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Transdel Pharmaceuticals Presents Phase 3 Study Data On Ketotransdel® At World Pain Congress In Montreal, Canada

Transdel Pharmaceuticals, Inc. (OTC Bulletin Board: TDLP), a specialty pharmaceutical company focused on developing topically administered products using its proprietary transdermal delivery platform, announced the final data set from its Phase 3 study of Ketotransdel® (TDLP-110) at the 13th World Congress on Pain in Montreal, Canada...

Medtronic Completes Enrollment Ahead Of Schedule In Key Trial Of Endeavor(R) Resolute Drug-Eluting Stent

Medtronic, Inc. (NYSE: MDT), announced today that enrollment in the 2,300-patient RESOLUTE All-Comers (R-AC) clinical study was completed in just six months, two months ahead of schedule. The randomized trial compares the safety and efficacy of Medtronic's Endeavor Resolute drug-eluting stent (DES) with Abbott Laboratories' Xience® DES.

Phase 2 Trial Of RP101 In Late-Stage Pancreatic Cancer Discontinued

SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) announced the discontinuation of the investigational treatments under its randomized, placebo-controlled, double-blind Phase 2 trial that is evaluating RP101 -- a nucleoside analog known as BvdU -- for the treatment of late-stage pancreatic cancer.

CEREPROTEC Method for Neuroprotection with Glycoluril Derivatives Patent Application has been Published

September 18, 2008A 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: ...
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Inhibitex Reports Independent Data Safety Monitoring Board Recommends Continuation Of Phase II Clinical Trial Of FV-100

Inhibitex, Inc. (Nasdaq: INHX) announced that the independent data safety monitoring board (DSMB) responsible for reviewing safety data from the Company's ongoing Phase II clinical trial of FV-100 met, as scheduled, after the Company had provided it with complete 30-day follow-up safety data on the third quartile (75%) of the patients that the Company plans to enroll in the trial...

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).

CuraGen Updates CR011-vcMMAE Data At ASCO

CuraGen Corporation (Nasdaq: CRGN) reported three data presentations from its ongoing clinical trials of CR011-vcMMAE, an antibody-drug conjugate that targets GPNMB, in patients with advanced breast cancer and melanoma at the 2009 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Orlando, Florida.

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 ...
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Children With Cerebral Palsy May Benefit From Cell Transplants

A unique cell type that supports and surrounds (ensheathes) neurons within the nose (olfactory system) known as olfactory ensheathing cells (OECs), possess the ability to regenerate, are relatively easy to obtain, and have become prime candidates for transplantation to repair a number of lesions in the central nervous system (CNS)...

Radioactive Seed Therapy Shows Significant Reduction In Lung Cancer Recurrence

Radiation oncologists at Allegheny General Hospital (AGH) in Pittsburgh will report to the American Society for Therapeutic Radiology and Oncology (ASTRO) in Boston that a newer, minimally invasive approach to treating high risk patients with Stage I non-small cell lung carcinoma (NSCLC) may significantly reduce the risk of local disease recurrence.

Tocilizumab Shows Sustained Efficacy In Rheumatoid Arthritis

PHILADELPHIA - Investigators are reporting that tolicizumab is an effective, long-term treatment option in multiple subgroups of rheumatoid arthritis (RA) patients. These include patients who have an inadequate response to disease-modifying anti-rheumatic drugs (DMARD-IR), patients who have an inadequate response to anti-TNF inhibitors (TNF-IR), and patients who have not failed methotrexate.

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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Bionovo To Advance Menerba To Phase 3 Clinical Testing In Europe

Bionovo, Inc. (Nasdaq: BNVI) announced that it has received final guidance from the European Medicines Agency (EMA) in order to advance Menerba, the company's lead drug candidate for menopausal symptoms, to Phase 3 clinical trials in Europe. The guidance defines the clinical and regulatory pathway to a European marketing authorization for Menerba...

Essentialis To Submit SPA For Hypertriglyceridemia

Essentialis, Inc., a clinical stage pharmaceutical company, announced today its intention to file a Special Protocol Assessment (SPA) with the FDA for the pivotal study to support the NDA filing on its lead drug, DCCR, for the treatment of very high triglycerides. The proposed study would include 280 randomized subjects with the primary efficacy endpoint assessed at 12 weeks.

