VANCOUVER, Washington, April 06, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that the first two COVID-19 patients have been treated with leronlimab under the Companys Phase 2 randomized clinical trial, which is for patients with mild-to-moderate indications. The Company anticipates that enrollment of more patients will accelerate this week at multiple clinical sites.
In addition, the Companys investigational new drug, leronlimab, has now been administered to 15 severely ill COVID-19 patients at four hospitals, 10 patients treated at a leading medical center in the New York City area and five patients at three other hospitals, all under an emergency investigational new drug (EIND), which were granted by the U.S. Food and Drug Administration (FDA) for each individual patient.
CytoDyn also anticipates initiating its other COVID-19 trial this week. This trial is a Phase 2b/3 for severely ill COVID-19 patients and is for 342 patients, double-blinded with a 2:1 ratio (drug to placebo ratio). Patients enrolled in this trial are expected to be administered leronlimab for two weeks, with the primary endpoint being the mortality rate at 14 days. The Company will perform an interim analysis on the data from 50 patients following two weeks of leronlimab therapy.
Bruce Patterson, M.D., Chief Executive Officer and founder of IncellDx, a diagnostic partner and advisor to CytoDyn, commented, We are encouraged by the positive results demonstrated with leronlimab in the New York patients. Our team is working hard to distribute leronlimab to multiple clinical sites to initiate therapy in patients with severe COVID-19 disease. While every patient is experiencing different comorbidities, we are seeing similar clinical responses, which we believe is a reflection of leronlimabs mechanism of action.
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, said, Our partnership with the New York medical team and now other hospitals has been exemplary. We are collaborating in every aspect to deliver leronlimab to patients in order to provide proof of concept as soon as possible. The outstanding coordination among the physicians, the hospital administrators, the FDA, and our team, will hopefully help mitigate the deleterious effects from this pandemic should we prove leronlimab as a solution. The lead physician in New York is a true medical hero, who deserves to be recognized for his contribution to humanity in the pandemic of COVID-19. We are very hopeful of sending the day three and day seven results of the first ten EIND patients to the FDA by the end of this week.
About Coronavirus Disease 2019SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.
About Leronlimab (PRO 140) The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH. Leronlimab has completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).
In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab 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.
In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. 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 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.
The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.
About CytoDyn CytoDyn is a late-stage 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 critical 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 GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral 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 April of 2020 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab 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 extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at 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. 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 Companys 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 Companys cash position, (ii) the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv) the Companys ability to enter into partnership or licensing arrangements with third parties, (v) the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Companys ability to achieve approval of a marketable product, (vii) the design, implementation and conduct of the Companys clinical trials, (viii) the results of the Companys 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 Companys 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 Companys 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.
CYTODYN CONTACTSInvestors: Dave Gentry, CEO RedChip Companies Office: 1.800.RED.CHIP (733.2447) Cell: 407.491.4498 email@example.com
- HRMC to open hematology and oncology clinic - The Ottawa Herald - June 29th, 2020
- Gift of Life, Root and Rutgers Researchers Launch COVID-19 Study - Patch.com - June 29th, 2020
- Obituaries in the Sunday and Monday Courier, June 28-29 - Waterloo Cedar Falls Courier - June 29th, 2020
