SAN DIEGO, Dec. 2, 2013 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (Nasdaq:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, announced today the appointment of Marilyn R. Carlson, D.M.D., M.D., RAC, as Chief Medical Officer and Wayne Alves, Ph.D., as Senior Director of Clinical Operations. These two executives will focus on the initiation and execution of the company's Phase 3 clinical trial of EVK-001 for gastroparesis, which is expected to commence in the first half of 2014.
Dave Gonyer, R.Ph., President and CEO of Evoke Pharma, said, "Dr. Carlson and Dr. Alves represent key corporate appointments as Evoke advances toward the initiation of its Phase 3 trial and adds staff to help ensure a timely initiation and execution. With the funding from our recent initial public offering in place, we are well positioned to advance the development of EVK-001 toward FDA approval and commercialization.
"Dr. Carlson has worked closely with Evoke since the company was founded in 2007 and her appointment is a significant step for the company as we gear up to begin our Phase 3 clinical trial. Dr. Carlson has been the key clinical and regulatory expert for Evoke through the entire development of EVK-001, including the most recent successful Phase 2b trial in gastroparesis. She has also participated in all of Evoke's meetings with the U.S. Food & Drug Administration (FDA). Dr. Carlson brings an enormous amount of talent and knowledge to Evoke and will be instrumental in the process we have ahead of us to reach FDA approval for EVK-001. Her track record in development of regulatory strategies and submissions and proven ability to drive clinical development will be invaluable to our efforts."
Dr. Carlson has more than 22 years of experience in the development and post-marketing support of drugs, biologics, devices and diagnostics. She is one of the founders of Agility Clinical, Inc., a contract research organization dedicated to working with biotechnology companies and companies focused on orphan drug development, and is the founder of entreMeDica, a consulting company that provides chief medical officer services to biotechnology and life sciences companies. Dr. Carlson has held senior medical, regulatory, and/or clinical positions at Synteract, Inc., Prometheus Laboratories, Inc., XOMA (US) LLC, and Procter & Gamble and has participated in more than 50 clinical studies in various capacities. She holds a Bachelor's degree from Hunter College of the City University of New York, a D.M.D. from the Harvard School of Dental Medicine and an M.D. from Case Western Reserve University School of Medicine, and completed an internal medicine residency at The Cleveland Clinic Foundation.
Mr. Gonyer also noted, "Dr. Alves is another important addition to our team of clinical executives. He has a tremendous background in driving the strategic and operational aspects of pharmaceutical development, and his work alongside Dr. Carlson will help Evoke advance toward the initiation of our Phase 3 trial."
Dr. Alves is a seasoned executive with a wealth of experience in leading cross-functional strategic and operational teams. Before joining Evoke, he was President and Principal Consultant of Sage Clinical Development, LLC, a pharmaceutical development consulting firm. Previously, he held senior project leadership and research positions at Cadence Pharmaceuticals, Inc., Valeant Pharmaceuticals, Xcel Pharmaceuticals, Inc. (acquired by Valeant), DevCo Pharmaceuticals and INC Research Inc. He has held Associate and Assistant Professorships at The University of Virginia, University of Pennsylvania and University of North Carolina at Chapel Hill. He received his Bachelor's and Master's Degrees from California State University, Hayward, a Ph.D. from the University of Massachusetts, Amherst, completed a Pre-Doctoral University Fellowship at The Johns Hopkins University, and was an NIMH Postdoctoral Fellow at the University of California, Los Angeles.
About Evoke Pharma, Inc.
Evoke Pharma is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. The Company is developing EVK-001, a metoclopramide nasal spray for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in women with diabetes mellitus. Diabetic gastroparesis is a GI disorder afflicting millions of sufferers worldwide, in which the stomach takes too long to empty its contents resulting in serious digestive system symptoms. Metoclopramide is the only product currently approved in the United States to treat gastroparesis, and is currently available only in oral and intravenous forms. EVK-001 is a novel formulation of this drug, designed to provide systemic delivery of metoclopramide through intranasal administration.
Safe Harbor Statement
Evoke cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar expressions. These statements are based on the company's current beliefs and expectations. These forward-looking statements include statements regarding: the timing and execution of Evoke's planned Phase 3 clinical trial of EVK-001 and Evoke's ability to advance the development of EVK-001 toward FDA approval and commercialization based on its capital resources. The inclusion of forward-looking statements should not be regarded as a representation by Evoke that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risk and uncertainties inherent in Evoke's business, including, without limitation: the inherent risks of clinical development of EVK-001, including potential delays in enrollment and completion of clinical trials, including the planned Phase 3 trial; Evoke will require substantial additional funding, including potentially to complete the planned Phase 3 clinical trial of EVK-001 as well as finance additional development requirements, and may be unable to raise capital when needed; the potential for adverse safety findings relating to EVK-001 to delay or prevent regulatory approval or commercialization; Evoke's reliance on outsourcing arrangements for many of its activities, including clinical development and supply of EVK-001; and other risks detailed in Evoke's prior press releases and in the periodic reports it files with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Evoke undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
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