SAN FRANCISCO, CA / ACCESSWIRE / June 3, 2019 / WideTrial Inc., a third-party sponsor of Expanded Access programs, has begun a partnership with Oncotelic Inc., a wholly owned subsidiary of Mateon Therapeutics Inc., to provide OT-101 to patients who cannot take part in research trials of the investigational product. Under the partnership, WideTrial will sponsor and manage programs for treatment use of OT-101 in pancreatic cancer, advanced melanoma, colorectal cancer, and glioblastoma.
OT-101 is a first-in-class RNA therapeutic targeting TGF beta and is the lead immune-oncology drug candidate of Oncotelic. It exhibited single-agent activity in relapsed/refractory cancer patients during Phase 2 testing in controlled clinical trial settings.
The partnership will utilize FDA’s long-standing allowance for Expanded Access, which permits companies to sponsor “treatment-use” programs to treat seriously ill patients who are not candidates for research trials. Like research trials, cohort Expanded Access programs (EAPs) are centrally monitored and coordinated under a single protocol. But the primary objective is treatment-use, not research. EAPs are intended to enable physicians to offer investigational product as an option to a wider range of suitable patients.
“We built WideTrial to solve the economic and operational barriers that drug developers face with Expanded Access,” said Jess Rabourn, CEO of WideTrial. “The new platform enables larger numbers of gravely ill patients to choose to try investigational medicines under a properly designed protocol. Though treatment is the primary objective, program sponsors can learn a lot from patients’ experiences in these programs.”
WideTrial is a privately held company with offices in San Francisco, CA and New York, NY.
Ian Manger, Ph.D.
Director of Clinical Sciences
SOURCE: WideTrial, Inc.
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