, European and multinational pharmaceutical companies. KRGI is your way to high quality design, conduct and analysis of clinical trials.
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Pharma Sales Executives Meet At Annual Summit To Exchange Sales Force Effectiveness Best-Practice, Network

The Russian-CIS pharmaceutical market is exploding. PriceWaterhouseCooper records suggest that the Russian Pharmaceutical market is growing by over 1/3 every year. This growth creates new challenges. How do you make your Sales Force more effective and not just larger to ensure long-term success? The Sales Force Effectiveness Summit, October 7-8, Moscow, addresses these issues head-on and presents best practices in meeting these challenges.

The Future Of Human Insulin: Tailored And Oral

The Business Intelligence firm La Merie S.L. conducted an analysis of the product portfolios and R&D pipelines of human insulin-based products. The study revealed that three companies dominate the worldwide insulin market, but experience more and more competition in volume sales of insulin by local manufacturers in off-patent countries, especially in China, India and Russia. The worldwide market of the major human insulin products in 2007 was US$ 10.2 bln.

Abbott Agrees To Settle Lawsuit Over Price Of Antiretroviral Norvir

Abbott Laboratories on Wednesday agreed to pay between $10 million and $27.5 million to settle an antitrust lawsuit filed by HIV/AIDS advocates and other drug companies over an increase in the price of the company's antiretroviral drug Norvir, the

Primarily, problems arise between sponsors and CRO-s when there are fundamental breakdowns in the delegation of responsibilities

As per ClinQua Inc. www.clinqua.com relationships exist on all levels of clinical development. Primarily, problems arise when there are fundamental breakdowns in the delegation of responsibilities or rather when someone is given control over a critical area when they are otherwise unqualified.
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GPhA Praises California Governor Schwarzenegger For Signing Workable E-Pedigree System

The Generic Pharmaceutical Association (GPhA) today praised California Governor Arnold Schwarzenegger for signing into law legislation that will establish an electronic pedigree system in California aimed at helping to maintain the security of the drug distribution chain against counterfeit drugs.

Indian Generic Drug Company Cipla Receives FDA Approval For U.S. Sale Of Antiretroviral Zidovudine

Indian generic pharmaceutical company Cipla recently received full FDA approval to sell and market in the U.S. an oral generic version of the antiretroviral drug zidovudine, the Drug Industry Daily reports. Cipla's application for zidovudine was considered under the expedited review provisions of the

Phase III Clinical Studies Of Aclidinium Bromide Show Statistical Significance Vs. Placebo In Patients With Chronic Obstructive Pulmonary Disease

Forest Laboratories, Inc. (NYSE: FRX) and Laboratorios Almirall, S.A. announced results from two global Phase III studies of aclidinium bromide, a novel long-acting inhaled anticholinergic for the treatment of patients with chronic obstructive pulmonary disease (COPD).

Anestvice Inc. Phase II Clinical Trials for PC-LM Device have been successfully completed.

The research was conducted on 24 patients ranging in age from 13 to 74 years (the average age was 46.6 ±5.4), who underwent surgery in the urology clinic of the Rostov State Medical University. It was sponsored by Anestvice Inc...
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More Than 500 Backlogged Whistle-Blower Cases Allege Health Care, Drug Company Fraud

Whistle-blower lawsuits alleging that pharmaceutical companies and government contractors defrauded the federal government have created a backlog of more than 900 cases at the Department of Justice, the Washington Post reports.

Merck Serono Launches Expansion Of Flagship Biotech Center To Meet Growing Patient Needs

Merck Serono, the division for innovative pharmaceuticals of Merck KGaA, Darmstadt, Germany, today held a cornerstone ceremony at the Merck Serono Biotech Center (MSBC), its production site in Corsier-sur-Vevey, Switzerland, to mark the expansion of the site.

Statement By Merck & Co., Inc., In Response To The FDA's Update Regarding A Safety Review On Bisphosphonates Including FOSAMAX®

The FDA announced its update on the safety review of bisphosphonates, including FOSAMAX®, that found no clear association between overall bisphosphonate exposure and the rate of serious or non serious atrial fibrillation. Increasing dose or duration of bisphosphonate therapy was also not associated with an increased rate of atrial fibrillation. These findings are based on the Agency's review of data from clinical studies of bisphosphonates.

