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Onyx reports positive results from carfilzomib Phase 2b 003-A1 study in multiple myeloma

Onyx Pharmaceuticals, Inc. today announced positive top-line results from the Phase 2b 003-A1 study of single-agent carfilzomib, a selective, next generation proteasome inhibitor, in patients with relapsed and refractory multiple myeloma.

26 Jul 2010

Vical's prophylactic Vaxfectin-formulated pDNA vaccine effective against HSV-2 in animal model

Vical Incorporated today announced that its prophylactic Vaxfectin®-formulated plasmid DNA (pDNA) vaccine against herpes simplex virus type 2 (HSV-2) protected mice against lethal challenge, provided sterilizing immunity and inhibited viral counts at both the primary and latent infection sites. The Vaxfectin® adjuvant substantially improved vaccine effectiveness. A related vaccine significantly reduced the recurrence of HSV-2 lesions in a therapeutic model using guinea pigs with latent infection.

26 Jul 2010

ESC concerned over interpretation of JUPITER sub-analysis trial results about HDL cholesterol

The European Society of Cardiology (ESC) is concerned that interpretations of a paper about cholesterol, published in the Lancet, could act to deter ongoing research efforts into developing new therapeutic strategies to increase high density lipoprotein (HDL) cholesterol. Caution, the ESC experts advise, should be displayed in the interpretation of the results.

26 Jul 2010

Cerenis, Novasep awarded French Government funding for development of CER-001 HDL mimetic

Cerenis Therapeutics SA (Cerenis), a biopharmaceutical company developing novel high-density lipoprotein (HDL) therapies to treat cardiovascular and other metabolic diseases, and Groupe Novasep (Novasep), a leading supplier of manufacturing solutions to the life sciences industries, announce today that they have received French Government funding through OSEO to finance the development of CER-001, a Cerenis HDL mimetic.

26 Jul 2010

L2FU reports 100% recovery of recent study's lost clinical trial patients

Recovering unnecessarily lost patient information is now a viable reality. Lost to follow up rates in clinical research trials can range from 20- 60%. As a result, patients who drop from a clinical trial and 'go missing' can impart a major set-back in pharmaceutical research. Failure to contact patients and obtain final closure data, or bring them back into the clinical trial (if the protocol allows) results in study delays, increased patient recruitment costs, compromised study data, and in some cases an insufficient amount of information to prove the safety and efficacy of a drug.

26 Jul 2010

North Shore-LIJ Health System seeks oropharynx patients for phase I clinical trial

The North Shore-LIJ Health System Department of Radiation Medicine announced today it is seeking patients with cancer of the oropharynx (back of the mouth) to participate in a Phase I clinical trial.Subjects must be newly diagnosed and not have undergone any previous treatment. Further, their cancer must be unassociated with the human papilloma virus (HPV-negative), or, if it is HPV-positive, they must be current or former pack-a-day smokers for at least 10 years.

26 Jul 2010

Experimental treatment for sickle cell disease enters Phase 3 clinical trials

An experimental treatment for sickle cell disease developed at the Los Angeles Biomedical Research Institute has entered Phase 3 clinical trials, David I. Meyer, PhD, LA BioMed president and CEO announced today.

26 Jul 2010

First patient enrolled in Phase 3 SyNAPSe study of BHR-100 for TBI

BHR Pharma, LLC announced today that the first patient has been enrolled in its SyNAPSe study, a global, Phase 3, pivotal trial to evaluate the safety and effectiveness of its intravenous progesterone infusion product (BHR-100) as a neuroprotective agent for treating severe (Glasgow Coma Scale scores of 4-8) traumatic brain injury patients.

23 Jul 2010

Tarsa Therapeutics completes patient enrollment in Phase III ORACAL trial of oral calcitonin

Unigene Laboratories, Inc. today noted that Tarsa Therapeutics has completed patient enrollment in the Phase III ORACAL trial of Tarsa's oral calcitonin product for the treatment of postmenopausal osteoporosis. Unigene licensed the product to Tarsa and owns 26% of the company.

23 Jul 2010

Update on Phase III Study of oral calcitonin for treatment of osteoarthritis

Emisphere Technologies, Inc. today announced that Novartis Pharma AG and its license partner Nordic Bioscience a/s have reported the following in connection with their Phase III Study 2302 in osteoarthritis assessing the safety and efficacy of oral calcitonin in the treatment of osteoarthritis of the knee.

23 Jul 2010

Novartis, Nordic Bioscience to continue oral calcitonin Phase III study in osteoarthritis patients

Unigene Laboratories, Inc. announced today that Novartis and its license partner Nordic Bioscience have decided to continue the companies' two-year, Phase III Study 2302 assessing safety and efficacy of oral calcitonin in patients with osteoarthritis of the knee. Novartis has a worldwide license to produce recombinant calcitonin under Unigene's patented SecraPep® E. coli manufacturing technology.

23 Jul 2010

Early HAART during TB treatment prolongs survival of untreated HIV-infected adults: CAMELIA study

A clinical trial in Cambodia has found it possible to prolong the survival of untreated HIV-infected adults with very weak immune systems and newly diagnosed tuberculosis (TB) by starting anti-HIV therapy two weeks after beginning TB treatment, rather than waiting eight weeks, as has been standard.

