TESORX ANNOUNCES COMMENCEMENT OF ENROLLMENT OF A CLINICAL TRIAL EVALUATING NOVEL ORAL TESTOSTERONE REPLACEMENT THERAPY IN PATIENTS WITH HYPOGONADISM
SAN FRANCISCO, Nov. 30, 2017 - TesoRx Pharma LLC, a biopharmaceutical company, today announced it commenced enrollment for a Phase 1/2a clinical trial of TSX-011 in patients with hypogonadism. TSX-011 is a novel oral testosterone replacement therapy ("TRT") to treat adult males suffering from conditions associated with low endogenous testosterone, also known as hypogonadism.
Results from the study are expected to validate dose response pharmacokinetics of TSX-011 (testosterone undecanoate) along with safety and tolerability. The open-label, three period study in hypogonadal males is expected to enroll 24 subjects. Efficacy will be assessed by measuring PK profiles in patients following a single ascending dose period, fixed twice-daily dose period and a dose-adjusted adaptive design period. Enrollment will include at least 10 evaluable native Japanese subjects intended to contribute towards TSX-011 regulatory approval efforts in Japan.
"The commencement of this study signals an important milestone in the development of TSX-011," said Dr. TR Thirucote, Chairman and CEO of TesoRx.
Dr. Michael Oefelein, Chief Medical Officer of the Company, added, "We look forward to announcing top-line results by the 2nd half of 2018 and advancing development towards approval in multiple major markets including the United States through our partnerships with Aspen Pharmacare and ASKA Pharmaceutical."
TSX-011 is a novel oral testosterone replacement therapy containing testosterone undecanoate designed to help restore testosterone levels in hypogonadal men. Men with hypogonadism currently have suboptimal treatment options dominated by gels carrying FDA black box warnings for inadvertent transference and inconvenient injectable and nasal formulations. In pre-clinical trials, TSX-011 demonstrated safety and efficacy and the potential for once daily dosing without the need to consume fatty foods. The global TRT market has been estimated to be in excess of $2 billionannually.
About TesoRx Pharma LLC
TesoRx Pharma LLC is focused on rapidly developing and commercializing pharmaceutical products in rare and specialty markets with limited treatment options and high unmet need. Its evolving pipeline includes assets in urology, oncology and rare diseases that have been formulated with TesoRx's proprietary proliposomal drug delivery system. The company was founded in 2010 through a collaboration with Western University of Health Sciences that includes joint R&D efforts at the TesoRx Centre of Excellence in Pomona, California. For further information visit www.tesorx.com.
About ASKA Pharmaceutical Co., Ltd.
ASKA Pharmaceutical Co., Ltd. is a leading Japanese pharmaceutical company focused on three fields: Internal medicine, obstetrics and gynecology and urology. Since its foundation in 1920, it has built up a record of achievement as a pharmaceutical manufacturer and marketing distributor of specialty hormone preparations with technical capabilities that are top-class among Japanese companies. For further information visit http://www.aska-pharma.co.jp/english/index.html