|XOMA Initiates Trial of Gevokizumab; Sarepta Reports Favorable Safety Results of AVI-7100|
|By Josh Gee|
|Tuesday, 30 September 2014 19:05|
"To ensure we designed a study that meets the needs of the U.S. clinicians treating patients who suffer from Behçet's disease uveitis, we worked closely with key opinion leaders to create a protocol that reflects how they treat patients with this serious disease," stated Paul Rubin, M.D., Senior Vice President, Research and Development, and Chief Medical Officer of XOMA. "It was important that the study design allows for the inclusion of patients experiencing active inflammatory episodes, as well as patients who are currently under control but may benefit from an alternative therapy."
The study is titled "A RandomizEd-Withdrawal, Double-Masked, Placebo-Controlled StudY of the Efficacy and Safety of GevokizUmAb in TReating Subjects with Behçet's Disease UveitiS" (EYEGUARD-US). Up to 28 patients will receive gevokizumab on an open-label basis to determine if they respond to therapy. At Day 28, those who respond to gevokizumab will be randomized, one to one, in a double-masked fashion to either gevokizumab 60 mg or placebo, dosed subcutaneously once monthly. The study's primary endpoint is the time to first ocular exacerbation following randomization.
"Opening EYEGUARD-US is a crucial step in our strategy to pursue Behçet's disease uveitis as our first indication for gevokizumab in the U.S.," commented John Varian, Chief Executive Officer of XOMA. "This strategy makes us less dependent on our EYEGUARD-A and C studies in the broader non-infectious uveitis population, which continue to enroll more slowly than hoped. EYEGUARD-US is designed as a well-controlled study to supplement data from the Phase 3 EYEGUARD-B study being performed by our partner SERVIER outside the U.S. and the ex-U.S. data previously generated from two Phase 2 trials of Behçet's disease uveitis patients."
Mr. Varian added, "Upon receipt of successful results from the EYEGUARD-B study, we plan to request a pre-BLA meeting with FDA. EYEGUARD-US is designed to supplement the Agency's need for information in U.S. patients, including potentially serving as a second pivotal study."
Sarepta Therapeutics Inc ( NASDAQ: SRPT), a developer of innovative RNA-based therapeutics, announced favorable safety results from the single ascending dose portion of a Phase I study of AVI-7100, the company's Influenza drug candidate. AVI-7100 uses Sarepta's advanced and proprietary PMOplus chemistry, which is also the basis of the company's clinical-stage Ebola and Marburg drug candidates.
The Phase I study is a randomized, double-blind, placebo-controlled trial designed to characterize the safety, tolerability and pharmacokinetics of single and multiple doses of an intravenous formulation of AVI-7100 in healthy adult volunteers.
The study is being conducted at the National Institutes of Health (NIH) through a collaboration between the company and the NIH's National Institute of Allergy and Infectious Diseases.
AVI-7100 utilizes a novel mechanism of action to target a well-conserved region of the influenza A virus, affording it the potential to act as a broad-spectrum treatment for multiple influenza strains, including Tamiflu-resistant flu strains.
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Hologic, Inc. (Nasdaq:HOLX), a leading developer, manufacturer and supplier of premium diagnostic products, medical imaging systems, and surgical products, with an emphasis on serving the healthcare needs of women, will visit the NASDAQ MarketSite in Times Square.
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Nature's Sunshine Products, Inc. (Nasdaq:NATR), a leading natural health and wellness company engaged in the manufacture and direct sale of premium-quality nutritional and personal care products, today announced that Dr. Nigel Gericke of Cape Town, South Africa, has joined Nature's Sunshine Products' ("NSP") Medical and Scientific Advisory Board.
Novadaq® Technologies Inc. (Nasdaq:NVDQ) (TSX:NDQ), the leading developer and provider of clinically relevant fluorescence imaging solutions for use in surgical and diagnostic procedures, today announced that it has entered into a partnership agreement for multiple LUNA™ fluorescence angiography systems with SerenaGroup™, in Cambridge, Massachusetts.
OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today announced the advancement of the first small molecule Wnt pathway inhibitor under its collaboration with Bayer Pharma AG.
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