GTx Incorporated

Last updated
GTx, Inc.
Company type Public
Nasdaq:  ONCT
Industry Pharmaceuticals
FoundedSeptember 24, 1997
Headquarters Memphis, Tennessee, United States
Products Enobosarm
Website www.gtxinc.com   OOjs UI icon edit-ltr-progressive.svg

GTx, Inc. was a pharmaceutical company that is working on drugs in the selective estrogen receptor modulator (SERM) and selective androgen receptor modulator (SARM) classes. Its drugs in development included enobosarm (ostarine) and GTx-758.

The company was founded in Memphis in 1997 by Mitch Steiner and Marc S. Hanover. [1] The company was originally called Genotherapeutics, changed its name to GTx, Inc. in 2001, and reincorporated in Delaware in 2003. [1] 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. [1] The company held its IPO in February 2004. [2] [3]

In 2006 GTx signed a partnership with Ipsen 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. [4] [5] In 2012 GTx sold its rights to toremifene to ProStrakan, a subsidiary of Kyowa Hakko Kirin, for around $19 million, and terminated its agreement with Orion. [6]

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. [7] The companies ended the deal in 2010. [8]

In August 2013 GTx announced that enobosarm had failed in two Phase III clinical trials to treat wasting in people with lung cancer. [9] In October 2013 the company laid off around 60% of its 88-person workforce, [10] and Steiner resigned 6 months later. [11] The company had invested around $35 million in the development of the drug. [11] 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. [12]

In 2016 GTx began Phase II trials, to see if enosobarm might be effective to treat stress urinary incontinence in women. [13]

In June 2019, GTx combined with Oncternal Therapeutics in a reverse merger, with the resulting company operating under the name Oncternal Therapeutics, Inc. [14]

Related Research Articles

<span class="mw-page-title-main">Selective estrogen receptor modulator</span> Drugs acting on the estrogen receptor

Selective estrogen receptor modulators (SERMs), also known as estrogen receptor agonists/antagonists (ERAAs), are a class of drugs that act on estrogen receptors (ER). Compared to pure ER agonists-antagonists, SERMs' activity is more tissue-specific, allowing them to selectively inhibit or stimulate estrogen-like action in various tissues.

Exelixis, Inc. is a genomics-based drug discovery company located in Alameda, California, and the producer of Cometriq, a treatment approved by the U.S. Food and Drug Administration (FDA) for medullary thyroid cancer with clinical activity in several other types of metastatic cancer.

<span class="mw-page-title-main">Toremifene</span> Chemical compound

Toremifene, sold under the brand name Fareston among others, is a medication which is used in the treatment of advanced breast cancer in postmenopausal women. It is taken by mouth.

A nonsteroidal compound is a drug that is not a steroid nor a steroid derivative. Nonsteroidal anti-inflammatory drugs (NSAIDs) are distinguished from corticosteroids as a class of anti-inflammatory agents.

Hormonal therapy in oncology is hormone therapy for cancer and is one of the major modalities of medical oncology, others being cytotoxic chemotherapy and targeted therapy (biotherapeutics). It involves the manipulation of the endocrine system through exogenous or external administration of specific hormones, particularly steroid hormones, or drugs which inhibit the production or activity of such hormones. Because steroid hormones are powerful drivers of gene expression in certain cancer cells, changing the levels or activity of certain hormones can cause certain cancers to cease growing, or even undergo cell death. Surgical removal of endocrine organs, such as orchiectomy and oophorectomy can also be employed as a form of hormonal therapy.

<span class="mw-page-title-main">Selective androgen receptor modulator</span> Class of pharmaceutical drugs

Selective androgen receptor modulators (SARMs) are a class of drugs that selectively activate the androgen receptor in specific tissues, promoting muscle and bone growth while having less effect on male reproductive tissues like the prostate gland.

