By a News Reporter-Staff News Editor at Pharma Business Week Tokai Pharmaceuticals, Inc., a biopharmaceutical company focused on developing new treatments for prostate cancer, announced the appointment of Adrian M. Senderowicz, M.D., to the position of chief medical officer and vice president, medical development. Dr. Senderowicz brings 15 years' experience as a board-certified medical oncologist with significant industry, clinical, academic and U.S. regulatory expertise. Tokai's lead candidate, galeterone (TOK-001), recently received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the potential treatment of metastatic castration-resistant prostate cancer (CRPC), an advanced and difficult-to-treat form of prostate cancer that occurs when the disease progresses despite the use of androgen deprivation therapy (see also Pharmaceutical Companies).
"With his deep oncology clinical, research, development and regulatory experience, Adrian's appointment as chief medical officer brings valuable expertise to Tokai as our lead product galeterone advances into Phase 2 development in patients with castration-resistant prostate cancer," said Martin D. Williams, president and chief executive officer, Tokai Pharmaceuticals. "The positive proof-of-concept data we shared earlier this year at both the AACR and ASCO annual meetings, as well as the recent Fast Track designation for galeterone, further validate its potential therapeutic utility for the treatment of prostate cancer."
Most recently, Dr. Senderowicz was senior medical director of oncology clinical development at AstraZeneca, where he was responsible for clinical development and regulatory programs for novel cancer therapeutics, including guiding the team through FDA approval of Caprelsa (vandetanib) for patients with advanced medullary thyroid carcinoma. Additionally, Dr. Senderowicz has served for the past two years as an adjunct professor in the Department of Biology at Temple University. Before his tenure at AstraZeneca, Dr. Senderowicz held a variety of leadership positions at the U.S. FDA Division of Oncology Drug Products in the Center for Drug Evaluation and Research. While at the FDA, Dr. Senderowicz served as a team leader responsible for planning, coordinating and evaluating the division's various oncology medical programs. Also, Dr. Senderowicz was a senior medical reviewer with the FDA's Division of Oncology, where he reviewed more than 100 submitted regulatory documents including Investigational New Drug applications, pre-Investigational New Drugs, New Drug Applications and Special Protocol Assessments. Prior to his work with the FDA, Dr. Senderowicz held a variety of clinical and research positions including head of the Prostate Cancer Clinic and chief, Molecular Therapeutics Unit, with the National Cancer Institute/National Institutes of Health. Dr. Senderowicz holds both M.D. and Instructor of Pharmacology degrees from the School of Medicine at the Universidad de Buenos Aires in Argentina.
"There is a clear, unmet medical need for new treatment options for prostate cancer patients, especially those with castration-resistant prostate cancer who often become resistant to androgen deprivation therapy," commented Dr. Senderowicz. "Galeterone's unique triple mechanism of action disrupts androgen receptor signaling to prevent the growth and survival of prostate cancer cells. Galeterone has tremendous potential and is differentiated from other castration-resistant prostate cancer therapies. I look forward to working with the Tokai team to advancing this innovative compound into later-stage clinical development." About Galeterone (TOK-001) Galeterone is a proprietary small molecule, oral drug for the treatment of prostate cancer that disrupts androgen receptor signaling via a novel triple mechanism of action. Galeterone has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the potential treatment of metastatic castration-resistant prostate cancer (CRPC), an advanced, difficult-to-treat form of prostate cancer that occurs when the disease progresses despite the use of androgen deprivation therapy.
Tokai recently completed ARMOR1, a Phase 1 proof-of-concept study of galeterone in patients with CRPC, part of the ARMOR (Androgen Receptor Modulation Optimized for Response) clinical development program and the company plans to initiate a Phase 2 clinical trial in patients with CRPC in the second half of the year.
In preclinical studies, galeterone acts as a highly selective CYP17 lyase inhibitor, as an androgen receptor antagonist, and decreases androgen receptor levels in prostate tumors - the only drug in development that has been shown to exhibit all three of these properties. In galeterone, these three distinct mechanisms of action are combined in one therapeutic compound. About Tokai Pharmaceuticals Tokai Pharmaceuticals is a U.S. biopharmaceutical company focused on developing new treatments for prostate cancer. The company's lead drug candidate, galeterone (TOK-001), is the first investigational new drug that can decrease overall androgen receptor levels in prostate tumors and in which three distinct mechanisms of action are combined to disrupt androgen receptor signaling in one oncotherapeutic. Privately held Tokai is based in Cambridge, Massachusetts and is backed by Apple Tree Partners and Novartis Venture Fund. For more information on the company and galeterone, please visit www.tokaipharma.com.
Keywords for this news article include: Pharmaceutical Companies, Tokai Pharmaceuticals Inc, Government Agencies, Offices and Entities.
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