Efficacy News and Research

RSS

Advaxis initiates ADXS11-001 clinical trial for cervix cancer

Advaxis, Inc., the live, attenuated Listeria monocytogenes (Listeria) immunotherapy company, has begun dosing patients in its 110 patient clinical trial of ADXS11-001 for the treatment of cervix cancer in women for whom cytotoxic treatment has failed.

24 Nov 2010

A new treatment landscape for triple-negative breast cancer

A concerted R&D effort directed at triple-negative breast cancer patients promises new treatment options in the near future, according to latest research from independent market analyst, Datamonitor.

24 Nov 2010

FTC/TDF tablet reduces HIV infection among high-risk individuals: iPrEx study

In a finding with the potential to fundamentally change strategies to slow the global HIV epidemic, a new study called iPrEx shows that individuals at high risk for HIV infection who took a single daily tablet containing two widely used HIV medications, emtricitabine and tenofovir (FTC/TDF), experienced an average of 43.8% fewer HIV infections than those who received a placebo pill. New England Journal of Medicine, is the first evidence that this new HIV prevention method, called pre-exposure prophylaxis or PrEP, reduces HIV infection risk in people.

24 Nov 2010

Important queries about PrEP, iPrEx trial for HIV infection

The results of the iPrEx PrEP effectiveness trial of once-daily TDF/FTC (brand name Truvada) in gay men, transgender women and other men who have sex with men are a landmark in HIV prevention research.

24 Nov 2010

iPrEx trial shows reduction in new HIV infections

Results of the world's first efficacy trial of an HIV-prevention approach called oral pre-exposure prophylaxis, or PrEP, were released online in the New England Journal of Medicine today.

24 Nov 2010

Provectus reports progress in PV-10 program for metastatic melanoma

Provectus Pharmaceuticals, Inc., a development-stage oncology and dermatology biopharmaceutical company, reports continued progress in its compassionate use program for PV-10. The program currently has enrolled more than 40 patients, ten of whom are expanded access patients from the company's Phase 2 trial of PV-10 for metastatic melanoma, as well as more than 30 new patients.

24 Nov 2010

Daily oral antiretroviral reduces HIV infection risk in MSM by 44%, study finds

A study that included nearly 2,500 HIV-negative men and transgender women who have sex with men has shown that a daily dose of Truvada, a pill containing the AIDS drugs emtricitabine and tenofovir, "can reduce risk of contracting [HIV] by an average of 44% - and by more than 70% if the subjects" follow the regimen closely, Los Angeles Times reports (Maugh, 11/23).

24 Nov 2010

XenoPort receives grant from Michael J. Fox Foundation to support Parkinson's disease therapies

XenoPort, Inc. announced today that it has been awarded a grant from The Michael J. Fox Foundation for Parkinson's Research to support a preclinical study of the efficacy and safety of a novel, orally administered prodrug of acamprosate in reducing L-Dopa induced dyskinesias (LID) in a pre-clinical model of Parkinson's disease.

24 Nov 2010

Gilead submits Truvada/TMC278 single-tablet regimen NDA to FDA

Gilead Sciences, Inc. today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of the single-tablet regimen of Truvada® (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine hydrochloride) for HIV-1 infection in adults. If approved, this would be the second product that contains a complete HIV treatment regimen in a single once-daily tablet.

23 Nov 2010

Vertex submits NDA for telaprevir for treating hepatitis C

Vertex Pharmaceuticals Incorporated announced that it has completed the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for telaprevir, Vertex's investigational treatment for people with hepatitis C.

23 Nov 2010

BioAlliance presents AMEP preclinical, phase I clinical results for melanoma at Electrochemotherapy Meeting

BioAlliance Pharma SA, a company dedicated to the supportive care and treatment of cancer patients, presented preclinical and promising preliminary phase I clinical results with its AMEP biotherapy at the "Electrochemotherapy 1st International Users' Meeting"(Bologna, Italy, November 19-20, 2010).

