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Bio-Path commences dosing in Liposomal Grb-2 Phase I cancer study

Bio-Path Holdings, Inc.,, a biotechnology company with drug development operations in Houston, Texas, announced today that the first patient has been dosed in a Phase I study of its cancer drug candidate, Liposomal Grb-2 (L-Grb-2 or BP-100-1.01), in patients with Acute Myeloid Leukemia (AML), Chronic Myelogenous Leukemia (CML), Acute Lymphoblastic Leukemia (ALL) or Myelodysplastic Syndrome (MDS).

30 Jul 2010

Curaxis completes reverse merger with Auto Search Cars

Curaxis Pharmaceutical Corp. is pleased to announce the completion of its reverse merger with Auto Search Cars, Inc.. The effective date of the Merger is July 29, 2010.

30 Jul 2010

Anthera initiates PEARL-SC Phase 2b study of A-623 for lupus

Anthera Pharmaceuticals, Inc., a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation, today announced it has initiated PEARL-SC, the Phase 2b study of A-623, a novel inhibitor of B-Cell Activating Factor, or BAFF, for the treatment of Systemic Lupus Erythematosus (lupus). Lupus patients suffer from a chronic autoimmune disease, which often leads to severe skin rash, fatigue, joint pain, major organ complications, and cardiovascular disease.

30 Jul 2010

Orexigen's Contrave COR-I trial results published online in journal Lancet

Orexigen® Therapeutics, Inc. announced that results from its COR-I trial of Contrave® were published online today in the journal Lancet. COR-I was the largest of the four, 56-week, Phase 3 trials supporting the New Drug Application for Contrave, currently under review by the U.S. Food and Drug Administration. Results show that patients taking Contrave were two to three times more likely to lose at least 5% or 10% of their body weight compared to those taking placebo, on both an intent-to-treat (ITT) and completers basis.

30 Jul 2010

Intra-Cellular Therapies ITI-007 Phase Ib/II clinical trial for schizophrenia meets primary endpoint

Intra-Cellular Therapies, Inc. today announced the results from a Phase Ib/II clinical trial in patients with schizophrenia with ITI-007, the Company's unique, investigational new drug for the treatment of schizophrenia. The trial met its primary endpoint demonstrating that ITI-007 was safe and well-tolerated in patients with stabilized schizophrenia.

30 Jul 2010

ACADIA initiates new pimavanserin Phase III trial for Parkinson's disease psychosis

ACADIA Pharmaceuticals Inc., a biopharmaceutical company utilizing innovative technology to fuel drug discovery and clinical development of novel treatments for central nervous system disorders, today announced that it has initiated a new Phase III trial designed to evaluate the efficacy, tolerability and safety of pimavanserin as a treatment for patients with Parkinson's disease psychosis (PDP).

30 Jul 2010

Anadys second-quarter net loss decreases to $3.0 million

Anadys Pharmaceuticals, Inc., a biopharmaceutical company dedicated to improving patient care by developing novel medicines for the treatment of hepatitis C, today reported its financial results and program highlights for the second quarter ended June 30, 2010.

29 Jul 2010

Celgene second-quarter non-GAAP total revenue increases 36% to $850 million

Celgene Corporation announced non-GAAP net income of $323.3 million, or non-GAAP diluted earnings per share of $0.69 for the quarter ended June 30, 2010. Non-GAAP net income for the second quarter of 2009 was $216.0 million or non-GAAP diluted earnings per share of $0.46.

29 Jul 2010

AVEO second-quarter total revenues increase to $15.6 million

AVEO Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today provided an update on recent research and development (R&D) and business accomplishments, and announced financial results for the quarter ended June 30, 2010.

29 Jul 2010

Saint Peter's University joins Curemark's clinical trial program for CM-AT autism treatment

Curemark, LLC , a drug research and development company focused on the treatment of neurological diseases, announced that Saint Peter's University Hospital in New Brunswick, New Jersey, is participating in the company's Phase III clinical trials for CM-AT, Curemark's autism treatment.

29 Jul 2010

Bionovo receives EMA final guidance for advancing Menerba to Phase 3 clinical trials

Bionovo, Inc. announced today 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.

29 Jul 2010

Rotigotine provides clinically relevant improvements in RLS symptoms: Study

UCB today announced the results of a 6-month, randomized, double-blind, placebo-controlled clinical study, published in the journal Movement Disorders, showing that Neupro® (rotigotine transdermal system, 2 and 3 mg/24 hours) provided sustained, clinically relevant improvements in symptoms of Restless Legs Syndrome (RLS). The study also showed high rates of complete remission seen with rotigotine 2 mg or 3 mg/24 hours.

29 Jul 2010

Nymox provides update on NX-1207 Phase 3 program for benign prostatic hyperplasia

Nymox Pharmaceutical Corporation provided an update today on the Company's Phase 3 program for NX-1207, Nymox's investigational drug for benign prostatic hyperplasia (BPH). The Safety Monitoring Committee meeting of July 22, 2010 for the Phase 3 U.S. pivotal trials of NX-1207 was favorable and indicated no significant safety concerns for the trials to date. Patient recruitment and trial activities for pivotal U.S. studies NX02-0017 and NX02-0018 are proceeding at over 70 well-known urology investigative sites throughout the U.S.

