NEW YORK, N.Y., April 30, 2020 – Starton Therapeutics Inc. (“Starton” or the “Company”), a biotechnology company focused on transforming standard of care therapeutics, today announced that it has filed PCT (“Patent Cooperation Treaty”) and US Non-Provisional patent applications entitled “Continuous Delivery of Lenalidomide and Other Immunomodulatory Agents” on April 21, 2020 (PCT Application No. PCT/US20/29159 and U.S. Application No. 16/854,810).
The PCT application, filed with the PCT receiving office at the U.S. Patent & Trademark Office, allows Starton to file patent applications to seek protection for the methods disclosed therein in most major market countries throughout the world. The U.S. non-provisional patent application was filed with the U.S. Patent and Trademark Office and, like the PCT application, relates to Starton’s technologies for methods of treatment with immunomodulatory compounds. The U.S. non-provisional patent application and any national stage applications based on the PCT application that are filed, if granted, have the potential to give 20 years of patent protection for the methods – until at least 2040.
Pedro Lichtinger, Starton Chairman and Chief Executive Officer, commented, “The technology embodied in this patent family will allow us to proceed with our planned first in human continuous delivery study in patients towards the end of this year. We believe that the technology, if replicated in the clinic, will provide a best in class, breakthrough product for hematological malignancies that can significantly improve patient outcomes.”
Jamie Oliver, Pharm.D., Starton Chief Medical Officer and inventor, stated, “The filing protects our invention of continuous delivery of lenalidomide and other immunomodulatory (imid) agents. We believe that the invention may have broad applications beyond multiple myeloma to include hematologic malignancies, mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), lymphomas, as well as solid tumor cancers or inflammatory diseases.”
The STAR-LLD program includes development of two continuous delivery formulations – a subcutaneous (SC) ambulatory pump and a multi-day transdermal formulation. The SC ambulatory pump program is currently engaging with contract manufacturers for a Phase 1 efficacy and safety study currently planned for treatment of late-stage chronic lymphocytic leukemia (CLL) patients. The open-label study is expected to provide initial efficacy and safety readouts within the next 18 months.
The STAR-LLD program has already displayed unprecedented efficacy results in a murine multiple myeloma model. The STAR-LLD continuous infusion displayed superior efficacy versus lenalidomide standard of care: tumor volume increase at day 29 was 483% with standard of care versus an -81% reduction in tumor volume in the STAR-LLD group. Progression-free survival was also significantly increased in the continuous infusion group, STAR-LLD had the longest survival with two animals surviving to 100 days, where all animals treated with lenalidomide standard of care had failed treatment by day 52.
About Starton Therapeutics
Clinical-stage biotechnology company focused on transforming standard of care therapeutics. Starton uses proven transdermal technology with proprietary drivers to obtain new indications or develop on-label superiority for patients with hematological malignancies. To learn more, visit www.startontx.com
This press release contains forward-looking statements that are subject to risks and uncertainties. These forward-looking statements include information about possible or assumed future results of the Company’s business, financial condition, liquidity, results of operations, plans and objectives. In some cases, you may identify forward-looking statements by words such as “may,” “should,” “plan,” “intend,” “potential,” “continue,” “believe,” “expect,” “predict,” “anticipate” and “estimate,” the negative of these words or other comparable words. These statements are only predictions. One should not place undue reliance on these forward-looking statements. The forward-looking statements are qualified by their terms and/or important factors, many of which are outside the Company’s control and involve a number of risks, uncertainties and other factors that could cause actual results and events to differ materially from the statements made. The forward-looking statements are based on the Company’s beliefs, assumptions and expectations of future performance, taking into account information currently available to the Company. Neither the Company nor any other person assumes responsibility for the accuracy or completeness of these statements. Information in this press release will be updated only to the extent required under applicable laws. If a change occurs, the Company’s business, financial condition, liquidity, results of operations, plans and objectives may vary materially for from those expressed in the aforementioned forward-looking statements.