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MENLO PARK, Calif., Aug. 5, 2014 /PRNewswire/ -- TesoRx Pharma, LLC., a specialty pharmaceutical company focused on rapidly developing and commercializing products in specialty and niche markets, announced today that it has closed $10 million in Series B-1 funding from existing and new private investors. The equity funding will be used to prepare for Phase 3 trials for TSX-002, a first-in-class oral formulation of unmodified testosterone, and to advance its pipeline and build out its commercial manufacturing facilities.
In conjunction with the financing, TesoRx also announced the hiring of Dr. Michael Oefelein to lead clinical development operations and regulatory strategy for TSX-002 and other TesoRx programs. In addition to leading all medical operations for the company, Dr. Oefelein will be responsible for overseeing data collection, interpretation and presentation of the clinical studies. He will represent and manage TesoRx clinical programs with regulatory agencies, investors and corporate partners and lead Clinical Quality Management activities for TesoRx.
Dr. Oefelein brings to TesoRx a 10-year track record of excellence in diverse academic, pharmaceutical and medical device fields. Prior to TesoRx, Dr. Oefelein served as Chief Medical Officer at Digirad and as Vice President, Global Therapeutic Area Head at Allergan Medical. He is a board-certified physician and a Fellow of the American College of Surgeons with extensive experience in the pharmaceutical and the device industry including, urology, dermatology, oncology, ophthalmology, and plastic and bariatric surgery. Over the course of his career, Dr. Oefelein has helped develop genitourinary oncology drugs including Degarelix, Zometa and Apaziquone, and non-oncology drugs including Levaquin, Botox and Serenity-120. Dr. Oefelein has also led safety evaluations for both devices (Silicone breast implants, Lap-Band) and pharmaceutical products (Bimatoprost, Latisse, Sanctura XR). He has authored nearly 100 peer-reviewed publications and delivered numerous scientific presentations at regional, national and international venues. In addition, he is an active member of numerous medical societies, including the Society of Urological Oncology, Society of Female Urology and Urodynamics, American Urological Association, American College of Surgeons and the Society of Laparoscopic Surgeons.
"I'm looking forward to taking on this role during this exciting time at TesoRx," said Dr. Oefelein. "The company's executive leadership is characterized by both outstanding scientific and medical credentials, and a strong record in company-building. I am confident that together we will bring TSX-002, the first and only orally available, pure testosterone therapy, to patients. Additionally, I am excited to participate in the advancement of other breakthrough TesoRx products that are in development."
Finally, TesoRx is pleased to announce it has received notices of allowed claims in Europe and the U.S. that are directed to enteric coated proliposomal dosage forms of testosterone for novel aspects of the TSX-002 formulation. When the respective European and U.S. patents issue with these allowed claims in the fall of 2014, they will join with previously-issued Australian and Canadian patents that contain similar claims, and will complement the company's licensed international and U.S. patent applications filed in 2013.
"We are very pleased with all of the positive news and have strong momentum as we get ready to embark on our pivotal Phase 3 study. With the continued strong support of our equity investors, TesoRx continues to make steady progress with our breakthrough TSX-002 formulation. The funding we have received will help us complete the clinical testing process and prepare to bring this important treatment to market. The expertise and leadership of Dr. Oefelein will be invaluable in this effort and we look forward to the significant value he will bring to the development of TesoRx products," said Ramachandran "TR" Thirucote, Ph.D., Chairman & CEO of TesoRx.
TesoRx Pharma, LLC, is a pharmaceuticals company focused on rapidly developing and commercializing pharmaceutical products in specialty and niche markets with significant sales potential. The company's initial product is a first-in-class oral formulation of unmodified testosterone, TSX-002, which uses a unique delivery mechanism and patented proliposomal formulation to address the first-pass metabolic challenges inherent with oral testosterone delivery. TSX-002 has been very well tolerated, with no liver toxicity, supraphysiological T levels or HDL reductions observed to date. TesoRx was founded in 2010 by Dr. Ramachandran "TR" Thirucote, Mr. Willem A Robberts and Dr. Guru Betageri, and is funded by private investors. For more information: www.tesorx.com.
Binay Curtis (Galaxy Six Strategies Public Relations): Binay(at)galaxysix(dot)com
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SOURCE TesoRx Pharma, LLC.