Results of CytoDyn’s PRO 140 CD01 Trial and Extension Study Published in HIV Clinical Trials

Data Provide Support for PRO 140 as long-acting, HIV-1 maintenance therapy

VANCOUVER, Washington, May 24, 2018 (GLOBE NEWSWIRE) — CytoDyn Inc. (OTC.QB:CYDY) announces that results from its CD01 Phase 2b clinical trial and extension study showing the potential of PRO 140, its novel humanized CCR5 monoclonal antibody, as a long-acting, single-agent maintenance therapy for HIV-1 infected patients were published in the peer-reviewed journal HIV Clinical Trials.

All HIV-1 infected patients enrolled in the CD01 Phase 2b trial exhibited suppressed viral load on antiretroviral therapy (ART) prior to enrolling into this trial.  Patients were administered 350 mg of PRO 140 weekly by subcutaneous injections as a single-agent therapy. More than half of enrolled patients (21 of 39) reached the trial endpoint of 14 weeks without virologic failure (two consecutive HIV-1 RNA levels of ≥ 400 copies/ml). Of the 18 patients considered non-responders, all achieved re-suppressed viral load upon resuming their prior ART regimen. PRO 140 was well tolerated with no treatment-related significant adverse events or study discontinuations due to adverse events.

“Notably nearly all trial patients who successfully reached the trial endpoint requested to continue into an extension study,” said Nader Pourhassan, Ph.D., CytoDyn President and Chief Executive Officer. “A portion of participants in the extension study have now exhibited HIV suppression for more than three years, providing support for PRO 140 as a potential important weapon in suppressing viral load in those infected with HIV-1.”

The article was authored by CytoDyn Inc. and Amarex Clinical Research scientists and PRO 140 discoverer Paul J. Maddon, MD, Ph.D.

About PRO 140

PRO 140 belongs to a new class of HIV/AIDS therapeutics – viral-entry inhibitors – that is 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 eight 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 by the FDA. The FDA also granted orphan drug designation to PRO 140 for the prevention of graft-versus-host disease (GvHD). The PRO 140 antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

About CytoDyn

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 humans and is currently in Phase 3 development. 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 eight 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, inflammatory indications where CCR5 and its ligand CCL5 may be involved. For more information on the Company, please visit http://www.cytodyn.com.

Forward-Looking Statements 

This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict, including statements regarding our current and proposed trials and studies and their enrollment, results, costs and completion. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as “believes,” “hopes,” “intends,” “estimates,” “expects,” “projects,” “plans,” “anticipates” and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Our forward-looking statements are not guarantees of performance and actual results could differ materially from those contained in or expressed by such statements. In evaluating all such statements, we urge you to specifically consider the various risk factors identified in our Form 10-K for the fiscal year ended May 31, 2017 in the section titled “Risk Factors” in Part I, Item 1A and in our Form 10-Q for the quarterly period ended February 28, 2018 in the section titled “Risk Factors” in Part II, Item 1A, any of which could cause actual results to differ materially from those indicated by our forward-looking statements.

Our forward-looking statements reflect our current views with respect to future events and are based on currently available financial, economic, scientific, and competitive data and information on current business plans. You should not place undue reliance on our forward-looking statements, which are subject to risks and uncertainties relating to, among other things: (i) the sufficiency of our cash position and our ongoing ability to raise additional capital to fund our operations, (ii) our ability to complete our Phase 2b/3 pivotal combination therapy trial for PRO 140 (CD02) and to meet the FDA’s requirements with respect to safety and efficacy to support the filing of a Biologics License Application, (iii) our ability to meet our debt obligations, if any, (iv) our ability to identify patients to enroll in our clinical trials in a timely fashion, (v) our ability to achieve approval of a marketable product, (vi) design, implementation and conduct of clinical trials, (vii) the results of our clinical trials, including the possibility of unfavorable clinical trial results, (viii) the market for, and marketability of, any product that is approved, (ix) the existence or development of vaccines, drugs, or other treatments for infection with the Human Immunodeficiency Virus that are viewed by medical professionals or patients as superior to our products, (x) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xi) general economic and business conditions, (xii) changes in foreign, political, and social conditions, and (xiii) various other matters, many of which are beyond our control. Should one or more of these risks or uncertainties develop, or should underlying assumptions prove to be incorrect, actual results may vary materially and adversely from those anticipated, believed, estimated, or otherwise indicated by our forward-looking statements.

