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Pharmaleads' Lead Candidate For Pain, PL37, Enters Phase I

Pharmaleads has obtained from the French Medicine Agency (AFSSAPS) the authorization to perform a single ascending dose Phase I study with PL37, its lead compound for oral treatment of neuropathic pain.

Arena Pharmaceuticals Announces Positive Phase 1b Clinical Trial Results Of APD791 For The Treatment Of Arterial Thrombosis

Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced positive results from a multiple-ascending dose Phase 1b clinical trial of APD791 to evaluate the compound's safety, pharmacokinetics and pharmacodynamics. APD791 is Arena's internally discovered oral drug candidate intended for the treatment of arterial thrombosis and other related conditions.

Landmark Study Shows Thrombolytic Treatment Improves Outcomes In Stroke When Given Up To 4.5 Hours After Symptom Onset

Thrombolytic treatment with Actilyse (alteplase; Boehringer Ingelheim) significantly reduces the risk of patients with mild to moderate stroke being left with any residual disability when given within 4.5 hours of symptom onset - extending the time for administration beyond the currently licensed three hours - according to a major study reported at the recent

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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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Elan And Biogen Idec Initiate First Clinical Trial Of TYSABRI(R) In Oncology - First Multiple Myeloma Patient Treated

Elan Corporation, plc (NYSE: ELN) and Biogen Idec (NASDAQ: BIIB) announced the initiation of the first clinical trial of TYSABRI® (natalizumab) in oncology. The first dose of TYSABRI was administered yesterday in the trial. The objectives of this Phase I/II study are to evaluate the safety and potential anti-tumor activity of TYSABRI in patients with relapsed or refractory multiple myeloma.

NV-128 Display Divergent Combined With Anti-ovarian Cancer Drug Display Lung-cancer Potential Benefits

Pre-clinical studies presented at the 9th International Conference on Membrane Redox Systems in Wellington New Zealand this week demonstrate that Novogen's NV-128 (a novel mTOR inhibitor), when used in combination with the Marshall Edwards, Inc.'s Phase III anti-ovarian cancer drug, phenoxodiol, produces potent synergistic anti-cancer activity against non-small cell lung carcinoma cell lines (NSCLC).

PharmaMar Presents New Data Of Zalypsis(R) And Irvalec(R) In Pediatric, Solid Tumours And Lymphoma

PharmaMar, a biotechnology company of Zeltia Group, has presented new data on two antitumoral compounds of marine origin, Zalypsis® and Irvalec®, in Phase I trials in clinical development and in vitro studies and with animal models. Zalypsis® is a novel chemical entity related to the marine natural compounds Jorumycin and the family of Renieramycins, obtained from molluscs and sponges, respectively.

Kriger's Instructors Provide A Sound Foundation For Anyone Wishing To Seek A Meaningful Career In The Clinical And Biopharmaceutical Industry

As a drug makes its way through the different phases of pre-clinical and clinical trials in human testing, the public and the company can rest assured that their product has been thoroughly tested and that each...
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Auspex Pharmaceuticals Announces Positive Results From Clinical Study Of SD-254, A Next-Generation Potential Treatment For Depression

Auspex Pharmaceuticals, a developer of next-generation medicines with improved safety and performance through the targeted deuteration of clinically validated drugs, today announced positive results from its Phase 1 clinical trial evaluating SD-254, a Selective Serotinin-Norepinephrine Reuptake Inhibitor (SNRI). Auspex is developing SD-254, a deuterium-substituted version of venlafaxine, for the treatment of Major Depressive Disorder.

Avigen Initiates Opioid Withdrawal Trial In Partnership With NIDA, Columbia University And The New York State Psychiatric Institute

Avigen, Inc. (Nasdaq: AVGN), a biopharmaceutical company innovating therapeutics for neurological care, today announced the launch of an exploratory study of the company's pipeline product, AV411 (ibudilast), for the treatment of opioid withdrawal symptoms. The study is largely funded by the National Institute on Drug Abuse (NIDA) and will be run jointly by the New York State Psychiatric Institute (NYSPI) and Columbia University.

