TesoRx Pharma LLC. Founded by Dr. TR Thirucote, Dr. Guru Betageri and Will Robberts
Company secures initial funding and licenses novel drug delivery platform from Western University of Health Sciences.
After successful Phase 1 study of TSX-002, TesoRx commences Phase 2 Clinical Study in male subjects
Study concludes that product is safe, well tolerated and increases Testosterone levels in all subjects.
TesoRx and CoreRx Announce Joint Venture to Manufacture First-in-Class Oral Testosterone Drug
TesoRx closes Series B Financing of $10Million and appoints Dr. Michael Oefelein as its new Chief Medical Officer
Company also has a new patents granted that significantly strengthens its patent estate.
First ex-USA licensing transaction with Aspen Pharmacare Holdings Limited for $100Million+
In addition to an upfront investment of $15Million, Aspen will be responsible for developing and commercializing TesoRx's testosterone treatment in a number of international territories. TesoRx retained the full rights to the product for the US, Europe, Japan, China, India and the Middle East.
Official Opening of the TesoRx Centre of Excellence at Western University
The ethos behind the Centre of Excellence is to leverage the scientific expertise of the university in collaboration with TesoRx to develop a portfolio of products that will advance innovative medical therapies which can be brought to market.
TesoRx adds a novel new bladder cancer therapy and a testosterone treatment for boys with Constitutional Delay in Growth in Puberty (CDGP) to its product pipeline
Both new therapies have the potential of being best-in-class treatments and were spawned from the same platform technology originally licensed from WUHS. The CDGP treatment utilizes TSX-002's formulation and is targeting an orphan indication approval. TesoRx is replacing the TSX-002 formulation targeting hypogonadism in men with a next generation modified Testosterone treatment leveraging its platform technology that will be known as THG-1001.
US FDA grants orphan designation for TesoRx’s Oral formulation of Unmodified Testosterone for the treatment of Constitutional Delay of Growth and Puberty
(CDGP) in Adolescent Boys
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. TSX-002 represents an exciting potential treatment option for patients compared to the current standard of care. Depot injections are prone to poor patient acceptance and potentially harmful testosterone peaks that may lead to closing patients’ growth platelets prematurely. Orphan designation is advantageous affording the possibility for a more efficient approval pathway, premium pricing and the possibility of qualifying for an FDA Accelerated Review Voucher (ARV).
TesoRx enters into partnering arrangement with ASKA Pharmaceutical to develop and commercialize TesoRx’s oral testosterone replacement therapy ("TRT") for the Japanese market.
ASKA, the market leader in Japan's TRT market, made an upfront option payment under the terms of the agreement that contains a future licensing fee, milestones and royalty payments. ASKA and TesoRx commenced cooperation on clinical studies for the US and Japanese markets.