- Efforts at coronavirus vaccines and treatments abound in the Bay Area - San Francisco Chronicle - June 23rd, 2020
- New Preclinical Data Demonstrates Immune-Enhancing Effects of Triple I/O Combination Therapy with BeyondSpring's Plinabulin - GlobeNewswire - June 23rd, 2020
- [Herald Interview] Spinning cord blood into stem cell therapies - The Korea Herald - June 22nd, 2020
- Children's Hospital Los Angeles Ranked No. 1 Children's Hospital in the Western U.S., No. 5 Nationally for Second Straight Year - Business Wire - June 22nd, 2020
- The BCG a Tuberculosis Vaccine Boosts Immune Cells and Reduces Risk of Other Infections - Gilmore Health News - June 18th, 2020
- FDA Approves Second Biomarker-Based Indication for Merck's KEYTRUDA (pembrolizumab), Regardless of Tumor Type - The Baytown Sun - June 17th, 2020
- UCLA receives nearly $14 million from NIH to investigate gene therapy to combat HIV - Mirage News - June 17th, 2020
- Orca Bio Emerges With Nearly $300 Million to Transform Allogeneic Cell Therapy - Stockhouse - June 17th, 2020
- UChicago working on COVID-19 saliva test Pandemic energizes health care unions Rehab hospital to be built in Libertyville - Crain's Chicago Business - June 17th, 2020
- UofL researchers to study health impacts of vaping, nicotine on youth - The Lane Report - June 14th, 2020
- Houston coronavirus updates: What you need to know about June 14 - msnNOW - June 14th, 2020
- Be The Match Appoints Amy Ronneberg as Chief Executive Officer - Southernminn.com - June 11th, 2020
- A&B could become premier stem cell producer - Antigua ... - June 11th, 2020
- Nick Cordero Had a 'Rocky Night' After He 'Spiked a Fever' During His Hospitalization, Wife Says - PopCulture.com - June 11th, 2020
- R3 International Now Offering New Stem Cell Therapy Program for Lyme Disease in Mexico - Yahoo Finance - June 10th, 2020
- Nick Cordero's Wife Says His COVID-19 Recovery Is 'Going in the Right Direction' - countryliving.com - June 10th, 2020
- Memorial Sloan Kettering - Hackensack Meridian Health Partnership Announces Funding for Inaugural Immunology Research Collaboration Projects - The... - June 10th, 2020
- Longeveron Announces Japanese Approval of Clinical Trial for Treatment of Aging Frailty With Longeveron's Stem Cells - Yahoo Finance - June 3rd, 2020
- Human Mesenchymal Stem Cells (hMSC) Market investigated in the latest research - WhaTech Technology and Markets News - June 3rd, 2020
- Longeveron Announces Japanese Approval of Clinical Trial for Treatment of Aging Frailty With Longeveron's Stem Cells | DNA RNA and Cells | News... - June 2nd, 2020
- CSL Behring and Seattle Children's Research Institute to Advance Gene Therapy Treatments for Primary Immunodeficiency Diseases - P&T Community - June 2nd, 2020
- New Leaders at ASTCT and CIBMTR Provide Guidelines and Measures for Combating COVID-19 and Protecting Transplant Patients - Business Wire - June 2nd, 2020
- Exceptional stem cell science on tap for ISSCR 2020 Virtual June 23-27, 2020 - 7thSpace Interactive - June 2nd, 2020
- CAR T-Cell Therapy Impresses in Indolent NHL - MedPage Today - June 1st, 2020
- In situ repair abilities of human umbilical cordderived mesenchymal stem cells and autocrosslinked hyaluronic acid gel complex in rhesus monkeys with... - May 23rd, 2020
- UH studying use of convalescent plasma to improve health of COVID-19 patients - Crain's Cleveland Business - May 23rd, 2020
- COVID-19: Recommendations for Treating MS and Related... : Neurology Today - LWW Journals - May 21st, 2020
- New hybrid embryos are the most thorough mixing of humans and mice yet - Science News - May 20th, 2020
- Hotel in Spain requires two negative Covid-19 tests to check in with a free antibody test during your stay - CNBC - May 20th, 2020
- 'Outpatient Is Still Chaos': What We Heard This Week - MedPage Today - May 20th, 2020
- Sumit Dewanjee, MD, is being recognized by Continental Who's Who - PRNewswire - May 7th, 2020
- Results From Pivotal Phase 2/3 Study of Emapalumab in Patients With Primary HLH Published in New England Journal of Medicine - BioSpace - May 7th, 2020
- COVID-19 Impact and Recovery Analysis | Global Cell Isolation Market 2020-2024 | Evolving Opportunities with Agilent Technologies Inc. and Becton,... - May 7th, 2020
- Stem Cell Alopecia Treatment Market Detailed Analysis of Current Industry Figures With Forecasts Growth by 2026 - 3rd Watch News - May 7th, 2020
- AMC to use stem cell therapy in treating graft-versus-host disease - Korea Biomedical Review - May 7th, 2020
- Drumming class finds a new rhythm with creative connections - Yes! Weekly - May 7th, 2020
- Drumming class finds a new rhythm with creative connections - Wake Forest University News Center - May 5th, 2020
- Insights on the Worldwide Cell Expansion Industry to 2027 - Analysis and Forecasts - Yahoo Finance UK - May 5th, 2020
