TesoRx Announces Creation of LIPAC Oncology and Advancement of Oncology Pipeline

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Developments solidify company leadership position and expansion of cancer treatments

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By utilizing the TesoRx technology and expanding upon it, we have moved further toward improving outcomes for patients while delivering significant value to our investors.

TesoRx Pharma, LLC, today announced the spinoff of LIPAC Oncology LLC, a pharmaceutical company utilizing TesoRx’s proliposomal drug delivery technology, to develop novel treatments for non-muscle invasive bladder cancer and other cancer indications. Additionally, LIPAC has filed an Investigational New Drug (IND) application to initiate human clinical trials for its lead therapeutic candidate. This news, along with today’s partnership announcement from TesoRx and ASKA to develop TesoRx’s oral testosterone drug in Japan, solidifies the company’s position as a leading growth pharmaceutical company focused on rapidly developing and commercializing pharmaceutical products in rare and specialty markets with limited treatment options and high unmet need.

The TesoRx technology had previously been successfully used to create novel formulations, with a highly differentiated oral testosterone replacement therapy as the lead TesoRx product. Clinical and pre-clinical studies validated the potential for the technology in creating a treatment for use in urology and other indications. LIPAC Oncology was spun out as a separate company to focus on developing novel cancer therapies with an initial treatment for non-muscle invasive bladder cancer.

“By utilizing the TesoRx technology and expanding upon it, we have moved further toward improving outcomes for patients while delivering significant value to our investors,” said TR Thirucote, Chairman and CEO of LIPAC. “Additionally, LIPAC’s ability to file an IND has proven our success in multiple pre-clinical studies.”

At this time, LIPAC is preparing to initiate human clinical trials for its lead therapeutic candidate, a proliposomal intravesical paclitaxel formulation (PLIP), in development for intravesical (bladder) instillation in the treatment of non-muscle invasive bladder cancer (NMIBC). NMIBC is a common and highly recurrent disease that can often be difficult to treat. Although bladder chemotherapies have been proven to reduce the recurrence of NMIBC while limiting systemic exposure to chemotherapeutics, none have been approved by the FDA for this indication and they suffer from significant formulation, supply and efficacy issues.

“We are excited about the potential of PLIP targeting bladder tumors more effectively,” said Michael Oefelein, Chief Medical Officer of LIPAC. “Pre-clinical data has demonstrated that liposomes adhere to the bladder wall that could significantly increase overall efficacy."

LIPAC anticipates beginning human clinical trials soon after the successful review of the IND. The company is also pursuing the development of treatments for additional oncology indications and has recently filed patents for a novel treatment for upper track urothelial carcinoma (UTUC), and has other treatment candidates in early stages of pre-clinical development.

About TesoRx Pharma LLC
TesoRx Pharma LLC is a growth pharmaceutical company 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 liposomal delivery technology. The company was founded in 2010 through collaboration with Western University of Health Sciences that includes joint R&D efforts at the TesoRx Centre of Excellence in Pomona, California. For more information, please visit http://www.tesorx.com.

About LIPAC Oncology LLC
LIPAC Oncology is a pharmaceutical company utilizing the proprietary liposomal delivery technology platform developed by its parent company, TexoRx, to develop treatments for cancer indications with unmet medical needs. LIPAC’s lead therapeutic candidate is PLIP, an IND-stage treatment in development for non-muscle invasive bladder cancer. The company was created in 2016 as a spinout from TesoRx Pharma LLC, a pharmaceutical company which had already used the platform technology to create therapeutic candidates for other indications.

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Binay Curtis
Galaxy Six Strategies
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