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New Drug Shows Promise Against Multiple Sclerosis PDF Print E-mail
Wednesday, 02 November 2011 06:13

An drug called Ocrelizumab has shown promise in a Phase 2 clinical trial involving 220 people with multiple sclerosis (MS), an often debilitating, chronic autoimmune disease that affects an increasing number of people in North America. It usually strikes young adults and is more common in women than in men.

Exelixis To Push Ahead on Prostate Cancer Trial Without FDA Agreement: Shares Plunge PDF Print E-mail
Tuesday, 01 November 2011 05:38

Exelixis has been talking with the FDA for months about reaching an agreement on the design of a pivotal trial for its prostate cancer drug, but now the company has essentially thrown up its hands and decided to push ahead in testing without any formal regulatory deal.

Shares of the company fell more than 30 percent, to $5.36, in after-hours trading following the announcement.

Bayer's Phase III Colorectal Cancer Trial Unblinded After Promising Interim Data PDF Print E-mail
Wednesday, 26 October 2011 06:03

A Phase III study evaluating Bayer HealthCare Pharmaceuticals’ regorafenib (Bay 73-4506) in patients with metastatic colorectal cancer (mCRC) has been unblinded to allow patients in the placebo arm to start receiving the investigational oral multikinase inhibitor. The Correct study is being conducted in 760 mCRC patients whose disease had progressed after approved standard therapy. Patients are randomized to receive either regorafenib plust best supportive care, or placebo plus best supportive care.

Biogen Idec and Abbott Present Positive Data for Daclizumab HYP from Select Phase 2B Trial at ECTRIMS/ACTRIMS PDF Print E-mail
Saturday, 22 October 2011 02:56

Today Biogen Idec (NASDAQ: BIIB) and Abbott (NYSE: ABT) announced additional results from the SELECT Phase 2b trial, the first of two registrational studies designed to evaluate the investigational compound daclizumab high-yield process (DAC HYP) in people with relapsing-remitting multiple sclerosis (RRMS).

OncoGenex Pharmaceuticals Initiates An International, Randomized, Phase II Clinical Trial Evaluating OGX-427 In Advanced Bladder Cancer PDF Print E-mail
Saturday, 22 October 2011 02:43
OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today that it has initiated patient enrollment in a randomized, Phase II clinical trial evaluating OGX-427, an inhibitor of heat shock protein 27 (Hsp27), in patients with advanced bladder cancer.
RegeneRx Phase 2 Dry Eye Data Expected Week of October 31st PDF Print E-mail
Friday, 21 October 2011 00:37

RegeneRx Biopharmaceuticals, Inc. (OTC Bulletin Board: RGRX) (“the Company” or “RegeneRx”) today announced that the database for Phase 2 clinical trial with RGN-259 for the treatment of dry eye syndrome has been locked and preliminary data analysis should be available the week of October 31st.

Pharmatech Oncology Announces Completion of SBIR Grant Research PDF Print E-mail
Friday, 21 October 2011 00:33
Pharmatech Oncology announces completion of a phase I Small Business Innovative Research (SBIR) grant project, funded by the National Cancer Institute (NCI).
Jan Medical begins clinical ‘concussion study’ of high school football players using its portable, brain-sensing system PDF Print E-mail
Thursday, 20 October 2011 00:54

Jan Medical ( announced today that patients have been enrolled in an outpatient clinical study — directed by Paul S. Auerbach, M.D., of Stanford University Medical Center — of the Company’s Nautilus NeuroWave™ portable continuous brain-sensing system. Dr. Auerbach is the Redlich Family Professor of Surgery in the Division of Emergency Medicine.

Phase IV Trials Plagued by Patient Enrollment Problems PDF Print E-mail
Thursday, 20 October 2011 00:50

Clinical development executives rank patient enrollment as the greatest opportunity to accelerate Phase IV clinical trial timelines, according to a new study by Cutting Edge Information.

First Results From Phase 3 Trial Show Malaria Vaccine Candidate Reduces The Risk Of Malaria PDF Print E-mail
Wednesday, 19 October 2011 16:14
First results from a large-scale Phase III trial of RTS,S, published online today in the New England Journal of Medicine (NEJM), show the malaria vaccine candidate to provide young African children with significant protection against clinical and severe malaria with an acceptable safety and tolerability profile.
Aeolus Pharmaceuticals Inc. (AOLS.OB) Announces Positive Results From Study of AEOL 10150 and Neupogen(R) as Combination Therapy for Treatment of Acute Radiation Syndrome PDF Print E-mail
Tuesday, 01 November 2011 06:44

MISSION VIEJO, CA--(Marketwire - November 01, 2011) - Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS) (PINKSHEETS: AOLS), a biotechnology company leveraging significant government funding to develop a platform of novel compounds in oncology and biodefense, today announced preliminary results from a study of AEOL 10150 and Neupogen® conducted by Christie Orschell, PhD of Indiana University. The primary endpoint of the study was to determine drug-drug interactions between Neupogen® and AEOL 10150, as well as to monitor safety and tolerability of the two treatments given simultaneously. Results of the study confirmed that AEOL 10150 does not interfere with the positive effects of Neupogen® on the hematopoietic, or bone marrow, syndrome of Acute Radiation Syndrome (ARS), and the two products in combination were safe and well tolerated.

