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Peer-reviewed articles elucidate role of clusterin in promoting tumor resistance to cancer treatment

OncoGenex Pharmaceuticals, Inc., announced today that two peer-reviewed articles have been published that further elucidate the biological function of clusterin, its role in promoting tumor resistance to cancer treatment, and the role of an inhibitor of clusterin such as custirsen (OGX-011) that is designed to knock down treatment resistance in the cells and enhance the effectiveness of cancer therapies.

1 Mar 2010

Synexus recruits 87% of agreed number of patients in major osteoporosis study within deadline

Following the recent announcement from Manchester-based Synexus that they had randomised 2,700 patients in just ten months for an osteoporosis study, the company has once again demonstrated that it is possible to recruit the agreed number of patients within the study deadline by recruiting 87% of patients to another study for the same therapeutic area.

From AES - Accelerated Enrollment Solutions 1 Mar 2010

[11C]PiB PET neuroimaging exhibits potential for monitoring therapeutics on amyloid beta load during Alzheimer’s disease treatment

Elan Corporation, plc today announced that findings from a Phase II study which suggested bapineuzumab reduced amyloid-beta deposits in the brains of Alzheimer’s disease patients as measured using a neuroimaging technique known as [11C]PiB PET, were published in the February 28, 2010 online edition of Lancet Neurology. Bapineuzumab is a compound under development by Pfizer and Janssen Alzheimer Immunotherapy, a Johnson & Johnson subsidiary in which Elan holds a minority equity interest.

1 Mar 2010

ADMET tester Absorption Systems joins Society of Toxicology as Affiliate

Absorption Systems, a leader in testing drugs for ADMET (Absorption, Distribution, Metabolism, Excretion and Toxicity), has joined the Society of Toxicology, the premier global professional association of toxicologists, as an SOT Affiliate. The firm, a contract research organization, has more than a decade of experience assisting pharmaceutical and biotechnology companies in determining which compounds in development should be advanced into clinical testing.

27 Feb 2010

Single submission of orphan drug designation annual report for both FDA and EMA

In recognition of World Rare Disease Day, the U.S. Food and Drug Administration and the European Medicines Agency (EMA) today announced a more streamlined process to help regulators better identify and share information throughout the development process of orphan drug and biologic products, which are developed specifically to treat rare medical conditions. Both agencies have agreed to accept the submission of a single annual report from sponsors of orphan drug and biologic products designated by both the United States and the European Union.

27 Feb 2010

Synta Pharmaceuticals presents preclinical and clinical data of Hsp90 inhibitor STA-9090

Synta Pharmaceuticals Corp., a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced that Dr. Geoffrey I. Shapiro of Dana-Farber Cancer Institute, presented preclinical and clinical data on STA-9090, a potent second-generation Hsp90 inhibitor, at IASLC (International Association for the Study of Lung Cancer) 10th Annual Targeted Therapies of the Treatment of Lung Cancer Meeting in Santa Monica, CA.

27 Feb 2010

Teva Pharmaceutical announces clinical study results of Copaxone in RRMS patients

Teva Pharmaceutical Industries Ltd. today announced the publication of data from the 15-year clinical study with Copaxone® (glatiramer acetate injection), which is the longest prospective and continuous evaluation ever conducted in relapsing-remitting multiple sclerosis (RRMS) patients. The data were published in the February issue of the journal Multiple Sclerosis.

26 Feb 2010

Antiretroviral therapy reduces mortality rates in patients co-infected with HIV and TB

Initiating antiretroviral therapy (ART) during tuberculosis therapy significantly reduced mortality rates by 56 percent in a randomized clinical trial of 642 patients co-infected with HIV and tuberculosis. The study, which provides further impetus for the integration of TB and HIV services, lays to rest the controversy on whether co-infected patients should initiate ART during or after TB treatment.

26 Feb 2010

Study confirms efficacy and tolerability of lacosamide for uncontrolled POS

A recent multi-center study has confirmed earlier study results that 400 mg/day of lacosamide provides a good balance of efficacy and tolerability for patients with uncontrolled partial-onset seizures (POS), and doses of 600mg/day may provide additional benefit for some patients.

26 Feb 2010

Resverlogix commences enrollment in RVX-208 Phase 2 clinical trial for atherosclerosis in ACS patients

Resverlogix Corp. announced today that it has officially activated the first site for the ASSURE 1 trial and commenced enrollment of patients for dosing of RVX-208. ASSURE 1 is the second Resverlogix Phase 2 clinical trial, led by Cleveland Clinic. This trial will examine RVX-208, Resverlogix's oral small molecule therapy for the treatment of atherosclerosis, in patients with acute coronary syndrome (ACS). This preparatory acute coronary syndrome study will ensure that 50 percent of the enrolled patients receive the IVUS (intravascular ultrasound) assessment.

26 Feb 2010

Genta initiates new dose-ranging study of tesetaxel drug

Genta Incorporated announced that the Company has initiated a new dose-ranging study of tesetaxel, the Company’s novel oral tubulin inhibitor, using a weekly dosing regimen. Tesetaxel -- a late Phase 2 oncology product -- is the leading oral taxane currently in clinical development.

26 Feb 2010

Kinex Pharmaceuticals announces KX2-391 Phase 2 safety and efficacy clinical trial in men with CRPC

Kinex Pharmaceuticals opened a Phase 2 clinical trial to evaluate the safety and efficacy of KX2-391 in patients with bone-metastatic, castrate-resistant prostate cancer (CRPC) who have not had prior chemotherapy.

