Date: 2015-02-03
Type of information: Completion of the trial
phase: 2b
Announcement: completion of the trial
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 February 3, 2015, CytoDyn, a biotechnology company focused on the development of new therapies for combating infection with human immunodeficiency virus (HIV), 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 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.
