Starton Therapeutics Announces the Opening of the First Clinical Site for STAR-LLD Lenalidomide Phase 1b Trial in Multiple Myeloma
- Gabrail Cancer & Research Center activated and open to screen patients, with Nash Gabrail, MD as lead investigator
- Site activation comes several months ahead of schedule, significantly accelerating Starton’s clinical program timeline
PARAMUS, N.J.--(BUSINESS WIRE)--Starton Therapeutics Inc. (“Starton” or “the Company”), a clinical-stage biotechnology company focused on transforming standard-of-care therapies with proprietary continuous delivery technology, announced Gabrail Cancer Center (GCC) in Canton, Ohio as the first site activated in the STAR-LLD Phase 1b clinical trial. Dr. Nash Gabrail, medical oncologist and founder of the Center, is the study’s lead investigator.
“Quality of life is just as important as life itself,” said Dr. Gabrail, the author and clinical researcher who believes that involvement in clinical trials, when available, is a fundamental part of patient care and the best option for cancer patients. “I’m thrilled to be the study’s lead investigator and excited about the potential opportunity STAR-LLD can bring multiple myeloma patients.”
Since 1990, GCC has built a national reputation for excellence in cancer patient care, management, diagnosis, research, education, and prevention. Due to the expansion of clinical trials and the addition of diagnostic imaging, GCC underwent two expansions to accommodate patients’ needs, and now attracts patients for clinical trials both nationally and internationally.
“We are pleased to be working with Dr. Gabrail and his team at Gabrail Cancer & Research Center again,” said Amy Chergey, Executive Director Clinical Operations at Starton. “The clinical and nursing staff are truly remarkable professionals who exhibit unwavering dedication to patient care, consistently going above and beyond to ensure the well-being of their patients. Their expertise, commitment and compassion create an environment of trust and healing for patients.”
GCC is open to screen patients and expects dosing to begin in the coming weeks.
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. The study also showed 100% efficacy (overall response rate ORR) at 144 mcg/day continuous LLD and 20% of animals in this cohort were tumor free after 100 days vs. 0% ORR with active control with daily pulsatile once daily dosing. 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 expand their potential use. To learn more, visit www.startontx.com.
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