23 Nov 2010

Radical change to Alzheimer’s management

The first disease-modifying drugs are expected to launch from 2013, radically changing the way Alzheimer’s disease is treated. With the potential to successfully slow or halt the progression of Alzheimer’s, blockbuster revenues are beckoning for such pipeline drugs, claims independent market analyst, Datamonitor.

23 Nov 2010

Parkinson Society Canada awards Quebec scientists $573,384 for research

Quebec Parkinson researchers receive a record $573,384 in funding from Parkinson Society Canada to increase their efforts to identify the causes of this degenerative brain disease for which there is currently no cure. At a Research Innovation event in Montreal this evening, hosted by Parkinson Society Quebec in partnership with McGill University and the CHUM, 11 Parkinson scientists will be lauded for their efforts in getting closer to a cure.

23 Nov 2010

Erbitux development program featured in ASCO's Clinical Cancer Advances report for third consecutive year

For the third year in a row, the American Society of Clinical Oncology (ASCO) has included Erbitux® (cetuximab) research in its annual report, Clinical Cancer Advances, which features the most significant studies of 2010. The report cites as a notable advance this year the finding that BRAF mutation status is a prognostic, not predictive, marker for Erbitux efficacy in metastatic colorectal cancer (mCRC).

23 Nov 2010

Compugen announces development of Protein Family Members Discovery Platform

Compugen Ltd. announced today the development of its Protein Family Members Discovery Platform, designed for the discovery of novel protein members belonging to various known and clinically important protein families.

23 Nov 2010

Preclinical trial shows Chimerix’s CMX001 inhibits HSV replication

Chimerix, Inc., a pharmaceutical company developing orally-available antiviral therapeutics, today announced that data demonstrating preclinical efficacy of Chimerix's lead antiviral compound CMX001 against herpes simplex virus (HSV) as well as its ability to penetrate the blood-brain barrier was published in the November 15, 2010 issue of The Journal of Infectious Diseases.

23 Nov 2010

Winston announces Phase II study results of Dolorac for chronic migraine at Lazard Conference

Winston Pharmaceuticals, Inc. a specialty pharmaceutical company focused on developing and commercializing novel pain management therapies, announced the results of its Phase II study on its patented Dolorac Nasal Solution (doxepin 0.4%) for prophylaxis of chronic migraine at the Lazard Capital Markets 7th Annual Healthcare Conference in New York.

22 Nov 2010

Omthera reaches agreement with FDA on SPA for Epanova Phase III trial in patients with very high triglycerides

Omthera Pharmaceuticals, Inc., a privately-held emerging specialty pharmaceuticals company, today announced that it has reached an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the design of its planned Phase III registration clinical trial of Epanova™, the Company's lead compound for the treatment of patients with very high triglycerides. Epanova is an Omega 3 fatty acid containing a novel formulation of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).

22 Nov 2010

Mimetogen initiates MIM-D3 Phase II clinical trial for dry eye disease

Mimetogen Pharmaceuticals Inc., a clinical-stage biotechnology company focused on developing novel small molecule compounds that mimic the effects of neurotrophins, today announced that it has initiated the first human clinical trial evaluating MIM-D3, a mimetic of nerve growth factor (NGF), in a Phase II clinical trial in patients with moderate to severe dry eye disease. MIM-D3 is a small cyclic peptidomimetic of NGF, a naturally occurring protein in the eye that is responsible for the maintenance of corneal nerves and epithelium, mucin and tear production.

22 Nov 2010

Profil Institute expands capabilities to detect cardiac safety signals in diabetes and obesity clinical trials

Profil™ Institute for Clinical Research, Inc., a company specializing in early phase clinical trials for diabetes and obesity, announced today the expansion of its capabilities for cardiac safety and cardiovascular efficacy studies in the company's early phase diabetes and obesity clinical trials.

22 Nov 2010