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Bioheart's MARVEL Phase II/III clinical trial successful

Bioheart, Inc. (OTCBB:BHRT), presented positive efficacy data from part 1 of its Phase II/III clinical trial at the Heart Failure Society of America (HFSA) Meeting in Boston, Massachusetts. Thomas Povsic, MD, Ph.D., Assistant Professor of Medicine at Duke University, presented the final data for Part 1 of the MARVEL Phase II/III Clinical Trial as a part of the Late Breaking Clinical Trials Session.

17 Sep 2009

ULURU reports Altrazeal clinical trial results

ULURU Inc. (NYSE Alternext: ULU) announced today the presentation of results from the first completed randomized clinical trial for Altrazeal at the SAWC Fall symposium in Washington D.C. September 16-18. The recently completed clinical study compared healing, pain and comfort of skin graft donor sites treated with either Altrazeal(TM) or with a leading commercial sodium carboxymethylcellulose-silver ("CMC-Ag") dressing.

17 Sep 2009

VOICE clinical study for testing the efficacy of two HIV prevention strategies

A new, large-scale clinical trial is examining whether antiretroviral medications normally used to treat HIV infection can also prevent HIV infection in women when applied as a vaginal gel or taken as oral tablets once daily.

16 Sep 2009

Amgen to present its four Phase 3 clinical trial results

Amgen today announced it will present detailed data from four Phase 3 studies as well as other data at the ECCO 15 - ESMO 34 European Multidisciplinary Congress, September 20 - 24, 2009 in Berlin, Germany.

16 Sep 2009

FDA provides Orphan-Drug designation for Keryx' KRX-0401 to treat multiple myeloma

Keryx Biopharmaceuticals, Inc. today announced that KRX-0401 (perifosine) has received Orphan-Drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of multiple myeloma. In August, the Company announced that it had reached an agreement with the FDA regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 trial in relapsed/refractory multiple myeloma and that the study is expected to start by year-end.

16 Sep 2009

CEL-SCI to commence its LEAPS-H1N1 clinical trial following FDA approval

CEL-SCI Corporation (NYSE Amex: CVM), a developer of vaccines and therapeutics for the prevention and treatment of infectious diseases and a late-stage oncology company, announced today that the U.S. Food and Drug Administration (FDA) has indicated that the Company can proceed with its first clinical trial to evaluate the effect of its investigational LEAPS-H1N1 treatment on the white blood cells of hospitalized H1N1 patients.

16 Sep 2009

Celsion's DIGNITY clinical trial aired on Good Morning America

Celsion Corporation announced today the Company’s DIGNITY clinical trial evaluating the use of ThermoDox in combination with hyperthermia for the treatment of Recurrent Chest Wall (RCW) Breast Cancer was aired during commercial breaks on Good Morning America and CBS Sunday Morning this past weekend.

16 Sep 2009

Medivir presented preclinical data from its cathepsin K inhibitor program at the ASBMR meeting

Medivir (STO:MVIRB) presented preclinical data on two candidate drugs (MIV-710, MIV-711) from its cathepsin K inhibitor program in a poster session during the ASBMR (American Society for Bone and Mineral Research) meeting.

16 Sep 2009

Savient updates on its Biologics License Application with the FDA for KRYSTEXXA

Savient Pharmaceuticals, Inc. (Nasdaq: SVNT) announced that on September 14, 2009, the Company completed a Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss the Complete Response Letter (CRL) received by Savient on July 31, 2009 regarding the Company's Biologics License Application (BLA) for KRYSTEXXA(TM) (pegloticase) as a treatment for chronic gout in patients refractory to conventional therapy.

16 Sep 2009

Pros and cons of HIV treatments in developing countries

Palumbo is co-leading a clinical study of anti-HIV medicines in Africa and India for the International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT). The randomized trial found that a cohort of 82 HIV-infected children ages 6 to 35 months responded better to treatment with the protease-inhibiting drug lopinavir (LPV/r) than did a cohort of 82 children in the same age group who received the anti-retroviral drug nevirapine (NVP).

16 Sep 2009

Optimer's North American phase 3 Fidaxomicin study results presented at the 49th ICAAC

Optimer Pharmaceuticals, Inc. (Nasdaq: OPTR) today announced that new data highlighting fidaxomicin's (OPT-80) lower CDI recurrence rates and reduced risk of vancomycin-resistant enterococci (VRE) acquisition from Optimer's North American phase 3 study were presented at the 49th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco.

16 Sep 2009

Phase III EXTEND trial results of pixantrone announced

Cell Therapeutics, Inc. (CTI) today released updated 18-month follow-up clinical data for its phase III EXTEND (PIX 301) trial of pixantrone (BBR2778) for patients with advanced, relapsed or refractory, aggressive non-Hodgkin's lymphoma (NHL). Responses were evaluated by an Independent Assessment Panel that was blinded to patient assignment.

