Graft-versus-host disease can occur any time after a transplant when donor bone marrow or stem cells attack the recipient

CytoDyn Inc (), a late-stage biotechnology company, said Wednesday that it has treated its first patient with its lead drug leronlimab (PRO 140), in its Phase 2 clinical trial for graft-versus-host disease (GvHD) under the modified trial protocol.

Graft-versus-host disease can occur at any time after a transplant. It is a rare condition that typically occurs when donor bone marrow or stem cells attack the recipient.

In a statement, the Vancouver, Washington-based company said the modified protocol now includes reduced intensity conditioning (RIC) patients and an open-label design under which all enrollees receive leronlimab. The modified protocol also provides for a 50% increase in the dose of leronlimab to more closely mimic preclinical dosing.

The next review of data by the independent data monitoring committee (IDMC) will occur after the enrollment of 10 patients under the amended protocol after each patient has been dosed for 30 days, said the company.

CytoDyn CEO Nader Pourhassan pointed out that GvHD is a life-threatening complication following bone marrow transplantation in patients with leukemia, who have compromised immune systems due to treatment with aggressive cancer therapies.

We selected GvHD as one of our immunology indications for leronlimab, as it targets and masks the CCR5 receptor on T cells. This receptor on T cells is an important mediator of inflammatory diseases including GvHD, especially in organ damage that is the most frequent cause of death in these patients, said Dr Pourhassan.

Based upon the compelling results in our preclinical studies, we are optimistic about the opportunities for leronlimab to provide a therapy for transplant patients to mitigate GvHD, he added.

A preclinical study by Dr Denis R Burger, CytoDyns former chief science officer, and Daniel Lindner, from the Department of Translational Hematology and Oncology Research, at The Cleveland Clinic, was published in the peer-reviewed journal called the Biology of Blood and Marrow Transplantation.

The US Food and Drug Administration earlier granted orphan drug designation to leronlimab for the prevention of GvHD. The designation provides CytoDyn with various incentives and benefits including seven years of US market exclusivity for leronlimab in GvHD, subject to FDA approval for use in this indication.

Leronlimab was earlier granted Fast Track status by the FDA for the treatment of HIV in combination with the cocktail known as highly active antiretroviral therapy (HAART), and for metastatic triple-negative breast cancer, a rare variety which doesnt respond to some treatments.

Leronlimab has completed nine clinical trials and has been given to 800 patients in HIV treatment programs, without a single drug-related serious adverse event. CytoDyn is developing leronlimab to battle multiple diseases. The company has also filed an IND application and a Phase 2 clinical trial protocol with the FDA to treat patients with NASH - damage caused by a build-up of fat in the liver.

Contact the author Uttara Choudhury at[emailprotected]

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CytoDyn treats first patient with leronlimab in Phase 2 trial for GvHD under modified protocol - Proactive Investors USA & Canada