CytoDyn publishes detailed CD12 trial results via Form 8-K After Investment Community Webcast, Monday, March 8th Further OTC: CYDY
These test results are currently being prepared for publication
VANCOUVER, Wash., March 8, 2021 (GLOBE NEWSWIRE) – CytoDyn Inc. (OTC.QB: CYDY)(“CytoDyn” or the “Company”), a late-stage biotechnology company developing Vyrologix ™ (leronlimab-PRO 140), a CCR5 antagonist with potential for multiple therapeutic indications, announced today that it has clinical CD12 data -Study will publish a Form 8-K following the investment community’s webcast on Monday, March 8, 2021. In the company’s recently completed CD12 Phase 3 study, Leronlimab was used for the treatment of patients with severe to critical COVID -19 rated.
A summary of the key results from this CD12 phase 3 study of leronlimab for the treatment of seriously to seriously ill COVID-19 patients is as follows:
| 1. | Survival benefit: In critically ill patients who were invasively mechanically ventilated, all-cause mortality (primary endpoint of the study) was reduced by 24% in the Leronlimab compared to placebo. | |
| 2. | Reduced time to recovery: The mean length of hospital stay was lower in the leronlimab group than in the placebo / SoC group in the critically ill population with a statistically significant p-value of 0.0050 using the Rank ANCOVA model . | |
| 3. | Living discharge: In addition, the patients who received leronlimab in this group had an improved chance of a “living discharge” on day 28 (28% versus 11%), a 166% better rate than the placebo group. | |
| As a result of an imbalance between enrolled patients over 65 years of age and under 65 years of age, an “age adjustment” analysis was performed, resulting in the following primary endpoint analysis: | ||
| 4th | Statistically significant results (p-value = 0.0319) for the primary endpoint (all-cause mortality on day 28) in participants who received Leronlimab + “commonly used COVID-19 treatments” compared to participants who received “frequently used COVID- 19 treatments ”. only in the placebo group in the entire modified intent-to-treat population (“mITT”). | |
| 5. | Statistically significant results (p-value = 0.0552) for the primary endpoint (all-cause mortality on day 28) in participants who received dexamethasone as a previous or concomitant SoC for COVID-19 compared to patients who received dexamethasone (without leronlimab) as SoC therapy in the entire mITT population. | |
| 6th | The primary endpoint (all-cause mortality on day 28) was not statistically significant among all patients with mITT. For age adjustment, the primary endpoint was much closer to the statistically significant value. Notably, the reduction in mortality in this 65 year old population and in the younger Leronlimab arm resulted in more than 30% less mortality than placebo and 9% less mortality in participants over 65 years of age. | |
Age adjustment analysis showed consistent numerical superiority over placebo for all other major secondary endpoints, with some secondary endpoints approaching statistical significance.
After communicating with MHRA, Health Canada and the US FDA, CytoDyn found its way to approval by conducting another study of 140 patients in the critically ill population with the same sites as the CD12 and / or multiple sites added.
About Leronlimab (PRO 140)
The FDA has given CytoDyn fast-track designation for two possible indications of leronlimab in critical diseases. The first indication is combination therapy with HAART in HIV-infected patients and the second in metastatic triple negative breast cancer. Leronlimab is a humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastasis, and other diseases including NASH. Leronlimab has completed 11 clinical studies in over 1,200 people and achieved its primary endpoints in a key phase 3 study (Leronlimab in combination with standard antiretroviral therapies in HIV-infected patients with treatment experience).
In the context of HIV / AIDS, leronlimab is an inhibitor of viral entry. It masks CCR5, protecting healthy T cells from viral infection by preventing the predominant HIV (R5) subtype from entering these cells. Leronlimab has been the subject of nine clinical studies, each of which showed that leronlimab can significantly reduce or control the HIV viral load in humans. The Leronlimab antibody appears to be a powerful antiviral agent that potentially results in fewer side effects and less frequent dosage requirements compared to the daily drug therapies currently in use.
In the cancer-related context, research has shown that CCR5 may play a role in tumor invasion, metastasis, and control of the tumor microenvironment. Increased CCR5 expression is an indicator of disease status in several cancers. 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 98% in a murine xenograft model. CytoDyn is therefore conducting a phase 1b / 2 clinical trial in humans in metastatic triple negative breast cancer and was recognized as a Fast Track by the FDA in May 2019.
