PLYMOUTH MEETING, Pa., Jan. 29, 2015 /PRNewswire/ -- Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced today it has appointed Mark Stephen Gelder, M.D. as Vice President, Clinical Development. Dr. Gelder will be responsible for planning and executing Inovio's clinical development strategy for its immunotherapies against human papillomavirus (HPV)-caused cervical cancer and dysplasia. He will report to Dr. Mark Bagarazzi, Inovio's Chief Medical Officer.
Dr. Gelder brings well over a decade of experience in the pharmaceutical industry. Prior to joining Inovio, Dr. Gelder was Chief Medical Officer at Heron Therapeutics, an oncology-focused biotechnology company. Dr. Gelder's previous experience includes leading therapeutic oncology programs at Pfizer, Wyeth and Bayer, where he was involved in the approval and launch of several cancer therapeutics. He has led international trials, developed global product launch plans, and directed the development and execution of phase I to phase IV studies.
Dr. Gelder received his M.D. from the University of Virginia School of Medicine and completed residency training in internal medicine and OB/GYN followed by a gynecologic oncology fellowship. He is a Fellow of the American College of Physicians and the American College of Obstetrics and Gynecology and has extensive clinical experience in both the academic and private practice settings. Prior to joining the industry, Dr. Gelder was an investigator in multiple clinical trials and has authored numerous scientific papers in the areas of women's health and oncology.
Dr. J. Joseph Kim, President and CEO, said, "We are extremely pleased to bring a gynecology- oncology expert like Mark Gelder to lead our HPV immuno-oncology programs. Mark's extensive global experience in oncology and his standing as a respected OB/GYN opinion leader will strongly support Inovio as we bring the first DNA-based immunotherapies for HPV-associated diseases into medical practice."
In 2014, Inovio reported top-line data from a large, controlled phase II study showing that VGX-3100 was able to eliminate HPV infection and cause complete regression of high grade cervical dysplasia (CIN 2/3). Inovio is taking the steps to publish a paper with the full data set in a peer-reviewed medical journal this year. Based on the results of the phase II, Inovio plans to initiate a phase III study in early 2016.
Inovio has also expanded clinical development of its DNA-based immune therapy products to treat different HPV types and the many diseases they cause by conducting clinical trials for HPV-associated cervical cancer, aero-digestive cancers and head and neck cancer, the fastest growing cancer in men. Interim safety and immunogenicity data from these studies are expected in 2015.
About Inovio's Cancer Immunotherapies
Inovio's DNA-based immunotherapy technology uniquely activates highly potent antigen-specific killer T cells targeting a specific cancer in the body. The company's technology provides the most natural interaction with the immune system next to an actual infection, therefore the activated therapeutic response remains controlled by the immune system and has to date not triggered unwanted inflammatory responses. These are ideal characteristics of an immuno-oncology product. Inovio achieved an industry first with clinically significant efficacy shown with its VGX-3100 HPV immunotherapy in a phase II study of cervical precancer. Inovio is now advancing multiple clinical and R&D stage active immunotherapies with the potential to address the full spectrum of precancers and cancers.
About Inovio Pharmaceuticals, Inc.
Inovio is revolutionizing the fight against cancer and infectious diseases. Our immunotherapies uniquely activate best-in-class immune responses to prevent and treat disease, and have shown clinically significant efficacy with a favorable safety profile. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include Roche, MedImmune, University of Pennsylvania, DARPA, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and University of Manitoba. For more information, visit www.inovio.com.
This press release contains certain forward-looking statements relating to our business, including our plans to develop electroporation-based drug and gene delivery technologies and DNA vaccines, our expectations regarding our research and development programs and our capital resources. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials and product development programs (including, but not limited to, the fact that pre-clinical and clinical results referenced in this release may not be indicative of results achievable in other trials or for other indications, that the studies or trials may not be successful or achieve the results desired, including safety and efficacy for VGX-3100, that pre-clinical studies and clinical trials may not commence or be completed in the time periods anticipated, that results from one study may not necessarily be reflected or supported by the results of other similar studies and that results from an animal study may not be indicative of results achievable in human studies), the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA vaccines, our ability to support our broad pipeline of SynCon® active immune therapy and vaccine products, our ability to advance our portfolio of immune-oncology products independently, including INO-5150, and to commence a phase I clinical trial for INO-5150 in the first half of 2015, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by the company or its collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that the company and its collaborators hope to develop, our ability to enter into partnerships in conjunction with our research and development programs, evaluation of potential opportunities, issues involving product liability, issues involving patents and whether they or licenses to them will provide the company with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether the company can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of the company's technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2013, our Form 10-Q for the quarter ended September 30, 2014, and other regulatory filings from time to time. There can be no assurance that any product in Inovio's pipeline will be successfully developed or manufactured, that final results of clinical studies will be supportive of regulatory approvals required to market licensed products, or that any of the forward-looking information provided herein will be proven accurate.