TrialSite recently reported that a California gastroenterology investigator, Dr. Sabine Hazan, was spearheading an Ivermectin-based combination study in Southern California. Now disclosed, the study collaborator includes Topelia Therapeutics, a new company formed by Dr. Hazan and leading Australian Ivermectin advocate Dr. Thomas Borody and others from both Australia and Progenabiome, LLC. Their first apparent commercialization target: Ivermectin as a treatment for COVID-19 in addition to early onset use of Hydroxychloroquine in combination with antibiotics and vitamins targeting COVID-19. The company’s principals apparently aren’t afraid to buck some trends, possibly to the ire of elements of the research and medical establishment.
Recently, TrialSite reported on a new study in California led by Dr. Sabine Hazan. Led by a biome-focused research organization called Progenabiome, LLC, the Phase 2 study investigates the efficacy of Ivermectin in combination with Doxycycline, similar to the successful combination reported by Dr. Tarek Alam from the Bangladesh Medical College. Separate and apart, TrialSite received enormous interest (and direct messages) in regards to the recent updated article from the prominent Australian scientists and physician Dr. Thomas Borody. Authored just days ago, thousands of people are following this researcher’s work.
Company Studies Economical and Available Therapies: But not ‘Politically Correct’
Now Dr. Thomas Borody has come together with Dr. Hazan and her colleagues from Progenabiome LLC, including prominent Southern California physician Alon Steinberg, well-known gastroenterologist Robert Clancy (associated with Dr. Borody at the Center for Digestive Diseases), patent attorney Daniel Cislo, and Malibu-based corporate counsel Lee Sacks to form Topelia Therapeutics.
Dedicated to investigating microbiome therapeutics at the clinical level, the venture seeks data that is “validated, verified and reproduced” in their bid to develop safe and effective therapies. Their mission: develop global solutions that provide peace and healing for all.
Topelia Therapeutics now is a partner in the Phase 2 combination Ivermectin and Doxycycline Phase 2 clinical trial led out of Progenabiome, LLC. The study team seeks up to 300 patients in this double-blind, randomized, placebo-controlled trial of a combination therapy to treat COVID-19 infection.
Not yet recruiting, the experimental arm of the study includes a treatment of Ivermectin (day 1 and 4) combined with a 10 day treatment of Doxycycline as well as 10 day treatment of Zinc, Vitamin D3 and Vitamin C.
This study is for those individuals that sign informed consent, have been tested positive for COVID-19, are between the ages of 18 and 75, not obese, and agree (if child rearing) to two birth control methods and agree to attend the treatment facility for 10 days. Those with comorbidities and more severe COVID-19 cases won’t be eligible.
Other COVID-19 Studies: Focus Hydroxychloroquine
The new venture has announced other studies with a focus on combination therapy centering on the early stage use of Hydroxychloroquine. See the link.
The new venture also announces other COIVD-19 focused studies including:
· Phase 2 interventional study including Hydroxychloroquine, Azithromycin, Vitamin C, Vitamin D and Zinc to treat COVID-19 infection
· Phase 2 open-label interventional study to test the efficacy of ResCure™ in treating COVID-19
· Combination study involving COVID-19 infection
· Phase 2 interventional study investigating the efficacy of quintuple therapy (HCQ, Azithromycin, Vitamin C, Vitamin D and Zinc) targeting COVID-19 infection
Born in Morocco, Dr. Hazan has dedicated it all to understanding life. With a residency completed at the University of Miami during the peak of the HIV epidemic, she learned quickly in the trenches taking care of extremely ill patients at Jackson Memorial Hospital and in the local jail. She was awarded prizes for her research early on. After her residency, Dr. Hazan became the first woman gastroenterology fellow at the University of Florida. There she accomplished a year of research and presented her findings in poster format at the American College of Gastroenterology (ACG) National Meeting. She learned of the microbiome then from Dr. Neil Stollman. After a successful practice in New York and engagement with the Canadian government, Dr. Hazan relocated to California and embarked on a successful career in clinical trials with husband and business partner Dr. Alon Steinberg.