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‘I am very excited to share with all of our stakeholders the excitement we have around our COVID-19 therapies during tomorrow’s conference call, as well as our expected timelines.”
Sound familiar?
From 2014
In late July, CREW’s executive director, Melanie Sloan, asked the Securities and Exchange Commission to investigate market manipulation of Northwest Bio’s stock. (Sloan told me her organization has never been contacted by the company and has no connection to its executives, investors or directors.)
In her letter, Sloan called particular attention to Adam Feuerstein, a biotech reporter whose relentlessly negative blog posts for thestreet.com this year have not only been filled with exaggeration, mischaracterization and half-truths, but curiously have also coincided with the spikes in short trading.
On March 11, for example, the day that German regulators announced their approval and Northwest Bio’s stock broke through $10, Feuerstein was quick to weigh in with a story that the company had withheld the news for two weeks to use it to divert attention from the fact that it had failed to deliver an interim report on the results of its Phase III trial back in the United States.
The next month, on April 3, the headline on Feuerstein’s post was that Northwest Bio acknowledged that the FDA might throw out results of its Phase III study. It sounds pretty ominous.
https://www.washingtonpost.com/business/northwest-biotherapeutics-stock-woes-highlight-the-harm-of-short-sales/2014/09/26/78b99b0a-4507-11e4-b47c-f5889e061e5f_story.html
Tomorrow night the ‘road show’ begins
Webcast tomorrow to discuss methodology of statistical analysis
PR next week to announce the results
NEWS: CytoDyn’s CEO Dr. Pourhassan to Appear on DrBeen Webcast Tomorrow July 18, 2020
YouTube - DrBeen Medical Lectures
Link: https://www.youtube.com/c/USMLEOnline
Facebook: DrBeen Medical
Link: https://m.facebook.com/drbeenmedical
Date: July 18, 2020
Time: 6:00 pm PT
https://www.globenewswire.com/fr/news-release/2020/07/17/2064072/0/en/CytoDyn-s-CEO-Dr-Pourhassan-to-Appear-on-DrBeen-Webcast-Tomorrow-July-18-2020.html
New article: Blocking inflammation on the way: Rationale for CXCR2 antagonists for the treatment of COVID-19
First clinical studies using the CCR5 antagonist ler- onlimab (NCT04343651, NCT04347239) and maraviroc (NCT04441385, NCT04435522), originally developed against HIV infection, for the treatment of COVID-19 are ongoing or planned to block the migration of inflamma- tory monocytes to the site of infection. Besides monocytes, several findings hint toward an active involvement of neutrophils in disease pathogenesis. Neutrophils are known to play an important role in the establishment of lung injury and ARDS
https://rupress.org/jem/article/217/9/e20201342/151957/Blocking-inflammation-on-the-way-Rationale-for
FOR THE LATEST DEVELOPING NEWS
Click Here
Dr. Fauci speaks about monoclonal antibodies
for COVID-19 at 11:00 mark
Interesting to see this at the top of the Cytodyn home page.
https://www.cytodyn.com/
New article: BLA blues
https://seekingalpha.com/article/4358911-cytodyns-bla-blues
Important heads up...
This is what happened with Cormedix.
Data Safety Monitoring Board (DSMB) has completed its review of the interim analysis of the data from the currently ongoing Phase 3 LOCK-IT-100 study for Neutrolin®. Because the pre-specified level of statistical significance was reached and efficacy had been demonstrated, the DSMB recommended the study be terminated early. No safety concerns were reported by the DSMB based on the interim analysis. The company will submit the results of the interim analysis to the U.S. Food and Drug Administration for its review.
http://www.cormedix.com/cormedix-inc-announces-positive-results-neutrolin-phase-3-lock-100-study-based-recommendation-independent-data-safety-monitoring-board/
‘Explained simply: Refuse-to-file actions allow FDA to inform a sponsor as quickly as possible of deficiencies in an NDA or BLA, helping companies to correct such issues rather than wait for FDA to issue a complete response letter.
Incomplete applications, including applications for which minor components have not been received within 30 calendar days after receipt of the original application, as may have been agreed upon at a pre-submission meeting, may also be refused for filing, the agency explains.’
https://www.raps.org/regulatory-focus%E2%84%A2/news-articles/2017/12/when-can-fda-refuse-to-file-ndas-and-blas-new-draft-guidance-explains
Here is our answer!
CytoDyn’s Leronlimab Prevents Transmission of SHIV in Macaque Study
https://www.globenewswire.com/fr/news-release/2020/07/07/2058964/0/en/CytoDyn-s-Leronlimab-Prevents-Transmission-of-SHIV-in-Macaque-Study.html
https://www.otcmarkets.com/stock/CYDY/quote#trade-data
6.9867
-0.48
-7.49%
5.93 / 5.94 (1894 x 7000)
Real-Time Best Bid & Ask: 04:14pm 07/07/2020
Hmmm??