The CCR5 receptor appears to play a central role in modulating the trade in immune cells at foci of inflammation. It can be critical in the development of acute graft versus host disease (GvHD) and other inflammatory diseases. Clinical studies by others also support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical effects of acute GvHD without significantly affecting transplanted bone marrow stem cell transplantation. CytoDyn conducted a phase 2 clinical study with leronlimab to further support the concept that the CCR5 receptor on transplanted cells is critical for the development of acute GvHD. Blocking the recognition of specific immune signal molecules by the CCR5 receptor is a viable approach to attenuating acute GvHD. The FDA granted Leronlimab the orphan drug designation for the prevention of GvHD. Due to the shortage of patients during the COVID-19 pandemic, the company suspended its phase 2 study for acute GvHD.
About CytoDyn
CytoDyn is a late-stage biotechnology company developing innovative therapies for multiple therapeutic indications based on Leronlimab, a novel humanized monoclonal antibody against the CCR5 receptor. CCR5 appears to play a crucial role in the ability of HIV to enter and infect healthy T cells. The CCR5 receptor also appears to be involved in tumor metastasis and immune-mediated diseases such as GvHD and NASH.
CytoDyn has successfully completed a phase 3 registration study with leronlimab in combination with standard antiretroviral therapies in HIV-infected patients with treatment experience. CytoDyn has worked diligently to resubmit its Biologics License Application (“BLA”) for this combination HIV therapy since receiving a denial of filing in July 2020 and then telephoning the FDA to review their written guidelines on filing to discuss. CytoDyn expects to refine its BLA in the first half of the calendar year 2021.
CytoDyn has completed a phase 3 study of leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-driven study for the leronlimab monotherapy indication. If successful, a label extension could be supported. Previous clinical results from several studies have shown that leronlimab can significantly reduce the viral load in people infected with HIV. No drug-related serious injection reactions were reported in approximately 800 patients treated with leronlimab, and no drug-related SAEs were reported in patients treated with the 700 mg dose of leronlimab. In addition, a phase 2b clinical study has shown that monotherapy with leronlimab can prevent the escape of viruses in HIV-infected patients. Some patients receiving leronlimab monotherapy have been virally suppressed for more than six years.
CytoDyn is also conducting a phase 1b / 2 clinical study with leronlimab in metastatic triple negative breast cancer. More information is available at 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. Words and expressions that reflect optimism, satisfaction or disappointment about the current outlook, as well as words such as “believes”, “hopes”, “intends”, “estimates”, “expects”, “projects”, “plans”, “anticipates” and variations thereof or the use of the future tense identify forward-looking statements, but their absence does not mean that any statement is not forward-looking. Forward-looking statements include, in particular, statements about Leronlimab, its ability to achieve positive health outcomes, the potential outcomes of clinical trials, studies or other programs or the ability to continue such programs, the ability to obtain regulatory approval for commercial sale, and the market for actual commercial sales. The Company’s forward-looking statements are not guarantees of performance, and actual results could differ materially from those contained in or contained in these statements due to risks and uncertainties, including: (i) the Company’s liquidity, (ii) that of the Company Company’s ability to raise additional capital to fund its business, (iii) the company’s ability to meet its debt obligations, if any, (iv) the company’s ability to enter into partnerships or licensing agreements with third parties, (v) the company’s ability to identify itself Patients who wish to enroll in clinical trials in a timely manner, (vi) the Company’s ability to obtain regulatory approval for a marketable product, (vii) the design, conduct and conduct of the Company’s clinical trials, (viii) the results of the kli Company studies niche studies, including the possibility of adverse clinical trial results, (ix) the market and marketability of approved products, (x) the existence or development of vaccines, drugs, or other treatments used by clinicians or patients as the products of the Company are considered superior, (xi) regulatory initiatives, regulatory compliance and approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political and social conditions, and (xiv) various other matters, of which many are beyond the control of the company. The company urges investors to specifically consider the various risk factors listed on their most recent Form 10-K, as well as any risk factors or warnings contained in a subsequent Form 10-Q or Form 8-K attached to the has been filed with the Securities and Exchange Commission. Except as required by law, the company assumes no responsibility to update forward-looking statements to reflect events or circumstances that occur after the date of this press release.
CONTACTS
Investors:
Michael Mulholland
Office: 360.980.8524, ext. 102
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