Optive Eyedrops Significantly Better At Improving Conjunctival Health Than Hylocomod For Those With Dry Eye

New research from the UK shows that Optive™ eye drops have a significantly better effect on conjunctival tissues of patients with mild to moderate dry eye compared with Hylocomod (Na-Hyaluronate) eyedrops1. Due to the chronic nature of dry eye, tissue recovery could be considered essential to achieving long term success...

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. It results in individuals who are motivated to make the ...
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Aestus Therapeutics Initiates Phase 2 Clinical Trial For Novel Neuropathic Pain Treatment

Aestus Therapeutics, Inc. (Aestus), announced that it has initiated screening of patients for a clinical trial to evaluate the efficacy of its novel pain therapeutic, ATx08-001. This placebo-controlled, two-dose level study will test the efficacy of ATx08-001 in reducing the pain following an outbreak of shingles...

Recruitment Completed In Ofatumumab NHL Pivotal Study

Genmab A/S (OMX: GEN) announced it has completed recruitment of patients in the pivotal Phase III study of ofatumumab (HuMax-CD20(R)) in rituximab refractory follicular non-Hodgkin's lymphoma (NHL). Eighty-one patients receiving treatment at the 1000 mg dose level of ofatumumab have been recruited in the study. Data from these patients will be included in the primary efficacy analysis.

Hypertension, Diabetes And Increased Carotid Artery Wall Thickness Means Increased Risk Of Stroke

Increased carotid artery wall thickness (CAWT), which can cause heart attack and stroke in many patients, is significantly related to diabetes and hypertension, according to a study performed at A.O.U. in Cagliari Sardegna, Italy (Chairman, Professor Giorgio Mallarini). During the study, 186 patients were evaluated using multidetector row CT to see if CAWT is associated with cardiovascular risk factors such as hypertension, diabetes mellitus, dyslipidemia and a history of smoking.

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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ThromboGenics And BioInvent Complete Patient Recruitment Of Phase II DVT Prophylaxis Study With Anti-Factor VIII (TB-402)

ThromboGenics NV (Euronext Brussels: THR) and co-development partner BioInvent International (OMXS: BINV) announce that they have completed recruitment of their Phase II trial of TB-402 ahead of schedule. TB-402 is a novel, long acting anticoagulant that is being developed for the prevention of deep vein thrombosis (DVT) following orthopaedic surgery. The results of this study, which has recruited 315 patients, are anticipated in the second quarter of 2010.

Focus On Patient Adherence In Clinical Trials Before Product Launch

McLean, VA - Dr. Dorothy L. Smith, President and CEO of McLean-based Consumer Health Information Corporation (CHIC) and a leader in patient advocacy, spoke about the importance of the patient's role in successful therapeutic outcomes during clinical trials to an audience comprised of pharmaceutical industry executives, clinicians and researchers.

Combination Therapy Benefits People With Quivering Heart

Approximately 250,000 Canadians are diagnosed with atrial fibrillation, a condition that causes the upper chambers of heart to quiver and leads to an increased risk of stroke and complications of circulatory system. Oral blood thinners, such as warfarin and aspirin, are the only proven therapies for atrial fibrillation.

CEREPROTEC Method for Neuroprotection with Glycoluril Derivatives Patent Application has been Published

September 18, 2008A 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: ...
(613) 686-5745 Cerepotec Pharmalef

Insmed And Premacure Cite Study Results Demonstrating Potential Effectiveness Of IPLEX(TM) In Preventing Blindness In Premature Infants

Insmed Inc.

New Data Support Role For Monitoring Of Cell-Mediated Immunity In Adult Patients Following Renal Transplantation

A recently published article by Sanchez-Velasco et al. in Clinical Transplantation has expanded our understanding of the clinical potential of monitoring cell-mediated immunity in adult patients at risk for organ rejection or infection subsequent to kidney transplantation.

Methylation Levels Key To Glioblastoma Survival

A new study analyzing gene expression among patients with glioblastomas has found that not all of the common, deadly brain tumors appear the same upon closer examination. The research, directed by scientists at The University of Texas M. D.

