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SOURCE TesoRx Pharma, LLC.
Phase 2 Study Concludes for first Unmodified Oral Testosterone Replacement Therapy (TRT), TesoRx
MENLO PARK, Calif., May 16, 2014 /PRNewswire/ -- TesoRx Pharma, LLC., a pharmaceuticals company focused on delivering a first-in-class oral formulation of unmodified testosterone (T), TSX-002, announced today its participation in American Urological Association (AUA) Conference Men's Symposium on May 18, 2014 in Orlando, FL, located outside room W224 of the Ocean County Convention Center. TesoRx is currently completing a Phase 2 study for TSX-002, the only orally available unmodified testosterone agent in development for Symptomatic Androgen Deficiency.
During the AUA Conference Men's Symposium, TesoRx is available to discuss the tremendous unmet need for improvement over current delivery methods such as T-gels, T injectables and T pellets that come with existing complications such as skin irritations, wide ranging T levels, mood swings and painful injections.
Currently, an estimated 39 percent of men over the age of 45 are hypogonadal, and, therefore, eligible for testosterone replacement therapy (TRT), according Global Industry Analysts. Of that eligible patient population, only 12 percent of patients are currently receiving TRT and 89 percent of TRT treatments are topical gels.
"TSX-002 has a superior safety profile compared to currently available products on the market today. Through clinical trials, TSX-002 has demonstrated strong bioavailability and PK/PD data, met FDA clinical endpoint guidelines and demonstrated safety and efficacy for patients," according to Ramachandran "TR" Thirucote, Ph.D., Chairman & CEO, TesoRx. "The unique science behind TSX-002 addresses the liver toxicity and other safety challenges of modified oral Testosterone treatments, which are not currently approved by the FDA. In the future, we expect a much greater preference for safer treatments that are bio-identical to the body's own Testosterone and that mimics the body's natural diurnal T-level patterns and less of a focus on chasing elevated average T-levels that could compromise safety."
TesoRx's unique delivery mechanism helps address the first-pass metabolic challenges inherent with oral testosterone delivery. The oral administration of TSX-002 utilizes a unique patented proliposomal formulation to achieve desirable serum levels for testosterone. TSX-002 has been very well tolerated, with no liver toxicity, supraphysiological T levels or HDL reductions observed to date.
In the Phase 2 Trial, all FDA endpoint guidelines have been achieved and TSX-002 was observed to be both safe and tolerable. The Phase 2 data readout is expected in June 2014 and Phase 3 commencement is expected in 2H 2014.
About TesoRx - TesoRx Pharma, LLC., is a pharmaceuticals company focused on delivering a first-in-class oral formulation of unmodified testosterone, TSX-002. The company was founded in 2010 by Dr. Guru Betageri, Dr. Ramachandran "TR" Thirucote and Mr. Willem A Robberts and is funded by private investors. For more information: www.tesorx.com.
About AUA - Founded in 1902, the American Urological Association (AUA) is a premier urologic association, providing invaluable support to the urologic community. The organization's mission is to promote the highest standards of urological clinical care through education, research and the formulation of health care policy. For more information: https://www.auanet.org
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