VANCOUVER, Canada I October 30, 2013 I CytoDyn Inc. (“CytoDyn”) (CYDY), a biotechnology company focused on the development of new therapies for combating infection with immune deficiency viruses, today announced that CytoDyn Chief Medical Officer David Feigal, M.D., has submitted a revised protocol to the U.S. Food and Drug Administration relating to an upcoming Phase IIb clinical trial of PRO 140, CytoDyn’s leading product under development as a treatment for Human Immunodeficiency Virus (HIV) infection.
The submission was for protocol 2102 titled, “Randomized, Double-blind, Placebo-controlled Clinical Trial of Observed Systemic, Long-acting, Anti-HIV treatment with a Monoclonal CCR5 antibody (PRO 140) as an Adjunct to a New, Optimized, Oral Antiretroviral Regimen in HIV-infected Recreational Drug Users with Viral Rebound and Poor Adherence to the Previous Antiretroviral Regimen.” Drexel University College of Medicine has received a grant from the National Institutes of Health to fund this clinical trial.
Prior to CytoDyn’s acquisition of PRO 140 from Progenics Pharmaceuticals, Inc., in October 2012, initial screening at study sites had commenced under Protocol 2102, but Progenics halted the study for strategic business reasons. Current plans call for opening the study for enrollment before the end of 2013.
“This continues to be a very exciting year for the Company,” said CytoDyn President and CEO Dr. Nader Pourhassan. “We have completed the ‘fill and finish’ process for our PRO 140 bulk drug product and placebo. The vials are now available for use in our clinical trials,” he added.
The Company
CytoDyn is a biotechnology company focused on developing subcutaneously delivered humanized cell-specific monoclonal antibodies (mAbs) as entry inhibitors for the treatment and prevention of Human Immunodeficiency Virus (HIV). The Company has one of the leading mAbs under development for HIV infection, PRO 140, which is a Late Stage II humanized mAb with demonstrated antiviral activity in man. PRO 140 blocks the HIV co-receptor CCR5 and clinical trial results thus far indicate that it does not affect the normal function of the cell. Results from Phase I and Phase IIa human clinical trials have shown that PRO 140 can significantly reduce viral burden in people infected with HIV. CytoDyn intends to continue to develop PRO 140 as a therapeutic anti-viral agent in persons infected with HIV. For more information on the Company, please visit www.cytodyn.com.
SOURCE: Cytodyn
Post Views: 136
VANCOUVER, Canada I October 30, 2013 I CytoDyn Inc. (“CytoDyn”) (CYDY), a biotechnology company focused on the development of new therapies for combating infection with immune deficiency viruses, today announced that CytoDyn Chief Medical Officer David Feigal, M.D., has submitted a revised protocol to the U.S. Food and Drug Administration relating to an upcoming Phase IIb clinical trial of PRO 140, CytoDyn’s leading product under development as a treatment for Human Immunodeficiency Virus (HIV) infection.
The submission was for protocol 2102 titled, “Randomized, Double-blind, Placebo-controlled Clinical Trial of Observed Systemic, Long-acting, Anti-HIV treatment with a Monoclonal CCR5 antibody (PRO 140) as an Adjunct to a New, Optimized, Oral Antiretroviral Regimen in HIV-infected Recreational Drug Users with Viral Rebound and Poor Adherence to the Previous Antiretroviral Regimen.” Drexel University College of Medicine has received a grant from the National Institutes of Health to fund this clinical trial.
Prior to CytoDyn’s acquisition of PRO 140 from Progenics Pharmaceuticals, Inc., in October 2012, initial screening at study sites had commenced under Protocol 2102, but Progenics halted the study for strategic business reasons. Current plans call for opening the study for enrollment before the end of 2013.
“This continues to be a very exciting year for the Company,” said CytoDyn President and CEO Dr. Nader Pourhassan. “We have completed the ‘fill and finish’ process for our PRO 140 bulk drug product and placebo. The vials are now available for use in our clinical trials,” he added.
The Company
CytoDyn is a biotechnology company focused on developing subcutaneously delivered humanized cell-specific monoclonal antibodies (mAbs) as entry inhibitors for the treatment and prevention of Human Immunodeficiency Virus (HIV). The Company has one of the leading mAbs under development for HIV infection, PRO 140, which is a Late Stage II humanized mAb with demonstrated antiviral activity in man. PRO 140 blocks the HIV co-receptor CCR5 and clinical trial results thus far indicate that it does not affect the normal function of the cell. Results from Phase I and Phase IIa human clinical trials have shown that PRO 140 can significantly reduce viral burden in people infected with HIV. CytoDyn intends to continue to develop PRO 140 as a therapeutic anti-viral agent in persons infected with HIV. For more information on the Company, please visit www.cytodyn.com.
SOURCE: Cytodyn
Post Views: 136
