CytoDyn Submits Phase 3 Trial Protocol Synopsis to FDA Following Their Guidance for Several Paths to Approval for PRO 140
VANCOUVER, Canada I February 3, 2015 I CytoDyn Inc. (CYDY), a biotechnology company focused on the development of new therapies for combating infection with human immunodeficiency virus (HIV), today announced that it had concluded its Phase 2b treatment substitution study and reported 39 patients out of 40 participating in the study passed 4 weeks of monotherapy with PRO 140. After the conclusion of the initial 14-week study, CytoDyn agreed to allow 14 patients to continue on the monotherapy in an extension study. A few patients have now progressed to nearly 6 months of successful PRO 140 monotherapy.
CytoDyn also reports it had a very productive recent meeting with the Food & Drug Administration (“FDA”) in connection with defining the Company’s path forward for approval of PRO 140. CytoDyn recently submitted to the FDA a protocol synopsis for a Phase 3 trial with PRO 140 and is awaiting the FDA’s response.
CytoDyn’s Phase 2b clinical study was designed to investigate the potential of allowing patients to enjoy treatment interruption from their current HAART regimen concurrent with a monotherapy consisting of weekly injections of PRO 140.
Results from the initial 14-week treatment substitution monotherapy trial (which excludes viral load failures due to patient screening errors) are as follows:
- 98% of the patients passed 4 weeks of monotherapy
- 91% of the patients passed 6 weeks of monotherapy
- 82% of the patients passed 8 weeks of monotherapy
- 70% of the patients passed 11 weeks of monotherapy (maximum allowable monotherapy without an extension study)
- 14 patients, who were offered to continue in an extension study with this monotherapy, are approaching 6 months without experiencing a viral load rebound.
Dr. Nader Pourhassan, President and CEO, commented: “We were very pleased that our current Phase 2b study clearly demonstrated PRO 140’s safety and efficacy over several weeks of monotherapy and has now strongly positioned it for various paths for approval following the successful outcome of future trials. We await the FDA’s guidance as to how best to proceed with our next trial.”
About CytoDyn
CytoDyn is a biotechnology company focused on the clinical development and potential commercialization of humanized monoclonal antibodies for the treatment and prevention of Human Immunodeficiency Virus (HIV) infection. The Company has one of the leading monoclonal antibodies under development for HIV infection, PRO 140, which has finished Phase 2 clinical trials with demonstrated antiviral activity in man. PRO 140 blocks the HIV co-receptor CCR5 on T-cells which prevents viral entry. Clinical trial results thus far indicate that PRO 140 does not negatively affect the normal immune functions that are mediated by CCR5. Results from six Phase 1 and Phase 2 human clinical trials have shown that PRO 140 can significantly reduce viral burden in people infected with HIV. A recent Phase 2b clinical trial has shown that PRO 140 can prevent viral escape in patients during 4-6 weeks of interruption from conventional drug therapy. 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.
About PRO 140
PRO 140 belongs to a new class of HIV/AIDS therapeutics — viral-entry inhibitors — that are intended to protect healthy cells from viral infection. PRO 140 is a fully humanized IgG4 monoclonal antibody directed against CCR5, a molecular portal that HIV uses to enter T-cells. PRO 140 blocks the predominant HIV (H5) subtype entry into T-cells by masking this required co-receptor, CCR5. Importantly PRO 140 does not appear to interfere with the normal function of CCR5 in mediating immune responses. PRO 140 has been the subject of seven clinical trials, each demonstrating efficacy by significantly reducing or controlling HIV viral load in human test subjects. PRO 140 has been designated a “fast track” product candidate by the FDA. The PRO 140 antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements as compared to daily drug therapies currently in use.
SOURCE: CytoDyn
Post Views: 117
CytoDyn Submits Phase 3 Trial Protocol Synopsis to FDA Following Their Guidance for Several Paths to Approval for PRO 140
VANCOUVER, Canada I February 3, 2015 I CytoDyn Inc. (CYDY), a biotechnology company focused on the development of new therapies for combating infection with human immunodeficiency virus (HIV), today announced that it had concluded its Phase 2b treatment substitution study and reported 39 patients out of 40 participating in the study passed 4 weeks of monotherapy with PRO 140. After the conclusion of the initial 14-week study, CytoDyn agreed to allow 14 patients to continue on the monotherapy in an extension study. A few patients have now progressed to nearly 6 months of successful PRO 140 monotherapy.
CytoDyn also reports it had a very productive recent meeting with the Food & Drug Administration (“FDA”) in connection with defining the Company’s path forward for approval of PRO 140. CytoDyn recently submitted to the FDA a protocol synopsis for a Phase 3 trial with PRO 140 and is awaiting the FDA’s response.
CytoDyn’s Phase 2b clinical study was designed to investigate the potential of allowing patients to enjoy treatment interruption from their current HAART regimen concurrent with a monotherapy consisting of weekly injections of PRO 140.
Results from the initial 14-week treatment substitution monotherapy trial (which excludes viral load failures due to patient screening errors) are as follows:
- 98% of the patients passed 4 weeks of monotherapy
- 91% of the patients passed 6 weeks of monotherapy
- 82% of the patients passed 8 weeks of monotherapy
- 70% of the patients passed 11 weeks of monotherapy (maximum allowable monotherapy without an extension study)
- 14 patients, who were offered to continue in an extension study with this monotherapy, are approaching 6 months without experiencing a viral load rebound.
Dr. Nader Pourhassan, President and CEO, commented: “We were very pleased that our current Phase 2b study clearly demonstrated PRO 140’s safety and efficacy over several weeks of monotherapy and has now strongly positioned it for various paths for approval following the successful outcome of future trials. We await the FDA’s guidance as to how best to proceed with our next trial.”
About CytoDyn
CytoDyn is a biotechnology company focused on the clinical development and potential commercialization of humanized monoclonal antibodies for the treatment and prevention of Human Immunodeficiency Virus (HIV) infection. The Company has one of the leading monoclonal antibodies under development for HIV infection, PRO 140, which has finished Phase 2 clinical trials with demonstrated antiviral activity in man. PRO 140 blocks the HIV co-receptor CCR5 on T-cells which prevents viral entry. Clinical trial results thus far indicate that PRO 140 does not negatively affect the normal immune functions that are mediated by CCR5. Results from six Phase 1 and Phase 2 human clinical trials have shown that PRO 140 can significantly reduce viral burden in people infected with HIV. A recent Phase 2b clinical trial has shown that PRO 140 can prevent viral escape in patients during 4-6 weeks of interruption from conventional drug therapy. 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.
About PRO 140
PRO 140 belongs to a new class of HIV/AIDS therapeutics — viral-entry inhibitors — that are intended to protect healthy cells from viral infection. PRO 140 is a fully humanized IgG4 monoclonal antibody directed against CCR5, a molecular portal that HIV uses to enter T-cells. PRO 140 blocks the predominant HIV (H5) subtype entry into T-cells by masking this required co-receptor, CCR5. Importantly PRO 140 does not appear to interfere with the normal function of CCR5 in mediating immune responses. PRO 140 has been the subject of seven clinical trials, each demonstrating efficacy by significantly reducing or controlling HIV viral load in human test subjects. PRO 140 has been designated a “fast track” product candidate by the FDA. The PRO 140 antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements as compared to daily drug therapies currently in use.
SOURCE: CytoDyn
Post Views: 117
