Phase 3 Study Offers Option to Substitute Pro 140 for HAART

CytoDyn Inc., a biotechnology company focused on the development of new antibody therapies for combating human immunodeficiency virus (HIV) infection, recently announced that it submitted a Phase 3 protocol for a monotherapy trial, along with the Topline Report for its Phase 2b monotherapy trial to the U.S. Food and Drug Administration (FDA). �

"We are pleased to have continuously progressed forward with our promising data from our previous monotherapy trial to the current extension arm of our monotherapy trial," said Dr. Nader Pourhassan, President and CEO. "The Phase 3 monotherapy trial is a crucial milestone for us and we believe that we are now on the last step of advancing this valuable product to the market, upon approval. We estimate that the market opportunity for monotherapy is well over a billion dollars."

This protocol submission was made under the open investigational new drug application (IND) as a monotherapy treatment for HIV and, accordingly, CytoDyn will be permitted to initiate this trial, subject to any comments from the FDA, which will be incorporated into the trial protocol. �

CytoDyn also expects to sign a new contract with Amarex Clinical Research, its principal CRO, to conduct this study. As previously announced, CytoDyn is currently conducting a pivotal Phase 3 trial for a HIV indication with PRO 140 as an adjunct therapy with the current standard of care for HIV, known as HAART (Highly Active Anti-Retroviral Therapy), and recently initiated a Phase 2 trial for treatment of Graft versus Host Disease (GvHD).

The 300-patient Phase 3 monotherapy trial seeks to provide patients with a treatment option that would enable the use of a long-acting, infrequently administered monotherapy for the chronic suppression of CCR5-tropic HIV-1 infection. �The study is designed to test the strategy of offering a carefully selected patient population on suppressive antiretroviral therapy the option of substituting PRO 140 for their oral drug regimen and remaining on PRO 140 for up to 48 weeks contingent on ongoing viral suppression.

CytoDyn's Phase 2b treatment substitution study with PRO 140 was completed in January 2015. As of today, eleven patients have continued with this monotherapy Phase 2b in an extension trial. A majority of these patients have been participating in this trial for nearly 17 months, with two patients approaching 19 months of complete viral load suppression.

The Topline Report contains the summary of the data from the recently concluded Phase 2b PRO 140_CD01 study and ongoing Phase 2b PRO 140 extension study. The CD01 study was designed to evaluate the efficacy, safety and tolerability of PRO 140 monotherapy for the maintenance of viral suppression in 40 subjects who were stable on effective combination antiretroviral therapy.

Subjects were shifted from daily oral antiretroviral therapy to PRO 140 monotherapy (with a weekly subcutaneous injection) for up to 12 weeks under the CD01 study. Those subjects who maintained viral suppression for 12 weeks were allowed to continue PRO 140 monotherapy for an additional 60 weeks under the CD01-extension study.

CytoDyn is a biotechnology company focused on the clinical development and potential commercialization of humanized monoclonal antibodies for the treatment and prevention of Human Immunodeficiency Virus (HIV) infection. CytoDyn has one of the leading monoclonal antibodies under development for HIV infection, PRO 140, which has finished Phase 2 clinical trials with demonstrated antiviral activity in man and is currently in Phase 3.

PRO 140 blocks the HIV co-receptor CCR5 on T-cells which prevents viral entry. Clinical trial results thus far indicate that PRO 140 does not negatively affect the normal immune functions that are mediated by CCR5. Results from six Phase 1 and Phase 2 human clinical trials have shown that PRO 140 can significantly reduce viral burden in people infected with HIV.

A recent Phase 2b clinical trial demonstrated that PRO 140 can prevent viral escape in patients during several weeks of interruption from conventional drug therapy. CytoDyn intends to continue to develop PRO 140 as a therapeutic anti-viral agent in persons infected with HIV and to pursue non-HIV indications where CCR5 and its ligand CCL5 may be involved.