NEW article: Washington-based biotech company advances COVID-19 treatment trials
https://www.washingtonexaminer.com/politics/washington-based-biotech-company-advances-covid-19-treatment-trials
Leronlimab, which is under review by the FDA as a treatment for HIV, is an antibody that attaches itself to certain immune cell receptors HIV agents.
— Washington Examiner (@dcexaminer) July 7, 2020
CytoDyn studies claim it can be effective in slowing the rate of inflammatory molecules production. https://t.co/CMjfTBghIB
What is a serious adverse event?
An adverse event is any undesirable experience associated with the use of a medical product in a patient. The event is serious and should be reported to FDA when the patient outcome is:
Death
Report if you suspect that the death was an outcome of the adverse event, and include the date if known.
https://www.fda.gov/safety/reporting-serious-problems-fda/what-serious-adverse-event
———————————
In a blinded trial, death is reported as a serious adverse event and analysis is conducted to determine mortality rates for each treatment arm. Data is TBD.
BARDA no longer funding immunomodulators as support for the therapeutic class to treat COVID-19 grows
According to BioCentury’s COVID-19 Resource Center, there are more than 100 immunomodulators and immunosuppressants in the clinic to treat COVID-19. New entries this week include therapies from Evelo Biosciences Inc. (NASDAQ:EVLO), Theravance Biopharma Inc. (NASDAQ:TBPH) and Fulcrum Therapeutics Inc. (NASDAQ:FULC).
HHS’s Biomedical Advanced Research and Development Authority updated its website early this month to reflect that it is no longer accepting funding proposals for immunomodulators to treat COVID-19, or therapeutics targeting lung repair for the disease. It did not give a reason for the change.
The about-face follows the U.K. approval of anti-inflammatory steroid dexamethasone, which reduced mortality by 35% in ventilated COVID-19 patients (see “Master Protocol Shows Survival Benefit”).
The change also comes as ACTIV -- a COVID-19 consortium that counts BARDA’s parent agency as one of its members -- readies to launch a master protocol of immunomodulators this month.
The Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) consortium is led by NIH and managed by the Foundation for NIH. Its members include 18 biopharma companies, FDA, CDC and the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR). BARDA is part of ASPR (see “ACTIV Coming into Focus”).
ACTIV is planning five master protocol trials, the first of which will test three host-targeted immune modulators against TNFa, CTLA-4 and CCR2/CCR5
CCR5 (CD195) - CC chemokine receptor 5
C-C chemokine receptor type 5, also known as CCR5 or CD195
https://www.biocentury.com/article/305582/barda-no-longer-funding-immunomodulators-as-support-for-the-therapeutic-class-to-treat-covid-19-grows
The only CCR-5 inhibitor (there are no CCR-2) in clinical trials? You guessed it.
https://www.biocentury.com/clinical-vaccines-and-therapies
White House Coronavirus Task Force Members Testify on Federal Response to Pandemic
11:00am ET
https://www.c-span.org/video/?473229-1/white-house-coronavirus-task-force-members-testify-federal-response-pandemic
White House Coronavirus Task Force members Dr. Anthony Fauci, Dr. Robert Redfield and Dr. Stephen Hahn testify on the federal response to the pandemic before the House Energy & Commerce Committee.
New Video: Dr. Yo
Important: Irish woman given special permission by US officials to fly to California for ground-breaking cancer trial
https://www.thesun.ie/fabulous/5515063/irish-woman-special-permission-fly-california-cancer-trial/
GE Healthcare CyDye™ DIGE Fluor Minimal Dye Labeling Kits
https://www.fishersci.com/shop/products/ge-healthcare-cydye-dige-healthcare-fluors-minimal-dye-labeling-kits-2nmol/45002245
Merck chief casts doubt on coronavirus vaccine timeframe
Merck chief executive Ken Frazier has cast doubt on the 12 to 18-month timeframe to develop an effective coronavirus vaccine, describing the widely-mooted schedule as “very aggressive”.
https://www.ft.com/content/7b72a568-9eed-460f-b100-7bf74e3f4cbf
Wow. Remdesivir Study: Only Helped Those On Oxygen, Finds Mortality Too High For Standalone Treatment
https://www.zerohedge.com/technology/remdesivir-study-finally-out-drug-only-helped-those-oxygen-finds-mortality-too-high
Gilead gets emergency FDA authorization for remdesivir to treat coronavirus, Trump says
Is LERONLIMAB a game changer?
Wow. Experimental coronavirus treatment leronlimab resulted in 'remarkable recoveries,' developer says
https://www.foxnews.com/science/experimental-coronavirus-treatment-leronlimab-remarkable-recoveries-developer
Cancer drug athlete Sarah Wright allowed to fly to US
CytoDyn, the company that manufactures the drug, said it had offered to pay the couple's travel expenses, adding: "We will do all we can for her."
https://www.bbc.com/news/uk-england-kent-52493714
‘With our first major paper very close to publication, we expect to have a second paper published shortly thereafter, as our MOA is as unique as our results.”
