GAINESVILLE, Fla., and CAMBRIDGE, Mass., Nov. 17, 2016 (GLOBE NEWSWIRE) -- Applied Genetic Technologies Corporation (NASDAQ:AGTC), a biotechnology company conducting human clinical trials of adeno-associated virus (AAV)-based gene therapies for the treatment of rare diseases, today announced the appointment of Michael Goldstein, M.D., M.B.A. as Chief Medical Officer (CMO) effective as of December 1, 2016. Dr. Goldstein will be responsible for leading the company’s clinical trials, providing medical oversight, and contributing to the overall strategic direction of the company. AGTC’s current Vice President and CMO, Jeffrey D. Chulay, M.D., DTM&H, will remain with the company as Executive Director of Clinical Strategy.
“Mike’s extensive clinical background in ophthalmology, along with his experience serving as CMO of a publicly traded company, will further strengthen our management team as we advance our lead gene therapy development programs,” said Sue Washer, President and CEO of AGTC. “We recognize Jeff’s substantial contributions throughout his ten years with AGTC and look forward to his ongoing contribution in his new role. We are extremely fortunate that the company will be able to continue to benefit from Jeff’s experience in gene therapy and his strong relationships with key opinion leaders to assure a smooth transition as Mike assumes the CMO position.”
Prior to joining AGTC, Dr. Goldstein held multiple roles of increasing responsibility with Eleven Biotherapeutics, including as Chief Medical Officer and Vice President of Clinical Research, where he worked with Eleven’s team to bring a novel treatment for dry eye disease from early research to a completed pivotal trial. Since 2002 he has served as Co-Director of Cornea and External Disease Service and Assistant Professor of Ophthalmology at the New England Eye Center. Previously, he was Director of Refractive Surgery Service and Assistant Professor of Ophthalmology at the University of Florida College of Medicine. Dr. Goldstein has published extensively and is a reviewer for multiple ophthalmology scientific journals. He holds an M.D. from Northwestern University Medical School, an M.B.A. from Northwestern University’s J.L. Kellogg Graduate School of Management and a B.A. in Political Economy from Williams College.
“AGTC’s gene therapy platform has multiple opportunities to provide long-term value to patients with inherited diseases and I am excited to be joining the company at this critical time,” said Dr. Goldstein. “My top priority is completing enrollment and analysis of a full data set from the ongoing Phase 1/2 clinical trials for the company’s XLRS and CNGB3 (achromatopsia) product candidates and both of the planned Phase 1/2 clinical trials for its CNGA3 (achromatopsia) and XLRP product candidates. I look forward to joining a team that has already laid the groundwork to realize the promise of gene therapy.”
AGTC is a clinical-stage biotechnology company that uses its proprietary gene therapy platform to develop products designed to transform the lives of patients with severe diseases, with an initial focus in ophthalmology. AGTC's lead product candidates are designed to treat inherited orphan diseases of the eye, caused by mutations in single genes that significantly affect visual function and currently lack effective medical treatments.
AGTC's product pipeline includes six named ophthalmology development programs across five targets (X-linked retinoschisis (XLRS), X-linked retinitis pigmentosa (XLRP), achromatopsia, wet age-related macular degeneration and blue cone monochromacy), two non-ophthalmology programs (alpha-1 antitrypsin deficiency and adrenoleukodystrophy) and AGTC is continuing to develop early research studies in additional indications. The company is also exploring genetic defects in cells in the inner ear that lead to deafness and expects to advance several product candidates into development within the next few years. AGTC employs a highly targeted approach to selecting and designing its product candidates, choosing to develop therapies for indications having high unmet medical need, clinical feasibility and commercial potential. AGTC has a significant intellectual property portfolio and extensive expertise in the design of gene therapy products including capsids, promoters and expression cassettes, as well as, expertise in the formulation, manufacture and physical delivery of gene therapy products.
Forward Looking Statements
This release contains forward-looking statements that reflect AGTC's plans, estimates, assumptions and beliefs. Forward-looking statements include information concerning possible or assumed future results of operations, business strategies and operations, preclinical and clinical product development and regulatory progress, potential growth opportunities, potential market opportunities and the effects of competition. Forward-looking statements include all statements that are not historical facts and can be identified by terms such as “anticipates,” “believes,” “could,” “seeks,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would” or similar expressions and the negatives of those terms. Actual results could differ materially from those discussed in the forward-looking statements, due to a number of important factors. Risks and uncertainties that may cause actual results to differ materially include, among others: no gene therapy products have been approved in the United States and only two such products have been approved in Europe; AGTC cannot predict when or if it will obtain regulatory approval to commercialize a product candidate; uncertainty inherent in the regulatory review process; risks and uncertainties associated with drug development and commercialization; factors that could cause actual results to differ materially from those described in the forward-looking statements are set forth under the heading “Risk Factors” in the Company's Annual Report on Form 10-K for the fiscal year ended June 30, 2016, as filed with the SEC. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements represent management's plans, estimates, assumptions and beliefs only as of the date of this release. Except as required by law, we assume no obligation to update these forward-looking statements publicly or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.
Last updated on: 20/11/2016
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