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The mutated spike form has a substitution at the 614 amino acid position with aspartic acid (D) replacing glycine (G). Essentially, D614G means D substituted at the 614 position for G. Supposedly, it makes it more virulent.
"D614 means the original form; the mutant form is referred to as D614G, or just G614.The coronavirus that causes COVID-19 uses its Spike protein to infect human cells. D614G refers to an amino acid mutation in this protein that has become increasingly common in SARS-CoV-2 viruses from around the world. The Spike protein (S) is a string of 1,273 amino-acids; in the original form from Wuhan the 614th of these amino acids has the chemical symbol “D” (aspartic acid), while in the mutated form, the 614th amino-acid is abbreviated “G” (glycine); so S D614G is short for “having a Spike protein with aspartic-acid at position 614 mutated to glycine.""
(From https://www.lanl.gov/updates/sars-cov-2-variant.php#d614g )
One note on this is much fewer of these patients in the M/M Phase 2 study were even in the hospital at onset. Reduction in hospitilization and oxygen needs differentiation is more seen borne out in SAE's then recovery from interventions.
CytoDyn’s Leronlimab Prevents Transmission of SHIV in Macaque Study ( https://www.cytodyn.com/newsroom/press-releases/detail/446/cytodyns-leronlimab-prevents-transmission-of-shiv-in )
July 07, 2020 5:02pm EDT
Results of preclinical study presented today in oral presentation at the 23rd International AIDS Conference (AIDS 2020)
VANCOUVER, Washington, July 07, 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 clinical indications for HIV, COVID-19, cancer, GvHD and NASH announced today the results from a preclinical macaque study evaluating leronlimab as pre-exposure prophylaxis (PrEP) to prevent sexual HIV transmission. The study evaluated the impact of a macaque-equivalent dose of either 350 mg (once weekly) or 700 mg (bi-monthly) leronlimab on acquisition of infection in a total of 18 animals, and found that the equivalent 700 mg bi-monthly leronlimab dose completely prevented rectal transmission of Simian-Human Immunodeficiency Virus (SHIV) in macaques. These results were presented today in an oral presentation titled “CCR5 antibody blockade protects rhesus macaques from rectal SHIV acquisition" at the 23rd International AIDS Conference (AIDS 2020).
“The results reported here in the preclinical macaque model of HIV sexual transmission support leronlimab as a possible PrEP agent at a time when long-acting human HIV PrEP options are limited,” said Dr. Jonah Sacha, Professor at Oregon Health & Science University, and the study’s lead investigator.
“We are eager to build upon these preclinical results describing leronlimab’s utility in HIV prevention by initiating clinical studies for leronlimab as a PrEP treatment. Current PrEP options require a continued daily dosing regimen in order to be effective and are inherently difficult to maintain in the long-term,” said Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn. “Coupled with its safety profile, leronlimab could offer a much needed simple and long-lasting preventative treatment option for people at risk of HIV infection,” concluded Dr. Pourhassan.
Subscribe to Dr. Been's Youtube channel and you'll get a notification when he goes live with the link to the interview with Dr. NP.
https://www.youtube.com/c/USMLEOnline
All good! Long and strong CYDY here for 4 years and loving the price action of late.
Just got to get this to the patients that need it!
I believe the study protocols were inverted from this so far for Covid; namely, for every 2 patients that received Leronlimab, only 1 patient received a placebo.
CytoDyn to Hold Conference Call to Provide Updates on COVID-19 (Phase 2, 3 & eIND), Cancer (mTNBC, Phase 2 for 22 Solid Tumor Cancers), HIV (BLA, Monotherapy), NASH, GvHD and MS
( https://www.cytodyn.com/newsroom/press-releases/detail/434/cytodyn-to-hold-conference-call-to-provide-updates-on)
VANCOUVER, Washington, May 22, 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 Nader Pourhassan, Ph.D., President and Chief Executive Officer, and Jacob Lalezari, M.D., Chief Science Officer, will host an investment community conference call on Tuesday, May 26, 2020 to provide a comprehensive update on several recent clinical and regulatory developments.
Management will dedicate approximately 30 minutes to address questions from analysts and investors.
Date: Tuesday, May 26, 2020
Time: 1:00 p.m. PT / 4:00 p.m. ET
Dial-In: 877-407-2986 US / 201-378-4916 International
A live audio webcast may also be accessed via CytoDyn’s corporate website at www.cytodyn.com under the Investors section/IR Calendar and will be archived for 30 days. Web participants are encouraged to go to the website 15 minutes prior to the start of the call to register, download and install any necessary software. The webcast can also be accessed via the following link:
https://78449.themediaframe.com/dataconf/productusers/cydy/mediaframe/38441/indexl.html
A replay of the conference call will be available until June 26, 2020. To access the replay, interested parties may dial 877-660-6853 (US) / 201-612-7415 (international) and enter conference identification number 13702767.
CONTACTS
Investors:
Dave Gentry, CEO
RedChip Companies
Office: 1.800.RED.CHIP (733.2447)
Cell: 407.491.4498
dave@redchip.com
Awesome presentation on the MOA for Leronlimab and very well detailed in easy to understand visuals!
