New York, NY (Press Release) – 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, Ph.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 cur­rent engaging with contract manu­fac­turers for a Phase 1 efficacy and safety study cur­rent 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 cur­rent 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.

Source: Starton Thera­peutics.