CytoDyn Inc. (CYDY) Reports HIV Single Agent Therapy Progress Following Improved Response Rate at Higher Dose

• PRO 140 single agent therapy is the first successful single agent therapy in the history of HIV for a sub-population of HIV
• Response rate for the company’s innovative PRO 140 nearly doubled after dosage increase
• About 70 percent of phase 3 trial participants treated with higher doses have achieved viral load suppression
• The monotherapy would allow patients to self-administer one dose per week of PRO 140 at home

Biotechnology company CytoDyn Inc. (OTCQB: CYDY) has announced significant developmental progress for its PRO 140 monotherapy for human immunodeficiency virus (HIV) after noticing improved response rates at higher doses of the treatment during phase 3 trials (http://ibn.fm/yuYub). The company has received clearance from the independent Institutional Review Board (IRB) to increase the weekly dose of PRO 140 from 525 mg to 700 mg, according to a company press release.

The dosage increase will apply to all newly enrolled patients but also to current trial participants who failed to maintain suppressed HIV viral load on a lower dose. Approximately 70 percent of trial participants who started PRO 140 at 525 mg and have been undergoing treatment between one and nine months are achieving HIV viral load suppression, according to CytoDyn President and CEO Nader Pourhassan, Ph.D. Increasing the dosage further, to 700 mg per week, is expected to have even better results. “This IRB decision is exciting for patients, our Company and our shareholders, given the potential for a higher patient response rate with PRO 140 as a single agent at the 700 mg dose level,” Pourhassan explained in a news release.

The CytoDyn CEO added that, as the phase 3 trial progresses, exact response rates for participants taking 525 mg per week could vary. So far, there has been a clear distinction between response rates at 525 mg and the lower 350 mg per week. We believe increasing the dosage to 700 mg has the potential to achieve an even higher response rate.

PRO 140 is one of the company’s leading monoclonal antibodies being developed for HIV infection and certain other immunological disorders, including cancer. PRO 140 works by blocking the HIV co-receptor CCR5 on T-cells that block viral entry. Phase 1 and 2 clinical trial results have indicated that PRO 140 has no negative effect on normal immune functions mediated by CCR5, while being able to significantly reduce viral loads in patients. The phase 3 trial aims to assess the safety, tolerability and efficacy of PRO 140 as a long-acting single-agent maintenance therapy for HIV chronic suppression. If successful, this monotherapy would allow patients to safely self-administer once per week at home, without needing to take daily pills any longer.

Participants in the phase 3 clinical trial were screened for CCR5-tropic HIV infection and had a suppressed viral load under an existing highly active antiretroviral therapy when they started the study. At the beginning, participants were administered weekly PRO 140 doses of 350 mg, with roughly 40 percent being able to maintain suppressed viral load at that dosage. After treating the first 150 patients, CytoDyn increased the weekly dose to 525 mg, and a majority of the patients who did not respond to the lower dose were able to successfully re-suppress their viral loads when switching to the increased dosage.

“Patients who achieve suppressed HIV viral load after 10 weeks tend to maintain suppressed viral load.  Interestingly, some patients in our Phase 2b extension study are now achieving suppressed HIV viral load for nearly four years with PRO 140 as a single agent,” Pourhassan added.

Additionally, all phase 3 trial participants that did not respond to PRO 140 were able to safely achieve suppressed HIV viral load when returning to their previous retroviral therapy. “This is a major achievement as patients continue to have options for maintaining HIV viral load suppression,” said one of the main investigators of the phase 2 monotherapy trial, Jacob Lalezari, M.D., director of Quest Clinical Research and assistant clinical professor of medicine at UCSF/Mount Zion Hospital.

Specializing in humanized monoclonal antibodies and their clinical development, CytoDyn’s groundbreaking advancements in treatments for HIV and other immune deficiency viruses are providing ample opportunities for investors. The company intends to develop PRO 140 both as monotherapy and as part of a combination therapy, but also to pursue non-HIV, inflammatory indications where CCR5 and its ligand CCL5 are involved.

For more information, visit the company’s website at www.Cytodyn.com

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