Bayer Reports Progress In Clinical Program For Riociguat

Based on positive Phase II trial findings, Bayer Schering Pharma will move into Phase III trials with its oral agent riociguat (BAY 63-2521). Riociguat is the first member of a new class of vasodilating agents called soluble guanylate cyclase (sGC) stimulators. It is being investigated as a new approach for the treatment of different forms of pulmonary hypertension.

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.
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Patient Enrollment For AspenBio Pharma's FDA 510(k) Clinical Trial For AppyScore(TM), World's First Appendicitis Blood Test, Nearing Halfway Point

AspenBio Pharma, Inc. (NASDAQ: APPY) an emerging bio-pharmaceutical company dedicated to the development of novel drugs and diagnostics for humans and animals, reported enrollment levels are approaching fifty percent in the ongoing FDA 510(k) clinical trial for AppyScore(TM), the world's first blood-based diagnostic tool for human appendicitis.

ASGE Encourages Patients To Speak To Their Doctor About Colorectal Cancer Screening Options

Results of the National CT Colonography Trial, published in the September 18 issue of the New England Journal of Medicine, show improvements in the technology's ability to diagnose intermediate- to large-sized polyps in the colon, but this method of testing is not as effective in diagnosing small polyps. CT colonography is one of several colorectal cancer screening options.

ZymoGenetics Presents Interim IL-21 Phase 2 Results In Renal Cell Cancer

ZymoGenetics, Inc. (NASDAQ: ZGEN) presented interim results today from a Phase 2 clinical trial evaluating Interleukin 21 (IL-21) in combination with Nexavar® (sorafenib) tablets in patients with metastatic renal cell cancer. Outpatient therapy with IL-21 and Nexavar as a second or third-line therapy for metastatic renal cell cancer was associated with anti-tumor activity, with manageable side effects.

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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Nymox's NX-1207 For The Treatment Of Benign Prostatic Hyperplasia In Phase 3 Program

Nymox Pharmaceutical Corporation (NASDAQ: NYMX) is pleased to announce that results from the most recently completed clinical studies of NX-1207, the Company's investigational drug for the treatment of benign prostatic hyperplasia (BPH), will be presented on Thursday, September 25 at the 82nd Annual Meeting of the North Central Section of the American Urological Association being held in Chicago. Neil D. Shore, MD, FACS, of Myrtle Beach, SC will make the podium presentation.

Promnising Novel Treatments And Current Clinical Trials For Alzheimer's Disease Therapies

The past 25 years have seen an explosion of scientific investigations into the basic neurobiology of Alzheimer's disease (AD). Unfortunately, the gap between bench and bedside remains as vast as ever. Recent progress, however, has resulted in the development of novel, and in some cases, unconventional approaches for effective treatment. New therapies are currently undergoing preclinical investigation or are in clinical trial phase.

Argos Therapeutics Initiates Phase 2 Trial In Renal Cell Carcinoma For Its ArcelisT Personalized Immunotherapy Platform

Argos Therapeutics announced the initiation of a Phase 2a trial of its AGS-003 therapy, in combination with sunitinib, for the treatment of newly diagnosed advanced renal cell carcinoma (RCC). AGS-003 is a product of the Company's ArcelisT technology, which is an immunotherapy platform for creating personalized, RNA-loaded, dendritic cell-based therapies perfectly matched to each patient's unique tumor burden.

Anestvise Inc. is Delivering Quality and Enabling Technology

Anestvice Inc. www.anestvice.com sponsors clinical trials towards manufacture of new medical devices...
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First European Patients Treated With The Percutaneous MitraClip(R) System

Evalve, Inc., the leader in the development of devices for the percutaneous repair of cardiac valves, announced that the first two patients have been treated with its MitraClip(R) system in Hamburg, Germany. The MitraClip system is the first commercially available device which enables a non-surgical option for patients suffering from the effects of mitral regurgitation (MR).