- These 5 Houston-area research institutions have bright minds at work to battle COVID-19 - InnovationMap - May 5th, 2020
- GCC Condemns Israeli Plans to Annex Parts of the West Bank - Asharq Al-awsat English - May 2nd, 2020
- Jerusalem residents concerned Israel is changing their residency rights - Arabnews - May 2nd, 2020
- Four UTSW Researchers Named to The National Academy of Sciences - D Magazine - May 1st, 2020
- CHMP Grants Positive Opinion for DARZALEX (daratumumab) Subcutaneous Formulation for the Treatment of Patients with Multiple Myeloma - Yahoo Finance - May 1st, 2020
- Verify the URL - InnovationMap - May 1st, 2020
- Houston banking exec shares tips for keeping online information secure amid COVID-19 threats - InnovationMap - May 1st, 2020
- Trials and Tribulations: Neurology Research During COVID-19 - Medscape - April 30th, 2020
- Into the Lungs and Beyond - Harvard Medical School - April 30th, 2020
- Five UC San Diego Professors Elected to National Academy of Sciences - UC San Diego Health - April 29th, 2020
- Suffering from ED? Discover how our combined treatments of Hormone Balancing and FDA Approved Acoustic Wave Pulse Therapy Ends Your ED - Magazine of... - April 29th, 2020
- BrainStorm-Cell Therapeutics to Announce First Quarter Financial Results and Provide a Corporate UpdateThursday, May 7, 2020, 8:30 am EDT - BioSpace - April 29th, 2020
- What Is The Economic Value of Receiving CAR T-Cell Therapy in an Outpatient Setting? - AJMC.com Managed Markets Network - April 24th, 2020
- Healing the heart by returning it to its infancy - FierceBiotech - April 24th, 2020
- What Factors Influence Hematological Recovery in Patients Who Receive CAR-T Therapies? - Cancer Therapy Advisor - April 24th, 2020
- Academy adds new members from UW who 'expand the boundaries of knowledge' - University of Wisconsin-Madison - April 24th, 2020
- FDA Approves New Therapy for Triple Negative Breast Cancer That Has Spread, Not Responded to Other Treatments - FDA.gov - April 24th, 2020
- A rampage through the body - Science Magazine - April 24th, 2020
- Israeli COVID-19 treatment with 100% survival rate tested on US patient - The Jerusalem Post - April 21st, 2020
- Stem Cell Therapy: A Promising Treatment for COVID-19? - Technology Networks - April 21st, 2020
- Meet the 5 female finalists for the 2020 M&T Bank John Travers Award - PennLive - April 21st, 2020
- Hackensack Meridian Health Studying the Blood of COVID-19 Survivors - The Ritz Herald - April 15th, 2020
- Reviewing the Latest Treatment Strategies in Patients with Transplant-Eligible Multiple Myeloma - Hematology Advisor - April 9th, 2020
- Autologous Stem Cell and Non-Stem Cell Based Therapies Market Industry Trends and Forecast to 2026 | Takeda Pharmaceutical Company Limited, Cytori... - April 9th, 2020
- Canadian Company STEMCELL Technologies Is an Essential Industry Partner for COVID-19 Research and Vaccine Development - Business Wire - April 9th, 2020
- 3 drug candidates authorized to treat COVID-19 patients - Korea Biomedical Review - April 7th, 2020
- Surgeon offers innovative treatments - Brunswick News - April 7th, 2020
- Health Tech: Dallas-based American Heart Association Awards $14M in Research Grants for Heart, Brain, and COVID-19 Innovation - dallasinnovates.com - April 7th, 2020
- Metrion Biosciences and International Scientific Consortium Publish Data and New Recommendations for in Vitro Risk Assessment of the Cardiac Safety of... - April 7th, 2020
- YOUR HEALTH: Something fishy to help improve eyesight - WQAD.com - April 6th, 2020
- Yiviva Announces Dosing of First Patient in Phase 2b Study of First-Line YIV-906 Plus Sorafenib Combination Therapy in the Treatment of Hepatocellular... - April 6th, 2020
- Coronavirus Business Tracker: How The Private Sector Is Fighting The COVID-19 Pandemic - Forbes - April 6th, 2020
- Treatment with CytoDyn's Leronlimab Indicates Significant Trend Toward Immunological Restoration in Severely Ill COVID-19 Patients - Associated Press - April 6th, 2020
- Coronavirus daily news update, April 6: What to know today about COVID-19 in the Seattle area, Washington state and the nation - Seattle Times - April 6th, 2020
- Celularity and Infectious Disease Research Institute will try out COVID-19 cell therapy - GeekWire - April 3rd, 2020
- Pinprick Blood Test To Identify Antibodies In Patients Approved By FDA - Kaiser Health News - April 3rd, 2020
- CytoDyn CEO Dr. Pourhassan to Appear on Fox Business Network Friday, April 3, 2020 at 2:00 pm ET to Discuss Leronlimab Treatment of 10 Severely Ill... - April 3rd, 2020
- Is There a New CAR T-Cell Treatment for Mantle Cell Lymphoma? - AJMC.com Managed Markets Network - April 3rd, 2020
- North Jersey hitting the surge - Politico - April 3rd, 2020