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CytoDyn’s Compassionate Use Protocol Receives FDA Clearance to Proceed

VANCOUVER, Washington, May 03, 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 received clearance from the FDA to proceed with its compassionate use protocol, which was submitted to the Agency on April 14. The compassionate use protocol will enable the first patient enrolled in the PRO 140_CD02 Phase 3 pivotal trial with PRO 140 in combination with HAART therapy to remain on PRO 140 upon successful conclusion of the Phase 3 trial period.

The compassionate use of PRO 140 for the patient reaching the end of the Phase 3 combination trial will begin in the first week of May 2016. Edwin DeJesus, M.D., is CytoDyn’s principal investigator for this patient.

In a letter to CytoDyn’s CEO, Dr. DeJesus indicated: “The patient had been exposed to multiple ART in the past, with subsequent development of resistance and intolerabilities. He was started on his current regimen just over five months ago, and he has done extremely well with an extraordinary response and tolerability. The patient is very satisfied with his treatment and he wants to continue it.”

“It is my personal impression that the use of PRO 140 is medically necessary for this subject to continue to sustain viral suppression. Therefore, I am requesting continued access to PRO 140 for this subject beyond the completion of patient's participation in PR0 140_CD02 study,” added Dr. DeJesus. “By continuing treatment with PRO 140, I expect this patient to maintain full virologic suppression. By patient’s own account, his quality of life has also significantly improved since he was started on this regimen.”

Nader Pourhassan, Ph.D., CytoDyn President and CEO, commented: “This patient has been treated with all four main classes of HIV drugs for more than 27 years and never achieved a completely suppressed viral load, which is crucial for preventing transmission. The patient’s viral load has historically ranged from 1,000 to 10,000 RNA copies per milliliter of blood for the past 27 years. This patient was able to achieve a suppressed viral load only after PRO 140 was added to his regimen.”

“We believe PRO 140 has the potential to change the HIV paradigm,” explained Dr. Pourhassan. “PRO 140 as a combination to current drugs could allow HIV patients to replace their most troubling portion of their HAART regimen. Moreover, we believe that PRO 140 as a monotherapy (single-agent maintenance therapy) could allow HIV patients that are exclusively infected with the R5 strain to replace their oral combination antiretroviral regimen with one weekly dose of PRO 140 through subcutaneous injection. Some patients in our current monotherapy extension trial are now approaching two years without oral combination antiretroviral drugs.”

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 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 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 compared to daily drug therapies currently in use.

About CytoDyn

CytoDyn is a biotechnology company focused on the clinical development and commercialization of humanized monoclonal antibodies for the treatment and prevention of human immunodeficiency virus (HIV) infection. CytoDyn is developing PRO 140 for the treatment of the HIV infection. PRO 140 is currently being evaluated in two Phase 3 clinical trials, the CDI-14 trial in combination with HAART therapy and the CDI-18 trial as a long-term monotherapy. Results from seven Phase 1 and Phase 2 clinical trials have shown that PRO 140 can significantly reduce viral burden in patients infected with the R5 subtype of HIV. Phase 2b clinical trial results demonstrated that PRO 140 can prevent viral escape in patients during several weeks of interruption from conventional drug therapy. CytoDyn intends to develop PRO 140 as a therapeutic antiviral agent in HIV-infected patients and to pursue non-HIV indications where CCR5 and its ligand CCL5 may be involved. For more information on CytoDyn, 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 Phase 3 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, 2015 and other reports filed with the U.S. Securities and Exchange Commission.

CONTACTS: Investors: LHA Jody Cain Office: 310-691-7100 E-mail: jcain@lhai.com Media: Dr. Nader Pourhassan Office: 360-980-8524 E-mail: npourhassan@cytodyn.com

Source:CytoDyn Inc.