GTx Announces Podium Presentation of SARM Preclinical and Clinical Trial Data at Endocrine Society's 2007 Annual Meeting.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 James T. Dalton, PhD, Vice President of Preclinical Research and Development at GTx, has been invited by the Endocrine Society to deliver a podium presentation on the discovery, clinical development, and therapeutic potential of selective androgen receptor modulators Selective androgen receptor modulators or SARMs are a novel class of androgen receptor ligands. (The name follows the terminology currently used for similar molecules targeting the estrogen receptor, "selective estrogen receptor modulators," such as Tamoxifen. (SARMs) at the 2007 Annual Meeting of the Endocrine Society at the Metro Center in Toronto, Canada. Dr. Dalton, who along with Duane Miller, PhD, Director of Medicinal Chemistry at GTx, invented SARMs, will present Abstract #S41-2, "Therapeutic Promise of Selective Androgen Receptor Modulators (SARMs): Preclinical and Clinical Proof of Concept Studies," during a symposium session on the afternoon of June 3, 2007. SARMs are novel, orally available small molecules which bind to the androgen receptor and are designed to deliver the beneficial effects of androgens while minimizing unwanted clinical side effects. GTx recently completed a Phase II proof of concept clinical trial evaluating the effects of Ostarine[TM], the first-in-class 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) , on muscle mass and performance in 120 elderly men and postmenopausal post·men·o·paus·al adj. Of or occurring in the time following menopause. postmenopausal Change of life Gynecology adjective Referring to the time in ♀ when menstrual periods stop for ≥ 1 yr women. GTx is planning to initiate a Phase IIb clinical trial evaluating Ostarine[TM] for the treatment of cancer cachexia in June of 2007 and to initiate a second Phase IIb clinical trial evaluating Ostarine[TM] for the treatment of muscle wasting in 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 by the end of 2007. 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 citrate /cit·rate/ (sit´rat) a salt of citric acid. citrate phosphate dextrose (CPD) anticoagulant citrate phosphate dextrose solution. ), 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 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 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 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 , 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 Modulator Any device or circuit by means of which a desired signal is impressed upon a higher-frequency periodic wave known as a carrier. The process is called modulation. The modulator may vary the amplitude, frequency, or phase of the carrier. , or SARM. GTx plans to initiate a Phase IIb Ostarine[TM] clinical trial for cancer cachexia in non-small cell lung cancer Lung Cancer, Non-Small Cell Definition Non-small cell lung cancer (NSCLC) is a disease in which the cells of the lung tissues grow uncontrollably and form tumors. Description There are two kinds of lung cancers, primary and secondary. patients in June of 2007. GTx plans to initiate a Phase IIb Ostarine[TM] clinical trial for the treatment of chronic kidney 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 quarterly report on form 10-Q filed with the U.S. Securities and Exchange Commission on May 7, 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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