16 Sep 2009

Novartis presents Phase II results of the QVA149 bronchodilator for the treatment of COPD

Sosei Group Corporation ("Sosei"; TSE Mothers Index: 4565) announce that Novartis have presented the results of their two Phase II studies evaluating the efficacy, safety and tolerability of QVA149 at the annual congress of the European Respiratory Society (ERS) in Vienna.

16 Sep 2009

NIMH awards Genomas an SBIR Grant to develop MRI DNA biomarkers for neuropsychiatric disease

Genomas(R), a biomedical company advancing DNA-Guided medicine, today announced the award of a 3-year Phase II Small Business Innovation Research (SBIR) Grant totaling $1.4 Million. The grant, entitled MRI DNA Biomarkers for Neuropsychiatric Disease, was awarded by the National Institute of Mental Health.

16 Sep 2009

NIAID awards Sanaria an SBIR Grant for expediting its malaria vaccine manufacturing process

Sanaria Inc. has received additional support from the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health in the form of a Phase II Small Business Innovation Research (SBIR) Grant. The award for two years is $1.99 million. Subject to satisfactory progress by Sanaria, continued funding for a third year will bring the total to nearly $3 million.

16 Sep 2009

FDA approves BioVex' design of a Phase III clinical trial to evaluate OncoVEX

BioVex Inc, a biotechnology company developing clinical stage treatments for cancer and the prevention of infectious disease, announced today that the U.S. Food and Drug Administration (FDA) has approved the design of a single, pivotal, Phase III clinical trial evaluating its lead product, OncoVEX (GM-CSF), for the first-line treatment of patients with squamous cell cancer of the head and neck.

15 Sep 2009

Alvine Pharmaceuticals raises funds for Phase 2a clinical trial of its lead compound ALV003

Alvine Pharmaceuticals, Inc., a privately held biopharmaceutical company focused on developing and commercializing therapeutics for autoimmune/gastrointestinal diseases, today announced the closing of a $21.5 million extension of its Series A financing.

15 Sep 2009

Hyperion enrolls first patient in HPN-100 investigational compound clinical trial

Hyperion Therapeutics today announced that the first patient has been enrolled in a clinical trial of investigational compound HPN-100 (glycerol phenylbutyrate) in children ages 6-17 with urea cycle disorders (UCD). The study will evaluate the safety, tolerability, and ammonia control of glycerol phenylbutyrate compared to BUPHENYL® (sodium phenylbutyrate).

15 Sep 2009

Palatin Technologies to announce clinical trial results of PL-3994

Palatin Technologies, Inc. (NYSE Amex: PTN) announced that a poster on clinical trial results with PL-3994, its product for heart failure, will be presented today at the 13th Annual Scientific Meeting of the Heart Failure Society of America in Boston.

15 Sep 2009

Extension study data on Fampridine-SR drug

Data from two long-term open-label extension studies of Fampridine-SR show that 86.0% of participants remained on therapy after a maximum treatment time of 15 months in study MS-F204EXT, and 69.5% remained on therapy after a maximum treatment time of 36 months in study MS-F203EXT.

15 Sep 2009

Drug Trial News

Bioheart's MARVEL Phase II/III clinical trial successful

ULURU reports Altrazeal clinical trial results

VOICE clinical study for testing the efficacy of two HIV prevention strategies

Amgen to present its four Phase 3 clinical trial results

FDA provides Orphan-Drug designation for Keryx' KRX-0401 to treat multiple myeloma

CEL-SCI to commence its LEAPS-H1N1 clinical trial following FDA approval

Celsion's DIGNITY clinical trial aired on Good Morning America

Medivir presented preclinical data from its cathepsin K inhibitor program at the ASBMR meeting

Savient updates on its Biologics License Application with the FDA for KRYSTEXXA

Pros and cons of HIV treatments in developing countries

Optimer's North American phase 3 Fidaxomicin study results presented at the 49th ICAAC

Phase III EXTEND trial results of pixantrone announced

Novartis presents Phase II results of the QVA149 bronchodilator for the treatment of COPD

NIMH awards Genomas an SBIR Grant to develop MRI DNA biomarkers for neuropsychiatric disease

NIAID awards Sanaria an SBIR Grant for expediting its malaria vaccine manufacturing process

FDA approves BioVex' design of a Phase III clinical trial to evaluate OncoVEX

Alvine Pharmaceuticals raises funds for Phase 2a clinical trial of its lead compound ALV003

Hyperion enrolls first patient in HPN-100 investigational compound clinical trial

Palatin Technologies to announce clinical trial results of PL-3994

Extension study data on Fampridine-SR drug

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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