CytoDyn Shares Exciting Results from their Triple-Negative Breast Cancer Treatment Program with The Stock Day Podcast
Phoenix, Arizona--(Newsfile Corp. - December 5, 2019) - The Stock Day Podcast welcomed CytoDyn (OTCQB: CYDY) ("the Company"), a biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. President and CEO of the Company, Dr. Nader Pourhassan, joined Stock Day host Everett Jolly.
Jolly began the interview by asking about where the company is with the path to final FDA approval for the Company's Leronlimab for HIV. Dr. Pourhassan shared that the Company is hoping to submit the final two sections of their BLA this month. "Hopefully, in a few days we will get direction on which dose we will submit the BLA for and that will take us to the end of December for clinical trial section," explained Dr. Pourhassan.
Dr. Pourhassan then elaborated on the Company's sales and commercialization strategy if the company receives FDA approval, adding that the initial launch will require substantial capital. "We've signed a non-binding agreement to license out the sales of the product in the United States," said Dr. Pourhassan. "The process is very extensive," said Dr. Pourhassan, adding that the Company expects to have the process finalized any day and has also secured a manufacturing agreement in the past with Samsung Biologics.
Jolly then asked about the Company's developments in the treatment of triple-negative breast cancer. "Triple-negative breast cancer is a very aggressive breast cancer. That aggressiveness also has something to do with the type of drug that can be given to these patients to survive," explained Dr. Pourhassan. "The maximum life expectancy for patients with metastatic triple-negative breast cancer (mTNBC) is anywhere from 9 to 15 months," said Dr. Pourhassan, adding that the current products for this condition are not very encouraging. "We thought that if our product could work on these patients, we would be able to get breakthrough designation and perhaps receive approval quickly," said Dr. Pourhassan. He then shared that the Company has submitted their IND application and have received green light to proceed with their mTNBC trial from the Institutional Review Board (IRB) for its safety.
"We have the green-light from the FDA and IRB, and we enrolled the first patient and have some results about that patient," shared Dr. Pourhassan. "After eight weeks of treatment, the metastasis has stopped," said Dr. Pourhassan. "If you're able to shrink the tumor and the metastasis has stopped, this is getting very exciting," said Dr. Pourhassan, adding that his mother-in-law has recently been added as a new patient for this treatment in a compassionate use agreement.
The conversation then turned to the Company's potential as they continue to progress. Dr. Pourhassan shared that the Company is currently in the process of enrolling additional patients in the mTNBC trial, which could provide them with enough data to receive final approval for its launch if the data turns out to be as fantastic as their first patient.
To close the interview, Dr. Pourhassan expressed his gratitude to the Company's supportive shareholders. "Everything we have set out to do has been very successful in the world of science and clinical trials," said Dr. Pourhassan, noting their success in the HIV, monotherapy, and cancer space. "Everything is going well. We need to just make sure that we get the approval and start having revenue - hopefully in 2020," closed Dr. Pourhassan.
To hear Dr. Nader Pourhassan's entire interview, follow the link to the podcast here: https://audioboom.com/posts/7442612-cytodyn-shares-exciting-results-from-their-triple-negative-breast-cancer-treatment-program-with-t
CytoDyn is a biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a key role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as graft-vs-host disease (GvHD) and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients. CytoDyn plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in 2019 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab (PRO 140) as a once-weekly monotherapy for HIV-infected patients and, plans to initiate a registration-directed study of leronlimab monotherapy indication, which if successful, could support a label extension. Clinical results to date from multiple trials have shown that leronlimab (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 leronlimab monotherapy can prevent viral escape in HIV-infected patients, with some patients on leronlimab monotherapy remaining virally suppressed for more than four years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and has received clearance to initiate a clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at www.cytodyn.com.
This press release contains certain forward-looking statements that involve risks, uncertainties, and assumptions that are difficult to predict. 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 vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the sufficiency of the Company's cash position, (ii) the Company's ability to raise additional capital to fund its operations, (iii) the Company's ability to meet its debt obligations, if any, (iv) the Company's ability to enter into partnership or licensing arrangements with third parties, (v) the Company's ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Company's ability to achieve approval of a marketable product, (vii) the design, implementation and conduct of the Company's clinical trials, (viii) the results of the Company's clinical trials, including the possibility of unfavorable clinical trial results, (ix) the market for, and marketability of, any product that is approved, (x) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Company's products, (xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Company's control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.
For more information, visit www.cytodyn.com or contact:
LifeSci Public Relations
Nader Pourhassan, Ph.D.
President & CEO
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