CytoDyn Submits Orphan Drug Application to FDA for Pretreatment With PRO 140 of Treatment-Naïve HIV Patients

VANCOUVER, Washington, July 21, 2016 (GLOBE NEWSWIRE) — CytoDyn Inc. (OTC.QB:CYDY), a biotechnology company focused on the development of new antibody therapies for combating human immunodeficiency virus (HIV) infection, announces that it has submitted to the U.S. Food And Drug Administration (FDA) an application for orphan drug designation for the use of PRO 140 (humanized monoclonal antibody to CCR5) in the pretreatment of HIV Type-1 (HIV-1) infection in treatment-naïve adults while they are waiting for drug resistance assay results to construct a subsequent Highly Active Antiretroviral Therapy (HAART) regimen.  The generation of these assay results typically takes approximately two weeks.

The basis for CytoDyn’s request is stated below in an edited excerpt from the Company’s recent letter to the FDA:  

The estimated incidence of new HIV infections in the U.S. is just under 50,000 per year, an estimated 47,129, 49,273 and 44,073 people were diagnosed with HIV infection in the U.S. in [2013, 2014 and 2015, respectively] (Centers for Disease Control and Prevention (CDC), 2016). CCR5-tropic strains are found in about 90% of treatment-naïve patients (Hoffmann, 2007; Brumme et al., 2005; Moyle et al., 2005; Mueller et al., 2007). PRO 140 is a unique product dissimilar from currently available treatments for HIV-1 Infection. Unlike HAART, PRO140 treatment can be initiated immediately after HIV diagnosis, while waiting for genotypic drug resistance assay results to construct an optimal antiviral regimen. Therefore, we would like to request orphan drug designation of PRO 140 for HIV-1 infection in treatment-naïve adults while waiting for drug resistance assay results to construct HAART regimen.

On July 18, CytoDyn submitted a protocol to the FDA for a Phase 2b clinical trial with PRO 140 for treatment-naïve HIV adults and the Company expects to file for a breakthrough therapy designation upon receipt of successful results for the first few patients. The Company believes that should the treatment-naïve trial be successful, it may position PRO 140 for a much faster path to approval compared with the Company’s two other Phase 3 trials with PRO 140.

CytoDyn President and CEO, Nader Pourhassan, Ph.D., commented: “We believe the construct of the treatment-naïve population trial demonstrates how different PRO 140 is compared with all other approved HIV drugs. PRO 140 is in a unique new class because it is the first self-administered, subcutaneous injectable antibody that could decrease the viral load of an HIV patient by as much as 1.65 log 10 by way of weekly injections in just three weeks.” 

Dr. Pourhassan added: “We are pleased with our ability to continue to identify additional new and innovative opportunities to advance PRO 140 along multiple concurrent paths toward approval. We believe this treatment-naïve path offers many advantages to CytoDyn to potentially receive its first approval from the FDA for use of PRO 140. CytoDyn has now positioned PRO 140 in two Phase 3 trials for chronic conditions in two different HIV patient populations and one clinical trial in acute condition for HIV.”

About PRO 140
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 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 does not have agonist activity toward CCR5 but does have antagonist activity to CCL5, which is a central mediator in inflammatory diseases. 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.

About CytoDyn
CytoDyn is a biotechnology company focused on the clinical development and potential commercialization of humanized monoclonal antibodies for the treatment and prevention of HIV infection. The Company has one of the leading monoclonal antibodies under development for HIV infection, PRO 140, which has completed Phase 2 clinical trials with demonstrated antiviral activity in man and is currently in Phase 3 clinical trials. 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 seven Phase 1 and Phase 2 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. For more information on the Company, please visit www.cytodyn.com.

Forward-Looking Statements
This press release includes forward-looking statements and forward-looking information within the meaning of United States securities laws, including statements regarding CytoDyn’s protocol for treatment naïve patients and its proposed trial and other current and proposed trials and studies and their results and completion. These statements and information represent CytoDyn’s intentions, plans, expectations, and beliefs and are subject to risks, uncertainties and other factors, many beyond CytoDyn’s control. These factors could cause actual results to differ materially from such forward-looking statements or information. The words “believe,” “estimate,” “expect,” “intend,” “attempt,” “anticipate,” “foresee,” “plan,” and similar expressions and variations thereof identify certain of such forward-looking statements or forward-looking information, which speak only as of the date on which they are made.

CytoDyn disclaims any intention or obligation to publicly update or revise any forward-looking statements or forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable law. Readers are cautioned not to place undue reliance on these forward-looking statements or forward-looking information. While it is impossible to identify or predict all such matters, these differences may result from, among other things, the inherent uncertainty of the timing and success of and expense associated with research, development, regulatory approval, and commercialization of CytoDyn’s products and product candidates, including the risks that clinical trials will not commence or proceed as planned; products appearing promising in early trials will not demonstrate efficacy or safety in larger-scale trials; future clinical trial data on CytoDyn’s products and product candidates will be unfavorable; funding for additional clinical trials may not be available; CytoDyn’s products may not receive marketing approval from regulators or, if approved, may fail to gain sufficient market acceptance to justify development and commercialization costs; competing products currently on the market or in development may reduce the commercial potential of CytoDyn’s products; CytoDyn, its collaborators or others may identify side effects after the product is on the market; or efficacy or safety concerns regarding marketed products, whether or not scientifically justified, may lead to product recalls, withdrawals of marketing approval, reformulation of the product, additional pre-clinical testing or clinical trials, changes in labeling of the product, the need for additional marketing applications, or other adverse events.

CytoDyn is also subject to additional risks and uncertainties, including risks associated with the actions of its corporate, academic, and other collaborators and government regulatory agencies; risks from market forces and trends; potential product liability; intellectual property litigation; environmental and other risks; and risks that current and pending patent protection for its products may be invalid, unenforceable, or challenged or fail to provide adequate market exclusivity. There are also substantial risks arising out of CytoDyn’s need to raise additional capital to develop its products and satisfy its financial obligations; the highly regulated nature of its business, including government cost-containment initiatives and restrictions on third-party payments for its products; the highly competitive nature of its industry; and other factors set forth in CytoDyn’s Annual Report on Form 10-K for the fiscal year ended May 31, 2016 and other reports filed with the U.S. Securities and Exchange Commission.

CONTACT: CONTACTS:
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Jody Cain, 310-691-7100
jcain@lhai.com

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