CytoDyn Inc. (OTCMKTS:CYDY) Files An 8-K Regulation FD DisclosureItem 7.01
On August9, 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 Exhibit99.1 to this Form8-K.
On August9, 2017, the Company announced that 33 patients are currently enrolled in its pivotal Phase2b/3 combination therapy trial. The Company has been in ongoing dialogue with the U.S. Food and Drug Administration (the “FDA”) regarding the number of patients enrolled in the trial. Patient enrollment will remain open in the trial until the Company holds a teleconference meeting with the FDA to discuss patient enrollment and analysis of data from the trial. The meeting is expected to be held in coming weeks.
The Company’s pivotal Phase 2b/3 trial combination trial is evaluating PRO140 with current standard of care antiretroviral therapy (“ART”). The trial protocol requires enrollment of 30 patients for the purpose of assessing the trial’s primary efficacy endpoint, which is reached at one week following initial treatment with PRO140. The safety portion of the Phase2b/3 trial continues for an additional 24weeks. The Company expects to complete the clinical portion of its first Biological License Application (BLA) submission during the first half of 2018.
The Company is also conducting a 300-patient Phase2b/3 trial with PRO140 as a single agent to replace the current standard of care ART and enrollment currently exceeds 100 patients.
| Item 7.01. | Financial Statements and Exhibits. |
| (d) |
Exhibit No. |
Description. |
| 99.1 | Press Release, dated August9, 2017 |
CytoDyn Inc. ExhibitEX-99.1 2 d437978dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 CYTODYN PROVIDES UPDATE ON ENROLLMENT IN ITS PIVOTAL PHASE 2b/3 HIV COMBINATION TRIAL 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.