Advances In Conceptualizing Disease Progression In Alzheimer's Disease

A hallmark of this year's ICAD meeting was the wealth of new clinical trials information in Alzheimer's Disease (AD). Years of basic and preclinical research have paved the road for development of new medications and biologics. Results from many new clinical trials were provided, ranging from promising Phase I and II trials to some disappointing Phase II and III results. Hundreds of new agents for the treatment of dementias are now in or approaching clinical trials.

Deputy Director From The FDA's Office Of Critical Path Programs To Deliver Rare Address At Clinical Trials Congress

The Institute for International Research is pleased to announce a featured presentation by Leonard Sacks, Deputy Director of the Office of Critical Path Programs from the US Food & Drug Administration (FDA) at the 7th annual Clinical Trials Congress (CTC). Dr. Sacks will illuminate how key stakeholders in public health and drug development should be forming partnerships with the FDA to advance the critical path to drug development. Dr.

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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Interim Analysis Of Top-Line Data From Phase II/III Study Shows Favorable Efficacy & Safety For Corthera's Relaxin In Acute Heart Failure

Corthera Inc. announced that an interim analysis of top-line data from Pre-RELAX-AHF, the Phase II portion of a Phase II/III multicenter, randomized, double-blind, international study, showed favorable efficacy and safety for relaxin, the company's investigational drug for treatment of acute heart failure. The interim Phase II results were presented by John R. Teerlink, M.D.

RAD001 Shows Promise In Renal Cell Cancer Patients Who Have Failed Targeted Therapies

The investigational once-daily oral mammalian target of rapamycin (mTOR) inhibitor RAD001 (with the proposed brand name Afinitor), formerly known as RAD001, significantly prolongs disease-free survival in patients with metastatic renal cell cancer who have stopped responding to targeted therapy, investigators reported here at the 33rd Annual Congress of the European Society of Medical Oncology (ESMO).

Results Of Gore EMPiRE Clinical Study - Study Reports Low Major Adverse Event Rates Using The GORE Flow Reversal System

L. Nelson Hopkins, MD, of the University of Buffalo and national co-principal investigator, presented results of the Gore EMPiRE Clinical Study(1) today at the 20th annual Transcatheter Cardiovascular Therapeutics scientific symposium, sponsored by the Cardiovascular Research Foundation.

Cereprotex displayed a significant anti-edema effect in a model of closed head injury.

Cereprotex displayed a significant anti-edema effect in a model of closed head injury. It significant decreases in the degree of edema developed after injury was found following treatment postponed one hour after traumatic injury..
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Structure Of 'Beneficial' Virus Solved By Scripps Research Team

The 3-D structure of the virus, known as Seneca Valley Virus-001, reveals that it is unlike any other known member of the Picornaviridae viral family, and confirms its recent designation as a separate genus "Senecavirus." The new study reveals that the virus's outer protein shell looks like a craggy golf ball - one with uneven divets and raised spikes - and the RNA strand beneath it is arranged in a round mesh rather like a whiffleball.

Enzon's HIF-1 Alpha Antagonist Shows Antitumor Activity

Enzon Pharmaceuticals, Inc. (Nasdaq: ENZN) presented data from its pipeline programs at the 2008 EORTC-NCI-AACR (European Organization for Research and Treatment of Cancer-National Cancer Institute-American Association for Cancer Research) annual meeting in Geneva, Switzerland.

PolyMedix Initiates Dosing In Phase I Clinical Study Of Novel Systemic Antibiotic Compound

PolyMedix, Inc. (OTC BB: PYMX), an emerging biotechnology company developing new therapeutic drug products to treat infectious diseases and acute cardiovascular disorders based on biomimetics, has initiated dosing and commenced a Phase I clinical study in Canada for its defensin mimetic antibiotic compound, PMX-30063. PolyMedix received a notice of no objection from Health Canada for the Company's Clinical Trial Application ("CTA") for PMX-30063 in May 2008.