<span class="mw-page-title-main">Afimoxifene</span> Chemical compound

Afimoxifene, also known as 4-hydroxytamoxifen (4-OHT) and by its tentative brand name TamoGel, is a selective estrogen receptor modulator (SERM) of the triphenylethylene group and an active metabolite of tamoxifen. The drug is under development under the tentative brand name TamoGel as a topical gel for the treatment of hyperplasia of the breast. It has completed a phase II clinical trial for cyclical mastalgia, but further studies are required before afimoxifene can be approved for this indication and marketed.

<span class="mw-page-title-main">Enobosarm</span> Investigational selective androgen receptor modulator

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 androgen receptor-positive breast cancer in women and for improvement of body composition in people taking GLP-1 receptor agonists like semaglutide. It was also under development for a variety of other indications, including treatment of cachexia, Duchenne muscular dystrophy, muscle atrophy or sarcopenia, and stress urinary incontinence, but development for all other uses has been discontinued. Enobosarm was evaluated for the treatment of muscle wasting related to cancer in late-stage clinical trials, and the drug improved lean body mass in these trials, but it was not effective in improving muscle strength. As a result, enobosarm was not approved and development for this use was terminated. Enobosarm is taken by mouth.

<span class="mw-page-title-main">Andarine</span> Chemical compound

Andarine is a selective androgen receptor modulator (SARM) which was developed by GTX, Inc for the treatment of conditions such as muscle wasting, osteoporosis, and benign prostatic hypertrophy (BPH), using the nonsteroidal antiandrogen bicalutamide as a lead compound. Development of andarine for all indications has been discontinued, in favor of the structurally related and improved compound enobosarm.

<span class="mw-page-title-main">Bionovo</span> Biotechnology company

Bionovo was an American biotechnology company focused on the discovery and development of botanically derived treatments for women's health and cancer based in Emeryville, California. The company had multiple drug candidates in U.S. Food and Drug Administration (FDA) clinical trials- Menerba a selective estrogen receptor beta agonist for hot flashes associated with menopause Seala a selective estrogen receptor beta agonist for menopausal vaginal dryness and Bezielle for advanced breast cancer. The company has ceased activity after filing for Chapter 7 bankruptcy protection in California. Bionovo's stock is no longer listed.

<span class="mw-page-title-main">Ligandrol</span> Chemical compound

LGD-4033, also known by the developmental code name VK5211 and by the black-market name Ligandrol, is a selective androgen receptor modulator (SARM) which is under development for the treatment of muscle atrophy in people with hip fracture. It was also under development for the treatment of cachexia, hypogonadism, and osteoporosis, but development for these indications was discontinued. LGD-4033 has been reported to dose-dependently improve lean body mass and muscle strength in preliminary clinical trials, but is still being developed and has not been approved for medical use. The drug is taken by mouth.

<span class="mw-page-title-main">Vosilasarm</span> Chemical compound

Vosilasarm, also known by the development codes RAD140 and EP0062 and by the black-market name Testolone or Testalone, is a selective androgen receptor modulator (SARM) which is under development for the treatment of hormone-sensitive breast cancer. It is specifically under development for the treatment of androgen receptor-positive, estrogen receptor-negative, HER2-negative advanced breast cancer. Vosilasarm was also previously under development for the treatment of sarcopenia, osteoporosis, and weight loss due to cancer cachexia, but development for these indications was discontinued. The drug is taken by mouth.

<span class="mw-page-title-main">GTx-758</span> Chemical compound

GTx-758 is a synthetic nonsteroidal estrogen which was under development by GTx, Inc. for the treatment of advanced prostate cancer. As of 2016, it had completed two phase II clinical trials.

<span class="mw-page-title-main">MK-0773</span> Chemical compound

MK-0773, also known as PF-05314882, is a steroidal, orally active selective androgen receptor modulator (SARM) that was under development by Merck and GTx for the treatment of sarcopenia in women and men. Clinical trials for sarcopenia began in late 2007 but the collaboration between Merck and GTx ended in early 2010 and GTx terminated development of MK-0773 shortly thereafter. MK-0773 was developed as a more advanced version of the related compound TFM-4AS-1.

