New PR.... CytoDyn Provides Update on Dose Esca
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Posted On: 08/14/2019 6:04:03 AM
New PR....
CytoDyn Provides Update on Dose Escalating Trial with Leronlimab for HIV Monotherapy for a Potential Pivotal Trial
564 patients have been enrolled in monotherapy trials to date with over 150 patients hitting the benchmark of one-year of sustained viral suppression
The response rate post-10 weeks of monotherapy is 68% with 350 mg dose, 94% with 525 mg and 85% with 700 mg
VANCOUVER, Washington, Aug. 14, 2019 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”), a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today an update on its HIV dose escalating monotherapy trial. HIV patients received dosages of 350 mg, 525 mg, or 700 mg of leronlimab once a week (229, 201, and 134 patients, respectively) with approximately 150 patients exhibiting sustained viral suppression at approximately one year of monotherapy. The rate of viral load suppression post-10 weeks of monotherapy was 68%, 94%, and 85% with 350 mg, 525 mg, and 700 mg, respectively. The failure criteria post-10 weeks was three increasing viral loads over 50 cp/mL or one viral load over 1000 cp/mL.
"These results position us well for our upcoming face-to-face meeting with the FDA regarding our pivotal monotherapy trial protocol,” stated CytoDyn President and CEO, Nader Pourhassan, Ph.D. "Even more impressive is the long-term durability of the antiviral response in some patients in our other trials, with six patients reaching three years successfully on monotherapy and another four patients nearing the five-year mark for suppressed viral load," he added. “Recent data suggests that the receptor occupancy test being fine-tuned by Dr. Bruce Patterson may effectively identify potential responders to monotherapy at the time of screening, thereby potentially raising the success rate in the monotherapy program,” Dr. Pourhassan concluded.
CytoDyn Provides Update on Dose Escalating Trial with Leronlimab for HIV Monotherapy for a Potential Pivotal Trial
564 patients have been enrolled in monotherapy trials to date with over 150 patients hitting the benchmark of one-year of sustained viral suppression
The response rate post-10 weeks of monotherapy is 68% with 350 mg dose, 94% with 525 mg and 85% with 700 mg
VANCOUVER, Washington, Aug. 14, 2019 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”), a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today an update on its HIV dose escalating monotherapy trial. HIV patients received dosages of 350 mg, 525 mg, or 700 mg of leronlimab once a week (229, 201, and 134 patients, respectively) with approximately 150 patients exhibiting sustained viral suppression at approximately one year of monotherapy. The rate of viral load suppression post-10 weeks of monotherapy was 68%, 94%, and 85% with 350 mg, 525 mg, and 700 mg, respectively. The failure criteria post-10 weeks was three increasing viral loads over 50 cp/mL or one viral load over 1000 cp/mL.
"These results position us well for our upcoming face-to-face meeting with the FDA regarding our pivotal monotherapy trial protocol,” stated CytoDyn President and CEO, Nader Pourhassan, Ph.D. "Even more impressive is the long-term durability of the antiviral response in some patients in our other trials, with six patients reaching three years successfully on monotherapy and another four patients nearing the five-year mark for suppressed viral load," he added. “Recent data suggests that the receptor occupancy test being fine-tuned by Dr. Bruce Patterson may effectively identify potential responders to monotherapy at the time of screening, thereby potentially raising the success rate in the monotherapy program,” Dr. Pourhassan concluded.
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