Kriger's Instructors Provide A Sound Foundation For Anyone Wishing To Seek A Meaningful Career In The Clinical And Biopharmaceutical Industry

As a drug makes its way through the different phases of pre-clinical and clinical trials in human testing, the public and the company can rest assured that their product has been thoroughly tested and that each...
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Titan Pharmaceuticals Announces Spheramine® Initial Phase IIb Results

Titan Pharmaceuticals, Inc. (AMEX:TTP) announced initial analyses show that Spheramine® did not meet the Phase IIb clinical study's primary or key secondary endpoints, with no significant differences detected between the Spheramine and sham surgery arms of the study after 12 months of follow-up.

IRX Therapeutics To Present Phase 2 Results At 7th International Conference On Head And Neck Cancer

IRX Therapeutics, a privately-held company dedicated to the discovery and development of proprietary therapies for the treatment of cancer and viral diseases, today announced that a symposium on findings from its Phase 2 clinical trial of IRX-2 will be held on July 22, 2008 at 6:30 am (PDT) during the 7th International Conference on Head and Neck Cancer at the San Francisco Marriot Hotel.

Researchers Identify Tumor Marker For Aggressive Thryoid Cancer

MicroRNA (miRNA) expression profiles can be used to identify an aggressive type of papillary thyroid cancer that is often otherwise difficult to detect, according to data to be presented on Oct. 2, 2008 at the 79th Annual Meeting of the American Thyroid Association (ATA) in Chicago, IL. miRNAs are a class of small RNA molecules that regulate a broad array of physiological and developmental processes.

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 coordinates the smooth progress of a clinical trial.
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The Side Effects Of Monotherapy With Lamivudine

Lamivudine has a high rate of antiviral resistance. Sequential anti-HBV treatment is commonly used for lamivudine resistance. We report 4 cases with rapid re-detection of HBV mutants during the lamivudine re-treatment. The article was published in the World Journal of Gastroenterology. In this report, four patients received lamivudine as an initial treatment of HBV. They had adefovir and lamivudine as a rescue therapy consecutively.

Bayer's Xarelto(R) Shows Encouraging Results In Patients With Acute Coronary Syndrome

Findings from the ATLAS ACS TIMI 46 study - a Phase II study of the novel oral anticoagulant Xarelto® (rivaroxaban) - were presented today as a late-breaking clinical trial at the American Heart Association's Scientific Sessions 2008 in New Orleans by C. Michael Gibson, M.D., Director of the TIMI Data Coordinating Center, Harvard Medical School, Boston, Massachusetts, USA.

Aspirin Only Benefits Diabetics With History Of Heart Disease Or Stroke

A new study by researchers in Scotland suggests that while there is evidence of benefit to non-diabetics with no history of heart disease or stroke, people with diabetes should not take aspirin to prevent heart disease and stroke unless they already have a history of these complaints. The study was the work of Jill Belch, professor of vascular medicine at the University of Dundee in Scotland, and colleagues, and is published online in the BMJ 16 October issue.

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Access Pharmaceuticals Presents New Data On The Company's Angiolix(R) Therapeutic Monoclonal Antibody

Access Pharmaceuticals, Inc. (OTC Bulletin Board: ACCP) presented data this week from preclinical studies on Angiolix showing that by blocking lactadherin, Angiolix has both an anti-angiogenic effect as well as a direct anti-proliferative effect on tumors themselves.

Cymbalta Receives European Approval For The Treatment Of Generalised Anxiety Disorder

Eli Lilly and Co (NYSE: LLY) and Boehringer Ingelheim have announced that the European Commission has approved the use of Cymbalta(R) (duloxetine) for the treatment of Generalised Anxiety Disorder (GAD). This approval -- the fourth for duloxetine in Europe -- was issued on 28 July following an initial positive opinion issued by the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) on 26 June 2008.

Transcatheter Aortic Valve Replacement A New Frontier In Cardiovascular Medicine

Replacing heart valves without the substantial trauma of opening the chest and the heart were little known concepts until the groundbreaking pulmonary and aortic transcatheter valve replacements performed during 2000 and 2002, respectively by Philipp Bonhoeffer and Alain Cribier.

