A biopharmaceutical firm, Theratechnologies Inc., has progressed to a higher dosage level in the third phase of its clinical trial for a drug called sudocetaxel zendusortide, which is being tested on patients with advanced ovarian cancer. The Medical Review Committee (MRC) confirmed the safety of the initial dosage and endorsed the move to a higher dose as per the revised dose optimization strategy. Recruitment for the second group of patients is underway, with one individual already signed up and given the elevated dose.
The first part of the trial involved six patients, each receiving a dose of 1.75 mg/kg. For the subsequent group, the dosage has been increased to 2.50 mg/kg. The MRC's approval to begin the second group came after observing that the first group experienced no more than one dose-limiting toxicity. The study's protocol classifies dose-limiting toxicities as any Grade 3 or higher toxicity occurring within the first treatment cycle or any worsening of peripheral neuropathy to Grade 3 or 4 within three months.
Dr. Ira Winer, a trial investigator, expressed optimism regarding the drug's safety and tolerability in the initial group of patients. Theratechnologies' Senior Vice President and Chief Medical Officer, Christian Marsolais, Ph.D., highlighted the significance of advancing to the next dosage level as it aids in further defining the drug's potential as a viable treatment option for advanced ovarian cancer patients.
Sudocetaxel zendusortide represents a novel peptide-drug conjugate targeting the sortilin receptor (SORT1), which is linked to aggressive disease and poor prognosis in various cancers. The drug is currently in Phase 1 clinical trials, and Theratechnologies has developed the SORT1+ Technology™ platform to create more peptide-drug conjugates targeting SORT1.
Theratechnologies, listed on the TSX and NASDAQ, is dedicated to developing and commercializing innovative therapies to meet unmet medical needs.
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