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Galapagos Selects Pre-clinical Candidate Drug For Cachexia

Galapagos NV (Euronext: GLPG) announced that it has selected a candidate drug to enter into pre-clinical development in the Company's cachexia (loss of weight and muscle mass) program. This candidate drug is a small molecule that Galapagos has developed in its Selective Androgen Receptor Modulator (SARM) program and which has demonstrated successful Proof of Concept in animal studies.

Research On Multi-Herb Formula For Respiratory Tract Health Compiled By Herbal Science Group

The nonprofit American Botanical Council (ABC) has just published a monograph summarizing the scientific and clinical studies of Sinupret®, a clinically-tested herbal combination for upper respiratory tract health, including conditions associated with sinusitis and bronchitis. A monograph is a technical paper focusing on one subject.

Meritage Pharma Initiates Phase 2b Clinical Trial Of Oral Viscous Budesonide For Pediatric Patients With Eosinophilic Esophagitis

Meritage Pharma, Inc. announced that it has initiated a dose-ranging Phase 2b clinical trial to evaluate oral viscous budesonide (OVB) for the treatment of children and adolescents with eosinophilic esophagitis (EoE), an allergic inflammatory condition of the esophagus. EoE can cause difficulty in swallowing and heartburn, and in severe cases it can lead to food impaction (food getting stuck in the esophagus) and in children, a failure to thrive (poor growth or weight loss).

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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Poniard Pharmaceuticals Announces Phase 2 Trial Of Picoplatin In Metastatic Colorectal Cancer Meets Primary Endpoint And Study Objectives

Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on innovative oncology therapies, announced final data from a randomized, controlled Phase 2 trial of picoplatin in metastatic colorectal cancer (CRC) patients...

Phase III Study Showed Two Years Of ACTEMRA(R) (tocilizumab) Inhibited Progression Of Joint Damage And Improved Disease Remission

Genentech, Inc., a wholly-owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced two-year results from a Phase III study, which showed that people with rheumatoid arthritis (RA) who received either a 4 mg/kg or 8 mg/kg dose of ACTEMRA® (tocilizumab), in combination with methotrexate, had no progression of joint damage, (75 and 83 percent, respectively, as assessed by radiograph) compared with people who received methotrexate alone (66 percent).

Alternative Therapy For Lupus Nephritis

Lupus is a rare but serious disease that mainly affects women of child-bearing age and occurs when the body's immune system goes awry, damaging a variety of organs. When kidneys are targeted, patients develop lupus nephritis, which can result in kidney failure and death. Lupus nephritis is often treated with the cancer drug cyclophosphamide, which suppresses the immune system but also causes hair loss, nausea, vomiting, and infertility.

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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Educating Physicians About Ventilation-Perfusion Scanning Leads To Reduced Patient Radiation Exposure

Educating physicians about ventilation-perfusion scanning (VQ) as an alternative to CT for the diagnosis of pulmonary embolisms led to a 23% decrease in patient exposure, according to a study performed at Albert Einstein College of Medicine, Montefiore Medical Center in Bronx, NY. "VQ scanning is a nuclear test which shows blood flow to the lung and airflow.

NOXXON Announces Initiation Of First-in-Human Clinical Trial With Hematopoietic Stem Cell Mobilizing Spiegelmer(R) NOX-A12

NOXXON Pharma AG, the biopharmaceutical company focusing on the development of novel drugs based on its unique proprietary Spiegelmer® technology, announced today the successful initial dosing of healthy volunteers in a first-in-human clinical trial with Spiegelmer® NOX-A12. NOX-A12 is NOXXON's second drug candidate entering the clinical stage of development within only five months.

Developing Alzheimer's Disease Model: AAPS And FDA Announce Appointment Of Research Fellow

The American Association of Pharmaceutical Scientists (AAPS) has announced the appointment of Demiana William Faltaos, Ph.D., to the position of Research Fellow at the Oak Ridge Institute for Science and Education (ORISE), where she will begin work this week to develop effective Alzheimer's disease-state models for a 2-year period. Dr. Faltaos' appointment comes at the end of a collaborative effort to recruit and screen scientific candidates for the position by AAPS and the U.S.