25 Feb 2010

Cannabis Science completes selection of initial cannabis-based pharmaceutical for FDA clinical trials

Cannabis Science Inc., a pharmaceutical cannabis company, is pleased to report to their shareholders that the choice of our initial cannabis-based pharmaceutical for FDA clinical trials has been made. The Company has reported several possible drugs for FDA clinical trials. Based on extensive studies, the Company has decided to contract with a group based in Colorado to handle the Company’s FDA filings.

25 Feb 2010

OncoGenex Pharmaceuticals receives CHMP advice on OGX-011 development plan in treatment of mCRPC

OncoGenex Pharmaceuticals announced today that it has received written, scientific advice from the European Medicines Agency (EMA) on the company's development plan for OGX-011 (also known as custirsen) for the treatment of men with metastatic castrate-resistant prostate cancer (mCRPC). The input received from the Committee for Medicinal Products for Human Use (CHMP) at the EMA was in overall agreement with OncoGenex's development plan regarding the proposed preclinical studies and both the study designs and analyses for the Phase III trials.

25 Feb 2010

Study demonstrates Prochymal treamtent is safe for cardiac patients

“Patients receiving Prochymal did better than those receiving only standard-of-care,” said Dr. Hare, lead author of the JACC publication.

25 Feb 2010

Harbor BioSciences to receive patent for Apoptone in treatment of prostate cancer, breast cancer and benign prostatic hypertrophy

Harbor BioSciences, Inc. today announced that the company has received a notice of allowance from the United States Patent Office of patent claims covering the use of its lead product candidate Apoptone®. The patent claims cover the use of Apoptone to treat prostate cancer, breast cancer and benign prostatic hypertrophy. Apoptone (HE3235) is a novel synthetic steroid analog of a dihydrotestosterone metabolite and has been found to stimulate cell death (apoptosis) in animal models of prostate and breast cancers.

25 Feb 2010

Anadys Pharmaceuticals' ANA598 combination demonstrates 73% cEVR in ongoing Phase II study for HCV

Anadys Pharmaceuticals, Inc. today announced preliminary results from an ongoing Phase II study demonstrating that 73% of hepatitis C patients treated with 200 mg ANA598 twice daily in combination with pegylated interferon and ribavirin (SOC) achieved undetectable levels of virus (<15 IU/mL) at week 12, known as complete Early Virological Response or cEVR.

25 Feb 2010

Welichem commences enrollment in WBI-1001 Phase IIa clinical trial for psoriasis

Welichem announced that the Company has begun to enroll patients in a Phase IIa clinical trial with its lead candidate, WBI-1001. The Phase IIa clinical trial is a 12-Week, double-blinded, placebo-controlled study. The objectives of the trial are to evaluate the efficacy of the WBI-1001 cream in comparison to the vehicle and also to evaluate the safety and tolerability of the cream in patients with psoriasis.

24 Feb 2010

Enzon Pharmaceuticals initiates treatment in PEG-SN38 Phase 1 study for pediatric cancer patients

Enzon Pharmaceuticals, Inc. today announced that the first patient has been treated in the Phase 1 study of PEG-SN38 for pediatric cancer patients. PEG-SN38 or EZN-2208 is Enzon’s PEGylated form of SN38, the active metabolite of the cancer drug Camptosar® (irinotecan HCl injection). The study is designed to find the recommended dose of PEG-SN38 in pediatric patients. The PEG-SN38 compound is currently being evaluated in Phase 2 studies for metastatic colorectal and breast cancer.

24 Feb 2010

Novelos Therapeutics' NOV-002 Phase 3 NSCLC trial fails to meet primary survival endpoint

Novelos Therapeutics, Inc., a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, today announced that the primary endpoint of improvement in overall survival was not met in Novelos’ pivotal Phase 3 trial in advanced non-small cell lung cancer (NSCLC) studying its lead product, NOV-002, in combination with first-line chemotherapy. Detailed trial results are expected to be presented via appropriate scientific venue later this year.

24 Feb 2010

Drug Trial News

Peer-reviewed articles elucidate role of clusterin in promoting tumor resistance to cancer treatment

Synexus recruits 87% of agreed number of patients in major osteoporosis study within deadline

[11C]PiB PET neuroimaging exhibits potential for monitoring therapeutics on amyloid beta load during Alzheimer’s disease treatment

ADMET tester Absorption Systems joins Society of Toxicology as Affiliate

Single submission of orphan drug designation annual report for both FDA and EMA

Synta Pharmaceuticals presents preclinical and clinical data of Hsp90 inhibitor STA-9090

Teva Pharmaceutical announces clinical study results of Copaxone in RRMS patients

Antiretroviral therapy reduces mortality rates in patients co-infected with HIV and TB

Study confirms efficacy and tolerability of lacosamide for uncontrolled POS

Resverlogix commences enrollment in RVX-208 Phase 2 clinical trial for atherosclerosis in ACS patients

Genta initiates new dose-ranging study of tesetaxel drug

Kinex Pharmaceuticals announces KX2-391 Phase 2 safety and efficacy clinical trial in men with CRPC

Cannabis Science completes selection of initial cannabis-based pharmaceutical for FDA clinical trials

OncoGenex Pharmaceuticals receives CHMP advice on OGX-011 development plan in treatment of mCRPC

Study demonstrates Prochymal treamtent is safe for cardiac patients

Harbor BioSciences to receive patent for Apoptone in treatment of prostate cancer, breast cancer and benign prostatic hypertrophy

Anadys Pharmaceuticals' ANA598 combination demonstrates 73% cEVR in ongoing Phase II study for HCV

Welichem commences enrollment in WBI-1001 Phase IIa clinical trial for psoriasis

Enzon Pharmaceuticals initiates treatment in PEG-SN38 Phase 1 study for pediatric cancer patients

Novelos Therapeutics' NOV-002 Phase 3 NSCLC trial fails to meet primary survival endpoint

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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