<span class="mw-page-title-main">Droloxifene</span> Chemical compound

Droloxifene, also known as 3-hydroxytamoxifen, is a nonsteroidal selective estrogen receptor modulator (SERM) of the triphenylethylene group that was developed originally in Germany and later in Japan for the treatment of breast cancer, osteoporosis in men and postmenopausal women, and cardiovascular disorders but was abandoned and never marketed. It reached phase II and phase III clinical trials for these indications before development was discontinued in 2000. The drug was found to be significantly less effective than tamoxifen in the treatment of breast cancer in two phase III clinical trials.

A sex-hormonal agent, also known as a sex-hormone receptor modulator, is a type of hormonal agent which specifically modulates the effects of sex hormones and of their biological targets, the sex hormone receptors. The sex hormones include androgens such as testosterone, estrogens such as estradiol, and progestogens such as progesterone. Sex-hormonal agents may be either steroidal or nonsteroidal in chemical structure and may serve to either enhance, inhibit, or have mixed effects on the function of the sex hormone systems.

<span class="mw-page-title-main">OPK-88004</span> Chemical compound

OPK-88004 is a non-steroidal indole derivative which acts as a selective androgen receptor modulator (SARM). It has been investigated by OPKO Health for the treatment of erectile dysfunction and symptoms associated with benign prostate hyperplasia.

<span class="mw-page-title-main">PF-06260414</span> Chemical compound

PF-06260414 is a drug which acts as a selective androgen receptor modulator (SARM), and was developed for androgen replacement therapy.

<span class="mw-page-title-main">Pimicotinib</span> Experimental drug

Pimicotinib (ABSK021), an oral, highly potent and selective small molecule inhibitor of colony-stimulating factor 1 receptor (CSF-1R) independently discovered by Abbisko Therapeutics. A number of studies have shown that blocking the CSF-1R signaling pathway could effectively modulate and change macrophage functions, and potentially treat many macrophage-dependent human diseases.

References

  1. 1 2 3 "GTX, INC. - FORM S-1/A". Gtx via SEC Edgar. 22 December 2003.
  2. ↑ Pritchard, Carolyn (2 February 2004). "GTX prices IPO of 5.4 mln shares at $14.50 each". MarketWatch.
  3. ↑ Hennessey, Raymond (4 February 2004). "With a Busy IPO Week Ahead, Mixed Reviews for 3 Offerings". Wall Street Journal.
  4. ↑ Carroll, John (2 November 2009). "GTx shares blitzed by FDA's toremifene rejection". FierceBiotech.
  5. ↑ Carroll, John (2 March 2011). "Ipsen bows out of troubled toremifene pact with GTx". FierceBiotech.
  6. ↑ "Press release: GTx Announces Sale of Fareston". GTx via FierceBiotech. 2 October 2012.
  7. ↑ Nagle, Mike (7 November 2007). "Merck flexes muscle with GTx deal". Outsourcing Pharma.
  8. ↑ Swanekamp, Kelsey (15 March 2010). "Merck And GTx Go Their Separate Ways". Forbes.
  9. ↑ "Enobosarm fails endpoints in Ph III study". The Pharma Letter. 20 August 2013.
  10. ↑ Carroll, John (2 October 2013). "Struggling GTx axes 53 staffers in restructuring after PhIII failures". FierceBiotech.
  11. 1 2 Sheffield, Michael (April 4, 2014). "Steiner resigns from GTx". Memphis Business Journal.
  12. ↑ Garde, Damian (4 April 2014). "GTx's CEO finds the door as the company moves on from a PhIII failure". FierceBiotech.
  13. ↑ "GTx begins Phase II trial of enobosarm to treat women with stress urinary incontinence - Drug Development Technology". Drug Development Technology. 14 January 2016.
  14. ↑ Therapeutics, Oncternal (2019-06-10). "Oncternal Therapeutics Completes Reverse Merger with GTx, Inc". GlobeNewswire News Room. Retrieved 2020-03-19.


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