Streamlining the process of Clinical Trials

The process of clinical trials can be costly to say the least. Clinical affairs consumes an average of 37% of R&D budgets. Despite decades of practice, sponsors continue to underestimate the time required to complete 80% of studies, with the average Phase 1 study running over by 42%, ...
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Results From Argos Therapeutics' Arcelis™ Immunotherapy Phase 2 Study For Treatment Of Renal Cell Carcinoma (RCC) Accepted For Presentation

Argos Therapeutics announced that results from its Arcelis™ immunotherapy Phase 2 study for the treatment of renal cell carcinoma (RCC) have been accepted for a poster presentation at the Ninth International Kidney Cancer Symposium on Oct. 1-2 in Chicago. The study is an open-label Phase 2 trial that enrolled 25 patients with newly diagnosed metastatic clear cell RCC...

Head-to-Head Study Showed Prasugrel Statistically Superior To Clopidogrel In Reducing Recurrent Cardiovascular Events

A new, pre-specified analysis of the landmark Phase III head-to-head TRITON-TIMI 38 study showed patients who took prasugrel for acute coronary syndromes (ACS) managed with an artery-opening procedure known as percutaneous coronary intervention (PCI) and had survived their first cardiov

State Of The Art Lecture: What Are The Most Important Ongoing Clinical Trials In Urologic Oncology Worldwide?

ORLANDO, FL (UroToday.com) - Dr. E. David Crawford presented information on challenges facing clinical trials from SWOG, ECOG and CALGB. Patient accrual for clinical trials is only 2-3%. Innumerable layers of rules and regulations have been created with numerous layers that increase costs and delays. He applauded prevention trials such as PCPT, SELECT, Toremifene for PIN and REDUCE. He gave poor marks for randomized treatment trials.

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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Novel Device May Enhance Chemotherapy Treatment In Brain Tumors

NovoCure Ltd. presented results evaluating the Novo-TTF device in vitro and in a pilot clinical trial that showed the device enhanced the efficacy of standard chemotherapy (temozolomide) treatment in newly-diagnosed glioblastoma multiforme (GBM) patients.

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 DimebonT 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.

Novartis Tasigna® Trial Shows Superior Results To Glivec® In Patients With Early-stage Chronic Myeloid Leukemia

In a large Phase III clinical trial, Tasigna® (nilotinib) demonstrated greater efficacy over Glivec® (imatinib) in the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase[1]...

The Birth of the Profession of Clinical Research Associate

According to the ICH Good Clinical Practice Guidelines, clinical research should be monitored by professionals—Clinical Research Associates, also known as Clinical Monitors. We asked Bruce Kriger, CEO of Kriger Research Group International www.kriger.com , leading training institution and ...
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HeartWare International Clinical Trial Shows 90% Survival At 180 Days

HeartWare International, Inc. (Nasdaq: HTWR) (ASX: HIN) announced updated results for its international clinical trial of the HeartWare(R) Left Ventricular Assist System. The results were presented by Dr. Martin Strueber, cardiothoracic surgeon at Hannover Medical School, at the annual meeting of the International Society for Heart and Lung Transplantation (ISHLT) held in Paris this week.

Idenix Pharmaceuticals Advances HCV Discovery Program To Clinic

Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral and other infectious diseases, today announced that it has initiated a first-in-man study of IDX184 under a United States investigational new drug (IND) application. IDX184 is a once-daily, oral nucleotide prodrug polymerase inhibitor for the treatment of chronic hepatitis C.

Estrogen Receptor Status Of HER2+ Breast Cancer Correlates With Response To Anti-HER Therapies

An international team of researchers has discovered molecular evidence that may explain why some women with HER2 over-expressing breast cancer do not respond to drugs designed to target this important molecule...

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 ...
(613) 686-5745 Cerepotec Pharmalef

Curis Announces Genentech's Initiation Of Phase II Clinical Trial In Advanced Ovarian Cancer With Hedgehog Pathway Inhibitor

Curis, Inc. (NASDAQ: CRIS), a drug development company seeking to develop next generation proprietary targeted medicines for cancer treatment, today announced that its collaborator Genentech has initiated a Phase II clinical trial of GDC-0449, an orally-administered small molecule Hedgehog pathway inhibitor, as a maintenance therapy for ovarian cancer patients in second or third complete remission.

Dynavax Completes Over 2000 First Immunizations In Phase 3 Study

Dynavax Technologies Corporation (NASDAQ: DVAX) reported completing the first immunizations of over 2,000 subjects enrolled in its large-scale Phase 3 study of HEPLISAV™. This starts a 12-month follow-up on these subjects and sets the study's completion for May 2011. Dynavax said this event supports its goal of a BLA submission for HEPLISAV in the second half of 2011...

