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Vertex Pharmaceuticals plans proof-of-concept clinical trials in RA and epilepsy

Vertex Pharmaceuticals Incorporated today provided an update on key 2010 business priorities in conjunction with the 28th Annual J.P. Morgan Healthcare Conference in San Francisco. The company also discussed recent progress in its lead development programs in hepatitis C virus (HCV) infection and cystic fibrosis (CF) and outlined proof-of-concept clinical trials planned in other serious diseases for 2010.

11 Jan 2010

Results of randomized, placebo-controlled study of Ambrotose complex announced

Mannatech, Incorporated, a global pioneer in the development of high-quality health, weight and fitness, and skin care solutions based on nutritional science, announced the results of a randomized, double-blind, placebo-controlled study that shows healthy middle-aged adults who took one teaspoon of Ambrotose® complex twice daily performed significantly better on memory tasks and were overall more positive in their mood.

9 Jan 2010

Acetylon Pharmaceuticals to utilise additional funding in multiple myeloma drug development

Acetylon Pharmaceuticals, Inc. announced today that it has closed on a $2 million investment from a new undisclosed private investor to bring its total financing to $9.25 million. This new investment will convert to stock in the next substantial round of preferred equity financing.

9 Jan 2010

LFB completes conversion of all acquired preferred stock

GTC Biotherapeutics, Inc. announced that LFB Biotechnologies, a wholly owned subsidiary of LFB S.A. (Laboratoire Français du Fractionnement et des Biotechnologies S.A., Les Ulis, France) and a strategic shareholder in GTC, has converted the convertible preferred stock it previously purchased in November 2009 under the terms described in the financing agreements approved by GTC shareholders in July 2009 into a total of 5.3 million shares of common stock.

9 Jan 2010

Plexxikon commences dosing in PLX4032 Phase 3 trial for metastatic melanoma

Plexxikon Inc. announces that enrollment has been initiated and the first patient has been dosed in a pivotal Phase 3 trial of PLX4032 (RG7204) in patients with metastatic melanoma. PLX4032 is a novel, oral and highly targeted drug that is designed to inhibit the BRAF cancer-causing mutation that occurs in about 50 percent of melanomas and about eight percent of all solid tumors. The randomized, controlled, Phase 3 “BRAF Inhibitor in Melanoma” (BRIM3) trial in previously untreated patients is part of the planned registration program for PLX4032.

9 Jan 2010

Savient Pharmaceuticals announces filing of KRYSTEXXA BLA resubmission on track

Savient Pharmaceuticals, Inc. provided an update on its activities directed toward the resubmission of its Biologics License Application (BLA) for KRYSTEXXA(TM) (pegloticase) as a treatment for chronic gout in patients refractory to conventional therapy and reaffirmed its belief that it continues to be on track for the filing of the BLA resubmission for KRYSTEXXA in the first quarter of 2010.

9 Jan 2010

Funxional Therapeutics completes Phase I study of FX125L

Funxional Therapeutics Ltd (Funxional) has announced today the successful completion of the Phase I programme of its novel anti-inflammatory, FX125L, an orally available small molecule that belongs to a new therapeutic class named Broad Spectrum Chemokine Inhibitors (BSCIs).

8 Jan 2010

TetraLogic Pharmaceuticals commences its TL32711 SMAC mimetic Phase 1 clinical trial

TetraLogic Pharmaceuticals announced today that the Company has completed dosing of the first cohort in a Phase 1 clinical trial of its selective SMAC mimetic, TL32711. The Phase 1 trial is an open-label, dose-escalation study evaluating the safety and tolerability of TL32711 in adults with solid tumors or lymphoma refractory to standard therapies. The study will also assess the pharmacokinetics, pharmacodynamics and anti-tumor activity of TL32711.

8 Jan 2010

Novelos Therapeutics to conclude pivotal Phase 3 trial in advanced non-small cell lung cancer

Novelos Therapeutics, Inc., a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, today announced that the 725th event (patient death) has been reached in its pivotal Phase 3 trial in advanced non-small cell lung cancer (NSCLC) studying its lead product, NOV-002, in combination with first-line chemotherapy.

8 Jan 2010

Access Pharmaceuticals completes enrollment for Prolindac monotherapy trail, begins combination study

ACCESS PHARMACEUTICALS, INC., today announced that it has completed enrollment and evaluation of the last additional cohort of patients in the ongoing clinical study of ProLindac as a monotherapy in ovarian cancer patients who have received at least two prior platinum based treatment regimens.

8 Jan 2010

Patient enrollment in Tolerx's Phase 3 clinical study DEFEND-1 completed

Tolerx, Inc., today announced the completion of patient enrollment in its Phase 3 clinical study DEFEND-1, which is evaluating the safety and efficacy of otelixizumab, a targeted T cell immunomodulator, in patients with new-onset autoimmune type 1 diabetes.

