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Rafael Holdings, Inc. reports developments as a biotechnology company focused on pharmaceutical development and interests in clinical-stage and early-stage pharmaceutical and medical device companies. Its lead program is Trappsol® Cyclo™, a hydroxypropyl-beta-cyclodextrin product candidate evaluated for Niemann-Pick Disease Type C1, with additional cyclodextrin-related work in neurodegenerative disease.
Recurring company news covers clinical development of Cyclo Therapeutics programs, scientific presentations, patent and licensing activity, quarterly and annual financial results, and governance changes. Updates also address the company’s consolidated expenses following the Cyclo Therapeutics acquisition and its portfolio interests in healthcare and medical-device development.
Rafael Pharmaceuticals has successfully enrolled 500 patients in its pivotal Phase 3 clinical trial, AVENGER 500, for metastatic pancreatic cancer, evaluating the compound CPI-613® (devimistat) with modified FOLFIRINOX. The trial is one of the largest of its kind and is taking place at 75 sites globally. The company aims to address significant treatment needs given the high mortality rate associated with this cancer. The FDA has approved the trial, which is expected to yield critical data regarding devimistat's efficacy and patient safety.
Rafael Pharmaceuticals announced positive results from a Phase 1 study of CPI-613® (devimistat) combined with gemcitabine and nab-paclitaxel for locally advanced or metastatic pancreatic cancer. The study, involving 26 patients, reported good tolerance and preliminary efficacy, indicating the drug's potential when administered at doses up to 1,500 mg/m². The findings will be presented at the ASCO 2020 Virtual Scientific Program. The FDA has granted devimistat orphan drug designation for several cancers and approved pivotal trials for pancreatic cancer and acute myeloid leukemia.
Rafael Pharmaceuticals has initiated a research collaboration to explore the effectiveness of CPI-613® (devimistat) alongside chemotherapy agents azacitidine and venetoclax for treating acute myeloid leukemia (AML). With a current five-year survival rate for AML at just 28%, this partnership aims to address significant treatment gaps.
The company is also conducting a Phase 3 clinical trial involving devimistat and chemotherapy agents cytarabine and mitoxantrone across nearly 50 sites worldwide. Devimistat has orphan drug designation from the FDA for several cancers, enhancing its potential in ongoing trials.
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