I just thought it would be good to remind all of us that have been here a while , and to tell those that are new that we already have a product being sold in Eastern Europe.
The patent cited on that page is owned by Harry H. Zhabilov, former CEO and now current CSO of Enzolytics.
"Rosetta Lifecare Bulgaria LTD is a drug and food supplements distributor, committed to the commercialization of its proprietary proteins for the treatment of debilitating infectious diseases. We, at Rosetta Lifecare Bulgaria LTD are proud to introduce EnzoImmune Active, an innovative dietary supplement which will help into leading healthy and happy life. We are always committed by Research & Development to bring out the new formulations and the best quality products to serve mankind.
Rosetta Lifecare Bulgaria LTD is partnering with companies with long-term experience in protein isolation and purification in immunochemistry and biochemistry along with experience in repetition with therapeutic proteins used in HIV and cancer. We also possess experience in the preparation of an application for a nutraceutical compound supplement."
It is being marketed as a LIQUID FOOD SUPPLEMENT, not a drug.
"LIQUID FOOD SUPPLEMENT in the form of a spray or drops. The active substance of the food supplement has been registered for use in the USA with FDA (NDI reg. # 1083). EnzoImunne Active is a registered trade mark of Rosetta Lifecare Bulgaria LTD and is produced under license in Bulgaria (EU) under reg. # 5293/903.
This bio-product has shown low toxicity and is well accepted by the body system. Clinical trials show improvements in immunity."
What is NDI reg. # 1083? Check out this post from this board in February.
They are meeting with US manufacturers this month. It is being marketed as a supplement instead of a drug. The FDA has been aware of their plans for over a year.
In that post I was trying to explain that Enzolytics has already brought its ITV-1 product to market in Europe, but as a dietary supplement, not a drug.
Now you may be asking why a company would decide to take a product like ITV-1, that has already been through stage 3 clinical trials, and go the supplement route.
Here are a couple of reasons to consider it.
1. There is much less regulatory red tape and further delay. For example, look at the FDA standards for marketing a supplement:
"The global dietary supplements market size is projected to reach USD 230.73 billion by 2027, registering a CAGR of 8.2% over the forecast period. The market is backed by rising health awareness globally among consumers of all age groups coupled with a considerable rise in the number of fitness centers and gymnasiums."
That article is from March 10, 2020 and doesn't even account for people wanting to boost their immune system because of COVID-19. When that is factored in, that 230 billion figure that was stated goes even higher.
Who wouldn't want a piece of that action? Supplements are sold everywhere...health food stores like GNC, grocery stores, Target, Walmart. You could make loads of money in volume sales, making $50 to $70 per sale. The EnzoImmune website in Europe sells a bottle for 59.99 Euros, which is roughly $70 dollars here.
An immune system booster/modulator that might help you get through Covid, the Flu, or even the common cold...at that low price...that is huge in its own right.
That is why Charles Cotropia said in the PR that they were meeting with manufacturers in October. EnzoImmune is going on the shelves any time now in the US.
The product is also patented through 2025, so Enzolytics has a lock until then.
We all know that Monoclonal Antibodies are the way, and Bioclonetics has the 95% effective Clone 3 patent for HIV treatment, but it has only been through in-vitro (petri dish) testing, not even primate testing.
Bioclonetics has tried for years to get funding to continue research and testing, and they have had little response as we have seen. They needed serious money if they were going to continue.
The merger with Enzolytics gives Bioclonetics two things. They get immediate working capital from Enzoimmune sales to continue their work, and they get ITV-1 to combine with Clone 3. See this part from the October 19, 2020 press release:
"This combination of our technologies is underway but will take some time due to the intricacies of the process. We do not have a date for completion of this process but will keep our investors informed as the process progresses.
All of our steps are taken with two objectives in mind. First our focus is on creating successful therapeutics against infectious diseases, including HIV and now our focus on the Coronavirus. Secondly, our efforts are also intended to increase the value of our technology and the value of our company - which directly translates into value for our investors. Please know that these are our two guiding objectives with every effort we make.
Enzolytics is a drug development company focusing on the commercialization of its proprietary proteins for the treatment of infectious diseases, including HIV. Enzolytics' flagship compound ITV-1 (Immune Therapeutic Vaccine-1) is a suspension of Inactivated Pepsin Fraction (IPF), which studies have shown is effective in the treatment of HIV/AIDS. IPF is the active drug substance of ITV-1 and is a purified extract of porcine pepsin. ITV-1 has been shown to modulate the immune system.
Our plans are to test in combination the Enzolytics ITV-1 peptide in conjunction with our anti-HIV monoclonal antibodies. There is reason to believe that there will be synergistic effect achieved with this combination therapy."
And there is this from the October 1, 2020 press release:
"The Companies plan to conduct binding studies combining the therapeutics produced by both companies to evaluate the beneficial effects and increased binding capability of the BioClonetics Clone 3 antibodies to multiple HIV isolates.
Thereafter, additional PBMC based in-vitro neutralization studies will be conducted with the BioClonetics Clone 3 recombinant antibodies in combination with the Enzolytics ITV-1 peptide. Based on the results, the best combination with be tested in primate studies at the California National Primate Research Center University of California, Davis, California."
The endgame is the true prize of a combined ITV-1 and Clone 3 product that will be marketed as a drug. They even have the UC Davis primate lab lined up to begin testing. However, getting that combined product to market may take time. Bigger payoff...longer timeframe. Maybe there will be government funding. Maybe there will be a buyout. We don't know yet.
In the mean time, they should have a steady flow of income from the EnzoImmune supplement sales, which could be substantial. They will be less dependent on outside money or government funding, which is always a good thing. They should have all the money they need to keep working on the combined product.
Great days ahead. Stay strong, Stay long, GO ENZC!!!
All of this is my opinion, based on my own research. Do your own homework as well.
From that search it looks like in addition to the straight ITV-1 product, Harry was trying to combine the ITV-1 product with hemp seed oil and kept getting shot down as a supplement because the oil contained CBD above FDA limits.
He seemed to be doing it under the Cannaworks Inc. company name.
It also looks like he tried again under the new name for Cannaworks Inc., ZBGTECH HOLDING, LLC.
The NDI 1168 from Cantech Pharma dated 11-06-2020 is for an ITV-1 and Vitamin C combination.
Found this Cantech Holding Inc. PR from 2017 which looks like ITV-1 combined with a T cell modulator by TCM Group. It was going to be a production and distribution plan in Mexico.
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