CytoDyn Announces Favorable Protocol Modifications for Pivotal Phase 3 Combination Trial With PRO 140 After Positive FDA Meeting
Primary endpoint results expected as early as the first quarter of 2017
Investor conference call scheduled for October 11, 2016
VANCOUVER, Washington, Oct. 06, 2016 (GLOBE NEWSWIRE) - CytoDyn Inc. (OTCQB:CYDY), a biotechnology company focused on the development of new antibody therapies for combating human immunodeficiency virus (HIV) infection, announces that the U.S. Food and Drug Administration (FDA) has accepted protocol modifications for the Company's Phase 3 pivotal trial with PRO 140 in combination with current standard-of-care antiretroviral therapy (ART) for highly treatment-experienced patients with HIV. The new protocol reduces the number of patients to be enrolled in the trial from 150 to 30 patients and lowers the primary endpoint for viral load reduction from viral load of 0.7log to viral load of 0.5log. The Company intends to provide data from its monotherapy trial (conducted in parallel to this study) to satisfy the safety portion of its pivotal trial and will meet with the FDA when the trial's primary end point data becomes available to further discuss the safety portion requirement.
“We view these protocol modifications as highly favorable in accelerating the clinical development of PRO 140 and advancing this therapy toward approval for patients infected with HIV,” said Nader Pourhassan, Ph.D., CytoDyn President and CEO. “Decreasing patient enrollment by 80% will dramatically reduce the cost of this trial, while advancing the anticipated time to report the primary endpoint results to as early as the first quarter of 2017. This pivotal trial could lead to the first FDA approval for PRO 140.”
Conference Call and Webcast Instructions
CytoDyn's management team will host a conference call and live audio webcast on Tuesday, October 11, 2016, at 1:00 p.m. PT / 4:00 p.m. ET to further discuss the Phase 3 trial protocol modifications and the anticipated time and cost reductions, among other corporate updates.
Interested participants and investors may access this conference call by dialing 877-407-2986 (U.S./Canada) or 201-378-4916 (international).
A live audio webcast may also be accessed via CytoDyn's corporate website at www.cytodyn.com under the Investors section/IR Calendar and will be archived for 60 days. Web participants are encouraged to go to the website 15 minutes prior to the start of the call to register, download and install any necessary software. The webcast can also be accessed via the following link: http://cytodyn.equisolvewebcast.com/inv-call-10-11-16 .
A replay of the conference call will be available until December 11, 2016. To access the replay, interested parties may dial 877-660-6853 (U.S./Canada) or 201-612-7415 (international); Conference ID: 13647094.
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. 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 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 months 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.
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.
This press release includes forward-looking statements and forward-looking information within the meaning of United States securities laws, including statements regarding CytoDyn's current and proposed trials and studies and their results, costs 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.
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