CytoDyn Inc. (OTCMKTS:CYDY) Files An 8-K Regulation FD DisclosureItem 7.01 Regulation FD Disclosure.
On August21, 2017, CytoDyn Inc. (the “Company”) issued a press release relating to the announcement described in Item 7.01 below, a copy of which is furnished as Exhibit 99.1 to this Form 8-K.
Item 7.01. Other Events
On August21, 2017, the Company announced that it has enrolled 34 patients in its pivotal Phase 2b/3 trial of PRO140 in combination with antiretroviral therapy (ART) in HIV-infected patients. Thirty-three of the enrolled patients have finished the one-week efficacy endpoint of the study and eleven patients have completed the full 25-week protocol with undetectable viral loads. Ten patients are currently in a rollover study after completing the 25-week trial. The U.S. Food and Drug Administration has set a meeting on October17, 2017, to discuss the next steps in the Company’s efforts towards the analysis of primary efficacy endpoint and filing of a Biologics License Application for PRO140.
Item 7.01. Financial Statements and Exhibits.
| (d) |
Exhibit No. |
Description. |
| 99.1 | Press Release, dated August 21, 2017 |
CytoDyn Inc. ExhibitEX-99.1 2 d423012dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 CytoDyn Provides Update on PRO 140 Pivotal Combination Therapy Trial in Patients with HIV VANCOUVER,…To view the full exhibit click here
About CytoDyn Inc. (OTCMKTS:CYDY)
CytoDyn Inc. is a clinical-stage biotechnology company. The Company is focused on the clinical development and commercialization of humanized monoclonal antibodies to treat Human Immunodeficiency Virus (HIV) infection. The Company’s lead product candidate, PRO 140, belongs to a class of HIV therapies known as entry inhibitors that block HIV from entering into and infecting certain cells. The Company’s product pipeline also includes Cytolin and CytoFeline. Cytolin is a mouse monoclonal antibody developed to identify a specific type of immune cell called a cytotoxic T cell, or cytotoxic T lymphocyte (CTL). CytoFeline is an anti-lymphocyte function-associated antigen-1 (LFA-1) antibody for the treatment of Feline Immunodeficiency Virus (FIV) infection. PRO 140 blocks HIV from entering a cell by binding to a molecule called C-C chemokine receptor type 5 (CCR5). The Company has finished Phase II clinical trials for PRO 140 with demonstrated antiviral activity in man.