Healthcare Industry News: Acapodene
News Release - April 10, 2007
GTx, Inc. Appoints Jeff Hesselberg as Vice President of Regulatory AffairsMEMPHIS, Tenn.--(HSMN NewsFeed)--GTx, Inc. (Nasdaq: GTXI ) announced today the appointment of Jeff Hesselberg as Vice President of Regulatory Affairs.
"Jeff Hesselberg brings additional strong regulatory expertise and leadership at a critical time for GTx as we prepare for the potential filings of New Drug Applications for Acapodene and as we advance Ostarine into late stage clinical trials," said Mitchell S. Steiner, M.D., Chief Executive Officer of GTx.
Mr. Hesselberg has over 19 years of experience in the biopharmaceutical industry, including 13 years of regulatory affairs drug development experience. From 1996 to May 2007, Mr. Hesselberg served as Manager, Associate Director, and then Director of Regulatory Affairs for ICOS Corporation. Most recently, Mr. Hesselberg worked on the successful development, launch and commercialization of Cialis® (tadalafil) for the treatment of erectile dysfunction. From 1984 to 1996, Mr. Hesselberg worked for Immunex Corporation and the Puget Sound Blood Center. Mr. Hesselberg holds a B.S. in Molecular Biology from the University of Wisconsin-Madison and a MBA from the University of Washington.
GTx, headquartered in Memphis, Tenn., is a biopharmaceutical company dedicated to the discovery, development, and commercialization of small molecules that selectively target hormone pathways to treat cancer, osteoporosis and bone loss, muscle wasting and other serious medical conditions. GTx is developing Acapodene® (toremifene citrate), a selective estrogen receptor modulator, or SERM, in two separate clinical programs in men: first, a pivotal Phase III clinical trial for the treatment of serious side effects of androgen deprivation therapy for advanced prostate cancer, and second, a pivotal Phase III clinical trial for the prevention of prostate cancer in high risk men with high grade prostatic intraepithelial neoplasia, or PIN. GTx has licensed to Ipsen Limited exclusive rights in Europe to develop and commercialize Acapodene®. GTx also is developing Ostarine(TM), a first-in-class selective androgen receptor modulator, or SARM. GTx plans to initiate a Phase IIb Ostarine(TM) clinical trial for cancer cachexia by the summer of 2007. GTx plans to initiate a Phase IIb Ostarine(TM) clinical trial for the treatment of chronic kidney disease and end stage renal disease muscle wasting by the end of 2007. GTx believes that Ostarine(TM) also has the potential to treat a variety of other indications associated with muscle wasting and bone loss including sarcopenia and osteoporosis.
Forward-Looking Information is Subject to Risk and Uncertainty
This press release contains forward-looking statements based upon GTx's current expectations. Forward-looking statements involve risks and uncertainties. GTx's actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the risks that (i) GTx will not be able to commercialize its product candidates if clinical trials do not demonstrate safety and efficacy in humans; (ii) GTx may not able to obtain required regulatory approvals to commercialize its product candidates; (iii) GTx's clinical trials may not be completed on schedule, or at all, or may otherwise be suspended or terminated; and (iv) GTx could utilize its available cash resources sooner than it currently expects and may be unable to raise capital when needed, which would force GTx to delay, reduce or eliminate its product development programs or commercialization efforts. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this press release. GTx's annual report on form 10-K filed with the U.S. Securities and Exchange Commission (the "SEC") on March 9, 2007, contains under the heading "Risk Factors," a more comprehensive description of these and other risks to which GTx is subject. GTx expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
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