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

The title of Clinical Research Associate is deceiving to some degree. Many people think of “associate” as a secondary low paying job. “Clinical Monitor” is a title that better describes what CRA job entails. A clinical research associate does not, in fact, assist anyone; the associate ...
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Experimental Drug For Multi-Drug Resistant TB Shows Promise In Trial

When added to the mix, a new experimental drug known as TMC207 appeared to make a cocktail of background drugs five times more powerful in successfully treating patients with multidrug resistant tuberculosis (MDR-TB). The study is published in the 4 June issue of the New England Journal of Medicine, NEJM and was the work of Dr David McNeeley and colleagues. McNeeley works for Tibotec, the subsidiary of Johnson & Johnson that is developing the drug.

Antidepressants: Benefit Of Reboxetine Not Proven

There is no scientific proof that people suffering from depression can benefit from taking reboxetine. However, clinical trials do provide proof of benefit of bupropion XL and mirtazapine: both agents can alleviate symptoms. This is the conclusion of the final report of the Institute for Quality and Efficiency in Health Care (IQWiG) published on 24 November 2009.

Unnecessary Regulation Harming Clinical Research In The UK, Say Experts

Increasing bureaucracy is the biggest single threat to clinical research in the UK and urgent action needs to be taken, argue experts on bmj.com today. European legislation introduced in 2001 was intended to simplify and harmonise the regulation of trials across the European Union. But it has led to long delays in approval, is "poorly coordinated, lacks inconsistency at all levels, and at times is completely illogical", write Professors Morris Brown and Paul Stewart.

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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FDA Approves First Hepatitis B Viral Load Test

The U.S. Food & Drug Administration (FDA) has approved the Roche COBAS(R) TaqMan(R) HBV Test, the first assay for quantitating Hepatitis B Virus DNA approved in the U.S. The test uses Roche's real-time PCR technology to quantify the amount of Hepatitis B virus DNA in a patient's blood. Doctors may use viral load testing results to establish a baseline level of infection and during treatment as an aid in assessing individual responses to therapy.

More Patients With Early Erosive Rheumatoid Arthritis Treated With ORENCIA(R) And Methotrexate Achieved DAS28 (CRP)-Defined Remission Versus MTX Alone

Bristol-Myers Squibb Company (NYSE: BMY) today announced results from a Phase IIIb study in adult patients with early moderate-to-severe erosive rheumatoid arthritis (RA) who had never received previous methotrexate (MTX) treatment. This study showed that ORENCIA® (abatacept) in combination with MTX had significantly more patients achieve a Disease Activity Score 28 using C-reactive protein [DAS28 (CRP)]-defined remission, compared with MTX plus placebo (PBO) (41.4 percent versus 23.

Multidisciplinary Cancer Congress

ECCO 15 - ESMO 34 will take place at the ICC Berlin - Internationales Congress Centrum, Messedamm 22, D-14055 Berlin, Germany (http://www.icc-berlin.de) from Sunday 20 September to Thursday 24 September 2009. ECCO 15 - ESMO 34 will build on the success of the previous ECCO (European Cancer Conference) and ESMO (European Society for Medical Oncology) conferences.

The World Is Getting Better!

According to Bruce Kriger, CEO of Kriger Research Group International www.kriger.com, leading training institution and clinical research organization, the world is getting better, no matter what critics say. Today’s life expectancy is the highest in human history. In Western countries, we ...
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Bayer And Onyx Initiate Phase 3 Trial Of Nexavar In Patients With Non-Responsive Thyroid Cancer

Bayer HealthCare Pharmaceuticals, Inc. and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) announced the companies have begun enrolling patients in an international Phase 3 trial to evaluate Nexavar® (sorafenib) tablets for the treatment of patients with radioactive iodine-refractory, locally advanced or metastatic differentiated thyroid cancer. This Phase 3 trial was started based on the results from Phase 2 clinical trials evaluating Nexavar in patients with advanced thyroid cancer.