First Patient Enrolled In Regeneron And Bayer HealthCare VEGF Trap-Eye Phase 3 Program In Central Retinal Vein Occlusion

Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) announced that the first patient has been enrolled in the Phase 3 program of VEGF Trap-Eye for the treatment of central retinal vein occlusion (CRVO), a leading cause of blindness in adults. Regeneron received a $20 million milestone payment from Bayer Healthcare that was triggered by the dosing of the first patient in the CRVO program.

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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Study Of Revlimid And Vidaza In Higher-Risk MDS Is Well-Tolerated And Has High Activity

Celgene International Sarl (NASDAQ: CELG) reported that results of a Phase I study combining REVLIMID and VIDAZA in patients with higher-risk myelodysplastic syndromes (MDS) found that the combination of these two therapies is well tolerated and has high activity. The data were reported during the 50th Annual Meeting of the American Society of Hematology.

SAPHRIS(R) (asenapine) Meets Primary Endpoint In Long-Term Extension Study In Patients With Predominant, Persistent Negative Symptoms Of Schizophrenia

Schering-Plough Corporation (NYSE: SGP) announced that its investigational agent SAPHRIS(R) (asenapine) met the primary endpoint over one year of treatment in an extension study in patients with predominant, persistent negative symptoms of schizophrenia. Negative symptoms of schizophrenia include apathy, lack of emotion and poor social functioning, among others. In the study, these symptoms were assessed using the validated 16-item Negative Symptom Assessment scale (NSA-16).

GenSpera Announces First Cancer Patient Treated With G-202 In Phase I Trial

GenSpera, Inc. (OTC.BB: GNSZ) announced that the first patient was treated in the Phase I clinical study of its cancer chemotherapeutic agent, G-202, at the University of Wisconsin Carbone Cancer Center, Madison, Wisconsin. The trial is also being conducted at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland...

The concept of outsourcing should not be new to pharmaceutical companies

The idea of outsourcing clinical trials took a dramatic increase two decades ago and continues to increase at a rapid pace. It is estimated that by 2006 close to 45% of all drug development finances will be allocated to outsourcing to such companies as Limdato, www.limdato.com. Prior to the ...
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Patients With Resectable Esophageal Adenocarcinoma Benefit From Neoadjuvant Chemoradiotherapy

Esophageal carcinoma (EC) is one of the major malignant diseases worldwide. Surgery alone cannot obtain satisfactory effects in patients with EC. Neoadjuvant chemoradiotherapy has been a hotspot for EC treatment research. Several related randomized controlled trials (RCTs) have been published, but opinions vary among clinicians as to the therapeutic effect of the new method...

Can Child Health Care Reduce Poverty Related School Failure?

Young children whose parents are active participants in their development by reading, talking, teaching and playing at every opportunity help their children become better prepared for school according to Alan Mendelsohn, M.D., Associate Professor of Pediatrics at NYU School of Medicine and Bellevue Hospital Center in New York City and his colleagues in developmental-behavioral pediatrics, developmental psychology, public policy and education.

CrystalGenomics Completes Phase I MAD Study Of Its Novel Antibiotic Candidate CG400549, And Prepares For Phase II Clinical Study

CrystalGenomics, Inc., a biopharmaceutical company with 3 clinical stage candidates, has announced that the draft Clinical Study Report (CSR) from CG400549's Phase I Multiple Ascending Dose (MAD) Study has just been received...

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 ...
(613) 686-5745 Cerepotec Pharmalef

Drug Inhibits Neuroblastoma Blood Supply In Pre Clinical Tests

Researchers from the Children's Cancer Hospital at The University of Texas M. D. Anderson Cancer Center have found a way to prevent blood vessels from aiding the growth of neuroblastoma, a childhood cancer. The pre-clinical study was presented today in a platform session at the 22nd annual meeting of the American Society of Pediatric Hematology/Oncology. Investigators at the Children's Cancer Hospital at M. D.

Cardiac Dimensions® Announces Expansion Of Clinical Reach With Initiation Of Two New Clinical Studies Of Its CARILLON® Mitral Contour System

Cardiac Dimensions®, Inc. announced the initiation of two new clinical studies using the CARILLON® Mitral Contour System™, an investigational device for percutaneous treatment of Functional Mitral Regurgitation (FMR)...