-NP
54 eINDs; data from 39 patients reported
32/39 alive = 82%
At least 8 extubated; 8/18 = 44%
2 of 8 from Montefiore (previously reported)
3 of 6 from SoCal
2 of 3 from Georgia
1 of 1 from N. Carolina
Additionally:
1 of 1 from another NY hospital taken off oxygen
Dr P didn’t need to formally request rapid review...
RAPID REVIEW UPDATE:
Owing to the surge in requests for rapid review of Covid-19 submissions, we have introduced a new policy. All Covid-19 submissions will automatically be handled on our Rapid Review track; there is no need to request it. To ensure that all Covid-19 papers can be handle expeditiously, we are not accepting other requests for Rapid Review at this time.
My bad. You’re right 2-3 weeks.
I just don’t know how we can present the data early (on Friday) without jeopardizing the publication via NEJM. Journals typically do not want you to present prior to pub.
Thoughts?
NEJM: RAPID REVIEW
We may have the publication BEFORE the Friday conference call.
https://www.nejm.org/author-center/request-a-rapid-review
;)
F.D.A. Plans to Announce Emergency Use of New Drug
https://www.nytimes.com/2020/04/29/us/coronavirus-usa-cases-deaths.html
COVID-19 treatments could be fast-tracked through new national clinical trial initiative
6 potential drugs will initially enter the programme, with the first of these beginning phase 2 studies – the stage of a clinical trial focused on the testing of a drug on patients to assess how effective it is and side effects – across the UK imminently.
https://www.gov.uk/government/news/covid-19-treatments-could-be-fast-tracked-through-new-national-clinical-trial-initiative
Chinese Experts Claim COVID-19 May Become An Annual Disease
https://www.ibtimes.com/coronavirus-update-chinese-experts-claim-covid-19-may-become-annual-disease-2966401
So important to have an effective treatment for this as a vaccine is likely years away (if ever).
In case anyone missed this....
During the FDA’s review period, the Company will dedicate all resources to ensure availability of leronlimab for COVID-19 patients; Cancer programs continue with positive results
VYROLOGIX - Trademark
Check out all the other trademarks filed by Cytodyn in 2020
https://trademarks.justia.com/owners/cytodyn-inc-2285370/
Image that was filed together with name available.
Another study halted: Regeneron and Sanofii said they will shut down part of a study exploring whether their arthritis therapy could treat certain hospitalized Covid-19 patients because the drug looked unlikely to help them.
https://www.wsj.com/articles/drug-study-halted-early-for-certain-covid-19-patients-after-no-benefit-seen-11587985203
Another article: Achilles’ heel of the killer virus: the highly important molecular targets for hitting SARS-CoV-2 that causes COVID-19
‘These cytokine receptors can be targeted specifically by therapeutic antibodies such as Kevzara, Actemra, and Leronlimab or by new under-devel- oping antibodies which subsequently reduce the presence of high levels of inflammatory cytokines, within the lungs, known as cytokine storm. In fact, the main cause of death in patients with acute respiratory symptoms is not the virus itself, but the development of an abnormal condition by cor- onavirus, leading to cytokine molecular storm. ‘
https://www.researchgate.net/profile/Reza_Yousefi3/publication/340897014_Achilles'_heel_of_the_killer_virus_the_highly_important_molecular_targets_for_hitting_SARS-CoV-2_that_causes_COVID-19/links/5ea3344c45851553faacc7ab/Achilles-heel-of-the-killer-virus-the-highly-important-molecular-targets-for-hitting-SARS-CoV-2-that-causes-COVID-19.pdf
NEJM article: https://www.nejm.org/doi/pdf/10.1056/NEJMc2011117?listPDF=true
Although effective treatment of Covid-19 is currently unknown,2 immunosuppressive man- agement included withdrawal of an antimetabo- lite in 24 of 28 patients (86%). In addition, tacro- limus was withheld in 6 of the 28 severely ill patients (21%). Hydroxychloroquine was admin- istered to 24 of these 28 patients (86%). Apixa- ban was administered to patients with d-dimer levels higher than 3.0 µg per milliliter. Six severely ill patients received the CCR5 inhibitor leronlimab (PRO 140, CytoDyn) on a compassion- ate-use basis, and 2 received the interleukin-6 re- ceptor antagonist tocilizumab. Interleukin-6 levels were very elevated (range, 83 to 8175 pg per mil- liliter) when leronlimab was initiated (on day 0) in the 5 patients with elevated interleukin-6 lev- els; these levels decreased markedly 3 days later (range, 37 to 2022 pg per milliliter) (see Table S2 in the Supplementary Appendix). However, only the 1 patient who had the lowest interleukin-6 level (at 83 pg per milliliter) remained in stable condition without intubation.
Supplemental Table (page 7)
https://www.nejm.org/doi/suppl/10.1056/NEJMc2011117/suppl_file/nejmc2011117_appendix.pdf