2015 FORM G4


Vancouver, WA (PRWEB) February 03, 2015

CytoDyn Inc. (OTC.QB: CYDY), a biotechnology company fascinated by the improvement of new remedies for combating infection with human immunodeficiency virus (HIV), today introduced that it had concluded its phase 2b treatment substitution learn about and mentioned 39 patients out of forty participating in the learn about passed 4 weeks of monotherapy with professional a hundred and forty. After the conclusion of the preliminary 14-week find out about, CytoDyn agreed to permit 14 patients to continue on the monotherapy in an extension learn about. just a few patients have now stepped forward to nearly 6 months of a hit professional one hundred forty monotherapy.

CytoDyn also experiences it had a very productive latest assembly with the meals &amp Drug Administration (“FDA”) in connection with defining the corporate’s direction forward for approval of professional one hundred forty. CytoDyn just lately submitted to the FDA a protocol synopsis for a section three trial with professional a hundred and forty and is looking forward to the FDA’s response.

CytoDyn’s section 2b scientific learn about was once designed to analyze the potential of permitting sufferers to enjoy treatment interruption from their present HAART regimen concurrent with a monotherapy which include weekly injections of pro 140.

outcomes from the initial 14-week therapy substitution monotherapy trial (which excludes viral load disasters as a result of patient screening error) are as follows:

98% of the patients handed four weeks of monotherapy
ninety one% of the sufferers handed 6 weeks of monotherapy
eighty two% of the patients handed 8 weeks of monotherapy
70% of the patients passed 11 weeks of monotherapy (maximum allowable monotherapy without an extension find out about)
14 sufferers, who have been supplied to continue in an extension find out about with this monotherapy, are coming near 6 months without experiencing a viral load rebound.

Dr. Nader Pourhassan, President and CEO, commented: “We had been very pleased that our current phase 2b study clearly verified professional one hundred forty’s safety and efficacy over a couple of weeks of monotherapy and has now strongly positioned it for quite a lot of paths for approval following the successful end result of future trials. We watch for the FDA’s steering as to how highest to proceed with our next trial.”

About CytoDyn

CytoDyn is a biotechnology company eager about the medical building and doable commercialization of humanized monoclonal antibodies for the remedy and prevention of Human Immunodeficiency Virus (HIV) infection. the corporate has one of the crucial best monoclonal antibodies below construction for HIV infection, pro 140, which has completed phase 2 scientific trials with established antiviral task in man.

professional a hundred and forty blocks the HIV co-receptor CCR5 on T-cells which prevents viral entry. scientific trial results so far indicate that pro one hundred forty does now not negatively have an effect on the normal immune features which can be mediated through CCR5. results from six section 1 and phase 2 human medical trials have proven that pro a hundred and forty can considerably reduce viral burden in folks contaminated with HIV. A latest phase 2b clinical trial has proven that professional one hundred forty can forestall viral escape in patients all through 4-6 weeks of interruption from typical drug remedy. CytoDyn intends to proceed to boost professional 140 as a therapeutic anti-viral agent in individuals contaminated with HIV. For more knowledge on the corporate please visit http://www.cytodyn.com.

About professional 140

pro one hundred forty belongs to a brand new classification of HIV/AIDS therapeutics — viral-entry inhibitors — that are meant to give protection to wholesome cells from viral an infection. professional one hundred forty is a fully humanized IgG4 monoclonal antibody directed in opposition to CCR5, a molecular portal that HIV uses to enter T-cells. pro one hundred forty blocks the predominant HIV (H5) subtype entry into T-cells by way of masking this required co-receptor, CCR5. Importantly pro a hundred and forty does now not appear to intervene with the traditional operate of CCR5 in mediating immune responses. pro 140 has been the topic of seven scientific trials, every demonstrating efficacy with the aid of considerably reducing or controlling HIV viral load in human check topics. pro 140 has been exact a “fast observe” product candidate through the FDA. the professional a hundred and forty antibody seems to be a formidable antiviral agent leading to probably fewer unwanted effects and no more commonplace dosing requirements as in comparison with daily drug remedies at the moment in use.

ahead-looking Statements

This press free up comprises forward-having a look statements and ahead-taking a look knowledge inside the which means of u.s. securities laws. These statements and knowledge characterize CytoDyn’s intentions, plans, expectations, and beliefs and are subject to risks, uncertainties and other elements, many beyond CytoDyn’s keep an eye on. These factors may cause exact results to fluctuate materially from such ahead-having a look statements or knowledge. The phrases “consider,” “estimate,” “expect,” “intend,” “strive,” “watch for,” “foresee,” “plan,” and equivalent expressions and diversifications thereof determine sure of such forward-taking a look statements or ahead-looking information, which discuss best as of the date on which they’re made.

CytoDyn disclaims any intention or obligation to publicly update or revise any forward-having a look statements or ahead-looking information, whether because of new data, future situations or in any other case, apart from as required by using applicable regulation. Readers are recommended not to position undue reliance on these ahead-taking a look statements or ahead-looking knowledge. whereas it is not possible to determine or predict all such matters, these differences may outcome from, amongst different things, the inherent uncertainty of the timing and success of and price associated with analysis, development, regulatory approval, and commercialization of CytoDyn’s merchandise and product candidates, together with the dangers that clinical trials is not going to commence or proceed as deliberate products appearing promising in early trials is not going to show efficacy or safety in better-scale trials future scientific trial information on CytoDyn’s products and product candidates can be detrimental funding for additional clinical trials might not be to be had CytoDyn’s merchandise may not obtain marketing approval from regulators or, if licensed, may just fail to gain adequate market acceptance to justify development and commercialization prices competing products at present in the marketplace or in construction could reduce the commercial possible of CytoDyn’s products CytoDyn, its collaborators or others may determine unwanted effects after the product is available on the market or efficacy or safety considerations relating to marketed merchandise, whether or not or not scientifically justified, could result in product recalls, withdrawals of selling approval, reformulation of the product, further pre-clinical checking out or clinical trials, changes in labeling of the product, the necessity for extra marketing purposes, or other adversarial events.

CytoDyn is also subject to further risks and uncertainties, together with dangers related to the movements of its corporate, educational, and different collaborators and government regulatory businesses risks from market forces and trends attainable product liability intellectual property litigation environmental and other dangers and risks that current and pending patent protection for its merchandise could also be invalid, unenforceable, or challenged or fail to offer ample market exclusivity. There are additionally tremendous dangers arising out of CytoDyn’s wish to lift extra capital to strengthen its merchandise and fulfill its monetary responsibilities the extremely regulated nature of its industry, together with government price-containment initiatives and restrictions on 1/3-party payments for its merchandise the extremely aggressive nature of its trade and other components set forth in CytoDyn’s Annual file on form 10-k for the fiscal yr ended could 31, 2015 and different reviews filed with the U.S. Securities and change commission.


Investor family members:

Wolfe Axelrod Weinberger mates, LLC

Contact: Robert Schatz, Managing Director

workplace: 212-370-4500

email: Rob(at)wolfeaxelrod(dot)com


Dr. Nader Pourhassan

place of job: 360-980-8524

e-mail: npourhassan(at)cytodyn(dot)com