New York, NY (Press Release) – Starton Thera­peutics Inc. (“Starton” or the “Company”), a bio­technol­ogy com­pany focused on trans­forming standard of care thera­peutics, to­day an­nounced the com­ple­tion of a proof of concept study of multiple myeloma with lena­lido­mide using a model which emulates trans­dermal de­livery. The results of the study dem­onstrate that a con­tin­uous sub­cu­tane­ous (SC) de­livery of lena­lido­mide is superior in terms of efficacy and equivalent in tolerability when com­pared to a standard once daily pulsatile dosing of Revlimid® (Celgene Corpo­ra­tion) in mice. The pos­i­tive out­come provides a clear path for de­vel­op­ment of trans­dermal lena­lido­mide in hema­to­logic malig­nan­cies in­clud­ing multiple myeloma and chronic lym­pho­cytic leukemia. Given the un­ex­pected nature of the pos­i­tive results, pat­ent appli­ca­tions have been filed for low dose con­tin­uous trans­dermal de­livery of the thalido­mide class of com­pounds.

The highest dose admin­istered in the trans­dermal model produced com­plete (40%) or partial re­sponses (60%) in all animals at a daily exposure, which is 72% lower than the standard once daily lena­lido­mide dose. The standard once daily lena­lido­mide treat­ment produced no CRs or PRs. The median tumor volume at the end of the study was 14 mm3 at the highest in­fusion dose and was 33-fold larger (473 mm3) in the lena­lido­mide once daily dosed con­trol group. In the 4 animals with a CR which re­ceived a con­tin­uous de­livery, there has been no recurrence of their tumors for 10 days after stopping treat­ment whereas all other animals have ex­peri­enced addi­tional tumor pro­gres­sion. Addi­tion­ally, the tolerability in terms of physical findings, body weight, and key hema­tol­ogy parameters were com­parable among the treat­ment groups.

"These results are unprecedented to our knowledge in this multiple myeloma model. Trans­dermal de­livery is unique in that it “flattens” plasma phar­ma­co­ki­­net­ics – it lowers the over­all exposure of lena­lido­mide by de­livering a targeted con­tin­uous blood level equal to the 12 hour blood level observed with a traditional daily pulsatile dose; this lowers the peak levels sig­nif­i­cantly and elevates the trough level for an extended period," said Dr. Jamie Oliver, Chief Medical Officer. "This de­livery creates a com­pletely new thera­peutic form of lena­lido­mide, which may per­form better than pulsatile treat­ment.”

The model selected was the NCI-H929 cell line human tumor xenograft in a SCID mouse, one of the most common cell lines used to study multiple myeloma. The 29-day study was per­formed in six groups of 10 animals each. To eval­u­ate efficacy and over­all tolerability, phar­ma­co­ki­­net­ics, tumor volume, body weight, physical findings, and CBC were assessed during the treat­ment period. The standard dosing regi­men for REVLIMID (lena­lido­mide) was used as a comparator to four dif­fer­en­t con­tin­uous de­livery dose levels.

"Having spent my career in hema­to­logical malig­nan­cies, these data sug­gest an exciting break­­through for patients," said Dr. Mohamad Hussein. "Starton’s 7-day lena­lido­mide may be par­tic­u­larly valuable for the CLL patient pop­u­la­tion where lena­lido­mide is rec­om­mended by NCCN guidelines but is lacking FDA ap­prov­al.”

About Starton Thera­peutics

Starton Thera­peutics is a clin­i­cal-stage bio­technol­ogy com­pany focused on trans­forming standard of care thera­peutics with a focus on hema­tol­ogy and on­col­ogy. Starton uses proven trans­dermal tech­nology with pro­pri­e­tary drivers to obtain new in­di­ca­tions or de­vel­op on-label superiority.

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.