Great presentation on the MOA and science behind Leronlimab by Dr. Been on YouTube!! Close to 300 live watchers for his live stream on it and almost 700 views so far since his ~1 hour long stream at 6 PM PST.
Dr. Been (Drbeen Medical Lectures) Live on YouTube talking about Leronlimab
From Yahoo Finance article "How Gilead's coronavirus drug breakthrough is setting the tone for other potential treatments"
https://finance.yahoo.com/news/gilead-news-sets-tone-for-coronavirus-treatment-potential-160507199.html
While there’s more work ahead, one thing is clear from the clinical trial results — the COVID-19 drug development landscape now has a clearer path forward. As Gilead’s CEO put it on Thursday, “one now has to compare with remdesivir or work with remdesivir.”
Leronlimab comparison with Remdesivir will be no comparison. Leronlimab will show superiority in all categories.
Here's where it's located on another ETF:
https://eqminqubator.com/covid-19-stock-index/
Initial companies on the Covid-19 Stock Index:
https://eqminqubator.com/covid-19-stock-index/
On the lastest Proactive Investors video, NP indicated that the study by the Italian PRESTIGIO Registry Study Group was in vitro and not in vivo. As stated in the PR, this was done via isolates for MDR-4 resistant patients.
Is there any chance in vivo results could differ with biological systems at play?
I'll raise that and give 8 cents, 9 cents even. I'll absorb all I can. Just let me know :D
CytoDyn Announces Data From Two Studies at the AACR Annual Meeting
STUDIES DEMONSTRATE THE EXPRESSION OF CCR5 AS A NOVEL BIOMARKER IN CIRCULATING TUMOR CELLS OF HER2 METASTATIC BREAST CANCER (MBC) PATIENTS AND THE ABILITY OF CYTODYN’S LERONLIMAB (PRO 140), A CCR5 INHIBITOR, TO BLOCK MBC
VANCOUVER, Washington, April 01, 2019 (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, highlighted two studies that will be presented on April 1st at the American Association of Cancer Research (AACR) Annual Meeting taking place March 29 to April 3 in Atlanta, Georgia.
The first study will present data showing the expression of CCR5 in circulating tumor cells (CTCs) of HER2 metastatic breast cancer (mBC) patients and documents the correlation between CCR5 and HER2 expression in CTCs. The second study will highlight murine xenograft data showing that CytoDyn’s humanized monoclonal antibody, leronlimab (PRO 140), can effectively block human breast cancer metastases and enhance the cell killing ability of DNA damaging chemotherapy by selectively targeting the CCR5 receptor.
“The key discoveries being announced today potentially contribute to a shift in the treatment paradigm for metastatic breast cancer patients,” stated Professor Richard G. Pestell, M.D., Ph.D., M.B.A., F.A.C.P., F.R.A.C.P., Chief Medical Officer and Vice Chairman of CytoDyn. “There are three key findings from today’s presentations. First, we now know that CCR5 is overexpressed on CTCs of HER2 metastatic breast cancer patients. Second, we now show in xenograft models that leronlimab (PRO 140) can effectively block CCR5 positive breast cancer metastasis,” continued Dr. Pestell. “And, third, we have now shown in murine xenograft models that by reducing the ability of breast cancer cells to metastasize, thereby keeping the tumor more contained, leronlimab can potentially provide standard DNA damaging chemotherapies more time to work. Potentially providing significantly improved efficacy of existing cancer therapies with fewer side effects,” concluded Dr. Pestell. CytoDyn has now opened a clinical trial (NCT03838367) that is assessing the efficacy of leronlimab (PRO 140) in metastatic triple negative breast cancer and will measure CTCs in the enrolled patients.
About Leronlimab (PRO 140)
The U.S. Food and Drug Administration (FDA) has granted a “fast track” designation to leronlimab (PRO 140) as a combination therapy with HAART for HIV-infected patients. Leronlimab (PRO 140) is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that appears to play multiple roles with implications in HIV infection, tumor metastases and immune signaling. Leronlimab (PRO 140) has successfully completed nine Phase 1/2/3 clinical trials in over 700 people, including a successful pivotal Phase 3 trial in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients.
In the setting of HIV/AIDS, leronlimab (PRO 140) belongs to a new class of therapeutics called viral-entry inhibitors; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab (PRO 140) has been the subject of nine clinical trials, each of which demonstrated that leronlimab can significantly reduce or control HIV viral load in humans. The leronlimab (PRO 140) 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 likely plays a central role in tumor invasion and metastasis and that increased CCR5 expression is an indicator of disease status in several cancers. Moreover, research has shown that drugs that block CCR5 can block tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. CytoDyn is conducting additional research with leronlimab (PRO 140) in the cancer setting and plans to initiate additional Phase 2 human clinical trials, in addition to triple-negative breast cancer, when appropriate.
The CCR5 receptor also appears to play a central role in modulating immune cell trafficking to sites of inflammation and may be crucial for 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 (PRO 140) to further support the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD and that blocking this receptor from recognizing certain immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted “orphan drug” designation to leronlimab (PRO 140) for the prevention of graft-versus-host disease (GvHD).