Safety And Cognitive Stability Are Key Findings In Phase IIA Trial Of New Alzheimer's Disease Treatment From Humanetics Corporation

The results of a preliminary clinical trial suggest that a new Alzheimer's drug from Humanetics Corporation is safe for daily use and that cognitive performance in patients with mild to moderate disease remained stable during the six-week course of the trial. The lack of decline in cognitive performance was an encouraging finding to be further evaluated in a Phase IIB clinical trial.

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 ...
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Synta Pharmaceuticals Initiates Phase 2 Clinical Trial Of STA-9090 In Gastrointestinal Stromal Tumors Following Failure Of Gleevec(R) And Sutent(R)

Synta Pharmaceuticals Corp. (NASDAQ: SNTA), a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced that it is initiating a Phase 2 clinical study of STA-9090 in patients with advanced gastrointestinal stromal tumors (GIST)...

Proprietary Zinc/Phytase Formulation Improved Botulinum Toxin A Results

A recent study conducted by oculoplastic surgeon Charles Soparkar, M.D., Ph.D. (The Methodist Hospital, Houston, TX) utilizing a patent-pending formulation of zinc and phytase (trademarked as ZYTAZE™), demonstrated that increasing zinc levels by oral administration for 4 days prior to a planned injection of botulinum toxin improved efficacy and/or duration in 41 of 44 patients tested (93%)...

Newly Discovered Mechanism By Which Blood Clots Form

Polyphosphate from blood platelets plays a key role in inflammation and the formation of blood clots, scientists from the Swedish medical university Karolinska Institutet have shown. The study, which is presented in the prestigious scientific journal Cell, describes how this mechanism can be used in treatment...

The Birth of the Profession of Clinical Research Associate

According to the ICH Good Clinical Practice Guidelines, clinical research should be monitored by professionals—Clinical Research Associates, also known as Clinical Monitors. We asked Bruce Kriger, CEO of Kriger Research Group International www.kriger.com , leading training institution and ...
(613) 686-5745 Cerepotec Pharmalef

Reata And Abbott Announce Positive Phase 2b Study Results For Bardoxolone Methyl

Reata Pharmaceuticals and Abbott (NYSE: ABT) announced data from a Phase 2b study which suggests that bardoxolone methyl, an investigational treatment for chronic kidney disease (CKD), may reduce the stage of CKD and improve estimated glomerular filtration rate (eGFR) and other measures of kidney function in the majority of patients receiving the drug...

Agennix AG Announces Longer-Term Mortality Results From Talactoferrin Phase 2 Trial In Severe Sepsis

Agennix AG (FRANKFURT: AGX) (XETRA: AGX) announced longer-term mortality results from the talactoferrin randomized, double-blind, placebo-controlled Phase 2 trial in severe sepsis. The trial evaluated talactoferrin versus placebo in 190 adult patients with severe sepsis enrolled at 25 leading centers across the U.S...

Octreotide LAR Thwarts Tumor Growth In Patients With Rare GI Tumors

The somatostatin analog octreotide LAR (SandostatinR LARR) can retard tumor progression in patients with metastatic neuroendocrine midgut tumors, according to interim results of a phase IIIb trial reported here at the American Society of Clinical Oncology's 2009 Gastrointestinal Cancers Symposium.

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 ...
(613) 686-5745 Cerepotec Pharmalef

Ampio Pharmaceuticals, Inc. Announces Initiation Of Phase 1B Clinical Trial For Its Anti-inflammatory Drug Ampion™

Ampio Pharmaceuticals, Inc. (NASDAQ: AMPE)("Ampio") announced that it received ethics board approval for a Phase 1B clinical trial in Australia of its biologic anti-inflammatory agent, Ampion™...

EyeGate Pharma Announces That EGP-437 Improved Signs And Symptoms Of Dry Eye Syndrome In A Phase II Study

Based on the top-level analysis of a Phase II study, EyeGate Pharma announces that EGP-437, a corticosteroid solution administered by a non-invasive ocular drug delivery system, improved signs and symptoms in patients with dry eye syndrome (DES). For the dry eye clinical trial, EyeGate worked with Ora, Inc., a leading global clinical research and development organization located in Andover, MA.


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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