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...
(613) 686-5745 Cerepotec Pharmalef

Study Shows Benefits Of A High Omega 3 Diet In Older Adults

A study conducted by Phoenix-based Kronos Longevity Research Institute (KLRI) found that a diet high in omega-3 fat improves insulin sensitivity and reduces inflammatory markers, but does not alter endocrine responsiveness. This study was recently published in Hormones and Metabolic Research. "As we age, hormone secretion and cell responsiveness decrease, possibly due to loss of cell membrane fluidity or alteration of the membrane," said Dr. S.

Agendia Launches TargetPrint(R) For Breast Cancer Patients

Agendia, a world leader in molecular cancer diagnostics, announced the launch of TargetPrint(R), a new diagnostic test that allows physicians to quantitatively determine the gene expression levels of the estrogen receptor (ER), progesterone receptor (PR) and Human Epidermal growth factor Receptor 2 (HER2) in breast cancer tumor biopsies.

Oral CGRP Receptor Antagonist Showed Statistically Significant Improvement In Migraine Relief Versus Placebo

Merck Sharp & Dohme Limited announced that in a Phase III clinical trial telcagepant (formerly known as MK-0974) - an investigational oral calcitonin gene-related peptide (CGRP) receptor antagonist - significantly relieved moderate-to-severe migraine attacks, including migraine pain and migraine-associated symptoms, compared to placebo. In addition, the overall rates of adverse events in this trial were similar for telcagepant and placebo.

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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Study Points To One Cause Of Higher Rates Of Transplanted Kidney Rejection In Blacks

A Johns Hopkins research team reports it may have an explanation for at least some of the higher organ rejection rates seen among black as compared to white kidney transplant recipients. In a study of 50 healthy adult men, 25 black and 25 white, significantly different amounts of certain immune system cells were found between the races.

Age Is Not A Major Factor In Cancer Survival, But Clinical Trials Exclude Older Patients

Age is not an independent factor in cancer survival rates and should not influence decisions about how to treat older patients, according to a study in the November issue of IJCP, the Independent Journal of Clinical Practice. A team of hospital and University-based researchers from Barcelona, Spain, carried out a detailed study of more than 200 patients diagnosed with cancer.

Suicide Prevention And Antidepressants

Antidepressants are the cornerstone of treatment of depressive disorders in health care. Their efficacy in treating depression is undisputable, although it leaves room for improvement. However, recent reports also suggest that antidepressants might, in some rare cases, actually worsen suicidal tendencies instead of alleviating them. As a consequence, research has intensified to clarify this issue, and regulatory authorities in many countries have reconsidered their cost-benefit ratio.

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

Kriger www.krigerinternational.com has maintained it's status within the industry because these training courses lead to the creation of highly trained individuals, due to the rigorous tasks that each student must perform in the projects.
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Preliminary Cerepro (R) Phase III Results Meet Primary Endpoint - Operable Primary Malignant Glioma

Ark Therapeutics Group plc (AKT:LSE) announces that the preliminary analysis of Study 904, a Phase III study of Cerepro (R), its novel gene-based therapy being developed as an Orphan Drug for the treatment of operable primary malignant glioma, demonstrates that the trial has met its primary endpoint. Cerepro (R) treatment resulted in significant improvements in median survival on the primary endpoint compared with various control groups.

Antisoma Starts Phase II Trial Of AS1402 In Breast Cancer

Cancer drug developer Antisoma plc (LSE: ASM; USOTC: ATSMY) announced that it has started a phase II trial evaluating the addition of AS1402 to the endocrine (hormonal) therapy letrozole in post-menopausal women receiving first-line treatment for advanced breast cancer. Approximately 110 patients will be randomly assigned to receive either letrozole plus AS1402 or standard treatment with letrozole alone.

A New Hand -- And Signs Of Sensory Recovery

Four months after a successful hand transplant -- 35 years after amputation in an industrial accident at age 19 -- a 54-year-old man's emerging sense of touch is registered in the former "hand area" of the his brain, says a University of Oregon neuroscientist. The finding, appearing online in advance of regular publication in the Oct.