About CytoDyn
CytoDyn is a biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab (PRO 140), 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 in immune-mediated illnesses, such as graft-vs-host disease (GvHD) and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab (PRO 140) in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients. CytoDyn plans to seek FDA approval for leronlimab (PRO 140) 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 (PRO 140) 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 (PRO 140) for the prevention of GvHD and has received clearance to initiate a clinical trial with leronlimab (PRO 140) 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.
CONTACTS
Investors:
Nader Pourhassan, Ph.D.
President & CEO
NPourhassan@CytoDyn.com
Marek Ciszewski, J.D.
Edison, Inc.
MCiszewski@EdisonGroup.com
https://ir.cytodyn.com/press-releases/detail/323
FDA Grants Rolling Review for CytoDyn’s Planned BLA for Investigational HIV Therapy Leronlimab (PRO 140)
FIRST PORTION OUT OF THREE PORTIONS OF BLA TO BE FILED IN MARCH
VANCOUVER, Washington, March 04, 2019 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, today announced that the FDA has reviewed and accepted CytoDyn’s request and plan to submit on a rolling basis its planned Biologics License Application (BLA). Leronlimab (PRO 140) is a humanized IgG4 mAb that is subcutaneously injected to block HIV-1 from entering and infecting immune cells.
“We are extremely proud of the effort of our entire team to reach this very important milestone,” stated Dr. Nader Pourhassan, President, CEO and Director of CytoDyn. “We are grateful to the FDA for its timely and professional review and acceptance of our request for a rolling review of our planned BLA for PRO 140. As previously announced, we expect to complete the first section (of three) of the BLA for PRO 140 with submission to the FDA in March 2019.”
https://ir.cytodyn.com/press-releases/detail/319
Good find....very interesting what the next few months will bring!
Key events next week - healthcare https://seekingalpha.com/news/3369706?source=ansh $QTNT, $UNH, $JNJ, $CYDY, $CAPR, $PFE, $ALPMF, $ALPMY, $LCI
Anyone hear anything about a business update next week?
Good thoughts. I wonder if anyone has done any thorough analysis with any statistical weight on this in any ad-hoc, published, or peer reviewed paper. Might add more credence to the PR if this was available as this latest PR was a non-mover, at least publicly in terms of SP, etc. Hindsight will always tell the tale and can't come soon enough!
https://m.facebook.com/patienteight/
Been watching for this patient for the past year....data on this patient is extremely promising. Sample size n =1 but just need to see the data on more. It's just around the corener...
8K just dropped
Investor conference call set for April 18th. Hope we see progress and updates on all our concerns and movement towards getting this product in the hands of the HIV patients that need it.
http://ir.cytodyn.com/press-releases/detail/255
I'm interested too. I tried to jump in with calls to Paulson but didn't get anywhere there. How do I get involved with these for future reference?
LOL....Had to post on this one.
Here's to expecting BTD granted in next several days and stellar adjunct data shortly after.
Hope my and others DD and bated breath and can be fulfilled and raise the bar on HIV treatment for many patients' benefit.
Nice pop there after lunch...looks like MM's are letting it go as buying pressure increases. Let's see if it's sustained.
No news announced yet on the eve of so many catalysts brings out people's tendency to create news and discussion....hence the board this week. Some was light-hearted while other was mean-spirited; let's keep the personal attacks off this board and collectively continue our dd and discussion on CYDY with the lively banter and camaraderie of previous weeks. Conflict can bring alignment and new facts to light but not when it's personal and directed at others and not revolving around the data, opinions, and facts at hand with CYDY. Here's to a good next week and some news of catalysts imminently approaching!
For those who haven't seen this, https://m.facebook.com/patienteight/ is the public Facebook profile of a patient with success on PRO-140. He's on week 9 of extension study with an update from February 15, 2017.
VL from November 2016 is < 20 while on PRO-140 while before (Nov. 2015) VL was at 696 and at a high once of 97K. He contracted HIV in 1985 and AIDS in 1995. Looks like PRO-140 is the solution for him and hope to be soon many others with this disease state.
Would have held a core long position and swing traded on ups and downs with earlier entry. Originally entered around $1.10 last summer but exited prior to dilution and timed reentry in the upper $0.60's.
Indeed I do count myself lucky on my entry point now but even an entry in the low $1's and averaging down over time til today would still position me and others in a great position for upcoming catalysts with a multi bagger on our hands. Just depends on hitting upcoming milestones and based on my dd and the additional discussion on this and other forums see amazing potential. Best of luck to all!
Charlie Sheen's interview hit front page of Yahoo.com with the following quote:
"I am so grateful," Sheen told Strahan, "for eight months now, I've been enrolled in an FDA study ... for a medication for a drug called PRO-140," adding that the drug is in the "late stages" of its trial run and "very close to being approved."
(Link: https://gma.yahoo.com/charlie-sheen-opens-battle-hiv-feel-im-carrying-122449346--abc-news-entertainment.html)
Long time lurker here but definitely LONG since summer 2016 with a position that I continue to add to...looking forward to the movement over this next year!! Wish I had heard about this before last year though but the time is ripe for catalysts to let this reach its potential!