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.

Neuronetrix Announces Preliminary Alzheimer's Study Results At The Society For Neuroscience Conference

Last week, at the Society for Neuroscience Conference in Washington DC, Neuronetrix announced preliminary results from a clinical study of their COGNISION(TM) System to diagnose Alzheimer's disease. The study was performed with Alzheimer's patients at the University of Kentucky's Sanders-Brown Center for Aging. The COGNISION(TM) System uses event-related potentials (ERP) to record brain activity while the patient listens to a sequence of sounds.

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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Experimental Breast, Lung Cancer Drug Shows Promise Against Prostate And Brain Cancers

US researchers have completed two preclinical studies, one on isolated human cells and the other on rodents, that concluded an experimental breast and lung cancer drug shows promise against prostate cancer, and glioblastoma, a type of brain cancer...

NIH Grant To Study Obesity Prevention In New Immigrants

Tufts University has received a grant from the National Institutes of Health (NIH) to design an obesity prevention program for new immigrants. Led by Principal Investigator Christina D. Economos, PhD, the clinical trial will randomize more than 400 mothers and their elementary school age children living in Somerville, Mass., and follow them for two years.

Theravance Announces Positive Phase 2 Clinical Results In The MABA Respiratory Program For The Treatment Of COPD

Theravance, Inc. (NASDAQ: THRX) announced the positive results from a Phase 2 study of the lead investigational compound GSK961081 ('081) in the inhaled bifunctional muscarinic antagonist-beta2 agonist (MABA) program. The MABA program was licensed to GlaxoSmithKline (GSK) in 2005 under the terms of the companies' Strategic Alliance Agreement as a potential treatment for patients with chronic obstructive pulmonary disease (COPD).

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

Clinproxy, www.clinproxy.com is a CRO (Contract Research Organizations), who specializes in evaluating the burden of the trial and eliminating surplus protocols by focusing the Investigator on aspects critical for validating the drug’s remedial benefits. Efficiency is all about resource ...
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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...

Exsulin Corporation Announces Publication Of Phase 2 Trial Results For Novel Islet Regeneration Treatment In Type 1 & Type 2 Diabetes

Exsulin Corporation announced milestones achieved and immediate plans to move forward as a well supported Minnesota-based company dedicated to the development of regeneration therapies for the treatment of diabetes mellitus. Exsulin's focus is on development of a drug with potential to become a breakthrough therapy for patients suffering from type 1 (T1DM) and type 2 diabetes (T2DM).

Genetic Immunity, InPlay Completes Patient Enrollment In Phase II Trial Of DermaVir Patch HIV Immunotherapeutic Nanomedicine Lead Product Candidate

Power of the Dream Ventures, Inc. (OTCBB: PWRV), Hungary's premier technology acquisition and development company, is pleased to present this Genetic Immunity release, based on a previously announced agreement whereby Power of the Dream Ventures will issue communications for Genetic Immunity on a going forward basis.

Kriger Research Group International joins TrialStat's CROFIRST Program

July 9, 2008, OTTAWA, ON - TrialStat Corporation, the industry's first clinical data solutions on demand company, today added Kriger Research Group International (KRC), a worldwide CRO specializing in the bio-medical field, to its CROFirst Program. The enhancements of TrialStat's CRO channel ...
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Bioniche Phase II Bladder Cancer Trial Results Published In The Journal Of Urology

Bioniche Life Sciences Inc. (TSX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, announced that The Journal of Urology has published an article summarizing the Phase II clinical trial results for the Company's proprietary Mycobacterial Cell Wall technology in bladder cancer.