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.
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USP's 2008 Annual Scientific Meeting To Convene Scientific Experts From Around The World

The U.S. Pharmacopeial (USP) Convention's 2008 Annual Scientific Meeting (ASM) will be held in Kansas City, Mo., September 24 to 26. The meeting is an opportunity to interact with the USP experts responsible for establishing internationally recognized standards for prescription and over-the-counter medicines, food ingredients and dietary supplements. The focus will be on Quality of Manufactured Medicines, Food Ingredients and Dietary Supplements.

Finalists Nominated For The 2008 European Biotechnica Award

The three finalists of the 2008 EUROPEAN BIOTECHNICA AWARD have been determined. The biotechnology companies nominated are Cambridge-based Astex Therapeutics Limited (UK), GENEART AG from Regensburg (Germany) and immatics biotechnologies GmbH based in Tübingen (Germany). The prize, worth EUR 100,000, is awarded to innovative European biotechnology and life sciences companies.

Prometheus Presents New Clinical Insights Into Diagnosis Of Crohn's Disease In Children From Analysis Of PROMETHEUS(R) IBD Serology 7 Test Results

Prometheus Laboratories Inc., a specialty pharmaceutical and diagnostic company, announced new findings regarding the correlation between serologic markers and the diagnostic predictions of children with Crohn's disease following an analysis of PROMETHEUS(R) IBD Serology 7 test results.

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...
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ESF Study Helps Stop Drugs Slipping Through Safety Net

Recent advances in genetic screening will lead to safer pharmaceutical drugs, with reduced adverse side effects, if the methods are incorporated in clinical development. A rallying call to bring key scientists into this growing field of pharmacogenics, the application of genetics to drug development and safety, was made recently at a major conference organized by the European Science Foundation (ESF) in collaboration with the University of Barcelona.

Women's Contraceptive Perceptions And Realities Don't Match Up

Women's feelings and behaviors concerning contraception are conflicted, yet many don't seek out methods that could better satisfy their needs, according to a new survey conducted on behalf of Schering-Plough by Harris Interactive(R).

Redpoint Bio Develops Method Of Measuring And Classifying Bitterness In Broad Range Of Orally Aversive Pharmaceuticals

Scientists at Redpoint Bio Corporation (OTCBB: RPBC) have developed a quantitative method to measure and classify the bitter or bad taste of frequently used medicines. The work points to approaches that have the potential to reduce or eliminate the aversive flavor of many widely prescribed orally-dosed drugs. The findings appear in the October 2008 issue of the peer-reviewed journal Behavioural Pharmacology.

Clinical Research Professionals are Still in Demand despite the World Economic Crisis

Despite the world economic crisis, the clinical research field is currently expanding faster than the introduction of newly qualified professionals that inevitably creates a demand. Most people are under the impression that the barriers to enter this industry are extremely difficult to overcome, but the truth is that everybody working in this industry had to start somewhere and as the industry grows positions need to be filled.
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CIMZIA(R) (Certolizumab Pegol) Provides Rapid And Sustained Relief From Signs And Symptoms Of Rheumatoid Arthritis For Two Years

UCB announced results from several Phase III clinical trials evaluating CIMZIA(R) (certolizumab pegol) - the only PEGylated anti-TNF (Tumor Necrosis Factor) - presented at the American College of Rheumatology (ACR) Annual Scientific Meeting.

Ugandan Pharmaceutical Company To Produce Drugs Aimed At Preventing Mother-to-Child HIV Transmission

The Ugandan pharmaceutical company Quality Chemicals later this year will begin producing antiretroviral drugs aimed at preventing mother-to-child HIV transmission in the country, George Baguma, the company's director of marketing, announced on Tuesday, the Monitor/AllAfrica.com reports.

