CytoDyn receives RFL from FDA for leronlimab + HAART in HIV

More Details

CytoDyn intends to request a Type A meeting with the FDA to discuss its request for additional information. The FDA’s request does not require any additional clinical trials to be conducted, rather the Company will conduct additional analysis of completed trials. 

Meanwhile CytoDyn is planning to lock and unblind the Phase 2 *redacted* trial data later this week. Periodic safety review by Data Safety Monitoring Committee (DSMC) for ongoing Phase 3 study (severe/critical population) is planned for next week. Both results are to be announced in July. 

The Importance

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

Opinion
Further Reading

Press release

CytoDyn plans 3-arm phase 3 trial for leronlimab with/versus remdesivir in redacted

Leronlimab was administered to more than sixty patients with redacted under emergency Investigational New Drug (eINDs) authorizations granted by the FDA. Preliminary results from this patient population led to CytoDyn’s Phase 2b/3 clinical trial for 390 patients, which is randomized, placebo-controlled with 2:1 ratio (active drug to placebo ratio). CytoDyn has also been granted a Phase 2 randomized clinical trial study in the U.S. for a Phase 2 randomized clinical trial for mild-to-moderate redacted population in the U.S. CytoDyn plans to update the public regarding current eIND results later this week.

“We believe the randomized head-to-head comparison of leronlimab to remdesivir and in combination will provide answers to the lingering question regarding effective treatment options for patients suffering from redacted. We look forward to working both in the United States and with potential international sites to help provide effective treatment options for redacted,” said Jacob Lalezari, M.D., Chief Science Officer of CytoDyn.

CytoDyn has assurance from its manufacturer that it will have available over 1 million vials this year and could ramp up production to 2-3 million vials this year alone,” said, Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn.

AF on CYDY redacted stock promotion

Adam Feuerstein writes on Cytodyn () again, and its stock promotion surrounding redacted, and says […]
“If you’re interested in the ongoing $ redacted stock promotion — and which parties are now in a position to sell their inflated shares — this blog post from BuyersStrike should be read.”

Earlier, AF said

  • Leronlimab did little or nothing for the redacted patients treated at Montefiore Medical Ctr in NY, according to a letter published in NEJM. Only 1 of 5 patients remained stable, without intubation.
  • If you’re betting on wretched, incompetent companies like $AYTU or $CYDY to save us from redacted, then mankind is truly headed for extinction. But we know all you really care about is a quick profit from your trade. You’ll do, say anything for $, right?
  • Lowering IL-6 means nothing without an positive outcome. Sorry, leronlimab is not the answer to redacted, regardless if Nader issues 14,000 press releases saying otherwise.
  • I wrote about $CYDY leronlimab here: statnews.com/2019/03/08/tak It’s not a unique mechanism. Similar competing drugs do not sell well.
  • It’s a remarkable deal because Vyera will never recoup its up-front payment to $CYDY. Leronlimab might deliver tens of millions of dollars per year in sales, if lucky.

Never really followed . Did not like the negative vibe surrounding the stock.

CytoDyn Inc., a late-stage biotechnology company, focuses on the clinical development and commercialization of humanized monoclonal antibodies to treat human immunodeficiency virus (HIV) infection. Its lead product is PRO 140, a therapeutic anti-viral agent, which is in Phase IIb extension study for HIV as monotherapy, rollover study for HIV as a combination therapy, Phase IIb/III investigative trial for HIV, Phase Ib/II trial for triple-negative breast cancer, and Phase II trial for graft-versus-host disease. CytoDyn Inc. has strategic agreement with Samsung BioLogics Co. Ltd. for the clinical and commercial manufacturing of leronlimab. The company was formerly known as RexRay Corporation. CytoDyn Inc. was incorporated in 2002 and is based in Vancouver, Washington.