GenVec Announces Interim Survival Data In Pivotal Trial Of TNFeradeT In Locally Advanced Pancreatic Cancer

GenVec, Inc. (Nasdaq:GNVC) announced today top-line results of an interim analysis from its ongoing Phase III Pancreatic Cancer Clinical Trial with TNFeradeT (PACT) in patients with locally advanced pancreatic cancer. This interim analysis of overall survival, conducted after the 92nd death (one-third of total expected events), was designed to determine whether the study should continue and took place in the time frame originally estimated.

Herceptin Now Approved In The EU For Patients With HER2-positive Advanced Stomach Cancer

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the European Commission has approved Herceptin (trastuzumab) in combination with chemotherapy for use in patients with HER2-positive metastatic stomach (gastric) cancer...

CROs in the new millennium

The Clinical Research Organization industry has reached a new level of development in clinical trials. There are now more than twelve hundred CROs with the greatest number existing in Europe, followed by North America and Asia. With research and development costs at an all time high, product ...
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Hollis-Eden Presents New Interim Data From Prostate Cancer Phase I/II Clinical Studies Of Apoptone (HE3235) At AACR Molecular Targets Conference

Hollis-Eden Pharmaceuticals, Inc. (Nasdaq: HEPH), reported preliminary results of its ongoing Phase I/II clinical trial with Apoptone® (HE3235) for hormone-resistant prostate cancer (also called castrate-resistant prostate cancer or CRPC).

AlphaRx Presents Positive Preclinical Data On Zysolin(TM) Inhalable Nanoparticles At Controlled Release Society Annual Meeting

AlphaRx, Inc. (OTCBB: ALRX) announced positive preclinical results which demonstrated that an inhaled tobramycin nanoparticle (Zysolin(TM)) formulation was a more effective treatment in animal models of acute Pseudomonas aeruginosa pneumonia when compared to inhaled and injected conventional tobramycin solutions. The data was presented recently in an oral podium session at the 36th Annual Meeting and Exposition of the Controlled Release Society in Copenhagen, Denmark.

New Biological Therapy Ilaris(R) Approved In US To Treat Children And Adults With CAPS, A Serious Life-Long Auto-Inflammatory Disease

The U.S. Food and Drug Administration (FDA) has approved Ilaris(R) (canakinumab) for the treatment of children and adults with cryopyrin-associated periodic syndrome (CAPS), which includes a number of rare, but life-long, auto-inflammatory disorders with debilitating symptoms and limited treatment options. The FDA granted priority review to Ilaris based on its potential to meet an important clinical need for patients with CAPS.

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. Consequently, the clinical climate has seen unprecedented ...
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Resolvyx Announces Positive Data From Phase 2 Clinical Trial Of The Resolvin RX-10045 In Patients With Dry Eye Syndrome

Resolvyx Pharmaceuticals, Inc., the leading resolvin therapeutics company, announced positive data from a Phase 2 clinical study evaluating RX-10045, a resolvin administered as a topical eye drop for the treatment of patients with chronic dry eye syndrome.

Anemic Patients With MDS Gain Long-Term Benefits From Erythropoietin And Myeloid Growth Factor Hormones

Myelodysplastic syndromes (MDS), a group of blood disorders that can lead to acute myeloid leukemia (AML) in some patients, often cause severe anemia (when the body lacks a sufficient number of functional red blood cells). While certain treatments can help manage the symptoms of anemia, some studies have suggested that they may lead to complications.

Transcept Pharmaceuticals Receives Complete Response Letter From FDA On Intermezzo(R) New Drug Application

Transcept Pharmaceuticals (Nasdaq: TSPT) announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter regarding the New Drug Application (NDA) for Intermezzo® (zolpidem tartrate sublingual tablet). The NDA, submitted by Transcept in September 2008, seeks approval to market Intermezzo® for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep.

