- Independent safety review approved dose escalation and initiation of next dosing cohort
- STAR-LLD generally well tolerated in all subjects dosed to date
- On track to complete dosing of all cohorts in May 2022
- Phase 1b/2 in newly diagnosed multiple myeloma being initiated
PARAMUS, N.J., MAY 4, 2022 – Starton Therapeutics Inc., a clinical stage biotechnology company provides updates on its first-in-human Phase 1 STAR-LLD clinical trial of its investigational continuous delivery lenalidomide, in healthy subjects. Four subjects in the first cohort received 24 hours of STAR-LLD continuous lenalidomide, and a single oral dose of lenalidomide after a 24 hour washout period. The Independent Data Monitoring Committee reviewed the totality of the safety data from the first cohort and recommended advancement to Part B, where subjects will receive the second-highest of three infusion strengths of STAR-LLD.
“We are encouraged by the progress of this Phase 1 clinical study so far. As expected, the STAR-LLD continuous infusion appears to be very well-tolerated with no related adverse events. I look forward to continuing to advance this program to the multiple myeloma patient popluations with a need for enhanced tolerability,” said Mohamad Hussein, Scientific Committee Chair.
The company also announced that the upcoming Phase 1b/2 clinical study in multiple myeloma is on track to begin enrollment in Q4 2022 at three already identified sites in the European Union. Starton plans to submit additional regulatory applications in the US and other countries to accelerate the Phase 1b/2 as part of its development approach for STAR-LLD.
STAR-LLD program: three delivery systems
Starton is pursuing three delivery systems for STAR-LLD, in addition to the subcutaneous ambulatory infusion under investigation in the ongoing Phase 1 clinical trial, the Company also has progressed with its transdermal adhesive patch development and development of a patch/pump on-body injector (OBI).
About The Phase 1 Clinical Trial
The clinical trial is a Phase 1 study to evaluate the 24-hour bioavailability, safety, tolerability, and pharmacokinetics STAR-LLD in healthy human subjects. The study is an open-label, crossover design used to confirm the plasma concentrations of STAR-LLD versus oral lenalidomide that will be further evaluated in a randomized Phase 1b/2 study in patients with multiple myeloma. STAR-LLD uses an ambulatory continuous subcutaneous infusion pump to deliver Starton’s proprietary solubilized lenalidomide in a continuous low dose delivery rather than once-a-day (QD) oral dose. The implication of this precise control is the maintenance of adequate and efficacious drug levels over the entire dosage interval. Starton’s previous in vivo studies found a 77% reduction in plasma lenalidomide exposure using a continuous subcutaneous infusion versus pulsatile dosing at the daily oral equivalent.
About STAR-LLD
STAR-LLD is a continuous delivery lenalidomide in development to expand the standard of care for the most common blood cancers, multiple myeloma and chronic lymphocytic leukemia (CLL). A preclinical proof-of-concept study for STAR-LLD demonstrated that MM tumors caused by human myeloma cells grew 25-fold if untreated, five-fold when treated with oral lenalidomide and shrank by 80% with STAR-LLD. The study also showed 100% efficacy (overall response rate ORR) at 144 mcg continuous LLD and 20% tumor elimination vs. 0% ORR with active control with daily pulsatile once daily dosing.
Starton has completed a pre-IND meeting for STAR-LLD SC and all IND-enabling preclinical and CMC studies.
Starton expects to reference prior findings of nonclinical safety for key sections of the New Drug Application (NDA) for REVLIMID®.
About Starton Therapeutics
A clinical-stage biotechnology company focused on transforming standard of care therapies with proprietary dermal technology, so people with cancer can receive continuous treatment to live better, longer. Starton’s proprietary transdermal technology is intended to increase efficacy of approved drugs, to make them more tolerable and expand their potential use. 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 from those expressed in the aforementioned forward-looking statements.
Starton Investor Relations:
+1 646 578 8740
