CytoDyn Inc.(CYDY)- OTCQB
  • Today, 8:09 AM
    • CytoDyn (OTCQB:CYDY) announces that 10 of 11 (one failure) patients in its Phase 2b extension study of HIV therapeutic candidate PRO 140 have experienced two years of complete viral suppression (plasma HIV-1 RNA <40 copies/mL). Patients in the study received a 350 mg dose of PRO 140 once weekly via subcutaneous injection in place of their HAART (multiple antiretroviral) regimens. In the next two months, nine more patients will reach their two-year benchmarks.
    • 40 patients were originally enrolled in the Phase 2b trial with 35 evaluable. 20 of the 35 (~57%) had viral suppression at the end of the 12-week study period and were eligible for the extension arm. 15 of the 20 were granted entry into the extension phase, but four of the 15 were disqualified due to lack of follow-up or issues unrelated to PRO 140.
    • The PRO 140 antibody is a viral entry inhibitor that targets the CCR5 (C-C chemokine receptor type 5) co-receptor, a protein on the surface of white blood cells that acts as a receptor for chemokines, signalling proteins that induce chemotaxis (chemical-induced movement) in nearby cells. This is the process by which the immune system's T cells are attracted to specific targets. HIV uses CCR5 to enter and infect host cells.
    • PRO 140 will compete against the only other CCR5 antagonist approved for the treatment of HIV infection, ViiV Healthcare's (NYSE:GSK)(NYSE:PFESelzentry (maraviroc).
    • PRO 140's value proposition compared to Selzentry (and HAART) is less toxicity, fewer side effects and once-weekly administration versus daily. According to the company, only ~20% of HIV patients have a completely suppressed viral load.
    • Previously: HIV patients receiving CytoDyn's PRO 140 doing well after one year of treatment (Sept. 21, 2015)
    | Today, 8:09 AM | 21 Comments
  • Wed, May 11, 4:18 PM
    • CytoDyn (OTCQB:CYDY) finalizes the private placement of 4,301,500 shares of common stock and accompanying five-year warrants to purchase up to 1,075,375 shares of common (one warrant to purchase 1/4 of a share of stock) at $1.35 at a combined price of $1.00.
    • Separately, the FDA has requested additional population data and scientific rationale to support the company's Orphan Drug request for PRO 140 for the treatment graft versus host disease. The company has until May to submit the additional information.
    | Wed, May 11, 4:18 PM | 9 Comments
  • Sep. 21, 2015, 12:47 PM
    • Certain HIV-infected patients who experienced viral load suppression in a Phase 2b study concluded last January continue to show viral load suppression a year later while receiving weekly subcutaneous injections of CytoDyn's (OTCQB:CYDY +2.1%) monoclonal antibody, PRO 140. The extension study was open to patients who elected to continue therapy and were CCR5 co-receptor-positive, which PRO 140 targets.
    • A Phase 3 study was initiated about three months ago.
    • The PRO 140 antibody is a viral entry inhibitor that targets the CCR5 (C-C chemokine receptor type 5) co-receptor, a protein on the surface of white blood cells that acts as a receptor for chemokines, signalling proteins that induce chemotaxis (chemical-induced movement) in nearby cells. This is the process by which the immune system's T cells are attracted to specific targets. HIV uses CCR5 to enter and infect host cells.
    • PRO 140 will compete against the only other CCR5 antagonist approved for the treatment of HIV infection, ViiV Healthcare's (GSK -0.4%)(PFE -1.3%Selzentry (maraviroc).
    • PRO 140's value proposition compared to Selzentry is less toxicity, fewer side effects and once-weekly administration versus daily.
    • According to the company, only ~20% of HIV patients have a completely suppressed viral load.
    • Previously: CytoDyn starts Phase 3 for injectable antibody for HIV infection (June 9)
    | Sep. 21, 2015, 12:47 PM | 8 Comments
  • Jun. 9, 2015, 7:56 AM
    • CytoDyn (OTCQB:CYDY) initiates a Phase 3 clinical trial evaluating its novel Fast Track-designated self-injectable antibody, PRO 140, for the treatment of HIV infection. The 25-week study will enroll 300 HIV-positive patients. The dosing of the first patient should happen in Q3. CRO Amarex Clinical Research, LLC will manage the trial.
    • The study will assess PRO 140 as a component of a HAART (Highly Active Anti-Retroviral Therapy) for treatment-experienced patients, the current standard-of-care for HIV-infected individuals.
    • The PRO 140 antibody is a viral entry inhibitor that targets the CCR5 (C-C chemokine receptor type 5) co-receptor, a protein on the surface of white blood cells that acts as a receptor for chemokines, signalling proteins that induce chemotaxis (chemical-induced movement) in nearby cells. This is the process by which the immune system's T cells are attracted to specific targets. HIV uses CCR5 to enter and infect host cells.
    • PRO 140 will compete against the only other CCR5 antagonist approved for the treatment of HIV infection, ViiV Healthcare's (NYSE:PFE) (NYSE:GSK) Selzentry (maraviroc). PRO 140's value proposition compared to Selzentry is less toxicity, fewer side effects and once-weekly administration versus daily.
    • According to the company, only ~20% of HIV patients have a completely suppressed viral load.
    | Jun. 9, 2015, 7:56 AM | 1 Comment
Company Description
CytoDyn is a publicly traded biotechnology company focused on the development of new therapies for combating infection with immune deficiency viruses. CytoDyn's lead product candidate, PRO 140, has the potential to drive groundbreaking advancements in developing the next generation of HIV... More
Sector: Healthcare
Industry: Biotechnology
Country: United States