Oncolys Biopharma, Inc. TSE:4588
Oncolys BioPharma : Announcement of FDA Clearance of Two IND Applications to Initiate Phase 2 Clinical Trials of OBP-601 (Censavudine, TPN-101)
Source: MarketScreener
NB: this is a summary translation of the press | August 16, 2021 |
release original drafted in Japanese for the disclosure | Oncolys BioPharma Inc. |
required in compliance with the TSE regulations. | |
Announcement of FDA Clearance of Two IND Applications
to Initiate Phase 2 Clinical Trials of OBP-601 (Censavudine, TPN-101)
in Neurodegenerative Diseases
Tokyo, Japan, August 16, 2021 -- Oncolys BioPharma Inc. (Head Office: Minato-ku, Tokyo; (JPX:4588), "Oncolys") today announced that Transposon Therapeutics, Inc. ("Transposon"), licensee of OBP-601 (Censavudine, TPN-101), received clearance for two Investigational New Drug applications (INDs) by the U.S. Food and Drug Administration (FDA). Transposon plans to initiate double-blind, placebo- controlled Phase 2 clinical trials of OBP-601 in patients with Progressive Supranuclear Palsy (PSP) and in patients with Amyotrophic Lateral Sclerosis (ALS) and/or Frontotemporal Degeneration (FTD). PSP, ALS and FTD are rare but devastating neurodegenerative diseases.
Oncolys entered into an exclusive worldwide license agreement with Transposon for OBP-601 on June 15, 2020, which led to the current INDs.
Oncolys originally licensed OBP-601, the nucleoside reverse transcriptase inhibitor (NRTI), from Yale University in 2006 and licensed it to Bristol-Myers Squibb Co. ("BMS") in 2010. BMS developed OBP-601 through Phase 2b for the treatment of HIV; however, the license agreement with BMS was terminated in 2014.
Oncolys will continue to hold joint development committee meetings with Transposon to support the development of OBP-601 into a new treatment modality for neurodegenerative diseases.
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About Oncolys BioPharma Inc.
Oncolys BioPharma Inc.(JPX:4588) develops novel cancer therapeutics and diagnostic products using gene modified viral technologies and aims to contribute to fulfill unmet medical needs for cancer and severe infectious diseases. Especially in oncology area, we utilize technology platform for oncolytic virus and develop Telomelysin and its next- generations for cancer treatment and TelomeScan for early detection of cancer and recurrence monitoring after surgery. We have established broad range of product pipeline to cover early detection of cancer, early treatment of local cancer, post-operative examination, and treatment of metastatic cancer. For more information, please visit http://www.oncolys.com/en/
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Oncolys BioPharma Inc.
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