LIPAC Oncology Announces Major Partnering Milestone Achieved in its License Agreement with Huons Co., Ltd.
MENLO PARK, Calif. and SEOUL, Korea, Dec. 10, 2020 /PRNewswire/ -- LIPAC Oncology LLC and Huons Co., Ltd. today announced the achievement of a major development milestone in their partnering agreement by finalizing its Clinical Study Report for a Phase 2A marker lesion clinical trial in patients with low-grade highly recurrent Non-Muscle Invasive Bladder Cancer (NMIBC) treated with LiPax (paclitaxel). LiPax, a proliposomal paclitaxel formulation in development for intravesical instillation in the treatment of NMIBC, demonstrated a 63 percent responder rate in highly recurrent and heavily pre-treated patients.
"This is an important milestone for LIPAC as we prepare for our Type B meeting with the U.S. Food and Drug Administration in early January to validate our Phase 2B/3 clinical study approach," said TR Thirucote, Ph.D., Chairman and CEO of LIPAC.
In September 2019, LIPAC and Huons announced that they entered into an exclusive licensing agreement to develop, manufacture, and commercialize LiPax for all indications in South Korea. This is the first milestone payment to LIPAC based on specific development, regulatory and commercial milestones and royalty payments based on sales.
"We are delighted to have reached this milestone in our agreement with LIPAC that brings us a step closer to making this essential therapy available to thousands of patients in Korea," said Mr. Key An UM, CEO of Huons. "Our interest in LiPax extends well beyond NMIBC as we continue our collaboration with LIPAC in additional orphan-designated programs for Upper Tract Urothelial Carcinoma, Ovarian Cancer, Mesothelioma, and Malignant Plural Effusion for Breast Cancer."
"Non-Muscle Invasive Bladder Cancer is difficult to treat and highly recurrent. By pairing a simple outpatient procedure (Transurethral Resection of Bladder Tumor or TURBT) with LiPax, we have an opportunity to substantially improve both clinical outcomes and quality of life for patients globally," said Michael Oefelein, M.D., Chief Medical Officer of LIPAC Oncology. "We were also pleased to present our Phase 2A data at the Society of Urological Oncology meeting earlier this month."
Based on a patient's biopsy results obtained from TURBT, NMIBC is stratified into three risk categories: low, intermediate, and high risk. To reduce recurrence and prevent progression, the American Urological Association NMIBC guidelines recommend intravesical therapy after TURBT. The low to intermediate risk category targeted by LiPax is estimated to comprise 90,000 Americans, yet no intravesical agent is approved by the U.S. Food and Drug Administration for this disease.
About LiPax
LiPax is a novel, investigational formulation of paclitaxel in Phase 2 development for the treatment of NMIBC. LIPAC Oncology's proprietary formulation utilizes their proliposomal technology platform to enhance the persistence and penetration of bladder tissue by paclitaxel. LiPax is designed to enhance the standard of care of outpatient endoscopic tumor removal through a histological risk assessment followed by intravesical instillation using a standard urinary catheter. LIPAC Oncology completed a Phase 2A clinical trial in August 2020 and intends to advance the program to a pivotal study to further investigate LiPax in the treatment of this condition.
About LIPAC Oncology LLC
LIPAC Oncology is a pharmaceutical company utilizing the proprietary proliposomal delivery system to enhance and reformulate proven cancer drugs into more effective treatments that include many orphan indications. The company was created in 2016 as a subsidiary of TesoRx Pharma LLC, a pharmaceutical company which has leveraged the platform technology to create therapeutic candidates for other indications. For more information, visit lipaconcology.com.
About Huons Co., Ltd
Huons Co., Ltd. is a pharmaceutical company based in South Korea that provides a wide variety of health and wellness solutions. The company is a leader in the development, manufacturing and distribution of pharmaceutical products and medical devices. Its product portfolio includes ethical drugs, over the counter products, nutritionals and medical devices. Huons offers its products in a wide range of formulations including capsules, tablets, vials, suspensions, syrups, injections and eye drops. In 2018 Huons was granted U.S. FDA approval of generic of lidocaine for local anesthetic injection. It markets its products in Latin America, the U.S., Asia, the Middle East, Africa and Europe. For more information, visit huons.com.
SOURCE LIPAC Oncology LLC
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