GlaxoSmithKline, Novartis Found Guilty Of Overcharging Alabama Medicaid Program, Must Pay State $114M

An Alabama state court jury on Tuesday found pharmaceutical companies GlaxoSmithKline and Novartis guilty of defrauding the state Medicaid program by charging artificially high prices for medications and ordered the two companies to pay more than $114 million in restitution, the

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

Damage to the nervous system may result from traumatic injury, such as penetrating or blunt trauma, stroke, or neurodegenerative disorders such as Alzheimer's disease, Parkinson's disease, Huntington's disease, amyotrophic lateral sclerosis (ALS), diabetic neuropathy or senile dementia...
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Urodynamix And Pfizer Inc. Collaborate On Urologist Program

Urodynamix Technologies Ltd. (TSX-V:URO) announced that it has entered into an agreement with Pfizer Inc. to collaborate on a series of promotional programs to increase awareness of UroNIRS(TM) Bladder Monitor technology among urologists and medical professionals.

GTCbio Announces Its Biomarker Discovery Europe Conference On October 2-3, 2008 In Dublin, Ireland

GTCbio just announced the 3rd edition of its Biomarker Series - the Biomarker Discovery Europe Conference - taking place on October 2-3, 2008 in Dublin, Ireland. Over the last several years, biomarkers have been an increasingly important and a heavily researched topic at all of the leading pharmaceutical and biotech companies worldwide.

Mpex Pharmaceuticals Announces Initiation Of A Phase 2 Clinical Trial Of Aerosol MP-376 In COPD

Mpex Pharmaceuticals, Inc. announced that it has initiated a Phase 2 clinical study with MP-376 for use as a maintenance therapy in reducing the incidence of pulmonary exacerbations in patients with chronic obstructive pulmonary disease (COPD). MP-376 is the company's novel formulation of levofloxacin inhalation solution. The Phase 2, U.S.

Espoir Bridge Recruiters has a well established database of over 60,000 candidates all over the world

Espoirbridge www.espoirbridge.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.
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Clinical News From Annals Of Internal Medicine

Vitamin D Deficiency Puts Older Women at Risk for Hip Fracture Previous studies of the effect of low blood vitamin D levels on the risk for hip fractures in older women have given inconsistent results. In this study, researchers took blood to measure vitamin D levels and gathered information about fracture risk from 800 women between the ages of 50 and 79. After following the women for up to nine years, the researchers re-examined them to see who developed hip fractures.

Attorney General Martha Coakley And 33 Other Attorneys General Announce $60 Milion Settlement With Pfizer

Today, Attorney General Martha Coakley's office, along with 33 other Attorneys General, reached a $60 million settlement with Pfizer Inc., resolving a five-year investigation into allegations of improper marketing of the drugs Bextra® and Celebrex®.

Transdel Enrolls First Patient For Ketotransdel(TM) Phase 3 Clinical Trial

Transdel Pharmaceuticals, Inc. (OTC Bulletin Board: TDLP), a specialty pharmaceutical company focused on developing non-invasive, topically administered medications, announced it has enrolled its first patient in the Phase 3 registration trial for Ketotransdel(TM).

Kriger Research Group International joins TrialStat's CROFIRST Program

Worldwide Contract Research Organization (CRO) Deploys ClinicalAnalytics 4.0 for its Clinical Trials
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FDA Approves Low-dose Regimen Of PREMARIN Vaginal Cream To Treat Moderate To Severe Postmenopausal Dyspareunia - Painful Sexual Intercourse

PREMARIN(R) (conjugated estrogens) Vaginal Cream 0.5 g has been approved by the U.S. Food and Drug Administration (FDA) for a new indication and a new less frequent twice-weekly dosing regimen to treat moderate to severe postmenopausal dyspareunia (painful sexual intercourse) announced Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE).

Expanded Indications, Novel Targets Driving Activity In Autoimmune Disease Therapeutics

Already a major therapeutic disease sector accounting for drug sales in excess of $18 billion worldwide, the incidence of autoimmune disease in developed countries is increasing. The impact of autoimmunity on patient quality-of-life is well known, but it has only been in the last ten years with the introduction of biological drugs capable of modulating the immune cascade that effective therapies for this most intractable family of diseases have become available.

Partnership To Develop Next Generation Of HIV Vaccines

Elevation Biotech, a start-up biotechnology company funded by LIFElab, an agency of the South African Department of Science and Technology, and the International AIDS Vaccine Initiative (IAVI), the world's only global non-profit organization dedicated solely to AIDS vaccine development, have partnered to develop the next generation of AIDS vaccine candidates. "An AIDS vaccine remains our best hope for ending AIDS.

