Southern California Research Institute Receives FDA Greenlight for Ivermectin Clinical Trial

Sep 10, 2020 | COVID-19, Hydroxychloroquine, Investor Watch, Ivermectin, News, Popular Posts, Progenabiome LLC

Southern California Research Institute Receives FDA Greenlight for Ivermectin Clinical Trial

California’s ProgenaBiome recently received the greenlight from the U.S. Food and Drug Administration (FDA) for two Phase 2 clinical trials involving investigational therapies targeting COVID-19: one of them based on hydroxychloroquine and the other ivermectin. With approved investigational new drug (IND) applications, a dynamic and accomplished California gastroenterology principal investigator, Dr. Sabine Hazan, and team now prepare to conduct important studies investigating two possible economical therapies for treating SARS-CoV-2, the virus behind the COVID-19 pandemic.

In late JulyTrialSite reported that Dr. Sabine Hazan, a prominent Malibu-based physician and researcher, and her organization called ProgenaBiome, LLC would sponsor a Phase 2 clinical trial investigating the efficacy of ivermectin in combination with Doxycycline, much like the successful combination tested by Dr. Tarek Alam from the Bangladesh Medical College, in combination of with dietary supplements including Zinc, Vitamin D3 and Vitamin C. Dr. Hazan-Steinberg was also previously profiled by TrialSite as a dynamic, patient-committed and passionate health care advocate.

Then in August, TrialSite reported that Dr. Hazan-Steinberg joined forces with Dr. Thomas Borody from Australia to form Topelia Therapeutics, a new company created to commercialize cost-effective treatments against COVID-19, including one based on hydroxychloroquine and the other based on ivermectin. TrialSite reminded that often progress is actually made by those willing to “buck the trend,” potentially leading to the possibility of economical, safe and effective treatment approaches targeting the novel coronavirus.

FDA Agrees on Investigation

Now the FDA has just issued two “Study May Proceed” letters to the clinical investigator and trial site research organization. The Southern California-based research team will commence two Phase 2 clinical trials, including two controversial therapies involving combinations with Zinc, Vitamin D3 and Vitamin C, the antimalarial drug first embraced by much of the research establishment and ivermectin. 

The Phase 2 ivermectin study NCT04482686 involves the treatment of 300 COVID-19 patients with a combination of therapies or a placebo and standard of care. The study treatment duration is 10 days with follow up for 6 months. The study drug combination includes ivermectin, Doxycycline, and dietary supplements including Zinc, Vitamin D3 and Vitamin C.

Meanwhile, the hydroxychloroquine Phase 2 study NCT04459702 seeks to determine whether a dual or quadruple therapy (involving the antimalarial drug as well as Azithromycin and Ritonavir and Lopinavir) is more effective at treating COVID-19. The FDA approved study calls for 200 participants.

Recent Ivermectin Study Results

TrialSite has chronicled the extensive use of Ivermectin to combat COVID-19 and recently reported positive results from a clinical trial at Zagazig University in Egypt. Led by Dr. Waheed Shouman, the study results reveal that based on a study size of 304 (203 in ivermectin group), ivermectin is effective as a prophylactic against SARS-CoV-2, the virus behind COVID-19. Critics undoubtedly will point to study size and a few other elements of the study, but this is the third study to evidence effectivity of ivermectin in association with COVID-19.

About ProgenaBiome

ProgenaBiome, based in Ventura, California, is a genetic sequencing research laboratory dedicated to continuing the work of the late Dr. Sydney Feingold, a doctor who recognized the power of anaerobic bacteria and spent his life correlating microbes to diseases. This group is on a mission to crack the genetic code of a trillion bacteria, fungi and viruses that live in the human gut.

Led by Dr. Hazan, the group is dedicated to patient-centered, long-term health care. Dr. Hazan is joined by a committed team of medical professionals including her husband—prominent Malibu physician, Dr. Alon Steinberg. Now ProgenaBiome, the lab, CRO and now sponsor, runs 42 ongoing clinical trials investigating immunity and disease, including six COVID-19 studies validating, testing, prophylaxis and treatment protocols for the novel coronavirus.

Lead Research/Investigator

Sabine Hazan, MD

13 Comments

  1. Walt

    About time, but 6 months follow up for an already FDA approved, safety profile known drug used by millions over the last 4 decades, seems ludicrous. Research science is failing society in this pandemic. A 10 day treatment period, tabulate the results and publish. Please spare us the old it must be safe garbage as this drugs safety profile is beyond reproach. People are still dying out there, this is not some sort of new vaccine based on unproven cell and DNA manipulation which I agree needs to be tested thoroughly, 6 month follow up is crazy in this situation. Just think about it if Ivermectin shows a relative mortality reduction of 50%, which other studies have shown, then waiting 6 months for nothing will create thousands if not tens of thousands of unnecessary deaths, more if it is actually shown to work well as a preventative treatment.

    • Adolfo Doval

      Take more time than a vaccine? Just let us know why? Why you going to take so long, IVM at the first stage take 14 days only to see results!!!!! Pls be humans .

  2. Suzanne Scott

    thank God for common sense scientists! WE NEED a treatment NOW cheap and effective GLOBAL AVAILABILITY!!!!! BIG PHARMA will try to discredit these…but the truth is already here!!!