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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Medivation Announces Positive Top-Line Results From Phase 2 Dimebon Study In Huntington's Disease

Medivation, Inc. (Nasdaq: MDVN) announced top-line results of a Phase 2 study showing that its investigational drug Dimebon(TM) significantly improved cognitive function in patients with mild-to-moderate Huntington's disease (HD). Cognitive function was significantly improved over placebo (p=0.03) as measured by the Mini-Mental State Examination (MMSE), the cognition scale most widely used by clinicians to assess patients with neurodegenerative diseases.

BioNumerik Pharmaceuticals Observes Evidence Of A Survival Increase In Lung Cancer Patients Participating In Tavocept(TM) Clinical Trial

BioNumerik Pharmaceuticals, Inc. ("BioNumerik") announced that patients with adenocarcinoma (the most frequently occurring form of lung cancer) participating in a Phase II clinical trial of Tavocept(TM) showed a survival increase of approximately 198 days (6.5 months). The trial observations included an approximate 40% reduction in mortality for adenocarcinoma patients receiving Tavocept.

Is Yakult Helpful In The Treatment Of Irritable Bowel Syndrome?

SIBO is a common feature in IBS and in fact may be directly related to the genesis of IBS symptoms. An ERBHAL on a lactulose breath test may indicate SIBO. Antibiotics and elemental diets have been shown to be effective in treating SIBO, but the efficacy of probiotics is untested. A pilot study was undertaken to determine the effect of L. strain Shirota (Yakult(R)) on intestinal fermentation patterns of IBS patients.

Cereprotex displayed a significant anti-edema effect in a model of closed head injury.

Cereprotex displayed a significant anti-edema effect in a model of closed head injury. It significant decreases in the degree of edema developed after injury was found following treatment postponed one hour after traumatic injury..
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Ardea Biosciences Presents Additional Phase 2a And Preclinical Data On Its Lead HIV Product Candidate, RDEA806

Ardea Biosciences, Inc. (Nasdaq:RDEA) announced today that additional data from a Phase 2a monotherapy study of RDEA806, our lead non-nucleoside reverse transcriptase inhibitor (NNRTI) in development for the treatment of human immunodeficiency virus (HIV), were presented at the 48th Annual ICAAC/IDSA 46th Annual Meeting in Washington, DC. Dr.

Pilot Study Of Wellstar's Thermal Imaging Device Completed By Duke University Medical Center

Wellstar International, Inc. (OTCBB: WLSI), a developer of thermal imaging, diagnostic software and equipment, announced today that an important, pilot evaluation of the Company's TMI infrared thermal imaging device has been completed by Duke University Medical Center. The device was utilized by physicians in the Wound Management Institute at Duke as a surveillance and assessment tool for the prevention of pressure ulcers and deep tissue injury.

National Institutes Of Health Launches ClinicalTrials.gov Results Database

The National Institutes of Health (NIH) announced an expanded ClinicalTrials.gov database. The database will accept basic results information, in addition to trial registrations.

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...
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M0002 Progresses To Phase IIb Trial Following Positive Results In Cirrhotic Ascites

Movetis NV, a European specialist pharmaceutical company, announced that M0002 is progressing to phase IIb following positive results of a phase IIa multiple-dosing trial for the treatment of ascites, the accumulation of fluid in the abdomen in patients with liver cirrhosis resulting from liver conditions such as hepatitis C, hepatitis B or alcoholism.

How HIV Vaccine Might Have Increased Odds Of Infection

In September 2007, a phase II HIV-1 vaccine trial was abruptly halted when researchers found that the vaccine may have promoted, rather than prevented, HIV infection. A new study by a team of researchers at the Montpellier Institute of Molecular Genetics in France shows how the vaccine could have enhanced HIV infection. The study, lead by Matthieu Perreau, will be published online on November 3 of the Journal of Experimental Medicine.


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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