TESORX’S ORAL FORMULATION OF UNMODIFIED TESTOSTERONE GRANTED ORPHAN DRUG DESIGNATION BY US FDA FOR THE TREATMENT OF CONSTITUTIONAL DELAY OF GROWTH AND PUBERTY (CDGP) IN ADOLESCENT BOYS
(San Francisco, CA) June 8, 2016 - TesoRx Pharma today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation for its novel oral formulation of unmodified testosterone (TSX-002) for the treatment of Constitutional Delay of Growth and Puberty (CDGP) in adolescent boys (age 14-17 years).
CDGP is diagnosed in approximately 100,000 adolescent boys in the USA each year exhibiting delayed growth and a transient state of hypogonadism. It is characterized by a significant fall in height and weight below the average of their peers and a lack of sexual maturation of between two to two and a half years from the population mean. The current standard of care via depot injections of testosterone is prone to poor patient acceptance and potentially harmful testosterone peaks, that may lead to closing patients’ growth platelets prematurely.
In Phase 2 clinical adult studies TSX-002 has shown the potential to deliver the requisite levels of testosterone for the treatment of CDGP with a safe and convenient oral formulation that mimics the body’s natural physiological pattern.
Dr. TR Thirucote, CEO at TesoRx Pharma said: “The Orphan Drug Designation is an important achievement as we advance our development plans for a safer and more convenient treatment for CDGP. We are committed to improving patient outcomes for patients suffering from CDGP and relieving the anxiety for those parents who are facing sub-optimal therapeutic options for their children.”
The Orphan Drug Designation program provides orphan status to drugs that are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US.
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 growing pipeline includes assets in urology, oncology and rare diseases that have been formulated with TesoRx’s proprietary proliposomal delivery technology. 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. More information at www.tesorx.com
More information at www.tesorx.com
Binay Curtis, Galaxy Six Strategies Public Relations: Binay@galaxysix.com