CytoDyn to file an additional Phase 3 Protocol for HIV Monotherapy
Investment Community Conference Call Scheduled for January 21, 2016
VANCOUVER, Wash., Jan. 19, 2016 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB:CYDY), a biotechnology company focused on the development of new therapies for combating human immunodeficiency virus (HIV) infection, today announced that its ongoing extension study of PRO 140 monotherapy in a cohort of HIV-infected patients has shown complete viral-load suppression for well over a year with some patients approaching 17 months. The Company believes that complete virologic suppression through treatment with a single agent, PRO 140, a safe and efficacious antibody, rather than through the widely used HAART combination therapy, could present a significant opportunity to treat HIV patients. Based on these monotherapy results, the Company plans to file a second Phase 3 protocol for PRO 140 monotherapy with the FDA. CytoDyn is currently conducting a pivotal Phase 3 trial for PRO 140 as an adjunct therapy with expected commercialization in 2017.
Dr. Nader Pourhassan, CytoDyn’s President and CEO commented that: “We believe PRO 140 can effectively address adherence to a complex therapeutic regimen, which is a major challenge in today’s HIV world. Only about 25% of HIV patients in the U.S. have a completely suppressed viral load. A large contributor to this problem is due to patients’ inability to adhere to a highly structured schedule to take their medications on a specific timetable every day of their lives (Anti-Retroviral Therapy or ART). PRO 140 is administered as a simple, weekly subcutaneous injection and could be the solution to this very serious adherence problem. Moreover, our clinical trials to date have clearly indicated that PRO 140 is safe and efficacious without the side effects and toxicities experienced in the current ART therapeutic regimen. We are optimistic about our current and upcoming trials of PRO 140 and believe our antibody presents a compelling alternative or adjunct therapy to ART for HIV patients.”
Management will hold an investment community conference call on Thursday, January 21, 2016, at 10:00 a.m. PT to discuss the Company’s current developments and future plans for PRO 140 (see details for the call below).
Conference Call and Webcast Instructions
CytoDyn’s management team will host a conference call and live audio webcast on January 21, 2016 at 10:00 a.m. PT.
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 the Investors section of CytoDyn’s corporate web site at www.cytodyn.com, and will be archived for 60 days. Web participants are encouraged to go to the web site 15 minutes prior to the start of the call to register, download and install any necessary software.
A replay of the conference call will be available until March 21, 2016. To access the replay, interested parties may dial 877-660-6853 (U.S./Canada) or 201-612-7415 (international); Conference ID: 13578723.
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. The Company 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. 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 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 towards 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 the Company’s Phase 3 and other current and proposed 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.
Media: Nader Pourhassan, Ph.D. Office: 360-980-8524 E-mail: email@example.com