29 Jul 2010

Advaxis provides update on survival information from ADXS11-001 phase 1 trial in cervix cancer

Advaxis, Inc., the live, attenuated Listeria monocytogenes (Lm) immunotherapy company, has updated the survival information from its phase 1 trial of ADXS11-001 which assessed the safety of this agent in advanced, metastatic, progressive cervix cancer in women whose disease progressed subsequent to treatment with cytotoxic therapy.

29 Jul 2010

Pivotal Phase 3 IMPACT study results of PROVENGE published in New England Journal of Medicine

Dendreon Corporation announced today the publication of data from the pivotal Phase 3 IMPACT study in the New England Journal of Medicine, showing that PROVENGE (sipuleucel-T) demonstrated a statistically significant improvement in overall survival compared to control in men with asymptomatic or minimally symptomatic metastatic castration resistant prostate cancer. The manuscript is published in the July 29, 2010 issue of the journal.

29 Jul 2010

Generex reports positive trends in ongoing Oral-lyn buccal insulin spray global Phase III trial

Generex Biotechnology Corporation, the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today announced that it has now achieved 75% of the required number of per-protocol completers in its ongoing six month pivotal global Phase III study of Generex Oral-lyn™, the Company's proprietary buccal insulin spray product.

29 Jul 2010

Teva Respiratory reports positive results from BDP HFA Nasal Aerosol Phase III trial in seasonal allergic rhinitis

Teva Respiratory today announced positive results from a Phase III trial evaluating the efficacy and safety of beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) Nasal Aerosol in the treatment of seasonal allergic rhinitis (SAR). The study met all efficacy endpoints, demonstrating a statistically significant benefit as compared to placebo. Furthermore, the safety profile of BDP HFA Nasal Aerosol was similar to placebo.

29 Jul 2010

Etubics enters Phase I trials for next generation vector vaccines

Etubics Corporation, a biopharmaceutical company developing next generation vector vaccines, has entered into Phase I trials at Duke University with its ETBX-011, a therapeutic vaccine candidate that is intended to treat Carcinoembryonic Antigen expressing cancers such as colorectal cancer. Etubics dosed its first patient yesterday. Etubics was recently granted clearance by the U.S. Food and Drug Administration for its Investigational New Drug application to begin studying ETBX-011 in humans.

29 Jul 2010

CMX157 shows potential to suppress replication of HIV in Phase 1 clinical trial

Chimerix, Inc., a biopharmaceutical company developing orally-available antiviral therapeutics, today announced the publication of research results demonstrating the potential of CMX157 (hexadecyloxypropyl tenofovir) to effectively suppress replication of human immunodeficiency virus (HIV) that cannot be treated with currently available nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs), including tenofovir disoproxil fumarate (Viread), due to the development of multi-drug resistance. Earlier this year, Chimerix initiated a dose-escalating Phase 1 clinical trial of CMX-157 to evaluate drug safety, tolerability and pharmacokinetics.

29 Jul 2010

Limerick to announce new results from LIM-0705 human trials at 23rd Transplantation Society congress

Limerick BioPharma, Inc., a developer of innovative therapies that help cells pump out unwanted or toxic substances, will announce new results from human trials of its lead compound, LIM-0705, at the 23rd International Congress of the Transplantation Society in Vancouver, Canada, in an oral presentation on August 19, 2010.

29 Jul 2010

Drug Trial News

Bio-Path commences dosing in Liposomal Grb-2 Phase I cancer study

Curaxis completes reverse merger with Auto Search Cars

Anthera initiates PEARL-SC Phase 2b study of A-623 for lupus

Orexigen's Contrave COR-I trial results published online in journal Lancet

Intra-Cellular Therapies ITI-007 Phase Ib/II clinical trial for schizophrenia meets primary endpoint

ACADIA initiates new pimavanserin Phase III trial for Parkinson's disease psychosis

Anadys second-quarter net loss decreases to $3.0 million

Celgene second-quarter non-GAAP total revenue increases 36% to $850 million

AVEO second-quarter total revenues increase to $15.6 million

Saint Peter's University joins Curemark's clinical trial program for CM-AT autism treatment

Bionovo receives EMA final guidance for advancing Menerba to Phase 3 clinical trials

Rotigotine provides clinically relevant improvements in RLS symptoms: Study

Nymox provides update on NX-1207 Phase 3 program for benign prostatic hyperplasia

Advaxis provides update on survival information from ADXS11-001 phase 1 trial in cervix cancer

Pivotal Phase 3 IMPACT study results of PROVENGE published in New England Journal of Medicine

Generex reports positive trends in ongoing Oral-lyn buccal insulin spray global Phase III trial

Teva Respiratory reports positive results from BDP HFA Nasal Aerosol Phase III trial in seasonal allergic rhinitis

Etubics enters Phase I trials for next generation vector vaccines

CMX157 shows potential to suppress replication of HIV in Phase 1 clinical trial

Limerick to announce new results from LIM-0705 human trials at 23rd Transplantation Society congress

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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