CytoDyn Announces Completion of FDA Meeting on Phase II Study of Leronlimab in Patients with Relapsed/Refractory Microsatellite Stable Colorectal Cancer
CYTODYN INC (CYDY)
NASDAQ:AMEX Investor Relations:
ir.cytodyn.com
Company Research
Source: GlobeNewswire
VANCOUVER, Washington, Aug. 12, 2024 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that it completed a meeting with the U.S. Food and Drug Administration (FDA) to gain alignment on the rationale and proposed dosing for the Company’s Phase II study that will investigate the preliminary safety and activity of leronlimab in combination with trifluridine plus tipiracil (TAS-102) and bevacizumab in participants with CCR5+, microsatellite stable (MSS), relapsed or refractory metastatic colorectal cancer (mCRC). The Company intends to proceed with a submission of its final study protocol to the FDA, formal engagement of a clinical research organization (CRO), and related preparatory work towards initiating the proposed trial. This open label, randomized (1:1), multicenter trial will evaluate the anti-tumor activity (via o
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CYDY
News
- CytoDyn Announces Preliminary Findings in Study with SMC LaboratoriesGlobeNewswire
- September 2024 Letter to ShareholdersGlobeNewswire
- CytoDyn Engages Leading CRO For Phase II Inflammation TrialGlobeNewswire
- Regulatory roundup: CytoDyn's cancer asset leronlimab likely to advance after basket trial completion [Yahoo! Finance]Yahoo! Finance
- CytoDyn Announces Settlement with Amarex Clinical Research LLC [Yahoo! Finance]Yahoo! Finance
CYDY
Sec Filings
- 9/13/24 - Form EFFECT
- 9/13/24 - Form EFFECT
- 9/9/24 - Form S-1
- CYDY's page on the SEC website