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GTx, Inc., incorporated on September 24, 1997, is a biopharmaceutical company dedicated to the discovery, development and commercialization of small molecules that targets hormone pathways to treat cancer, osteoporosis and bone loss, muscle loss and other serious medical conditions. As of December 31, 2009, the Company is developing toremifene citrate, a selective estrogen receptor modulator (SERM), in two separate clinical programs in men: toremifene 80 milligram (mg) in a pivotal Phase III clinical trial to reduce fractures and treat other estrogen deficiency side effects of androgen deprivation therapy (ADT) in men with prostate cancer, and, toremifene 20 mg in a pivotal Phase III clinical trial for the prevention of prostate cancer in high risk men with precancerous prostate lesions, called high grade prostatic intraepithelial neoplasia (PIN).
Additionally, the Company is developing selective androgen receptor modulators (SARMs), a class of drugs with the potential to treat cancer cachexia (cancer induced muscle loss), chronic sarcopenia, which is the loss of skeletal muscle mass resulting in reduced physical strength and ability to perform activities of daily living, and other musculoskeletal wasting or muscle loss conditions. It is developing GTx-758, an oral luteinizing hormone (LH), inhibitor for the first line treatment of advanced prostate cancer. During the year ended December 31, 2009, it completed two Phase I clinical trials, a single ascending dose clinical trial and a multiple ascending dose clinical trial, evaluating GTx-758 in healthy male volunteers. In February 2010, the Company initiated a Phase II clinical trial evaluating the ability of GTx-758 to reduce testosterone to castrate levels.
FARESTON
The Company markets FARESTON (toremifene citrate) 60 mg tablets, approved for the treatment of metastatic breast cancer in postmenopausal women in the United States. Toremifene is the active pharmaceutical ingredient in FARESTON and is developed in two separate clinical programs for toremifene 80 mg and toremifene 20 mg. It sells FARESTON primarily through wholesale drug distributors. The Company’s clinical products include Toremifene 80 mg, Toremifene 20 mg, Ostarine and GTx-758.
Toremifene, is a SERM, which is developed as a once-a-day oral tablet to reduce fractures and treat other estrogen deficiency side effects of ADT in men with prostate cancer (80 mg dose), and prevent prostate cancer in high risk men with high grade PIN (20 mg dose). Under a license and supply agreement with Orion, Orion manufactures and supplies the Company with FARESTON, the 60 mg dose of toremifene citrate, for sale in the United States to treat metastatic breast cancer in postmenopausal women, as well as toremifene 20 mg for its Phase III clinical trial for the prevention of prostate cancer in high risk men with high grade PIN.
SARMs
SARMs are drugs with the potential to treat cancer cachexia (cancer induced muscle loss), chronic sarcopenia, which is the loss of skeletal muscle mass resulting in reduced physical strength and ability to perform activities of daily living, and other musculoskeletal wasting or muscle loss conditions. Ostarine is an oral nonsteroidal agent designed to have anabolic activity on muscle and bone without unwanted side effects on prostate and skin. In addition, Ostarine is developed in an oral dosage form. In it’s Phase I clinical trial, a double blind, placebo controlled, single ascending dose study in 96 healthy male volunteers, Ostarine was well tolerated and there were no drug-related serious adverse events. The second Phase I clinical trial was a double blind multiple ascending dose 14 day study to evaluate the safety, tolerability, pharmacokinetics, and specific pharmacodynamic characteristics of Ostarine in 48 male volunteers.
LH Inhibitor
GTx-758 is a small molecule, which the Company develops for the first line treatment of advanced prostate cancer. In animal models, GTx-758 suppressed secretion of luteinizing hormone (LH), by feedback inhibition on the pituitary, inhibiting the production of androgens by the testes. ADT is the common treatment for patients who have advanced prostate cancer. ADT reduces testosterone, a primary growth factor for prostate cancer, to castrate levels. It is accomplished either surgically by removal of the testes or chemically by LHRH therapy. In preclinical animal models, GTx-758 has demonstrated the potential to reduce testosterone concentrations in blood to castrate levels, increase BMD, and prevent hot flashes.
During 2009, the Company evaluated GTx-758 in healthy male volunteers in two Phase I clinical trials, a single ascending dose clinical trial and a multiple ascending dose clinical trial completed. GTx-758 was well tolerated in both trials. In February 2010, the Company initiated a Phase II clinical trial evaluating the ability of GTx-758 to reduce testosterone to castrate levels in 70 subjects.
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