We intend that all forward-looking statements made in this press release will be subject to the safe harbor protection of the federal securities laws pursuant to Section 27A of the Securities Act, to the extent applicable. Except as required by law, we do not undertake any responsibility to update these forward-looking statements to take into account events or circumstances that occur after the date of this press release. Additionally, we do not undertake any responsibility to update you on the occurrence of any unanticipated events which may cause actual results to differ from those expressed or implied by these forward-looking statements.

CONTACTS:

Investors:
LHA Investor Relations
Jody Cain
310-691-7100
jcain@lhai.com

Media:
Bioscribe, Inc.
Joan E. Kureczka
415-821-2413
Joan@bioscribe.com

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OrthoPediatrics Corp. to Present at Jefferies & William Blair Healthcare Conferences

WARSAW, Ind., May 24, 2018 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (“OrthoPediatrics”) (NASDAQ:KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, announced today that Mark Throdahl, President & Chief Executive Officer, and Fred Hite, Chief Financial Officer, are scheduled to participate in two investor conferences in June 2018.

      Event:   Jefferies 2018 Healthcare Conference
      Format:   One-on-One Meetings Only
      Date:   Wednesday, June 6th, 2018
           
      Event:   William Blair 2018 Growth Conference
      Format:   Presentation and One-on-One Meetings
      Date:   Wednesday, June 13th, 2018
      Time:   2:00-2:30 pm CT / 3:00-3:00 pm ET

An audio webcast of the June 13th presentation will be available online at OrthoPediatrics’ investor relations website, http://ir.orthopediatrics.com. A replay of the presentation will be available for 90 days.

Investors attending the conference who would like to schedule a one-on-one meeting with OrthoPediatrics management may do so by contacting their Jefferies or William Blair representative, or Emma Poalillo of The Ruth Group at epoalillo@theruthgroup.com. 

About OrthoPediatrics Corp.
Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 25 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma & deformity, scoliosis and sports medicine/other procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and 38 countries outside the United States.

Investor Contacts
The Ruth Group
Tram Bui / Emma Poalillo
(646) 536-7035 / 7024
tbui@theruthgroup.com / epoalillo@theruthgroup.com

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Watson Publishes a Guide to Beta-glucan

West Haven, CT -, May 24, 2018 (GLOBE NEWSWIRE) — Americans consume only about half of the daily recommended amount of dietary fiber.  While the new FDA daily value (DV) for fiber is 28 grams, the average intake for Americans is 15 grams per day. The Dietary Guidelines for Advisory Committee (DGAC) identified Dietary fiber as a nutrient of public health concern due to the health impacts of underconsumption. However, as food manufacturers work to boost the fiber content of their food products, it’s important to know that all fibers are not created equal.

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Cover image of Beta-glucan guide
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Beta-glucan guide
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Beta-glucan is a fiber that may be best known for its FDA-approved heart health claim, which is that diets low in saturated fat and cholesterol that include 3 grams of beta-glucan per day from oats or barley may reduce the risk of heart disease. “As a staple in U.S. households, bakery products provide an ideal opportunity to deliver the health benefits consumers are looking for,” stated Moira Watson, Vice President of Marketing and Communication for Connecticut-based company Watson Inc. “Fiber is the perfect place to start. Consumers associate baked goods with fiber and actively look for fiber on the label. Fortifying with beta-glucan achieves not only a boost in fiber but also a heart-healthy option for consumers and a product that stands out from other baked goods.” concluded Watson.

Food processors can add Beta-glucan to bread, rolls, bagels, muffins, and even specialty items such as nutrition bars. Watson Inc. has composed a guide to beta-glucan to assist industrial bakeries, wholesale bakers, and food manufacturers in learning more about the market demand for foods fortified with beta-glucan. It covers beta-glucan, sources of beta-glucan, claims available, and information on the new FDA definition of fiber, and can be downloaded from the Watson website here.

About Watson:  For four generations, Watson has striven to improve health and wellness. We are committed to sharing our ideas and inspirations with our customers and to helping them reach their goals. Watson is one of the highest quality suppliers of products and services geared towards enhancing human and pet nutrition around the world, and a leader in developing quality products and nutritional ingredient systems. Expertise in microencapsulation, agglomeration, micronizing, spray drying and film technology allows us to develop unique formulations.  Learn more about Watson here.

Attachments

Moira Watson
Watson Inc
203-932-3000
moira.watson@watson-inc.com