Bioheart Announces 35 Leading U.S. Heart Failure Centers Engaged In Phase II/III Marvel Trial Of Myogenic Cells For Treating Advanced Heart Failure

Bioheart, Inc., (Nasdaq: BHRT), announced that 35 of the leading U.S. Heart Failure Centers have engaged in Bioheart's Phase II/III MARVEL(1) Trial of myogenic cells for treating advanced heart failure. "With 35 leading heart failure centers engaged, we are making tremendous progress in patient screening and enrollment," said Dr.

Evalve Announces Enrollment Completion Of The EVEREST Randomized Study

Evalve, Inc., the leader in the development of devices for the percutaneous repair of cardiac valves, announced the completion of randomized enrollment in the Endovascular Valve Edge-to-Edge REpair STudy (EVEREST), which is evaluating the MitraClip(R) system as a non-surgical repair option for patients suffering from mitral regurgitation (MR). MR is the most common type of heart valve insufficiency in the United States, affecting millions of people worldwide.

Indevus Announces Agreement With Teva To Develop Pagoclone For The Treatment Of Stuttering

Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV) announced that it has signed a development, license and commercialization agreement with Teva Pharmaceutical Industries Ltd. for the exclusive, worldwide rights to pagoclone.

New Information On Hormone Replacement Therapy And The Risk Of Heart Attacks Provided By Danish Study

It's not what you take but the way that you take it that can produce different results in women who take hormone replacement therapy (HRT), according to new research on the association between HRT and heart attacks, published online in Europe's leading cardiology journal, the European Heart Journal [1] today (Wednesday 1 October).

Stratatech Successfully Completes Clinical Trial Of StrataGraft^ Skin Substitute - Trial's Primary Clinical Endpoint Achieved

Stratatech Corp. , a regenerative medicine company focused on the development and commercialization of cell-based, tissue-engineered skin substitute products, today announced that it has successfully completed the multi-center, 15-patient clinical trial of its StrataGraft^

Cervical Dystonia - FDA's First-Cycle Review Of Dysport(R) To Be Completed By Year-End

Ipsen (Paris:IPN) announced that the U.S. Food and Drug Administration (FDA) provided notification that the Prescription Drug User Fee Act (PDUFA) action date for Dysport^ (botulinum toxin of type A) Biologics License Application (BLA) for the treatment of patients with cervical dystonia has been extended to no later than 28 December 2008. This regulatory decision will not impact the anticipated company launch plan timing.

A.P. Pharma Announces Positive Phase 3 Results With APF530 In The Prevention Of Chemotherapy Induced Nausea And Vomiting

A.P. Pharma, Inc. (NASDAQ:APPA), a specialty pharmaceutical company, announced today positive results from its pivotal Phase 3 study comparing te efficacy of APF530 (the Company's proprietary, sustained release formulation of granisetron) with Aloxi^ for the prevention of chemotherapy induced nausea and vomiting (CINV).

Aethlon Medical Initiates First Clinical Study Of A Medical Device To Treat HIV/AIDS Patients

Aethlon Medical, Inc. (OTCBB:AEMD) announced today that it has initiated patient enrollment in the "first-in-man" clinical study of a medical device to treat the Human Immunodeficiency Virus (HIV), the disease that causes Acquired Immune Deficiency Syndrome (AIDS). The device, known as the Aethlon Hemopurifier^, assists the immune response in combating infectious disease through real-time therapeutic filtration of infectious viruses and immunosuppressive proteins.

More Minority Physicians Would Help Improve Minorities' Participation In Clinical Trials, Opinion Piece Says

"The first step in addressing the underrepresentation of black Americans in research ... is to recruit more minority physicians into clinical research," Ken Getz -- chair of the Center for Information and Study on Clinical Research Participation and a senior research fellow at Tufts University

Columbia Laboratories Reports Results From Phase II Clinical Trial Of Vaginally-administered Lidocaine For Dysmenorrhea

Columbia Laboratories, Inc. (Nasdaq: CBRX) today announced results from its Phase II study of vaginally-administered lidocaine, which the Company is investigating for the prevention and treatment of dysmenorrhea. No treatment currently exists to prevent dysmenorrhea. Seventy women with a history of moderate-to-severe dysmenorrhea participated in this first documented attempt to show prevention of uterine cramping and pain.

Additional Positive Findings For APOPTONEв„ў (HE3235) In Preclinical Models Of Castration-Resistant Prostate Cancer

Hollis-Eden Pharmaceuticals, Inc. (NASDAQ:HEPH) today presented new findings that suggest APOPTONEв„ў (HE3235) is inhibiting in preclinical models of castration-resistant prostate cancer, the ability of tumors to synthesize the hormones necessary for their survival, as well as significantly down regulating the androgen receptor.

Follow-On Phase I Study For Novel Oral Anti-Inflammatory Drug Targeting Rheumatoid Arthritis And Type 1 Diabetes

VGX Pharmaceuticals, a biopharmaceutical company that is developing DNA vaccines for cancer and HIV and therapeutics for other diseases, announced today the results of a Phase I single ascending dose (SAD) study that demonstrated that its lead anti-inflammatory compound, VGX-1027, was generally safe and well tolerated in humans. As a result, VGX Pharmaceuticals and VGX International, a Korean affiliate that is jointly developing VGX-1027, have commenced a multiple ascending dose (MAD) study.

