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CytoDyn's Two-Year Update on Its PRO 140 Monotherapy
Study in HIV Accepted at CROI 2017
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an abstract featuring results from its ongoing Phase 2b extension study with PRO 140 as a monotherapy for the treatment of patients with HIV has been accepted for a poster presentation, as well as a "themed discussion" at the Conference on Retroviruses and Opportunistic Infections (CROI), which is being held in Seattle from February 13 to 16, 2017. The abstract, "PRO 140 Single-Agent Maintenance Therapy for HIV-1 Infection: A 2-Year Update," This presentation will include four or five abstracts merged into a special theme-oriented, hour-long discussion featuring a brief summary of noteworthy results, conclusions and discussion points. The presentations will be followed by an interactive discussion that synthesizes the relevant information of the abstracts, covers key points of agreement and controversy and draws comparisons to related work in the scientific field. The abstract will provide an update on 10 patients with HIV who have successfully achieved complete viral load suppression for more than two years with PRO 140 administered in weekly subcutaneous injections. Complete virologic suppression is defined as plasma HIV-1 RNA less than 40 copies/mL, which is the lower limit of detection in the commercial assay for HIV detection and is the level at which HIV transmission is reduced by more than 96%....."The results from this ongoing extension study are highly significant as PRO 140 is being substituted for the current standard of care Highly Active Antiretroviral Therapy (HAART)," said Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn. "Only about 30% of patients achieve lifelong viral load suppression on HAART, which also has notable drawbacks such as highly regimented daily dosing, toxicity and incomplete recovery of the immune system. All patients in the Phase 2b monotherapy study were evaluated for infection with strains of HIV-1 that utilize the CCR5 co-receptor as PRO 140 targets CCR5 with high affinity and potently blocks HIV-1 cell entry. http://www.cytodyn.com/media/press-releases/detail/247/cytodyns-two-year-update-on-its-pro-140-monotherapy
PRO140 SC Monotherapy (MT) Provides Long-Term, Full Virologic Suppression in HIV Patients http://www.natap.org/2016/HIV/062216_03.htm
PRO140 Phase III Trials Have Begun For Injectable Antibody to Fight HIV http://www.natap.org/2016/HIV/062716_01.htm
CytoDyn Files for Breakthrough Therapy Designation With the FDA for PRO 140 in HIV Therapy
VANCOUVER, Washington, Jan. 11, 2017 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB:CYDY), a biotechnology company focused on the development of new therapies for combating human immunodeficiency virus (HIV) infection, today announced the Company filed a request for Breakthrough Therapy Designation with the FDA for PRO 140 as a treatment for HIV-1 infection in treatment-experienced patients with virologic failure.
While the standard of care for HIV infection has been a combination of medications from different antiretroviral classes that interfere with different steps of the HIV lifecycle, there is now a significant number of long-term survivors who are facing issues of drug resistance and need new treatment options. The Company believes this request for Breakthrough Therapy Designation addresses this unmet need for novel therapies for the growing number of heavily treatment-experienced HIV patients.
Based on results from four completed and ongoing clinical trials, the Company believes the PRO 140 treatment option addresses the unmet medical need for therapy options for HIV-1 infected patients with uncontrolled viral load, despite conventional Antiretroviral Therapy (ART).
Dr. Nader Pourhassan, CytoDyn's President and CEO, commented: "Investigators from several sites have requested continued access to PRO 140 to allow patients to continue deriving clinical benefit and maintain HIV-1 viral suppression after the end of treatment in the CD02 Phase 3 Combination Therapy study. Seven patients have entered the rollover study to receive continued access to PRO 140 after the completion of the 25-week treatment period in this study. Additionally, 10 patients in the ongoing Phase 2b extension arm of Monotherapy trial have shown suppressed viral load for two years. We believe PRO 140 has demonstrated its value as a combination therapy and as a single agent in patients with the R5 strain of HIV and are hopeful that receiving Breakthrough Therapy Designation will speed our BLA process to get this product to the market."
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 HIV infection. The Company has one of the leading monoclonal antibodies under development for HIV infection, PRO 140, which has completed 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 seven 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 months 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 and to pursue non-HIV indications where CCR5 and its ligand CCL5 may be involved. 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 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 toward 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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