GTx, Inc. was a
pharmaceutical company
The pharmaceutical industry is a Medicine, medical industry that discovers, develops, produces, and markets pharmaceutical goods such as medications and medical devices. Medications are then administered to (or Self-medicate, self-administered b ...
working on drugs in the
selective estrogen receptor modulator
Selective estrogen receptor modulators (SERMs), also known as estrogen receptor agonists/antagonists (ERAAs), are a class of drugs that act on estrogen receptors (ERs). Compared to pure ER agonists–antagonists (e.g., full agonists and silent ...
(SERM) and
selective androgen receptor modulator
Selective androgen receptor modulators (SARMs) are a class of drugs that tissue selectivity, selectively activate the androgen receptor in specific tissue (biology), tissues, promoting muscle and bone growth while having less effect on male re ...
(SARM) classes. Its drugs in development included
enobosarm
Enobosarm, also formerly known as ostarine and by the developmental code names GTx-024, MK-2866, and S-22, is a selective androgen receptor modulator (SARM) which is under development for the treatment of hormone sensitive cancer, androgen rece ...
(ostarine) and
GTx-758.
The company was founded in Memphis in 1997 by Mitch Steiner and Marc S. Hanover.
[ The company was originally called Genotherapeutics, changed its name to GTx, Inc. in 2001, and reincorporated in Delaware in 2003.] The company licensed toremifene from Orion Corporation, and licensed andarine, enobosarm and prostarine from the University of Tennessee Research Foundation; the SARM compounds from Tennessee had been invented by Duane D Miller and James T Dalton, who later joined the company and served as Chief Scientific Officer.[ The company held its IPO in February 2004.
In 2006 GTx signed a partnership with ]Ipsen
Ipsen is a French biopharmaceutical company headquartered in Paris, France, with a focus on drug development and commercialization in three therapeutic areas: oncology, rare diseases and neuroscience. Ipsen is one of the world's top 15 biopha ...
to develop toremifene, a selective estrogen receptor modulator to prevent prostate cancer and to prevent bone loss in men with prostate cancer; the FDA rejected the application to market the drug for this use in 2009, and Ipsen terminated the arrangement in 2011. In 2012 GTx sold its rights to toremifene to ProStrakan, a subsidiary of Kyowa Hakko Kirin
is a Japanese pharmaceutical and biotechnology company under the Kirin Holdings, and is among the 40 largest in the world by revenue. The company is headquartered in Chiyoda-ku, Tokyo and is a member of the Nikkei 225 stock index.
History
On ...
, for around $19 million, and terminated its agreement with Orion.
By 2007 enobosarm was in a Phase II trial, and that year GTx signed an exclusive license agreement for its SARM program with Merck; Merck bought $30M in GtX stock, paid an upfront fee of $40M, and agreed to fund $15M in research over the next three years. The agreement also included royalties on any product brought to market and around $400M in biodollars. The companies ended the deal in 2010.
In August 2013 GTx announced that enobosarm had failed in two Phase III clinical trials to treat wasting in people with lung cancer. In October 2013 the company laid off around 60% of its 88-person workforce, and Steiner resigned 6 months later.[ The company had invested around $35 million in the development of the drug.] The company said at that time that is planned to pursue approval of enobosarm in Europe; the company was also still developing GTx-758 for castration-resistant prostate cancer.
In 2016 GTx began Phase II trials, to see if enosobarm might be effective to treat stress urinary incontinence in women.
In June 2019, GTx combined with Oncternal Therapeutics in a reverse merger, with the resulting company operating under the name Oncternal Therapeutics, Inc.
References
Pharmaceutical companies of the United States
Pharmaceutical companies established in 1997
Companies listed on the Nasdaq
Companies based in Memphis, Tennessee
Health care companies based in Tennessee
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