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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Novartis MF59® Adjuvanted Cell Culture-based Vaccine Shows Strong Immune Response In A(H1N1) Clinical Trials

A pilot trial of Novartis adjuvanted cell culture-based A(H1N1) vaccine[1] indicates that the "swine flu" vaccine elicited a strong immune response and was well tolerated. The trial was run by the UK's University of Leicester and University Hospitals of Leicester. The vaccine, to be called Celtura®, was tested with 100 healthy volunteers, aged between 18 and 50. The trial evaluated the tolerability and immunogenicity of the vaccine.

Arena Pharmaceuticals Submits New Drug Application To FDA For Lorcaserin For Weight Management

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

Single NX-1207 Dose Significantly Improved BPH Symptom Scores And Significantly Reduced Prostate Size After 90 Days

Nymox Pharmaceutical Corporation (NASDAQ: NYMX) is please to announce that the presentation of NX-1207 clinical study data at the AUA South Central Section annual meeting in Santa Ana Pueblo, NM was featured in the Urology Times, the widely distributed and most read publication of U.S. urologists.

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 ...
(613) 686-5745 Cerepotec Pharmalef

In Treatment Of Hot Flushes Acupuncture Not Found To Be Effective

Acupuncture cannot be shown to have any positive effect on hot flushes during the menopause. This is the conclusion of a systematic review of literature by three groups in Daejon, Busan (South Korea) and Exeter (UK), published in the current edition of the peer-reviewed journal Climacteric. Many women are concerned by the unfavourable publicity given to HRT use, but still have to deal with the symptoms which can occur during and after the menopause.

New Hope To Beat Cancer

Aurora St. Luke's Medical Center is one of the first institutions in the world to offer a new skin cancer research study that trains the patient's immune system to kill cancer cells. The Young Tumor-Infiltrating Lymphocyte (Y-TIL) trial is a phase 2 clinical trial being offered with technical support from the National Cancer Institute (NCI) in Bethesda, Md. Milwaukee native Jeff Capstran participated in an earlier stage of this trial at NCI.

NicOx Announces Favorable Blood Pressure Data For Naproxcinod In A Large ABPM Study

NicOx S.A. (Euronext Paris: COX) announced positive top-line results from a 118 patient Ambulatory Blood Pressure Monitoring (ABPM) trial (the 111 study), which compared the 24-hour blood pressure profile of escalating doses of naproxcinod and naproxen in osteoarthritis (OA) patients with controlled hypertension.

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

The title of Clinical Research Associate is deceiving to some degree. Many people think of “associate” as a secondary low paying job. “Clinical Monitor” is a title that better describes what CRA job entails. A clinical research associate does not, in fact, assist anyone; the associate ...
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Brain Health Will Be The Focus Of Staying Sharp

STAYING SHARP IN CONCORD: LEADING BRAIN EXPERTS DISCUSS SUCCESSFUL AGING WHAT: Brain function and health will be the focus of the Staying Sharp session on October 4 at the Embassy Suites Hotel Resort and Conference Center in Concord, NC.

Recent Releases: HIV Prevention; Clinical Trials Debate; Definition Of Global Health; Drug Resistant TB

Future Studies Needed To Determine If 'Test And Treat' Approach Could 'End HIV Pandemic Within 50 Years,' Researchers Say In a Journal of the American Medical Association

Newly Phase 3 Data Confirm Liraglutide Lowers Blood Sugar And Weight In Type 2 Diabetes Patients

Liraglutide treatment leads to greater reductions in HbA1c when added to one oral antidiabetic drug (OAD) compared to adding another OAD, according to two new medical publications. Liraglutide is a human glucagon-like peptide-1 (GLP-1) analog currently in FDA and EMEA review for the treatment of type 2 diabetes.

Pharmaceutical companies are relying on outsourcing strategies

It is imperative that pharmaceutical and biotechnology companies pass their product through the testing and regulatory process in a rapid, cost-effective manner. To accomplish this goal, pharmaceutical companies are relying on outsourcing strategies to provide the services that can ...
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JACC Intervention Publishes MIV's VESTASYNC I Trial Preliminary Results - Hydroxyapatite Non-Polymer-Based Sirolimus-Eluting Stent

MIV Therapeutics, Inc. (OTCBB: MIVI) (FRANKFURT: MIVN), a leading developer of next-generation coatings and advanced drug-delivery systems for cardiovascular stents and other implantable medical devices, announced that the Journal of the American College of Cardiology Intervention (JACC Intervention) published preliminary results from the VESTASYNC I trial.