23 Jul 2010

Boehringer Ingelheim's VERxVE study of nevirapine meets primary endpoint

New data were presented today at the 18th International AIDS Conference from the VERxVE study that show an investigational, once-daily extended-release (400 mg QD) formulation of nevirapine was non-inferior to twice-daily immediate release Viramune® (nevirapine) tablets (200 mg BID), both in combination with Truvada® (tenofovir and emtricitabine) tablets in treatment-naive HIV-1 infected patients through 48 weeks.

23 Jul 2010

NPS completes patient randomization in GATTEX Phase 3 study for PN dependent short bowel syndrome

NPS Pharmaceuticals, a specialty pharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, today announced the completion of patient randomization in its Phase 3 registration study of GATTEX® (teduglutide). The double-blind, placebo-controlled safety and efficacy study, which is known as STEPS, is being conducted in patients with parenteral nutrition (PN) dependent short bowel syndrome (SBS) and is now fully randomized with 86 patients.

23 Jul 2010

Cytrx’s tamibarotene achieves molecular complete remission in advanced acute promyelocytic leukemia

CytRx Corporation, a biopharmaceutical company specializing in oncology, today announced that a 44-year-old female patient with advanced acute promyelocytic leukemia (APL) achieved molecular complete remission with no evidence of disease in the blood cells and/or bone marrow following treatment with CytRx's oncology drug candidate tamibarotene.

23 Jul 2010

Independent DSMB recommends Inhibitex to complete FV-100 Phase II clinical trial for shingles

Inhibitex, Inc. today 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. Based upon its review, the DSMB recommended that the trial continue to completion without modification.

23 Jul 2010

Tibotec reports Phase 3 trial results of TMC278 vs. EFV in treatment-naive HIV-1-infected adults

Tibotec Pharmaceuticals announced today results from two pivotal Phase 3, double-blind, randomized clinical trials comparing the efficacy, safety and tolerability of its investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC278 (rilpivirine) versus efavirenz (EFV), each administered once daily with a nucleoside/nucleotide background regimen in treatment-naive, HIV-1-infected adults.

22 Jul 2010

Achillion nominates ACH-2928 NS5A clinical candidate for treatment of HCV

Achillion Pharmaceuticals, Inc., a leader in the discovery and development of treatments for the most challenging infectious diseases, today announced the nomination of a lead clinical candidate in its fourth proprietary program against hepatitis C virus (HCV) infection. The candidate, ACH-2928, is an NS5A inhibitor that in preclinical studies has demonstrated excellent potency against HCV RNA replication, as well as good pharmacokinetic and safety profiles.

22 Jul 2010

Tarsa completes enrollment in Phase III ORACAL trial for postmenopausal osteoporosis

Tarsa Therapeutics, Inc. today announced progress in the ORACAL trial of its oral calcitonin product for the treatment of postmenopausal osteoporosis. The company has completed patient enrollment in this multinational, randomized, double-blind, placebo-controlled Phase III trial designed to enroll approximately 550 patients. In addition, Tarsa announced that the independent Data Monitoring Committee (DMC) for the ORACAL trial has completed two separate safety reviews of patient data and recommended that the trial proceed as planned.

22 Jul 2010

Merrimack, sanofi-aventis initiate dosing in MM-121 and exemestane combination Phase 2 breast cancer study

Merrimack Pharmaceuticals, Inc. and sanofi-aventis announced today that the first patient has received an initial dose in a Phase 2 randomized double blind clinical study combining MM-121 with exemestane (Aromasin®) in breast cancer patients.

22 Jul 2010

Drug Trial News

Onyx reports positive results from carfilzomib Phase 2b 003-A1 study in multiple myeloma

Vical's prophylactic Vaxfectin-formulated pDNA vaccine effective against HSV-2 in animal model

ESC concerned over interpretation of JUPITER sub-analysis trial results about HDL cholesterol

Cerenis, Novasep awarded French Government funding for development of CER-001 HDL mimetic

L2FU reports 100% recovery of recent study's lost clinical trial patients

North Shore-LIJ Health System seeks oropharynx patients for phase I clinical trial

Experimental treatment for sickle cell disease enters Phase 3 clinical trials

First patient enrolled in Phase 3 SyNAPSe study of BHR-100 for TBI

Tarsa Therapeutics completes patient enrollment in Phase III ORACAL trial of oral calcitonin

Update on Phase III Study of oral calcitonin for treatment of osteoarthritis

Novartis, Nordic Bioscience to continue oral calcitonin Phase III study in osteoarthritis patients

Early HAART during TB treatment prolongs survival of untreated HIV-infected adults: CAMELIA study

Boehringer Ingelheim's VERxVE study of nevirapine meets primary endpoint

NPS completes patient randomization in GATTEX Phase 3 study for PN dependent short bowel syndrome

Cytrx’s tamibarotene achieves molecular complete remission in advanced acute promyelocytic leukemia

Independent DSMB recommends Inhibitex to complete FV-100 Phase II clinical trial for shingles

Tibotec reports Phase 3 trial results of TMC278 vs. EFV in treatment-naive HIV-1-infected adults

Achillion nominates ACH-2928 NS5A clinical candidate for treatment of HCV

Tarsa completes enrollment in Phase III ORACAL trial for postmenopausal osteoporosis

Merrimack, sanofi-aventis initiate dosing in MM-121 and exemestane combination Phase 2 breast cancer study

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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