Conatus Pharmaceuticals Terminates Phase 2 Clinical Trial of CTS-1027 PDF Print E-mail
Thursday, 27 October 2011 04:59 DIEGO, October 25, 2011 — Conatus Pharmaceuticals Inc. announced today the termination of its Phase 2 clinical trial of CTS-1027 in HCV patients. This decision follows reports of laboratory abnormalities and adverse events in a subset of clinical trial participants.

Biogen Idec, Inc. (Massachusetts)'s Oral MS Drug Shines in Phase 3 Study PDF Print E-mail
Sunday, 23 October 2011 01:09
WESTON, Mass., Oct 21, 2011 (BUSINESS WIRE) -- Today Biogen Idec announced positive data from the Phase 3 DEFINE clinical trial of oral BG-12 (dimethyl fumarate) in people with relapsing-remitting multiple sclerosis (RRMS). Results showed that 240 mg of BG-12, administered either twice a day (BID) or three times a day (TID), significantly reduced the proportion of patients who relapsed by 49 percent and 50 percent, respectively, at two years compared with placebo. Detailed data from DEFINE will be presented at the 5th Joint Triennial Congress of the European and Americas Committees on Treatment and Research in Multiple Sclerosis (ECTRIMS and ACTRIMS) in Amsterdam, including a platform presentation on Friday, October 21, 2011 at 9:30 a.m. CEST.
Alemtuzumab (Lemtrada™*) Significantly Reduces Relapses in Multiple Sclerosis vs Interferon Beta-1a in a Phase III Study PDF Print E-mail
Saturday, 22 October 2011 02:54

Sanofi (EURONEXT: SAN and NYSE: SNY) and its subsidiary Genzyme announced today new results from the CARE-MS I trial, the first of two randomized, Phase III clinical trials comparing the investigational drug alemtuzumab (Lemtrada) to Rebif® (high dose subcutaneous interferon beta-1a) in patients with relapsing-remitting multiple sclerosis (MS).

Halozyme Announces Positive Results From Phase 2 Ultrafast Insulin Trials In Patients With Type 1 And Type 2 Diabetes PDF Print E-mail
Saturday, 22 October 2011 02:41
Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the diabetes, cancer, dermatology and drug delivery markets, today announced positive results from two Phase 2 clinical trials of its ultrafast PH20 insulin analog formulations in patients with Type 1 and Type 2 diabetes.
Amid Continued Clinical Trial Failures, No Novel Acute Ischemic Stroke Drug Therapies Are Forecasted to Launch Through 2020 PDF Print E-mail
Friday, 21 October 2011 00:35

Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that, amid continued clinical trial failures of investigational treatments, no novel drug therapies are forecasted to launch for the treatment of acute ischemic stroke (AIS) through 2020.

Oral BG-12 (Dimethyl Fumarate) Significantly Reduced Multiple Sclerosis (MS) Relapses and Disability Progression in Define Phase 3 Clinical Trial PDF Print E-mail
Friday, 21 October 2011 00:32

Today Biogen Idec (NASDAQ: BIIB) announced positive data from the Phase 3 DEFINE clinical trial of oral BG-12 (dimethyl fumarate) in people with relapsing-remitting multiple sclerosis (RRMS).

Cytonet's Liver Cell Therapy Trial for Children With UCD Expands to Canada PDF Print E-mail
Thursday, 20 October 2011 00:51
The Canadian health authority, Health Canada, recently granted Cytonet approval to extend the SELICA III trial, which has been open in the United States since 2010, into Canada.
Phase II Study Showed Ocrelizumab Maintained Significant Reduction in Disease Activity for Multiple Sclerosis Patients for Almost Two Years PDF Print E-mail
Thursday, 20 October 2011 00:48

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced 96-week results1 from a Phase II study of ocrelizumab in patients with relapsing-remitting multiple sclerosis (RRMS), the most common clinical form2 of the disease.

Investigational Laquinimod Demonstrates Its Potential as a New Oral Treatment For RRMS PDF Print E-mail
Wednesday, 19 October 2011 01:30
eva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI) today announced the presentation of Phase III clinical and pre-clinical data, which collectively demonstrate that once-daily oral laquinimod modulates the pathological processes of multiple sclerosis to impact disease activity, disability progression and brain volume loss.
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