On July 20, 2023 Sathgen Therapeutics, a division of a leading chemicals conglomerate in India – Godavari Biorefineries Limited (GBL), reported the completion of the first cohort in a Phase 1 clinical trial for their first-in-class New Chemical Entity, MSP008-22 (Press release, Sathgen Therapeutics, JUL 20, 2023, https://www.prnewswire.com/news-releases/sathgen-therapeutics-announces-dosing-of-the-first-patient-cohort-with-msp008-22-a-novel-anti-cancer-drug-301881833.html [SID1234633345]). The clinical trial program is managed by Clinexel Life Sciences, a renowned contract research organization in the health sector.
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Sathgen Therapeutics aims to develop MSP008-22 for difficult-to-treat cancers, starting with triple negative breast cancer (TNBC) and prostate cancer as proof-of-principle. MSP008-22 effectively targets treatment-resistant cancer cells in preclinical models, and demonstrates an excellent safety profile with no serious adverse events in the first patient cohort.
Professor Sendurai Mani, Associate Director, Legorreta Cancer Center, Brown University, and Scientific Co-Founder, Sathgen Therapeutics, stated, "TNBC is responsible for 30% of breast cancer-related deaths. The lack of estrogen and progesterone receptors and HER2 expression makes it challenging to treat using conventional hormone therapy. MSP008-22 will address this significant unmet need for TNBC patients."
Dr. Sangeeta Srivastava, Executive Director, GBL, and CSO, Sathgen Therapeutics, said, "A major milestone for us, this clinical trial marks our first program to enter clinical development. MSP008-22 is our lead candidate for treating TNBC and prostate cancer, and enhances the efficacy of standard-of-care chemotherapy."
Mr. Samir Somaiya, Chairman and MD, GBL, and Executive Co-Founder, Sathgen Therapeutics, highlighted, "At GBL, research is the cornerstone of our enterprise, creating continuous value for society. We are dedicated to pioneering drug discovery to generate sustainable advantages. The trial represents a crucial milestone in our mission to help patients with hard-to-treat cancers."
Dr. Deepa Arora, CEO, Clinexel, explained, "The successful completion of the first cohort of this study (NCT05478486) in patients with advanced solid tumours without any adverse events is very encouraging. We are working to bring a safe and effective oral therapy to benefit patients with TNBC or prostate cancer."