XOMA Initiates Trial of Gevokizumab; Sarepta Reports Favorable Safety Results of AVI-7100 Print E-mail
By Josh Gee   
Tuesday, 30 September 2014 19:05
Below is a look at some of the headlines for companies that made news in the healthcare sector on September 30, 2014. XOMA Corporation (Nasdaq: XOMA), a leader in the discovery and development of therapeutic antibodies, today announced that its EYEGUARD-US supplemental clinical study is open for enrollment to patients at study sites located in the United States. The objective of this trial is to assess the efficacy and safety of gevokizumab in treating Behçet's disease uveitis.

"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.


Also Tuesday:

Acasti Pharma Inc. (Nasdaq:ACST) (TSX-V:APO)
, an emerging biopharmaceutical company, announces top-line results for its pharmacokinetic (PK) trial evaluating the bioavailability and safety of CaPre® on healthy individuals taking single and multiple daily oral doses of the Corporation's new investigational drug candidate composed of a patent-protected highly concentrated novel omega-3 phospholipid for the prevention and treatment of certain cardiometabolic disorders.

Akorn, Inc. (Nasdaq:AKRX)
, a niche pharmaceutical company, today announced that it has signed a definitive agreement ("Agreement") to acquire certain rights to short-acting bronchodilator Xopenex® (levalbuterol HCI) Inhalation Solution (IS) from Sunovion Pharmaceuticals Inc. for $45 million, paid in cash at closing, net of certain liabilities. According to IMS Health, the U.S. market for both the generic and branded versions of Xopenex® IS was approximately $280 million for the twelve-month period ending August 2014.

Amedica Corporation (Nasdaq:AMDA)
, a commercial biomaterial company focused on using its Silicon Nitride technology platform to develop, manufacture and sell a broad range of medical devices, is pleased to announce its Board of Directors has elected B. Sonny Bal, MD, JD, MBA, to serve as its President and Chief Executive Officer effective September 30, 2014.

Amicus Therapeutics (Nasdaq:FOLD)
today announced that Bradley Campbell, Chief Operating Officer and Chip Baird, Chief Financial Officer, will present a corporate overview at the Leerink Partners Rare Disease Roundtable in New York, NY on Wednesday, October 1, 2014 at 8:50 a.m. ET.

Argos Therapeutics, Inc. (Nasdaq:ARGS)
, a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis™ technology platform, today announced that it has entered into a $25 million venture loan led by Horizon Technology Finance Corporation (Nasdaq:HRZN).

Arno Therapeutics, Inc. (OTCQB:ARNI)
, a clinical stage biopharmaceutical company focused on the development of oncology therapeutics, today announced that Chief Executive Officer Dr. Alex Zukiwski is scheduled to present at the 13th Annual BIO Investor Forum, being held October 7-8, 2014 at The Palace Hotel in San Francisco, CA.

Biocept, Inc. (Nasdaq:BIOC),
a molecular oncology diagnostics company specializing in biomarker analysis in circulating tumor cell (CTC) and circulating tumor DNA (ctDNA), today announced that Michael Nall, Biocept President and CEO, is scheduled to present a corporate overview at the 13th Annual BIO Investor Forum on October 7, 2014 at The Palace Hotel in San Francisco.

Celldex Therapeutics, Inc. (Nasdaq:CLDX)
announced today the publication of two papers highlighting early studies of glembatumumab vedotin in breast cancer and metastatic melanoma in the Journal of Clinical Oncology (JCO).

Cellular Biomedicine Group Inc. (Nasdaq:CBMG)
, a biomedicine firm engaged in the development of new treatments for degenerative and cancerous diseases, today announced it has completed the previously announced acquisition of privately held Agreen Biotech Co. Ltd. China ("AG") and its founder's U.S. patent.

Ekso Bionics Holdings, Inc. (OTCQB:EKSO)
, a robotic exoskeleton company, announced today that it has signed a Memorandum of Understanding with SoldierSocks, a 501(c)(3) dedicated to working with veterans and veteran organizations.

Heat Biologics, Inc. (Nasdaq:HTBX)
, a clinical stage biopharmaceutical company focused on the development of cancer immunotherapies, announced today that Jeff Wolf, Chief Executive Officer, will be presenting at the 13th Annual BIO Investor Forum.

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.

Marrone Bio Innovations, Inc. (Nasdaq:MBII)
, a leading global provider of bio-based pest management and plant health products announced today the successful results of a Zequanox treatment conducted at Christmas Lake in Shorewood, Minn.

Matinas BioPharma Holdings, Inc. (OTCQB:MTNB)
, an emerging biopharmaceutical company focused on the development and commercialization of omega-3 fatty acid-based prescription therapeutics for the treatment of cardiovascular and metabolic conditions, today announced that Roelof Rongen, President and Chief Executive Officer, will be presenting at the 13th Annual BIO Investor Forum being held October 7-8, 2014 at the Palace Hotel in San Francisco, California.

mCig®, Inc. (OTCQB:MCIG)
, a technology company that owns, manufactures, and distributes the mCig®, VitaCig®, and Vapolution products, is pleased to announce that the Company has formed a 100% owned subsidiary: mCig CBD Technologies, LLC. in the state of Colorado for the purpose of designing and manufacturing a new line of products that will leverage the VitaCig technology for delivery of Cannabis plant derivatives.

Merrimack Pharmaceuticals, Inc. (Nasdaq:MACK)
announced today additional clinical and biomarker data from a Phase 2 study in ER/PR-positive, HER2-negative metastatic breast cancer showing that patients with high heregulin mRNA levels achieved a statistically significant benefit from combining the novel agent MM-121 with exemestane.

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.

Pacific Biosciences of California, Inc. (Nasdaq:PACB)
will hold its quarterly conference call to discuss its Third Quarter 2014 Financial Results on Thursday, October 23, 2014, at 4:30pm Eastern Time.

Premier, Inc. (Nasdaq:PINC)
has named Bimal R. Shah, MD, MBA, vice president of Premier Research Services.

Relypsa, Inc. (Nasdaq:RLYP)
, a biopharmaceutical company, today announced that John Orwin, Chief Executive Officer, will present a corporate overview at the 13th Annual BIO Investor Forum on October 7, 2014 at 2:30 p.m. PT.

Rexahn Pharmaceuticals, Inc. (NYSE MKT:RNN)
a clinical stage biopharmaceutical company developing best-in-class therapeutics for the treatment of cancer, today announced that Peter D. Suzdak, PhD, the Company's Chief Executive Officer, will present at the 13th Annual BIO Investor Forum.

Vital Therapies, Inc. (Nasdaq:VTL)
, a biotherapeutic company developing ELAD®, a cell-based therapy targeting the treatment of acute liver failure, today announced that it plans to commence an underwritten public offering of 2,500,000 shares of its common stock.

"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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