    • Raj

      Amen👏🙏🏻👍

  3. Jason K Milner

    I’m happy the United States is starting to see the possibility of ivermectin doxycline combination might cure covid 19 I just wished they had started approving in February.

    • Kashif javaid

      In Pakistan many physicians treat covid patients with above mentioned combination succefully one of my friend also treated with this procedure although he had pcr-ve for covid-19.

  4. Paul Elkins

    Kudos to ProgenaBiome for running this study, and including supportive Vitamins/Minerals in the study (Vit C, D, and Zinc)! However, the study completion date isn’t until Jan 2023 with a Primary Endpoint completion at Aug 2022. That’s way too long to wait! Hopefully, ProgenaBiome is planning to release interim results much sooner.

    The NIH should have funded trials such as this months ago to expedite the results. The FDA should have already issued EUAs for safe repurposed therapeutics such as IVM/Doxy that have shown efficacy in early trails and studies.

  5. Dennis Abrameit

    Here’s an idea.Ivermectine is already used to treat diseases worldwide .Maybe these people that are being treated for strangeloides also have Corona at the same time and maybe ivermectin has already cured these cases,and if so would prove the value of ivermectin as a Corona cure. The interesting question is has it ?

  6. Julie Nicholson

    Professor Thomas Borody is using the Ivermectin, Doxycycline, Zinc treatment in some of the Australian nursing homes hardest hit by the Corona virus at this moment in time. We should know by the end of September to October what the results are.

    • Hoyt Nelson

      I don’t really know, but my impression is that this is a really casual thing, without the organization or data collection that would comprise a trial. GPs call the pharmacy to be told what the dosages are for Borody’s “triple therapy” (that has 5 components LOL). They try it with their patients. Maybe they make a phone call to Borody’s office someday? “Worked with most of my patients, Tommy.”

      It will be almost the worst ivermectin evidence to date, the winner being the Toronto nursing home where one floor didn’t catch covid-19 and it had two doses of ivermectin instead of 1, therefore…

      Borody might be doing it right, distributing a protocol about random assignment to IVM or no-IVM, making sure the pharmacy sends bottles with identical-looking pills so GPs can’t detect the placebos, there’s standard data collection across GPs. That might make a worthwhile study.

      I very very very much doubt that’s what’s happening. Borody’s during the TV interviews are so off-hand when he brings up the alleged GPs, I get a strong impression that all he’s done is have a staffer pass the pharmacy’s phone number to anyone who calls for BorodyMectin(tm) magic formula. Just a guess, I’d love to be wrong.

      Why is Borody being so cagey about the dosages? His is the only entry I’ve ever seen in ClinicalTrials.gov that doesn’t spell out the dosages, e.g. 200mcg/kg. He mentioned that he wants to create a blisterpack. He has 150 patents so he knows what he has to do to protect intellectual property. Does his caginess forebode an eventual patent on BorodyMectin(tm)? $399/pill for components that cost $3?

      TrialSite News knows this (TSN knows everything!) but maybe y’all don’t.

      There are two other US trials.

      https://clinicaltrials.gov/ct2/show/NCT04530474?term=ivermectin+united+state&cond=covid-19&draw=2&rank=1

      Temple University, N=200, placebo-controlled, one 12mg dose of ivermectin, primary completion date 2020-06-30

      https://clinicaltrials.gov/ct2/show/NCT04374019?term=ivermectin+united+state&cond=covid-19&draw=2&rank=2

      University of Kentucky, N=240, 4 arms, no controls, 1 are is IVM on days 1 and 2, primary completion date 2020-05.

  7. James Roguski

    Many thanks to Trial Site News for being such a great source of information. In all seriousness, TSN should receive a Pulitzer Prize for their reporting !

    I also provide an ivermectin information resource center – please review and share it with others if you find it to be valuable.

    The Complete Guide To Health dot com

    Contact me directly anytime – my phone number is on the bottom of the website.

  8. Hoyt Nelson

    Why is “Southern California Research Institute” in the title of this article?

    That’s a real organization, that’s been around since Borody was in elementary school (1973):

    https://www.duiattorneyhome.com/glossary/southern-california-research-institute-(scri)

    It publishes papers (click the icon to see the author’s affiliation):

    https://pubmed.ncbi.nlm.nih.gov/15002863/#affiliation-1

    As far as I can tell, SCRI has nothing to do with the Borody trials. According to their ClinicalTrials entries, the ivermectin sponsors are ProgenaBiome and Topelia Therapeutics, the hydroxychloroquine sponsors are ProgenaBiome and Big Corona Ltd.

    Googling for:

    “Southern California Research Institute” (hazan OR borody)

    turns up this article, nothing else.

    I’m so confused!

    • TrialSite

      Dear Hoyt,
      We don’t here refer to that specific organization but rather generically describe the actual sponsor, which happens to be a So Cal-based research institute. So the name of the group is Progenabiome which also happens to be a So Cal research institute (capitalized in the title, so hence the confusion). In this case they have also teamed up with Australia’s Dr. Thomas Borody and formed a company called Topelia Therapeutics.
      Sorry for any confusion.
      Admin

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