Starton Therapeutics Receives Authorization from the FDA to Proceed with STAR-LLD Lenalidomide Phase 1b Clinical Trial in Multiple Myeloma
- FDA approves Phase 1b study of continuous delivery lenalidomide in multiple myeloma
- Study to evaluate combination of STAR-LLD, Velcade, and dexamethasone
- Initial evidence of safety and efficacy of continuous delivery of lenalidomide
- Interim analysis to review safety and activity data
- None
- FDA agrees to the planned Phase 1b study in second-line transplant-ineligible patients in multiple myeloma
- Treatment regimen will include Velcade® (bortezomib) and dexamethasone and replace oral Revlimid® with STAR-LLD
The
Pedro Lichtinger, chairman and CEO of Starton Therapeutics commented, “Today’s announcement marks a significant development for Starton and patients in need of approved drugs and improved quality of life, and we are excited to begin this critical program in transplant-ineligible patients with multiple myeloma. This study will provide initial evidence of the impact of continuous delivery of lenalidomide both in terms of safety and efficacy, as well as provide clarity for signals of improvement in patients outcomes.”
As part of the development plans, the FDA agreed to have a meeting to review the initial data on safety and activity from the study as an interim analysis, while patients continue treatment for efficacy endpoints. This interim review is aimed at helping develop the plans for the approval path forward with Phase 2 studies for multiple myeloma, as well as other malignancies where lenalidomide has shown activity but is not approved for the new indications planned for study.
Dr. Jamie Oliver, Starton’s chief medical officer noted, “We are very happy with the agreed protocol, which allows a quick read for the key safety and efficacy data which we will review with the FDA. The upcoming Phase 1b clinical study in multiple myeloma is on track to begin enrollment in Q4 2023. Treatment of second-line patients at our proposed optimal dose of continuous lenalidomide in combination with the proteasome inhibitor Velcade and dexamethasone allows us to demonstrate activity in an established standard of care regimen by replacing Revlimid with STAR-LLD.”
Starton has signed an agreement for a business combination with Healthwell Acquisition Corp. I (Nasdaq: HWEL) (“Healthwell”). Please see "Additional Information and Where to Find It" below for additional information related to the proposed business combination.
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 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
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.
About Healthwell
Healthwell is a blank check company, also commonly referred to as a special purpose acquisition company, or SPAC, formed for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses or entities.
Additional Information and Where to Find It
In connection with the transactions contemplated by the business combination agreement, dated April 27, 2023 (as amended on May 15, 2023 and as many be further amended or supplemented from time to time, the “Business Combination Agreement,” and all of the transactions contemplated thereunder, the “Transaction”), by and among Starton, Healthwell, HWEL Holdings Corp., a
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The information herein does not purport to be all-inclusive. The information herein is derived from various internal and external sources, with all information relating to the business, past performance, results of operations and financial condition of Healthwell derived entirely from Healthwell and all information relating to the business, past performance, results of operations and financial condition of Starton derived entirely from Starton. No representation is made as to the reasonableness of the assumptions made with respect to the information therein, or to the accuracy or completeness of any projections or modeling or any other information contained therein. Any data on past performance or modeling contained therein is not an indication as to future performance.
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Starton is aware that its CEO appeared on the television program “Unicorn Hunters” on June 7, 2021. During that appearance, the CEO made a number of representations as to Starton’s approach to reformulating drug products to improve efficacy, tolerability and patients’ quality of life. As part of these representations, the CEO raised the specific example of Starton’s investigational reformulation of Revlimid. While Starton believes in the value of its product, it understands that any clinical superiority claims cannot be made absent specific findings from rigorous clinical studies which Starton has not undertaken. The CEO’s comments on the television program were not intended to suggest Starton has conducted such studies; Starton does not have data to support these specific representations and disclaims any representations or purported representations by its CEO which either stated or implied the contrary.
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Starton Therapeutics
Investors@startontx.com
Healthwell
HealthwellSPAC@edelman.com
Source: Starton Therapeutics Inc.
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