CytoDyn Announces Legal Actions Against its Former CRO, Amarex Clinical Research
All clinical activities have been moved away from Amarex; a complete update on all activities will be provided to shareholders next week by Drs. Recknor, Kelly, Ray, and Pourhassan
VANCOUVER, Washington, Oct. 07, 2021 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today the filing of a complaint for declaratory and injunctive relief and motion for a preliminary injunction against NSF International, Inc. and its subsidiary Amarex Clinical Research (“Amarex”), the Company’s former Contract Research Organization (“CRO”). Over the past eight years, Amarex provided clinical trial management services to the Company and managed numerous clinical trials. The Company’s complaint alleges that Amarex failed to perform its obligations under the master services agreement and work orders that governed the relationship between the parties. As a result, the Company suffered substantial damages. The Company’s lawsuit filed in the U.S. District Court for the District of Maryland seeks a declaration that Amarex breached its contracts with CytoDyn, as well as an injunction requiring Amarex to provide CytoDyn access to databases of clinical trial data that Amarex has been wrongfully withholding.
The Company simultaneously filed a demand for arbitration with the American Arbitration Association. The arbitration demand alleges that Amarex failed to perform services to an acceptable professional standard and failed to perform certain services required by the parties’ agreements. Further, the demand alleges that Amarex billed the Company for services it did not perform. The Company contends that, due to Amarex’s failures, it has suffered avoidable delays in obtaining regulatory approval of leronlimab and has been paid for services not performed. Furthermore, as part of reinstating the “rolling review” status for the Company’s BLA resubmission, the FDA has requested potential submission dates for each component of the BLA. The Company communicated to the agency that it will submit its CMC and non-clinical sections in November (next month). The Company also reported to the FDA the clinical section could be delayed to the first quarter of 2022, however, certain portions may be submitted earlier during the review, if acceptable to the FDA.
Christopher Recknor, M.D. with extensive experience in clinical trial management, led the discovery of Amarex deficiencies and is in the process of rapidly implementing alternatives to Amarex. Dr. Recknor stated, “Our goal for clinical development is to diversify our CRO base. To intensify our resources on clinical development, the HIV BLA resubmission will now be led by Dr. Nitya Ray. We are confident we can achieve a successful submission with internal resources. With the current CytoDyn team in place for clinical development and operations, we expect results from our NASH study by the end of calendar 2021. We are in discussions with the FDA regarding our new Long-Hauler’s trial CD18, which we hope to start in November 2021, if cleared by the agency. We are also in the process of filing for Breakthrough Therapy designations for mTNBC and breast cancer with brain metastasis.”
Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, commented, “We are aggressively pursuing these legal actions against Amarex. We believe their numerous failures have delayed the availability of leronlimab to thousands of patients for multiple indications and harmed our shareholders. We are very grateful to our team for being able to manage all of our trials, despite the numerous obstacles that we had to overcome in the last several months.”
Leronlimab, among various potential applications, is a viral-entry inhibitor in HIV/AIDS. It binds to CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab does not work on other strains of HIV (for example X4), however, R5 is the most dominant strain of HIV. Five clinical trials have demonstrated leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent with fewer side effects and less frequent dosing requirements than currently used daily drug therapies. Cancer research has shown CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment cntrol (for example, through angiogenesis). Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 97% in a murine xenograft model. As a result, CytoDyn is conducting two clinical trials, one, a Phase 2 in mTNBC, which was granted Fast Track designation by the FDA in 2019, and a second, a Phase 2, basket trial which encompasses 22 different solid tumor cancers.
The CCR5 receptor plays a central role in modulating immune cell trafficking to sites of inflammation. After completing two clinical trials with COVID-19 patients (a Phase 2 and a Phase 3), CytoDyn initiated a Phase 2 investigative trial for post-acute sequelae of SARS COV-2 (PASC), also known as COVID-19 Long-Haulers. This trial evaluated the effect of leronlimab on clinical symptoms and laboratory biomarkers to further understand the pathophysiology of PASC. It is currently estimated that between 10-30% of those infected with COVID-19 develop long-term sequelae. Common symptoms include fatigue, cognitive impairment, sleep disorders, and shortness of breath. CytoDyn plans to pursue clinical trials to evaluate leronlimab’s effect on immunological dysregulation in other post-viral syndromes, including myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).
CytoDyn is also conducting a Phase 2 clinical trial for NASH to evaluate the effect of leronlimab on liver steatosis and fibrosis. Pre-clinical studies revealed a significant reduction in NAFLD and a reduction in liver fibrosis using leronlimab. There are currently no FDA approved treatments for NASH, which is a leading cause of liver transplant. About 30 to 40 percent of adults in the U.S. live with NAFLD, and 3 to 12 percent of adults in the U.S. live with NASH. There have been no strong safety signals identified in patients administered leronlimab in multiple disease spectrums, including patients with HIV, COVID-19, and oncology.
CytoDyn successfully completed a Phase 3 pivotal trial using leronlimab combined with standard antiretroviral therapies in HIV-infected patients who were heavily treatment-experienced individuals with limited treatment options. CytoDyn is working diligently to resubmit its Biologics License Application ("BLA") for this HIV combination therapy since receiving a Refusal to File in July 2020. In July 2021, CytoDyn announced that it had submitted a dose justification report to the FDA, an integral step in the resubmission process for its BLA, which it expects to complete by the first quarter of calendar 2022. CytoDyn also completed a Phase 2b/3 investigative trial with leronlimab used as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label expansion approval. Clinical results to date from two trials have shown that leronlimab can maintain a suppressed viral load in a sub-population of R5 HIV patients who chose to switch from their daily pills regimen to once-a-week subcutaneous dose of leronlimab. Several patients on leronlimab’s Phase 2b extension arm have remained virally suppressed for almost 7 years and many patients in our Phase 2b/3 investigative trial are passing two and some four years of monotherapy with suppressed viral load.
CytoDyn is also conducting a Phase 2 clinical trial with leronlimab in mTNBC, a Phase 2 basket trial in solid tumor cancers (22 different cancer indications), Phase 2 investigative trial for post-acute sequelae of SARS COV-2, also known as COVID-19 long haulers, and a Phase 2 clinical trial for NASH. CytoDyn has already completed a Phase 2 and Phase 3 trial for mild-to-moderate and severe-to-critical COVID-19 patients, respectively, for which CytoDyn did not meet its primary or secondary endpoints except for the secondary endpoint in the critically ill subpopulation. More information is at www.cytodyn.com.
Investors and stockholders will be able to obtain a copy of the definitive proxy statement and other documents filed by the Company free of charge from the SEC's website, www.sec.gov. The Company's stockholders will also be able to obtain, without charge, a copy of the definitive proxy statement and other relevant filed documents by directing a request by mail to CytoDyn Inc. at 1111 Main Street, Suite 660, Vancouver, Washington 98660.
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