PHOENIX, AZ / ACCESSWIRE / November 9, 2018 / CytoDyn Inc. (OTCQB: CYDY) (the "company"), is a biotechnology company developing a novel humanized CCR5 monoclonal antibody for multiple therapeutic indications. Nader Z. Pourhassan, Ph.D., President and CEO, talked with Stock Day's Everett Jolly.
Jolly started the interview by asking about CytoDyn Inc.'s flagship product, PRO 140.
"We do have a rolling submission with the FDA," explained Pourhassan. "So, we can submit as we get each module ready. By the end of the first quarter of 2019, we should have all of our BLA modules submitted to the FDA, if we do, our fast track designation for PRO 140 allows us to have accelerated approval which is 6 months."
PRO 140 is a humanized IgG4 monoclonal antibody that binds to CCR5, a cellular receptor that plays multiple roles with implications in HIV infection, tumor metastasis, and immune signaling.
"We hope to have our final approval in the fourth quarter of 2019," said Pourhassan.
Jolly then asked when Pourhassan thought PRO 140 would be available to the public. For our designated label for this study, he said his best estimate was 2020.
"Most biotech companies, when they finish the biologic application, they have an 85% chance to get approved. 9 out of 10 who don't get approved is because of the safety of the product. Our product has received fast track designation due to having great safety among all of the approved drugs," said Pourhassan.
Pourhassan also went into the hopes for the drug in the realm of HIV, he explained patients often experience complications with dosing for other HIV drugs.
"Our product is a simple, one dose per week and it's a simple injection," explained Pourhassan. "This is once per week, self-administered at home. They can forget about their HIV for the rest of the week."
Jolly then asked once it gets pass the FDA, is the company going to commercialize and he asked Pourhassan how big is the market they are trying to penetrate.
"The combination therapy with PRO 140 and other pills would give patients quite a lot of benefit, is $1.2 Billion dollars. This market size is verified by a 3rd party report. The other market size for our other phase 3 trial is about $4 billion per year. This market price is based on a low estimate of cost to patient of $24,000, per year," explained Pourhassan.
He said the market size is high. In order to commercialize the product, they will assemble a team to start the process. He said they are open to partnering with larger companies. He says they are looking a half-a-billion dollars in sales for 2020.
Jolly then turned the conversation to the company's work in cancer treatment. The company recently announced it has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) to conduct a Phase 1b/2 clinical trial with PRO 140 (leronlimab) for treatment in breast cancer.
"The cancer only kills if it can metastasize," said Pourhassan. "If we show that PRO 140 can stop metastasis as we have in in-vitro studiesthen we have the potential to save many lives in triple negative breast cancer, and many other cancer, very quickly."
To hear the entire interview, listen to the Stock Day Podcast, here. https://upticknewswire.com/featured-interview-ceo-dr-nader-pourhassan-of-cytodyn-inc-otcqb-cydy-2/
About CytoDyn
CytoDyn is a biotechnology company developing innovative treatments for multiple therapeutic indications based on PRO 140 (leronlimab), a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 plays a key role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor is also implicated in tumor metastasis and in immune-mediated illnesses such as graft-vs-host disease (GvHD) and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with PRO 140 in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients. The Company plans to seek FDA approval for PRO 140 in combination therapy and plans to complete the filing of a Biological License Application (BLA) in the first quarter of 2019 for that indication.
CytoDyn is also conducting a Phase 3 investigative trial with PRO 140 as a once-weekly monotherapy for HIV-infected patients, and plans to initiate a registration-directed study of PRO 140 monotherapy indication, which if successful, could support a label extension. Clinical results to date from multiple trials have shown that PRO 140 can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, results from a Phase 2b clinical trial demonstrated that PRO 140 monotherapy can prevent viral escape in HIV-infected patients, with some patients on PRO 140 monotherapy remaining virally suppressed for more than four years. CytoDyn is also conducting a Phase 2 trial to evaluate PRO 140 for the prevention of GvHD and expects to initiate clinical trials with PRO 140 in metastatic triple-negative breast cancer in 2018. More information is at www.cytodyn.com.
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Investors:
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Jody Cain
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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 the proposed transaction with ProstaGene, the closing conditions and the likelihood of closing the proposed transaction with ProstaGene, the Company's clinical focus, and the Company's current and proposed trials. 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. The Company's 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, the Company urges investors to specifically consider the various risk factors identified in the Company's Form 10-K for the fiscal year ended May 31, 2018 in the section titled "Risk Factors" in Part I, Item 1A, and in our Form 10-Q for the quarterly period ended August 31, 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 the Company's forward-looking statements.
The Company's forward-looking statements reflect its 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. Investors should not place undue reliance on the Company's forward-looking statements, which are subject to risks and uncertainties relating to, among other things: (i) the sufficiency of the Company's cash position and the Company's ongoing ability to raise additional capital to fund its operations, (ii) the Company's ability to complete its 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) the Company's ability to meet its debt obligations, if any, (iv) the Company's ability to identify patients to enroll in its clinical trials in a timely fashion, (v) the Company's ability to achieve approval of a marketable product, (vi) design, implementation and conduct of clinical trials, (vii) the results of the Company's 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 HIV that are viewed by medical professionals or patients as superior to the Company's 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 the Company's 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 the Company's forward-looking statements.
The Company intends 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 of 1933, as amended, to the extent applicable. Except as required by law, the Company does 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, the Company does not undertake any responsibility to update investors upon the occurrence of any unanticipated events which may cause actual results to differ from those expressed or implied by these forward-looking statements.
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