- Two patients have been dosed and a third is in screening
- The first patient has completed cycle 1 successfully where he obtained a measurable response with a decrease in M-protein from 1.7 to 0.9 gm/dL (47% reduction) with no adverse events noted and has begun cycle 2
- Second patient similarly completed the first week without untoward effects
Paramus, NJ – Starton Therapeutics Inc. (“Starton” or “the Company”), a clinical stage biotechnology company transforming standard of care therapies with proprietary dermal technologies, announced today that it has enrolled one third of its STAR-LLD 1b clinical trial. The study is assessing the safety, pharmacokinetics, and efficacy of continuous subcutaneous administration of low-dose lenalidomide (STAR-LLD) in combination with dexamethasone and bortezomib (Velcade®) in 28-day cycles. Second-line transplant ineligible, relapsed/refractory multiple myeloma patients are eligible for the study.
“Enrolling one third of the patients required for the study within two months of site activation is a phenomenal achievement,” said Dr. Jamie Oliver, Starton’s Chief Medical Officer. “We believe STAR-LLD may be able to supplant the use of Revlimid in multiple myeloma and potentially in other indications where Revlimid isn’t currently approved.” He went on to say: “It is notable that the initial responses seen to date mirror the continuous delivery regimen in animal efficacy studies where all animals experienced a partial response or better in a single cycle. In contrast, a once daily injection of lenalidomide, which emulates daily Revlimid dosing, did not produce any meaningful objective responses in the standard multiple myeloma animal model.”
“While it is still early, these preliminary results hold promise that lenalidomide treatment can be administered with minimal side effects when combined with bortezomib and dexamethasone,” said Dr. Nash Gabrail at the Gabrail Cancer Center, the study’s lead investigator, adding: “I continue to be encouraged about the potential of STAR-LLD in the treatment of multiple myeloma.”
Dr. Mohamad Hussein, a global leader in the treatment of multiple myeloma and a member of Starton’s Board of Directors, added, “The observed decrease in M protein along with no reported adverse events this early in the study is encouraging for the potential of STAR-LLD. It’s exciting to know we could potentially bring improved care and outcomes to those we serve.”
About STAR-LLD
STAR-LLD is a continuous delivery lenalidomide in development to expand and replace the standard of care for the most common blood cancers, multiple myeloma (MM) 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 daily lenalidomide and shrank by 80% with STAR-LLD over a single 28-day cycle. The study also showed a 100% overall response rate (ORR) using continuous LLD while 20% of animals in this cohort were tumor free after 100 days compared to a 0% ORR in animals treated with a 70% higher dose of lenalidomide given in single daily doses. In addition, a Phase 1 bioavailability study in healthy men comparing STAR-LLD to Revlimid demonstrated the drug is well tolerated and is >91% bioavailable by the subcutaneous route. It was also observed that the Cmax is <90% lower than oral Revlimid. These data support the safety of the planned Phase 1 dose of 400 mcg/hr (9.6 mg a day) versus a standard 25 mg a day dose of Revlimid.
About Starton Therapeutics
A clinical-stage biotechnology platform company focused on transforming standard of care therapies with proprietary continuous delivery 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 to expand their potential use. To learn more, visit www.startontx.com.
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