8 Jan 2010

University Hospitals Case Medical Center conducts Phase 2 clinical trial of gene therapy for AD

University Hospitals Case Medical Center is one of 12 sites conducting the first Phase 2 clinical trial of a gene therapy for Alzheimer's disease (AD). The study uses a viral-based gene transfer system called CERE-110, which is designed to deliver nerve growth factor (NGF) into the brain.

8 Jan 2010

Phase 1 clinical trial of SIRT1 inhibitor for the treatment of Huntington’s Disease commenced

Elixir Pharmaceuticals, Inc. announced today that its partner, Siena Biotech S.p.A., has commenced Phase 1 clinical testing of Elixir’s potent, first-in-class SIRT1 (sirtuin-1) inhibitor for the treatment of Huntington’s Disease.

8 Jan 2010

Initiation of double blind placebo controlled multi-center trial of DAS181 announced

NexBio, Inc. announced today the initiation of a double blind placebo controlled multi-center trial in the U.S. and Mexico of DAS181 (Fludase®) for the treatment of laboratory confirmed influenza infection.

8 Jan 2010

Pfizer and Debiopharm Group enter into co-development agreement to conduct Phase 3 trial of tremelimumab

Pfizer Inc. (Pfizer) and Debiopharm Group™ (Debiopharm) announced today that they have entered into a co-development agreement to conduct a Phase 3 trial of tremelimumab (CP675,206), a fully human anti-CTLA4 monoclonal antibody for the treatment of patients with unresectable, Stage IV melanoma.

8 Jan 2010

Positive results from phase 2 study evaluating the safety and efficacy of Qnexa announced

VIVUS, Inc. today announced positive results from a phase 2 study evaluating the safety and efficacy of Qnexa®, an investigational drug, for the treatment of obstructive sleep apnea (OSA). VIVUS recently completed phase 3 development of Qnexa for the treatment of obesity and submitted a New Drug Application (NDA) to the FDA for that indication.

7 Jan 2010

Positive top-line results from Phase III study of aclidinium bromide announced

orest Laboratories, Inc. and Almirall, S.A. (ALM.MC) today announced positive top-line results from ACCORD COPD I, a three-month Phase III study comparing aclidinium 200µg and 400µg BID versus placebo.

7 Jan 2010

BioVex's Phase 3 melanoma study amended to include first line patients

BioVex Inc, a company developing new generation biologics for the treatment of cancer and prevention of infectious disease, announced today that the U.S. Food and Drug Administration (FDA) has agreed that BioVex's ongoing OPTiM clinical study in unresectable Stage IIIb-IV melanoma be amended to include untreated (i.e., first line) patients as well as previously treated patients as defined in the original protocol.

7 Jan 2010

Phase II clinical trial results of Liposome-Entrapped Paclitaxel announced

NeoPharm, Inc. today announced the results of a Phase II clinical trial of Liposome-Entrapped Paclitaxel (LEP) an active component of Taxol®. This multicenter, open-label trial of LEP was conducted at 5 centers in India.

7 Jan 2010

Phase II clinical trial of Gilead Sciences' elvitegravir, GS 9350 and Truvada meets primary objective

Gilead Sciences, Inc. today announced that a Phase II clinical trial of its investigational integrase inhibitor-based, once-daily, fixed-dose “Quad” regimen of elvitegravir, GS 9350 and Truvada® (emtricitabine and tenofovir disoproxil fumarate) for the treatment of HIV-1 infection met its primary objective.

7 Jan 2010

Drug Trial News

Vertex Pharmaceuticals plans proof-of-concept clinical trials in RA and epilepsy

Results of randomized, placebo-controlled study of Ambrotose complex announced

Acetylon Pharmaceuticals to utilise additional funding in multiple myeloma drug development

LFB completes conversion of all acquired preferred stock

Plexxikon commences dosing in PLX4032 Phase 3 trial for metastatic melanoma

Savient Pharmaceuticals announces filing of KRYSTEXXA BLA resubmission on track

Funxional Therapeutics completes Phase I study of FX125L

TetraLogic Pharmaceuticals commences its TL32711 SMAC mimetic Phase 1 clinical trial

Novelos Therapeutics to conclude pivotal Phase 3 trial in advanced non-small cell lung cancer

Access Pharmaceuticals completes enrollment for Prolindac monotherapy trail, begins combination study

Patient enrollment in Tolerx's Phase 3 clinical study DEFEND-1 completed

University Hospitals Case Medical Center conducts Phase 2 clinical trial of gene therapy for AD

Phase 1 clinical trial of SIRT1 inhibitor for the treatment of Huntington’s Disease commenced

Initiation of double blind placebo controlled multi-center trial of DAS181 announced

Pfizer and Debiopharm Group enter into co-development agreement to conduct Phase 3 trial of tremelimumab

Positive results from phase 2 study evaluating the safety and efficacy of Qnexa announced

Positive top-line results from Phase III study of aclidinium bromide announced

BioVex's Phase 3 melanoma study amended to include first line patients

Phase II clinical trial results of Liposome-Entrapped Paclitaxel announced

Phase II clinical trial of Gilead Sciences' elvitegravir, GS 9350 and Truvada meets primary objective

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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