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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 announced the initiation of a Phase 2 clinical trial for CPI-613® (devimistat) combined with hydroxychloroquine, targeting clear cell sarcoma. This collaboration involves Sara’s Cure and SARC, focusing on a rare cancer that predominantly affects young adults. The trial, part of Rafael's mission to develop treatments for hard-to-treat cancers, will take place at several U.S. sites, including Cleveland Clinic and University of Michigan. CPI-613® aims to enhance chemotherapy effectiveness while reducing side effects, having already received FDA orphan drug designation for multiple cancers.
Rafael Pharmaceuticals has announced the initiation of a Phase 2 clinical trial for CPI-613® (devimistat) in combination with hydroxychloroquine to treat clear cell sarcoma. This rare cancer primarily affects young adults and has limited treatment options. Collaborating with Sara's Cure and SARC, the trial will enroll patients at several U.S. sites, including Cleveland Clinic and Indiana University. Devimistat targets cancer cell metabolism, enhancing the efficacy of chemotherapy while reducing side effects. The trial aims to provide hope for patients with this challenging disease.
Rafael Pharmaceuticals announced that the U.S. FDA has granted Fast Track designation for its lead compound, CPI-613® (devimistat), for treating metastatic pancreatic cancer. This designation highlights the urgent need for new treatment options for this aggressive cancer. Rafael also achieved target enrollment of 500 patients for its Phase 3 trial ahead of schedule. Additionally, devimistat has received Orphan Drug Designation for soft tissue sarcoma. The drug aims to enhance the effectiveness of chemotherapy while minimizing side effects, representing a significant advance in cancer treatment.
Rafael Holdings, Inc. (NYSE: RFL) reported revenue of $4.9 million and a loss per share of $0.66 for the fiscal year ending July 31, 2020. Fourth quarter revenue matched last year's at $1.2 million, but the loss per share widened from $0.16 to $0.34 due to increased investments in the Barer Institute. The company also achieved full enrollment for its pivotal Phase 3 clinical trial for metastatic pancreatic cancer. The FDA granted Orphan Drug Designation for its lead compound, CPI-613®, for treating soft tissue sarcoma.
Rafael Pharmaceuticals announced the upcoming launch of a clinical trial targeting clear cell sarcoma, following the FDA's Orphan Drug Designation for CPI-613 (devimistat) to treat this rare soft tissue cancer. Clear cell sarcoma is notably scarce, with significant unmet treatment needs. The trial will focus on patients with relapsed or refractory cases. This news follows the Company's successful enrollment of 100 patients in a Phase 3 trial for acute myeloid leukemia.
Rafael Pharmaceuticals announced significant progress in its Phase 3 clinical trials, surpassing 100 patient enrollments in the ARMADA 2000 trial for relapsed or refractory acute myeloid leukemia (AML). This pivotal trial evaluates the efficacy of CPI-613® (devimistat) combined with high-dose cytarabine and mitoxantrone. Rafael has also enrolled 500 patients in a parallel trial for advanced pancreatic cancer. The company emphasizes patient safety during the COVID-19 pandemic, with active trials in over 60 sites globally. The FDA and EMA have granted orphan drug designation to devimistat for these conditions.
Rafael Pharmaceuticals announced a partnership with Ono Pharmaceutical to initiate a Phase 1 study in Japan for CPI-613® (devimistat) in patients with pancreatic cancer. This trial will evaluate the combination of devimistat and modified FOLFIRINOX in patients who are resistant or intolerant to conventional chemotherapy. The announcement follows Rafael's completion of patient enrollment for its global Phase 3 AVENGER 500 trial. Rafael aims to enhance pancreatic cancer treatment options in Japan, where survival rates are notably low.
Rafael Holdings (NYSE: RFL) announced its participation at The LD 500 Virtual Conference on September 3, 2020. Chief Financial Officer David Polinsky will present at 12:40 PM EDT and host one-on-one meetings with investors. The conference runs from September 1-4. Rafael Holdings invests in clinical stage oncology companies, including Rafael Pharmaceuticals and LipoMedix Pharmaceuticals. The company also owns commercial real estate assets in New Jersey and Jerusalem. For further information, contact David Scher at david@ldmicro.com.
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.