Dosing Began In TransMolecular's Phase 1/2 Clinical Trial For Intravenous Administration Of 131Iodine-TM601 In Recurrent Malignant Glioma Patients

TransMolecular, Inc., a biotechnology company focused on targeted therapies for cancer, announced today that dosing was initiated in a Phase 1/2 trial of 131I-TM601 delivered intravenously (IV) for the treatment of adult patients with recurrent malignant glioma. The trial will focus on investigating the tolerability, safety, and therapeutic efficacy of multiple doses of 131I-TM601 when administered intravenously.

Premature Ejaculation - Plethora Solutions Has Completed European Phase III Trial Of PSD502

Sciele Pharma, Inc. ("Sciele") (NASDAQ:SCRX), a specialty pharmaceutical company, today announced that Plethora Solutions Holdings PLC ("Plethora") (AIM:PLE), the specialist developer of products for the treatment and management of urological disorders, has completed its European Phase III study of PSD502 for the treatment of premature ejaculation (PE) in Europe. The study was initiated in December 2007 and these results from the blinded study are expected in the fourth quarter of 2008.

Tranzyme Pharma Announces Positive Phase IIb Results With Its Ghrelin Agonist, TZP-101, For Postoperative Ileus (POI)

Tranzyme Pharma today announced positive Phase IIb results for its first-in-class, highly potent and selective ghrelin agonist, TZP-101, for the management of postoperative ileus (POI). Results demonstrated that TZP-101 was both safe and highly effective in reducing the duration of ileus following surgery in patients undergoing open bowel resection.

Beta Blockers Reduce Mortality In Patients With COPD After Vascular Surgery

In the first study to directly examine the effects of beta-blockers on surgical patients with chronic obstructive pulmonary disease (COPD), researchers have found that, contrary to previous thought, beta-blockers significantly reduce mortality in COPD patients. "Patients with COPD frequently have unrecognized, atherosclerotic disease. This is also a major cause for late morbidity and mortality," said principle investigator Don Poldermans, M.D., Ph.D.

Lilly Announces Initiation Of Second Global Phase III Trial Of Investigational Alzheimer's Disease Compound

Eli Lilly and Company (NYSE: LLY) announced it will begin enrolling patients in a second Phase III study of LY450139, a gamma-secretase inhibitor being investigated as a potential treatment to delay the progression of mild to moderate Alzheimer's disease. The study, called IDENTITY 2, is expected to enroll 1,100 patients from 22 countries.

Alimera Reports Results From The Six-Month Interim Readout Of The Human PK Iluvien(TM) Study

Alimera Sciences, Inc., a privately held biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, reported the interim month six safety and efficacy results from the first human pharmacokinetic (PK) study of Iluvien(TM). Iluvien is an intravitreal insert being developed for the treatment of diabetic macular edema (DME).

Transcept Pharmaceuticals Submits New Drug Application For Intermezzo(R) For Treatment Of Middle-of-the-Night Awakenings

Transcept Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its lead product candidate, Intermezzo(R) (zolpidem tartrate sublingual lozenge).

ImmunoVaccine Technologies' DepoVax(TM) Shows Positive Results For Cancer And Infectious Diseases

ImmunoVaccine Technologies' (IVT) patented depot vaccine formulation, DepoVax(TM) is showing positive pre-clinical results, with single-dose efficacy achieved in therapeutic cancer and several infectious disease vaccine models. The results of this research will be presented October 4th at the Ehrlich II conference in Germany. Collaborators from the University of Miami will also be reporting on the capabilities of IVT's depot formulations for delivery of DNA and SiRNA in vivo.

HIV Drug Maraviroc Effective For Drug-Resistant Patients

As many as one quarter of HIV patients have drug resistance, limiting their treatment options and raising their risk for AIDS and death. Now, maraviroc, the first of a new class of HIV drugs called CCR5 receptor antagonists, has been shown to be effective over 48 weeks for drug-resistant patients with R5 HIV-1, a variation of the virus found in more than half of HIV-infected patients.

Advanced Ovarian Cancer Patient Enrollment Phase 2 Study Of IMC-1121B Commences

ImClone Systems Incorporated (NASDAQ: IMCL), a global leader in the development and commercialization of novel antibodies to treat cancer, today announced that the first patient has been treated in its disease-directed Phase 2 clinical trial of IMC-1121B in patients with advanced ovarian cancer. IMC-1121B is ImClone's proprietary fully human, IgG1 anti-vascular growth factor receptor-2 (VEGFR-2) monoclonal antibody.

Vitamin C Supplements May Reduce Benefit From Wide Range Of Anticancer Drugs

In pre-clinical studies, vitamin C appears to substantially reduce the effectiveness of anticancer drugs, say researchers at Memorial Sloan-Kettering Cancer Center.

Genes Affect Weight Loss Drug Effectiveness

A study conducted by researchers at Mayo Clinic shows that obese patients with specific genetic makeup had enhanced response to the weight loss drug sibutramine, while others who lack these genetic factors lost little or no weight. The findings are published in the October issue of Gastroenterology (http://www.gastrojournal.org).

Clinical Trials In India 44% Less Expensive Than US Trials

Conducting clinical trials in India is an average of 44% less expensive than conducting US-based trials, according survey data. A new study by pharmaceutical business intelligence leader Cutting Edge Information, "Streamlining Clinical Trials," finds that the average clinical trial costs pharmaceutical companies $125 million in the US compared to $70 million in India, on average.