Dieting May Cut Risk For Gum Disease, Mostly In Males

For men, especially older men, dieting may help reduce the risk of gum disease more than for women, according to a new study by researchers at the University of Maryland, Baltimore and other institutions. The study, published in the journal Nutrition, also provides the latest clue to a powerful link between chronic inflammation and poor health, according to Mark Reynolds, DDS, PhD, associate professor at the Dental School, part of UMB.

Dainippon Sumitomo Pharma Announces Lurasidone Phase III Data In Patients With Schizophrenia

Dainippon Sumitomo Pharma Co., Ltd., (DSP) announced today positive results from the first phase 3 clinical trial for lurasidone, which is under clinical development globally, for the treatment of patients with schizophrenia. In this six-week, double-blind, placebo-controlled trial, lurasidone 80 mg/day was significantly more effective than placebo for the treatment of acute schizophrenia. In addition, lurasidone was well-tolerated and had a relatively low discontinuation rate.

Clinical Trials Do Not Need To Be Expensive!

Many CRO Directors will argue that the foreseeable burden of clinical investigation is cost and the weight of that burden falls onto clients. The clinical climate has seen extraordinary escalation in federal regulations to make sure that the integrity of the products that are ...
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In Deadly Recurrrent Glioblastomas, Avastin Dramatically Improves Response, Survival

The targeted therapy Avastin, alone and in combination with the chemotherapy drug CPT-11, significantly increased response rates, progression-free survival times and survival rates in patients with a deadly form of brain cancer that had recurred. Patients with recurrent glioblastoma have a grim prognosis, and conventional treatments were typically limited to largely ineffective and highly toxic chemotherapies.

Starpharma Holdings Limited (ASX:SPL) Completes Patient Testing In Retention Of VivaGel Antiviral Activity Study

Starpharma Holdings Limited (ASX:SPL)(PINK:SPHRY) today announced the completion of patient testing in a clinical trial of VivaGel(R) that explores the length of time the antiviral activity of VivaGel remains following application. The study, in 12 healthy women, is designed to measure the level of antiviral activity retained by VivaGel(R) after vaginal administration, and therefore how long before sex VivaGel(R) could be applied to prevent infection.

ONGLYZAT (Saxagliptin) Receives Positive Opinion In Europe For The Treatment Of Type 2 Diabetes

Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) announced that their marketing authorization application for ONGLYZAT (saxagliptin) received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for the treatment of type 2 diabetes in adults as add-on therapy with metformin, a thiazolidinedione or a sulphonylurea.

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

Often one of the biggest burdens facing clinical trials is patient recruitment. The act of recruiting patients for a trail can be tedious at the best of times and often results in missed deadlines and an incredible hit to the sponsor’s budget. Limdato www.limdato.com along with its team of ...
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Researchers Find Room Design Can Enhance Patient Care

The design of a consultation room can improve the quality of a visit to the physician's office. A collaborative research study developed by Nurture by Steelcase and Mayo Clinic, was conducted to understand the extent to which a consultation room designed to support present-day clinical encounters could affect the consultation between patients and clinicians.

New Study Shows That Pegasys Regimen Provides Higher Cure Rates For Hepatitis C Patients

A new, independently-conducted study being presented at AASLD shows that PEGASYS(R) (peginterferon alfa-2a (40KD)) regimens result in higher cure rates for hepatitis C patients compared to regimens with another pegylated interferon.(1) Comparing Today's Standard Treatment Regimens: The Milan Safety Tolerability Study Prof. Colombo, Head of the 1st Division of Gastroenterology and A.M.


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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