GTx to Host an Analyst Day to Provide an Update on ACAPODENE Phase III Clinical Programs and Information on the Clinical Development and Commercialization Strategy for Ostarine.MEMPHIS Memphis, city, ancient Egypt Memphis (mĕm`fĭs), ancient city of Egypt, capital of the Old Kingdom (c.3100–c.2258 B.C.), at the apex of the Nile delta and 12 mi (18 km) from Cairo. , Tenn. -- GTx, Inc. (Nasdaq: GTXI) announced today that at an Analyst Day meeting to be held 11 a.m. to 2 p.m. on April 17 in New York City New York City: see New York, city. New York City City (pop., 2000: 8,008,278), southeastern New York, at the mouth of the Hudson River. The largest city in the U.S. , the company will present an update of the pivotal Phase III ACAPODENE[R] clinical trials and information about its clinical development and commercialization plans for Ostarine[TM], its first-in-class selective androgen receptor modulator (SARM SARM Saskatchewan Association of Rural Municipalities SARM Selective Androgen Receptor Modulator SARM Department for Standardization, Metrology and Certification (Armenia) SARM Set Asynchronous Response Mode (HDLC) ). Dr. Matthew Smith, Associate Professor of Medicine at Harvard Medical School Harvard Medical School (HMS) is one of the graduate schools of Harvard University. It is a prestigious American medical school located in the Longwood Medical Area of the Mission Hill neighborhood of Boston, Massachusetts. , the Lead Principal Investigator for the Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the of ACAPODENE 80 mg for the treatment of multiple serious side effects of androgen deprivation therapy, and Dr. Samir Taneja, Associate Professor of Urologic Oncology at New York University New York University, mainly in New York City; coeducational; chartered 1831, opened 1832 as the Univ. of the City of New York, renamed 1896. It comprises 13 schools and colleges, maintaining 4 main centers (including the Medical Center) in the city, as well as the School of Medicine, the Lead Principal Investigator for the Phase III clinical trial of ACAPODENE 20 mg for the prevention of prostate cancer in men with high grade prostatic intraepithelial neoplasia Prostatic intraepithelial neoplasia (PIN) is a non-invasive lesion in the prostate gland which is though to be a precursor to prostate cancer. Microscopically, PIN is a collection of irregular cells which are fully contained within the gland structure and have not spread to (PIN), will present the current status and expected timelines for these clinical programs. Dr. Mark Stearns, Chief Scientific Officer of MacroArray Technologies, LLC (Logical Link Control) See "LANs" under data link protocol. LLC - Logical Link Control , also will present clinical data as well as his company's plans for the continued development and commercialization of a urine test to identify men with high grade PIN. At this meeting, GTx and a group of expert physicians and scientists plan to provide additional supporting data from the company's recently completed Phase II Ostarine clinical trial as well as discuss the scientific rationale, clinical development plans, and commercialization strategy for the indications the company has selected for development. The experts will include William Evans, PhD, Professor of Geriatrics, Physiology, and Nutrition at the Donald W. Reynolds Donald W. Reynolds (1906-1993) was an American businessman and philanthropist. During his lifetime, he was best known for his involvement in the Donrey Media Group. Biography Reynolds was the son of Gaines W. Institute on Aging at the University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) is part of the University of Arkansas System, a state-run university in the U.S. state of Arkansas. The main campus is located in Little Rock. , who will discuss the Phase II Ostarine trial and the pathophysiology of muscle wasting disorders; Michael Schuster, MD, Professor of Clinical Medicine at Weill Medical College of Cornell University, who will discuss cancer cachexia, which GTx has selected as the first indication for Ostarine development with initiation of the Phase IIB clinical trial to commence by the summer of 2007; and Talat Ikizler, MD, Associate Professor of Medicine at Vanderbilt University School of Medicine, who will discuss chronic kidney disease Chronic kidney disease (CKD), also know as chronic renal disease, is a progressive loss of renal function over a period of months or years through five stages. Each stage is a progression through an abnormally low and progressively worse glomerular filtration rate, which is and end stage renal disease muscle wasting, which GTx has selected as the second indication for Ostarine development with initiation of the Phase IIb clinical trial by the end of 2007. Mitchell Steiner, MD, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of GTx, will outline the development plans and timelines for Ostarine. Finally, James Dalton, PhD, GTx Vice President of Preclinical Research and Development, will provide an update on the company's preclinical pipeline and introduce the new clinical programs that the company plans to initiate over the next 12-18 months. Analysts and investors interested in attending the meeting may register online at www.gtxanalystday.com or by calling 866-367-4135. The meeting will be held in the ballroom of the Loews Regency Hotel at Park Avenue and 61st Street in Manhattan. The GTx Analyst Day meeting will be webcast. The link for the webcast is http://phx.corporate-ir.net/phoenix.zhtml?p=irol-eventDetails&c=148196 &eventID=1526644 (Due to the length of this URL URL in full Uniform Resource Locator Address of a resource on the Internet. The resource can be any type of file stored on a server, such as a Web page, a text file, a graphics file, or an application program. , it may be necessary to copy and paste To copy files from one location to another or to copy text and images from one document to another. All modern operating systems and applications have a copy and paste capability that is typically selected from an Edit menu. See cut and paste and Win Copy between windows. it into your Internet browser's URL address field. You may also need to remove an extra space in the URL if one exists.), and it will also be accessible from the GTx website at www.gtxinc.com. A replay of the webcast will be accessible until May 3. About GTx 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[R] (toremifene citrate), a selective estrogen receptor modulator se·lec·tive estrogen receptor modulator n. Abbr. SERM A nonsteroidal compound, such as raloxifene or tamoxifen, designed to mimic the effect of estrogen on a specific tissue or body part by binding only to that part's estrogen receptors. , or SERM SERM abbr. selective estrogen receptor modulator SERM Selective estrogen receptor modulator, see there , 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[R]. 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 be 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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