CytoDyn Inc. (CYDY) Sees Promising HIV Treatment Trial Results, Gets Go-Ahead to Raise Dosage

• Response rate to PRO 140 rose from 40 percent at 350mg dose to 70 percent at 525mg
• Institutional Review Board (IRB) allows trials of viral-entry inhibitor to continue at 700mg dose
• PRO 140 is an FDA fast-track candidate

Following clinical trial results showing that its new anti-HIV treatment is more effective at higher dosages, biotechnology company CytoDyn Inc. (OTCQB: CYDY) is set to give trial participants an increased weekly dose of PRO 140 (http://ibn.fm/oyLRe).

The latest round of trial results showed that the response rate among trial participants treated with the viral-entry inhibitor rose from 40 percent at a 350mg weekly dose to 70 percent at 525mg. The Institutional Review Board (IRB) has given CytoDyn the go-ahead to give newly-enrolled trial participants a 700mg weekly dose of the viral-entry inhibitor. Current trial participants who did not respond to the lower dosage will also be allowed to continue on the 700mg weekly dose.

In a news release, CytoDyn president and CEO Nader Pourhassan, Ph.D., said, “We are able to increase the dose of PRO 140 due to its positive safety profile in prior clinical trials.” He added that the treatment’s safety is a key reason why the IRB has approved the higher dosage.

“Also of note, patients who achieve suppressed HIV viral load with 52 mg tend to maintain suppressed viral load after 10 weeks of monotherapy,” Pourhassan added. “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.”

The development of PRO 140 is of particular interest, because it could allow people living with HIV to take just one weekly dose instead of the daily pills required by current therapies.

An antibody rather than a drug, PRO 140 works by blocking the most prevalent HIV subtype from entering healthy cells, thus protecting them from infection. Recognizing the treatment’s potential, the FDA has designated PRO 140 a fast-track candidate. To qualify for fast-track status, a treatment must be intended for a serious condition and must also show an advantage over currently available treatment options.

Pourhassan noted, “Approximately 70 percent of trial participants who started with PRO 140 at the 525mg dose and have been treated between one and nine months are achieving HIV viral load suppression. This response rate is very promising and we are excited to evaluate PRO 140 at an even higher dose.”

Speaking of those trial participants who did not respond to PRO 140, the principal investigator of CytoDyn’s current trial said that these patients had been able to successfully return to their previous highly active antiretroviral therapy (HAART) treatments.

Jacob Lalezari, Assistant Clinical Professor of Medicine at UCSF/Mount Zion Hospital, noted, “Of key importance in the Phase 3 monotherapy trial, all non-responders to PRO 140 have safely achieved suppressed HIV viral load upon returning to their prior HAART regimens before PRO 140 monotherapy.”

In addition to HIV treatment, PRO 140 is also being explored for other inflammatory indications and is being studied in a phase 2 graft versus host disease clinical trial for patients with acute myeloid leukemia or myelodysplastic syndrome who are undergoing bone marrow transplant or are at risk of developing graft versus host disease.

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

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