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.
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Major Quality Systems Seminar Prescribes The 'Inside Track' To American Pharmaceutical Gmps & Approvals

A major three-day seminar promises everyone involved in the manufacture and supply of pharmaceuticals to the US with an unrivalled opportunity to gain not only exclusive and authoritative insights into the latest Food & Drug Administration's current Good Manufacturing Practice (cGMPs), but also expert advice on the FDA's new product approval review process, the organisation and management of clinical trials, and on effective product marketing.

ViRexx Announces Approvals Of Rights Offering

ViRexx Medical Corp. (TSX:VIR) (AMEX:REX) ("ViRexx"), a company focused on developing innovative-targeted therapeutic products that offer better quality of life and a renewed hope for living.

European Biotech Industry Identifies The Real Culprits Causing Food Price Rises

The European Biotech Industry Association (EuropaBio) questions the premises and the methods used by recent reports, including the recently leaked and unofficial World Bank internal note which claims that 75% of the recent price increase of food is due to increasing demand for biofuel.

Kriger Research Group International joins TrialStat's CROFIRST Program

Worldwide Contract Research Organization (CRO) Deploys ClinicalAnalytics 4.0 for its Clinical Trials
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ViroPharma Announces Presentation Of Cinryze(TM) Data In Acute Treatment Of Hereditary Angioedema

ViroPharma Incorporated (Nasdaq: VPHM) announced the presentation of data from its ongoing, open-label study, showing that in this study Cinryze(TM) C1 inhibitor therapy successfully treated all types of acute hereditary angioedema (HAE) attacks seen in the study through the date of analysis. Patients suffering acute attacks of HAE who were treated with Cinryze experienced improvement in symptoms at a median time of 30 minutes post treatment.

Nuvo Research Presents Positive Phase III Study Results For Pennsaid At Leading Rheumatology Conference

Nuvo Research Inc.

BioReliance Introduces New Protein Array Platform - ReliArrayT - Provides Antibody Detection With Greater Speed, Sensitivity And Scalability

BioReliance announces the introduction of its new protein array platform that offers greater sensitivity, reduced testing time and reliable results. The platform, brand-named ReliArrayT, can simultaneously screen for four non-human pathogens in animal serum. "It is essential to researchers that they can depend on the results of serological screenings. These tests ensure that their research animals are healthy and will keep their research results uncompromised.

ClinQua Inc: Regulatory Agencies Do Not Require Clinical Trials To Be Expensive!

Mr. David Mills former ClinQua Clinical Trials Inc. www.clinqua.com executive argues that the inevitable burden of clinical investigation is cost, and unfortunately, the weight of that burden falls onto consumers...
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New National Patient And Surgeon Surveys Show Post-Surgical Care Critical To Optimal Weight Loss After Bariatric Surgery

Those patients who were most compliant with surgeon recommendations after bariatric surgery lost 35 percent more weight the first year and tend to keep more weight off even after five years, according to new patient and bariatric surgeon surveys conducted by Harris Interactive(R), for the American Society for Metabolic & Bariatric Surgery (ASMBS).

Spellex Releases Spellex Biotech V.2008, New Upgrade Of The World's First Bioscience Spell Checking Software

Spellex Corporation announces the new release of the 2008 version of their popular bioscience spelling software for Microsoft and other programs. The new release includes more than 210,000 specialty words from the bioscience industry and new spelling engine enhancements. Benefits: The Spellex Biotech spelling dictionary allows users to save time and increase their accuracy.

Napo Announces Positive Clinical Data Indicating Crofelemer, Could Effectively Treat Cholera

Napo Pharmaceuticals (LSE: NAPL/NAPU) announces positive clinical data on the effectiveness of crofelemer from a study for CRO-ID in treating severely ill cholera patients in conjunction with an antibiotic and rehydration therapy. A double-blind placebo-controlled study was conducted in one hundred (100) patients with confirmed severe cholera.

