Cytodyn Inc (CYDY)

[tonecee]

CytoDyn Files Protocol for Extended Access to PRO 140 for Patients Who Reach the End of PRO 140 Pivotal Phase 3 Trial
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VANCOUVER, Washington, Oct. 24, 2016 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB:CYDY), a biotechnology company focused on the development of new antibody therapies for combating human immunodeficiency virus (HIV) infection, announced today that it filed a new roll-over protocol allowing all ongoing patients who reach the end of the Phase 3 combination study to continue receiving PRO 140.

The primary intent of this roll-over protocol is to provide PRO 140 for a second patient, who has completed this study, and all other future patients who complete participation in the Phase 3 combination study and would require continued access to PRO 140 to form a viable regimen, in the judgment of the treating physician.

CytoDyn submitted, and received, a single-subject compassionate use protocol when the first patient completed the Phase 3 combination study and the treating physician requested continued access to PRO 140 in order for the patient to continue deriving clinical benefit and to maintain HIV-1 viral suppression.

The Company expects that other clinical sites will have the same request, as the patients enrolled in the Phase 3 combination study are heavily treatment experienced and may require continued access to PRO 140 to maintain viral suppression. Therefore, CytoDyn decided to submit a new roll-over protocol that would allow all ongoing and future patients who successfully complete one week of efficacy followed by 24 weeks of safety treatment with PRO 140 under the Phase 3 combination study to receive continued access to PRO 140.

CytoDyn recently announced that following a meeting with the U.S. Food and Drug Administration, the Company reduced the number of patients required for its Phase trial to thirty (30) patients. In addition, the primary endpoint was reduced to a viral load drop of 3 fold (0.5log) from a drop of 5 fold (0.7log). Furthermore, data from CytoDyn’s second monotherapy trial (with first patient dosing expected in 2016) will be used for the safety portion of the Phase 3 combination therapy trial.

Dr. Nader Pourhassan, President and CEO, commented: “Investigators in the ongoing Phase 3 combination trial have expressed a medical need for enrolled patients to remain on PRO 140 in order to maintain a suppressed viral load.” Dr. Pourhassan added: “We are pleased that our primary endpoint results for this pivotal Phase 3 trial could be achieved by the first quarter of 2017. In addition, we are encouraged by the lowering of the primary endpoint to a viral load reduction of 3 fold after one week, which compares favorably to the 10 fold to 20 fold viral load drop demonstrated by PRO 140 in three previous clinical trials with the same or less dose of PRO 140 in one week.”

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