leadf
logo-loader
viewCytoDyn Inc.

CytoDyn taps Chiral Pharma to win local approval for leronlimab in the Philippines

CytoDyn CEO Nader Pourhassan said the company was committed to “making leronlimab available in the Philippines”

CytoDyn Inc. - CytoDyn taps Chiral Pharma to win local approval for leronlimab in the Philippines
CytoDyn has enrolled the requisite 195 patients in its Phase 3 trial of leronlimab in severe-to-critical coronavirus (COVID-19) patients and an analysis will be shared in mid-October

CytoDyn Inc (OTCQB:CYDY), which is developing its flagship drug leronlimab (PRO 140) to battle multiple diseases, said on Tuesday that it has appointed Chiral Pharma, a subsidiary of Philippine New Marketlink Pharmaceutical Corporation (NMPC), to register leronlimab for potential approval from the health regulator in the Philippines to treat coronavirus (COVID-19) patients. 

In a statement, CytoDyn CEO Nader Pourhassan said the company was committed to “making leronlimab available in the Philippines.”

Vancouver, Washington-based CytoDyn completed its Phase 2 trial to evaluate the effectiveness and safety of leronlimab in patients with mild-to-moderate COVID-19 in July this year. Patients receiving leronlimab experienced 64% fewer serious adverse events (SAEs) during the trial than patients receiving placebo. The Phase 2 clinical trial for mild-to-moderate patients in the US produced statistically significant results on the National Early Warning Score 2 scale (NEWS2).

READ: CytoDyn to meet with UK regulators to discuss Fast-Track approval for leronlimab, schedules sitdown with FDA

CytoDyn has also enrolled the requisite number of patients for a Phase 3 randomized clinical trial for severe-to-critically ill COVID-19 patients in hospitals in the US. An interim analysis on the first 195 patients will be shared by mid-October.

The US Food & Drug Administration (FDA) has granted Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer.

Contact the author Uttara Choudhury at [email protected]

Follow her on Twitter: @UttaraProactive

Quick facts: CytoDyn Inc.

Price: 2.485 USD

OTCQB:CYDY
Market: OTCQB
Market Cap: $1.42 billion
Follow

Add related topics to MyProactive

Create your account: sign up and get ahead on news and events

NO INVESTMENT ADVICE

The Company is a publisher. You understand and agree that no content published on the Site constitutes a recommendation that any particular security, portfolio of securities, transaction, or investment strategy is...

In exchange for publishing services rendered by the Company on behalf of CytoDyn Inc. named herein, including the promotion by the Company of CytoDyn Inc. in any Content on the Site, the Company receives from said...

FOR OUR FULL DISCLAIMER CLICK HERE

CytoDyn provide update on their path to approval for treatment of COVID-19

CytoDyn (OTCQB: CYDY) CEO Nader Pourhassan joined Steve Darling from Proactive to provide an update on how and when they expect to have approval for Leronlimab for Covid treatment.  Pourhassan also told Proactive about what the recent decision by the FDA to approve Remdesivir as a...

1 week, 1 day ago

2 min read