Efficacy News and Research

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ORAL Solo Phase 3 study shows tasocitinib reduces signs and symptoms of active RA

Pfizer Inc. today announced results of ORAL Solo (1045), a Phase 3 study that showed tasocitinib (CP-690,550), an investigational, novel, oral JAK inhibitor, administered as monotherapy met two primary endpoints, demonstrating a statistically significant reduction in signs and symptoms of moderately to severely active rheumatoid arthritis (RA) and improvement in physical function as measured by ACR20 response rates and mean change in HAQ-DI, respectively, versus placebo at three months.

9 Nov 2010

ORVACS launches ERAMUNE 01 Phase II study to decrease HIV viral reservoirs

ORVACS has launched a Phase II study designed to test the hypotheses that combination therapy with potent antiviral agents and immunomodulator can lead to a decrease in the HIV viral reservoirs and, ultimately, to eradication of the virus. The study is currently being conducted at clinical sites in France, Spain, Italy, and the United Kingdom.

9 Nov 2010

Genta commences tesetaxel Phase 2b clinical trial as 1st-line chemotherapy for metastatic breast cancer

Genta Incorporated today announced that the Company has initiated a new Phase 2b clinical trial of tesetaxel as 1st-line chemotherapy for women with metastatic breast cancer. Tesetaxel is the leading oral taxane currently in clinical development. The new trial will be conducted at Memorial Sloan-Kettering Cancer Center, New York, NY and at the Accelerated Community Oncology Research Network (ACORN) based in Memphis, TN.

9 Nov 2010

SIMPONI injection improves inflammation, structural damage in RA patients

Magnetic resonance imaging (MRI) analyses from two Phase 3 clinical trials showed that once every four week subcutaneous injections of SIMPONI (golimumab) 50 mg plus methotrexate resulted in statistically significant improvements in markers of inflammation and structural damage in patients with active rheumatoid arthritis (RA) compared with placebo plus methotrexate.

9 Nov 2010

Dabigatran etexilate benefits AF patients with previous stroke or transient ischemic attack

Today, The Lancet Neurology published positive results from a sub-group analysis of the landmark Randomized Evaluation of Long-Term Anticoagulant Therapy (RE-LY®) trial - the largest atrial fibrillation (AF) outcomes trial ever completed (18,113 patients in 44 countries worldwide). The new findings fully support the convincing results from the RE-LY® trial and show that AF patients with previous stroke or transient ischemic attack (TIA) may benefit substantially from treatment with dabigatran etexilate.

9 Nov 2010

EpiCept third quarter net loss decreases to $3.2 million

EpiCept Corporation today announced operating and financial results for the three and nine months ended September 30, 2010, and provided an update with respect to the Company's key business initiatives.

9 Nov 2010

Women prefer silicone implants after double mastectomy

A new study has found that women who receive silicone implants after a double mastectomy are more satisfied with their breasts than women who receive saline implants. Published early online in CANCER, a peer-reviewed journal of the American Cancer Society, the findings may help physicians and breast cancer survivors as they together make decisions related to postmastectomy reconstructive surgery.

9 Nov 2010

BioCryst to present data on BCX4208 for gout at ACR Scientific Meeting

BioCryst Pharmaceuticals, Inc. announced the presentation of new data related to the efficacy and safety of BCX4208 for the treatment of gout at the 74th ACR Scientific Meeting being held in Atlanta, Georgia.

9 Nov 2010

New data on Soliris for PNH treatment to be presented at ASH Annual Meeting

Alexion Pharmaceuticals, Inc. today announced that researchers are scheduled to present new data relating to Soliris (eculizumab) as a treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH) during the 52nd Annual Meeting of the American Society of Hematology (ASH), to be held December 4 - 7, 2010 at the Orange County Convention Center in Orlando.

9 Nov 2010

Fuisz receives U.S. Patent for new generation of glucose, analyte analyzers

Fuisz Pharma today announced the issuance of U.S. Patent 7,824,612 Bodily fluid analyzer, and system including same and method for programming same.

8 Nov 2010

NUVO announces positive results from WF10 Phase 2 clinical trial for severe allergic rhinitis

Nuvo Research Inc. a specialty pharmaceutical company focused on the research and development of drug products that are delivered into and through the skin using its topical and transdermal drug delivery technologies and on the development of its immune modulating drug candidate WF10, today announced that its European Phase 2 clinical trial evaluating WF10 as a treatment for severe allergic rhinitis met its primary endpoint.

8 Nov 2010

CytRx reports $4.4 million net loss for third quarter 2010

CytRx Corporation, a biopharmaceutical company specializing in oncology, today reported financial results for the three months and nine months ended September 30, 2010, and provided a business update. The Company also announced the filing of a shelf registration statement with the Securities and Exchange Commission to replace its existing shelf registration, which expires in December 2010.

8 Nov 2010

FDA authorizes Athersys' MultiStem Phase II clinical trial for ulcerative colitis

Athersys, Inc. announced today that the U.S. Food and Drug Administration (FDA) has authorized commencement of a Phase II clinical trial evaluating the safety and efficacy of administration of MultiStem, Athersys' allogeneic investigational cell therapy product, for the potential treatment of ulcerative colitis.

8 Nov 2010

MAP Pharmaceuticals reports positive results from LEVADEX QT trial for migraine

MAP Pharmaceuticals, Inc. today reported successful results from a thorough QT trial of its investigational LEVADEX™ orally inhaled migraine therapy. The trial evaluated the potential of a supra-therapeutic dose to cause an increase in the QT interval. Results of the trial showed that a supra-therapeutic dose of LEVADEX does not increase QTc intervals. LEVADEX is a novel orally inhaled migraine therapy that has completed Phase 3 efficacy development for the acute treatment of migraine.

8 Nov 2010

Santarus's budesonide MMX drug shows positive result for active ulcerative colitis

Santarus, Inc. a specialty biopharmaceutical company, today announced positive top-line results from a second Phase III clinical study evaluating the safety and efficacy of budesonide MMX for the induction of remission of mild or moderate active ulcerative colitis.

8 Nov 2010

XenoPort third quarter net loss decreases to $19.9 million

XenoPort, Inc. announced today financial results for the third quarter and nine months ended September 30, 2010. Revenues for the third quarter were $0.4 million, compared to $0.4 million for the same period in 2009. Net loss for the third quarter was $19.9 million, compared to a net loss of $24.4 million for the same period in 2009.

8 Nov 2010

Tai Chi benefits individuals with arthritis

In the largest study to date of the Arthritis Foundation's Tai Chi program, participants showed improvement in pain, fatigue, stiffness and sense of well-being.

8 Nov 2010

CARMAT signs agreement with Edwards Lifesciences for total artificial heart

CARMAT, the designer and developer of the world's most advanced artificial heart, today announced that it has signed an agreement with Edwards Lifesciences, the global leader in the science of heart valves and hemodynamic monitoring. According to this agreement, CARMAT will be using the Carpentier-Edwards' biological heart valves in its artificial heart.

8 Nov 2010

Blocking beta glucuronidase enzyme could eliminate side effects of CPT-11 in colon cancer treatment

A debilitating side effect of a widely used but harshly potent treatment for colon cancer could be eliminated if a promising new laboratory discovery bears fruit.

8 Nov 2010

Vapor rub improves sleep for children with cold symptoms

Applying a vapor rub is effective for treating children with night-time cough and congestion and improves sleep for children with cold symptoms, according to Penn State College of Medicine researchers.

8 Nov 2010