CytoDyn Release: First Self-Injectable HIV Antibody: 98% Success Rate In Phase 2b Clinical Trial, Could Be Commercial
Vancouver, WASHINGTON – August 18, 2015 – The first self-injectable antibody, PRO 140, has documented an impressive 98% success rate in a Phase 2b clinical trial for patients with HIV. In a monotherapy study, some HIV patients using PRO 140 are experiencing a completely suppressed viral load for 11 months. PRO 140 could be commercial in 2017 if it has positive results from the upcoming Phase 3 trial.
With over 1.2 million individuals already infected in the U.S., and new infections surpassing 50K annually, PRO 140 has received more than $28M in grants from the NIH.
PRO 140 blocks the HIV co-receptor CCR5 on T-cells, preventing viral entry. PRO 140 effectively reduces viral loads by as much as 1.8log with one dose per week. If the HIV patient’s viral load is completely suppressed, the transmission rate becomes almost zero.
For now, the path to first approval for PRO 140 is in the treatment experience population.
Dr. Nader Pourhassan, CytoDyn Inc. President/CEO states, “Results from six Phase 1 and Phase 2 human clinical trials have shown that PRO 140 can significantly reduce viral load in people infected with HIV. Our Phase 3 protocol provides for an upcoming 25-week study with 300 HIV-positive patients. Selection of clinical sites, IRB approvals, patient screening, and other administrative matters are underway and expected to be completed in time for the first patient to be dosed in the third quarter of this year. Although CytoDyn has a green light to start its Phase 3 clinical trial of PRO 140, the Company may apply for a ‘breakthrough’ designation with PRO 140 as the first self-injectable antibody for HIV therapy.” Phase 3 trials are expected to be conducted at over 30 sites in the U.S. The Company plans to submit its NDA (New Drug Application) for final approval of PRO 140 in November of 2016. PRO 140’s previous fast-track candidate designation carries a possibility of accelerated approval.
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 and is currently in Phase 3. 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 demonstrated that PRO 140 can prevent viral escape in patients during several 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 (R5) 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 does not have agonist activity towards CCR5 but does have antagonist activity to CCL5 which is a central mediator in inflammatory diseases. 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.
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With over 1.2 million individuals already infected in the U.S., and new infections surpassing 50K annually, PRO 140 has received more than $28M in grants from the NIH.
PRO 140 blocks the HIV co-receptor CCR5 on T-cells, preventing viral entry. PRO 140 effectively reduces viral loads by as much as 1.8log with one dose per week. If the HIV patient’s viral load is completely suppressed, the transmission rate becomes almost zero.
For now, the path to first approval for PRO 140 is in the treatment experience population.
Dr. Nader Pourhassan, CytoDyn Inc. President/CEO states, “Results from six Phase 1 and Phase 2 human clinical trials have shown that PRO 140 can significantly reduce viral load in people infected with HIV. Our Phase 3 protocol provides for an upcoming 25-week study with 300 HIV-positive patients. Selection of clinical sites, IRB approvals, patient screening, and other administrative matters are underway and expected to be completed in time for the first patient to be dosed in the third quarter of this year. Although CytoDyn has a green light to start its Phase 3 clinical trial of PRO 140, the Company may apply for a ‘breakthrough’ designation with PRO 140 as the first self-injectable antibody for HIV therapy.” Phase 3 trials are expected to be conducted at over 30 sites in the U.S. The Company plans to submit its NDA (New Drug Application) for final approval of PRO 140 in November of 2016. PRO 140’s previous fast-track candidate designation carries a possibility of accelerated approval.
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 and is currently in Phase 3. 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 demonstrated that PRO 140 can prevent viral escape in patients during several 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 (R5) 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 does not have agonist activity towards CCR5 but does have antagonist activity to CCL5 which is a central mediator in inflammatory diseases. 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.
Help employers find you! Check out all the jobs and post your resume.