Date: 2015-08-05
Type of information: Initiation of patient enrollment
phase: 3
Announcement: initiation of patient enrollment
Company: CytoDyn (Canada)
Product: PRO 140
Action
mechanism: monoclonal antibody/viral-entry inhibitor. 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 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. Cytodyn acquired the product from Progenics in 2012.
Disease: HIV infection
Therapeutic area: Infectious diseases
Country:
Trial details:
Latest
news: * On August 5, 2015, CytoDyn, a biotechnology company focused on the development of new therapies for combating human immunodeficiency virus (HIV) infection, announced that the Company has initiated its first clinical site for its Phase 3 trial. The Company's Phase 3 trial protocol provides for a 25-week study with 300 HIV-positive patients. Dr. Pourhassan added: "As we previously mentioned, our primary end point for this Phase 3 trial is to reduce the viral load in HIV patients, who have experienced a viral load breakout, by 0.7log (a 5-fold drop) in one week with one 350mg dose of PRO 140. A previous Phase 2a study completed in 2009 with HIV patients, demonstrated a viral load suppression of more than 1log (a more than 10-fold drop) in one week with one 324 mg dose of PRO 140 (nearly a 10% lower dosage). We believe the primary end point will be met if PRO 140 achieves half of what it previously demonstrated with a nearly 10% higher dosage than the previous study. The last 24 weeks of this Phase 3 trial will allow patients to change their failing pill regimen to a new optimized regimen, coupled with a weekly 350mg injection of PRO 140. In summary, patients will receive 24 weeks of PRO 140 treatment along with a new optimized HAART regimen and we are optimistic about our results." * On July 29, 2015, CytoDyn announced that the Company's QA/QC expert, Dr. Robert Schiff, has approved for release inventory suitable to satisfy CytoDyn's current Phase 3 trial. The Company's 25-week Phase 3 trial includes 300 patients and will require approximately 15,000 vials of PRO 140. In February 2014, the FDA provided certain guidance to the Company in order to qualify its existing inventory of PRO 140 to be used in future Phase 3 trials. In an effort to satisfy the qualification standards, the Company engaged several vendors to develop and perform numerous assays for qualification. In 2012, CytoDyn purchased the PRO 140 program from Progenics, which included over 20kg of PRO 140 product and continues to maintain over 10kg of PRO 140 drug product for future use. * On June 9, 2015, CytoDyn announced that it has initiated its first Phase 3 study for PRO 140, the Company\'s novel self-injectable antibody for the treatment of HIV. The Company\'s Phase 3 protocol provides for a 25-week study with 300 HIV-positive patients. Selection of clinical sites, IRB approvals, patients screening and other administrative matters are underway and are expected to be completed in time for the first patient to be dosed in the third quarter of this year. The Company believes that upon successful completion of this Phase 3 study, CytoDyn will have the opportunity to seek accelerated approval for PRO 140 based on the previously FDA granted fast-track candidate designation. Additionally, CytoDyn may apply for a \"breakthrough\" designation for PRO 140, as the first self-injectable antibody for HIV therapy. The Company\'s first Phase 3 study is designed to allow PRO 140 as a component of a HAART (Highly Active Anti-Retroviral Therapy) regimen for treatment experienced patients. CytoDyn believes that its PRO 140 antibody, which targets the CCR5 co-receptor, has compelling advantages over Maraviroc, the only other CCR5 antagonist approved for HIV therapy. These advantages include less toxicity, fewer side effects and once-a-week versus daily administration, which together may improve patient compliance. The FDA is in agreement with CytoDyn\'s proposed regulatory path for the first approval for PRO 140 and the Company plans to request a meeting with the FDA to discuss potential additional indications for HIV therapy with PRO 140 following the submission of the \"top-line report\" of the recently completed Phase 2b treatment substitution study. To maintain its aggressive approach on moving PRO 140 expeditiously through this Phase 3 study, CytoDyn recently signed a new contract with Amarex Clinical Research, LLC, as its CRO, to manage this Phase 3 trial. * On May 4, 2015, CytoDyn announced that it has reached an agreement with the FDA on the Company\'s previously submitted Phase 3 protocol synopsis for PRO 140, the Company\'s novel self-injectable antibody for the treatment of HIV, and submitted the full Phase 3 protocol to the FDA. The Company\'s Phase 3 protocol provides for a 25-week study with 300 HIV patients, which could start as early as 30 days after submission.
