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Adding on all these dips
Going to be a wild ride
Treatment with CytoDyn's Leronlimab Indicates Significant Trend Toward Immunological Restoration in Severely Ill COVID-19 Patients
Most recent 3-day laboratory results from 8 severely ill COVID-19 patients are promising
April 02, 2020 06:00 ET | Source: CytoDyn Inc.
VANCOUVER, Washington, April 02, 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 three-day effect of leronlimab in eight severely ill COVID-19 patients demonstrated a significant improvement in several important immunologic bio-markers. Patient test data reveals improvement in cytokines, IL-6, and a trend toward the normalization of the CD4/CD8 ratio.
The Company’s investigational new drug, leronlimab, has been administered to 10 severely ill patients with COVID-19 at a leading medical center in the New York City area under an emergency IND recently granted by the FDA. The Company recently initiated enrollment in a Phase 2 trial for leronlimab treatment of COVID-19 patients with mild-to-moderate indications and under the same IND, is now proceeding with its second COVID-19 clinical, a Phase 2b/3 trial for the treatment of critically ill patients.
Bruce Patterson, M.D., Chief Executive Officer and founder of IncellDx, a diagnostic partner and advisor to CytoDyn, commented, “We are very pleased with our most recent laboratory data for patients treated with leronlimab for COVID-19 infection. We continue to see increases in the profoundly decreased CD8 T-lymphocyte percentages by Day 3, normalization of CD4/CD8 ratios, and resolving cytokine production including reduced IL-6 correlating with patient improvement. The current data suggests a trend toward the restoration of immune function and mitigation of the cytokine storm. This is consistent with prior laboratory results in the first four patients treated for COVID-19 with leronlimab.”
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, said, “As leronlimab continues to provide hope for many patients, our management team is focused to ensure we can distribute the drug across the country in a timely fashion. These results, although anecdotal, appear to be very promising. We are now initiating enrollment for two clinical trials, first trial is a Phase 2 for mild-to-moderate and second trial is a Phase 2b/3 for a severely ill population.”
About Coronavirus Disease 2019
SARS-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 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 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.
CYTODYN CONTACTS
Investors:
Dave Gentry, CEO
RedChip Companies
Office: 1.800.RED.CHIP (733.2447)
Cell: 407.491.4498
dave@redchip.com
https://www.globenewswire.com/news-release/2020/04/02/2010581/0/en/Treatment-with-CytoDyn-s-Leronlimab-Indicates-Significant-Trend-Toward-Immunological-Restoration-in-Severely-Ill-COVID-19-Patients.html
Off to the races
Pushing towards $3
So much pressure building.
Very tightly wound. Getting ready to breakout.
Big money loading here
Picked up a nice pile of shares today. Amazing stuff that I've read and listened to. Much needed in this time of global crisis.
Have to hit the ask if one wants shares and don't get much too.
Nice ask slaps going into last hour. Very grateful for those low .04s earlier.
Added a few more to the stash. Patience will pay off.
Much appreciated.
What a shame
Scooped up some of those .0472s
Fidelity restricts buying of penny stocks that show a stop sign.
Great opportunity here. Will be getting a starter position this week and look to add as possible.
This week per reply.
Yes. It should be out this week.
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EMPM
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New post on the Korean forum: http://www.ipo38.co.kr/forum/?o=v&code=268400&no=968&page=1
Same, added with some spare cash I had. Ridiculous gifts of shares given away.
Gifts staring in front of everyone's eyes. No one to blame except yourself if you do not take advantage of these ridiculous prices.
Picked up a few of those .07s even though my bid was much higher.
Adding time
No surprise considering the filing yesterday about amending prior 10-Qs and 10-Ks. Anticipating the filings will be all ready before the name change for the 20th of next month.
Selling dried up. Just two MMs sitting under .26 at the moment.
Happy to see them being proactive and not waiting till the SEC raises concerns.
Thank you as always
EMPM .25s starting to go
Ibox has been updated and cleaned up a bit.
Nice blast of the ask
Thinning out just before opening
Yes, and no reverse split either as commonly found in these 14c statements.
$EMPM Name change to Saean Industries, Inc official per SEC filing released this morning.
https://www.sec.gov/Archives/edgar/data/1478682/000149315220002132/pre14c.htm
$EMPM Name change to Saean Industries, Inc official per SEC filing released this morning.
https://www.sec.gov/Archives/edgar/data/1478682/000149315220002132/pre14c.htm
.22 block being chipped away
Nice block buy
I've had zero worries since my first purchases back in early June last year. Only the strong willed will see the big payout when it is all said and done.
No sizeable shares for sale