CytoDyn Concludes Phase 2b Study With 98% Success With 4 Weeks of Monotherapy - Many HIV Patients in Extension Study With Some Approaching 6 Months
CytoDyn Submits Phase 3 Trial Protocol Synopsis to FDA Following Their Guidance for Several Paths to Approval for PRO 140
VANCOUVER, Wash., Feb. 3, 2015 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB:CYDY), a biotechnology company focused on the development of new therapies for combating infection with human immunodeficiency virus (HIV), today announced that it had concluded its Phase 2b treatment substitution study and reported 39 patients out of 40 participating in the study passed 4 weeks of monotherapy with PRO 140. After the conclusion of the initial 14-week study, CytoDyn agreed to allow 14 patients to continue on the monotherapy in an extension study. A few patients have now progressed to nearly 6 months of successful PRO 140 monotherapy.
CytoDyn also reports it had a very productive recent meeting with the Food & Drug Administration ("FDA") in connection with defining the Company's path forward for approval of PRO 140. CytoDyn recently submitted to the FDA a protocol synopsis for a Phase 3 trial with PRO 140 and is awaiting the FDA's response.
CytoDyn's Phase 2b clinical study was designed to investigate the potential of allowing patients to enjoy treatment interruption from their current HAART regimen concurrent with a monotherapy consisting of weekly injections of PRO 140.
Results from the initial 14-week treatment substitution monotherapy trial (which excludes viral load failures due to patient screening errors) are as follows:
- 98% of the patients passed 4 weeks of monotherapy
- 91% of the patients passed 6 weeks of monotherapy
- 82% of the patients passed 8 weeks of monotherapy
- 70% of the patients passed 11 weeks of monotherapy (maximum allowable monotherapy without an extension study)
- 14 patients, who were offered to continue in an extension study with this monotherapy, are approaching 6 months without experiencing a viral load rebound.
Dr. Nader Pourhassan, President and CEO, commented: "We were very pleased that our current Phase 2b study clearly demonstrated PRO 140's safety and efficacy over several weeks of monotherapy and has now strongly positioned it for various paths for approval following the successful outcome of future trials. We await the FDA's guidance as to how best to proceed with our next trial."
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. 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 has shown that PRO 140 can prevent viral escape in patients during 4-6 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. 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 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. 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, 2014 and other reports filed with the U.S. Securities and Exchange Commission.
CONTACT: Investor Relations: Wolfe Axelrod Weinberger Associates, LLC Contact: Robert Schatz, Managing Director Office: 212-370-4500 E-mail: Rob@wolfeaxelrod.com Media: Dr. Nader Pourhassan Office: 360-980-8524 E-mail: firstname.lastname@example.org