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.
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States Consider Legislation To Restrict Access To Physician Prescribing Information For Data Mining Companies

A number of states have begun to consider legislation that would restrict access to physician prescribing information for data mining companies as part of a "backlash against pharmaceutical marketing efforts," the AP/Arizona Republic reports. Data mining companies, such as

Roche To Stop Antiretroviral Research, Company Says

Pharmaceutical company Roche in a memo circulated last week announced that it will stop research on antiretroviral drugs because of "disappointing results in clinical trials," the Financial Times reports.

Novexel's NXL104/ceftazidime Combination Commences Phase II Clinical Trial In Hospital Patients With Complicated Urinary Tract Infections

Novexel, a speciality pharmaceutical company focused on the discovery and development of novel antibiotics designed to overcome the significant global problem of microbial resistance, announces that its most advanced injectable antibacterial, which combines Novexel's broad spectrum beta-lactamase inhibitor, NXL104, with the well established cephalosporin antibiotic, ceftazidime, has entered Phase II clinical trials.

The World Is Getting Better!

According to Bruce Kriger, CEO of Kriger Research Group International www.kriger.com, leading training institution and clinical research organization, the world is getting better, no matter what critics say.
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European Forum For Industrial Biotechnology, Brussels, Belgium, 15-17 September

The European Forum for Industrial Biotechnology 2008 (EFIB2008) will take place from 15 to 17 September in Brussels, Belgium. Organised by EuropaBio (the European Association for Bioindustries) and IntertechPira, the event will feature two workshops, networking sessions and a two-day forum with approximately 30 leading speakers from biotech research, academia and the industry as well as environmental organisations and the European Commission.

House Members Send Letter To Secretary Of State Rice Requesting Information On Antiretrovirals Supplied To PEPFAR By Ranbaxy

Rep. John Dingell (D-Mich.) and members of the House Committee on Energy and Commerce on Friday sent a letter to Secretary of State Condoleezza Rice requesting information about alleged safety problems with antiretrovirals manufactured by the Indian generic pharmaceutical company Ranbaxy and distributed through the


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 .
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.

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.
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.

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.

This step can be repeated in the future in order to produce more of compound III.
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.

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.

At this moment Cereprotec Inc. www.cereprotec.com is prepared to start clinical trials and is actively seeking serious investors.
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.

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.
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.

This company is also developing a family of other promising novel chemical compounds.

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.
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.

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.
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.

Moreover, oral delivery improves patient compliance, improves treatment, reduces patient inconvenience, and reduces treatment costs.

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.

Clinical trials are expected to begin at a number of centers across the United States, Canada and European Union.
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 distinctive products Pharmalef Developments will introduce several new products in new fields, including Rheumatology, Immunology and Respiratory Diseases.
Pharmalef Developments plays a vital role in proper documenting the drug development process.New drugs are the lifeblood of the pharmaceutical industry. Yet strict testing and documentation requirements mean only one in many drug candidates make it to market.

Pharmalef Developments www.pharmalef.com can play a vital role in documenting the drug development process. By 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.
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.

They entered into many collaborations with leading academic centers, CRO-s and biotechnology companies to complement our in-house R&D capabilities.

They are always interested in forming new partnerships covering early-stage research, novel compounds or technologies and implementation of clinical trials.
CEREPROTEC Method for Neuroprotection with Glycoluril Derivatives Patent Application has been Published September 18, 2008

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

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.

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.

3. The method according to claim 2, wherein R.sub.1 to R.sub.4 each is methyl.

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.

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.

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.

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.

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.

9. The method according to claim 8, wherein said head trauma injury is closed head injury.

10. The method according to claim 6, wherein said injury, disease, disorder or condition is brain damage caused by a cardiovascular event.

11. The method according to claim 10, wherein said cardiovascular event is cardiac arrest or cardiac surgery.

12. The method according to claim 6, wherein said injury, disease, disorder or condition is a cerebrovascular disorder or disease.

13. The method according to claim 12, wherein said cerebrovascular disorder is brain ischemia or stroke.

14. The method according to claim 6, wherein said injury, disease, disorder or condition is a neurodegenerative disease or disorder.

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.

16. The method according to claim 6, wherein said injury, disease, disorder or condition is dementia.

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.

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.

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.

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.

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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