Some notes/quotes, from interviews...
5/24 Interview...
"we're starting with E. Coli because E. Coli account for 70% of sepsis infections, but we're branching off to other bacteria, both gram positive and gram negative bacteria."
"We prefer to go after non-human genes such as the genes in bacteria or virus or fungii because that optimizes a lot of our procedures..."
"First of all, what tends to work in a small animal, will work in a large animal, will work in humans. There's a smaller likelyhood of generating some sort of immuno-genic problem."
"Second, we have found a delivery system that works for bacteria that are in the bloodstream." (anyone stating otherwise is basically calling Dr. Skolnick a liar, which, of course, are 'fightin' words')
"We're about to make the transition from mice to a larger animal and we are in the process of preparing our project plan for submission to the FDA; Pre-IND, IND and all the rest."
The PR's...
1) "annoucement of another patent filing"
2) "following that, we'll probably have some more results from the latest wave of experiments. We also have some good results in some our other experimental areas.
3) "we have some staff expansions in the works"
4) "And, we're working on getting some stability in the funding for the company, there will be some releases about that as we go forward."
5/26 Interview...
The gram negative bacteria, upon death, release the toxins that cause the host, human patient, to die, as in blood poisoning. Gram positive bacteria is a little bit different, but not much.(not a quote)
"There is a ceratin bacterial load that the body can handle. When the bacterial load gets to be above a certain level, serious illness or death generally result. What we aim to do is keep the bacterial load below that level and let the body's own defenses do what they need to do best."
"We are on a regular track to get our stuff to the FDA to get approval in what's called an IND application. Our next step is... well, actually, we have three next steps. We are doing the toxicology that the FDA requires, we're doing the microbiology that they require, and we've pretty much completed our studies in small animals which have been mice and we're going to a large animal and we're trying to decide whether that will be dogs or pigs. And we're consulting with FDA con-...knowledgeable people who seem to think they know the best models that the FDA will look at. We will start those animal trials probably within the next couple of weeks and gather the data and we're hoping to get to the FDA for a pre-IND conference sometime...end of the third quarter, fourth quarter and we're hopeful could actually be in clinical trials in the first quarter of 2005."
"So far, we've experimented with injections. We put the material directly into the bloodstream and let it circulate because that's where the bacteria are. And, we found a way to make our technology penetrate into bacterial cells...it doesn't seem to penetrate into mamillian cells...or the body's cells, and so we think it's going to be both effective and safe and we're looking forward to seeing some additional results in large animals and getting it into humans and to market."
Working on other bacteria besides the E. Coli which is responsible for about 70% of septic infections. (Not a quote)
"Our technology lets us, with a screening library, find the particular sequences we need to make to go after various bacterial genes and we're trying to enlarge the sphere so that it isn't just one gene that's our target."
7/12/04 Interview…
“…the biggest problem with staph A. is that there are various strains of it that have become totaly resistant to virtually every antibiotic and we are now testing sequences against those strains and hope to have some results shortly to show that the same techniques that we’ve used against e.coli will work against staph and strep.”
“We’re going to larger animals now and we’ll take that data to the FDA and all the other data we’ve compiled about the pharmacology and the microbiology the FDA requires and apply for what’s called an Invetigational New Drug application so that we can then go to clinical trials and test it in humans. We are also readying our Herpes compund for submission to the FDA”
7/14/04 Interview…
“We’re working very hard for getting our first two products to go to the FDA for what’s called an Investigational New Drug application so we can conduct clinical trials... our major concentration is getting these ready to go and satisfying FDA requirements. We’re also applying for some more small business innovation research grants. We’ve recievd two and we have two more in the pipeline.”
7/28/04 Interview…
Regarding the patent PR - “…as we develop new scientific results, we add them to what we’ve already done and add claims to protect the new material….file first in what’s called the national phase, the United States and then we extend those patents to worldwide protection in selected countries.”
“We’ve now started experimenting with ‘VRSA’ and ‘MRSA’ and began to see some interesting and positive results in that area and that will probably be the subject of the next major patent filing in addition to some of the results we’ve gotten from our animal sepsis experiments.”
“One of the most exciting areas for us is what we’re able to do now against the resistant bacteria. We’re finding that the approach works since we’re doing it against these fundamental genes across whole stains of various species like staph. Staph doesn’t know when its…we talk about this fundamental gene that it’s resistant or not so we’re having some good success going after it.”
8/4/04 Interview…
“There are certain kinds of tests that you just need to complete before you can go to the FDA for what’s called a pre-IND conference and then apply for the Investigational New Drug application which is what we’re going to do. We think we’re getting very close to being able to do that with the Herpes product and following closely behind with the anti-microbial.”
“What we’ve seen so far is that the application of the cream can, if it’s applied when the prodrome or the tingling starts, say for labial herpes, can prevent the lesion from forming. When its applied to the lesion, it seems to go away faster. People who have used (the herpes cream) found that the frequency between attacks seems to decrease, that is the length of time seems to increase. “
“All of these kinds of results are just anecdotal, they don’t count for very much when you go to the FDA. We have to go into a bonafide and sanctioned clinical trial and that’s what we hope to do.”
“We are in the hands of what I would call the FDA apparatus, although the FDA is not supervising it, they have certain procedures that you have to go through, for instance, with the anti-microbials, we have to do what are called minimum inhibitory concentration tests and we’ve started those. And, there are a couple of other things that are just absolutely essential that they require and we’re just marching down the line trying to knock off one at a time.”
AI
