Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.CytoDyn, a biotechnology company focused on the development of new therapies for combating human immunodeficiency virus (HIV) infection, has reached an agreement with the FDA on the Company's previously submitted Phase III protocol synopsis for PRO 140, the Company's novel self-injectable antibody for the treatment of HIV, and submitted the full Phase III protocol to the FDA today.
Subscribe to our email newsletter
The Company’s Phase 3 protocol provides for a 25-week study with 300 HIV patients, which could start as early as 30 days after submission.
The Company believes that upon successful completion of this Phase 3 study, CytoDyn will have the opportunity to seek accelerated approval for PRO 140 based on previously FDA granted fast-track candidate designation.
Additionally, CytoDyn may apply for a breakthrough designation for PRO 140, as the first self-injectable antibody for HIV therapy.
The Company’s recently completed Phase 2b treatment substitution trial demonstrated that 98% of all patients treated with PRO 140 successfully passed four weeks of monotherapy without virologic failure.
CytoDyn then offered 14 patients the option to continue in an extension study, and all 14 patients successfully passed six months of monotherapy without experiencing virologic failure, with some study patients now reaching eight months of successful monotherapy.
Management will hold an investment community conference call on Tuesday, May 5, 2015, at 1:00 p.m. PT to discuss the Company’s future plans for PRO 140 (see details for the call below).
The Company’s first Phase 3 study is designed to allow PRO 140 as a component of a HAART regimen for treatment experienced patients. HAART is the current standard of medical care for individuals with HIV. Management believes the market size for a HAART therapy, which includes the PRO 140 antibody, along with other PRO 140 indications, could exceed a billion dollars.
CytoDyn believes that its PRO 140 antibody has compelling advantages over Maraviroc, the only other CCR5 antagonist for HIV therapy. These advantages include less toxicity, fewer side effects and once-a-week versus daily administration which together may improve patient compliance.
The FDA is in agreement with CytoDyn’s proposed regulatory path for the first approval for PRO 140 and the Company plans to request a meeting with the FDA to discuss potential additional indications for HIV therapy following the submission of the "top-line report" of the recently completed Phase 2b treatment substitution study.
Dr. Nader Pourhassan, President and CEO, commented: "CytoDyn is proud to have developed the first self-injectable antibody for the treatment of HIV by reaching this substantial Phase 3 milestone on the path to approval.
"The FDA has been helpful in guiding us to define the preferred regulatory path for our first approval and we plan to explore a label-expansion path with the FDA shortly after this study starts." Dr. Pourhassan added: "Only about 20% of the HIV population in the U.S. have a completely suppressed viral load.
"The rate of transmission of HIV increases by over 99% when the viral load is not suppressed. PRO 140 has been recognized by the NIH and FDA as a product that can potentially address the challenges faced by patients suffering from HIV. We believe the FDA’s prior designation of PRO 140 as a candidate for fast track approval speaks volumes about its potential.
"We are very pleased to have advanced PRO 140’s development into a Phase 3 trial in just a few short years and are optimistic about its future to improve the lives of HIV-positive people."