Here are my thoughts and opinions on the latest PR :
"The Phase 1 clinical trial of Kevetrin targeting solid tumors at Dana-Farber Cancer Center and Beth Israel Deaconess Medical Center is progressing as expected with the next cohort to begin treatment at escalated dosing levels. Studies evaluating the p21 biomarker will soon begin and the first data report is expected in mid-March."
- "progressing as expected" is a big deal, because we know how often the expected low toxicity of kevetrin has been touted in past PRs and company statements. So as stated all cohorts are moving forward, which really speaks for itself. Data is king to Dana Farber, and they like what they see so onward and upward they go. Aside from the dosing elevation, Dr Menon personally coming out and once again mentioning P21 studies is very telling, and sets up a potentially very big market catalyst for roughly one month from now. The first data report is expected in mid march, and if all goes well, i could envision another PR that clearly and comprehensively announces P21 expression is confirmed, and P53 is activated.
- This is the big "it works" announcement with proof that kevetrin is directing a newly repaired "guardian angel" P53 gene to fight cancer cells once again. Don't underestimate the impact of the marketability of being able to talk about the guardian angel gene fighting your cancer for you, this can grab the attention of the non-investor average Joe pretty quickly. This should turn some heads in the press and may generate significant airplay for the company as it is making a major medical breakthrough. This is one announcement that I think many are eager to hear. I would not be surprised if as a result of this announcement, we get a "wild card" event soon after like the NY Times article back in december, but with CTIX and Kevetrin as the center of focus.
“We are excited by the advancement of the clinical trials of Kevetrin as we move toward finding the MTD (maximum tolerated dose),” said Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. “While we are still early in the trials, we are eager to receive information on the p21 biomarker as it could represent a major breakthrough in cancer research. There has been no shortage of commentary and discussions in the scientific community recently about the latest initiatives of the U.S. Food and Drug Administration to further expedite novel drugs to market for areas of great unmet medical need. Obviously, we will be exploring this option for Kevetrin, however an application for this type of rapid movement through the regulatory process can only be made after the completion of the phase 1 clinical study.”
- a couple of exciting statements here.
1. Again the P21 reference, including IMO purposely building anticipation ("eager" for info) and excitement by clearly stating that this can be a major breakthrough in cancer research. A statement like this would not be put into a PR unless there is a great deal of confidence in the results to come.
2. The discussion of expediting novel drugs is very promising, especially how its mentioned in the broader context of the discussions across the biotech industry. to me this is subtle but purposeful as it does all but flat out say "we are going for breakthrough designation" when the time is right and the data is there to support it. I cant help but think of PC_C and what that designation has meant for that company so far.
Regarding Prurisol, Dr. Menon and Cellceutix Chief Executive Officer Leo Ehrlich have recently returned from meetings with Dr. Reddy’s Laboratories Ltd., (Dr. Reddy’s”), a New York Stock Exchange listed company, at Dr. Reddy’s state-of-the-art manufacturing facility and headquarters in Hyderabad, India.
Dr. Reddy’s has completed the process development of Prurisol and is now in the formulation stage for the manufacturing of Prurisol for the upcoming clinical trials in Europe planned for the second quarter of 2013.
- another anticipated and now confirmed development for Prurisol, all systems go for production of the final product in preparation of the POC trial coming up soon in Europe
“At our meetings with Dr. Reddy’s, we met with over twenty scientists working on the Prurisol project. I was very impressed with the comprehensive scientific team that they have dedicated to our project,” said Leo Ehrlich. “While they had already informed us that they had reduced the number of manufacturing steps, Dr. Reddy’s has now advised that they have further condensed the process, which is delivering much higher yields than originally anticipated that ultimately will save us valuable time and money in the production of Prurisol.”
- confidence inspiring statement - the supply chain for the final product offers a top level scientific team offering impeccable quality, even further increased efficiency, reduced lead time, and reduced cost of production - something that will have a big implication not only for the company and the upcoming trial, but for product valuation once the trial proves that prurisol works. This is shaping up to be a very attractive, effective, lean and mean product ready to go to the highest bidder when that time comes.
The Company is pleased to report that the recently filed registration statement with the Security and Exchange Commission is now effective, thus concluding the imposed “quiet period”. Additional updates on the planned studies testing Kevetrin against Acute Myelogenous Leukemia at the University of Bologna as well as other corporate developments relating to research on Kevetrin at a world-renowned cancer center in the Southwest United States are forthcoming shortly.
The statements about the quiet period ending and the Euro trial and SW cancer center announcements are also purposely put one after another, to basically make a pre-announcement that further confirmation and info is on the way "shortly", which in my opinion could be as soon as next week or a few weeks at most. We've learned from a prior PR that they've been working on the SW cancer center agreement, so it wouldn't surprise me if they have this lined up and ready to announce very soon now that the quiet period is concluded.
All in all, this is really just a wide ranging and comprehensive update on all fronts, and continues to build on the momentum of the Dana Farber trial, while also continuing to establish the narrative that Cellceutix is rapidly moving out of the realm of the speculative, and into the arena of established hard clinical trial data, upcoming proof of efficacy, and a rapid management execution of a solid business plan that will serve the company and shareholders well when it is time to step up to the plate with the FDA and/or big pharma.
All just my humble opinion of course, but this PR was more than i hoped for and has made my whole weekend! I know we suck at predicting SP as evidenced by the Dec 1st contest, but IMO i think we have enough going on here that its not unreasonable to think we could see double the current SP by spring time possibly? Time will tell, its going to be an interesting ride for us all
"The Phase 1 clinical trial of Kevetrin targeting solid tumors at Dana-Farber Cancer Center and Beth Israel Deaconess Medical Center is progressing as expected with the next cohort to begin treatment at escalated dosing levels. Studies evaluating the p21 biomarker will soon begin and the first data report is expected in mid-March."
- "progressing as expected" is a big deal, because we know how often the expected low toxicity of kevetrin has been touted in past PRs and company statements. So as stated all cohorts are moving forward, which really speaks for itself. Data is king to Dana Farber, and they like what they see so onward and upward they go. Aside from the dosing elevation, Dr Menon personally coming out and once again mentioning P21 studies is very telling, and sets up a potentially very big market catalyst for roughly one month from now. The first data report is expected in mid march, and if all goes well, i could envision another PR that clearly and comprehensively announces P21 expression is confirmed, and P53 is activated.
- This is the big "it works" announcement with proof that kevetrin is directing a newly repaired "guardian angel" P53 gene to fight cancer cells once again. Don't underestimate the impact of the marketability of being able to talk about the guardian angel gene fighting your cancer for you, this can grab the attention of the non-investor average Joe pretty quickly. This should turn some heads in the press and may generate significant airplay for the company as it is making a major medical breakthrough. This is one announcement that I think many are eager to hear. I would not be surprised if as a result of this announcement, we get a "wild card" event soon after like the NY Times article back in december, but with CTIX and Kevetrin as the center of focus.
“We are excited by the advancement of the clinical trials of Kevetrin as we move toward finding the MTD (maximum tolerated dose),” said Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. “While we are still early in the trials, we are eager to receive information on the p21 biomarker as it could represent a major breakthrough in cancer research. There has been no shortage of commentary and discussions in the scientific community recently about the latest initiatives of the U.S. Food and Drug Administration to further expedite novel drugs to market for areas of great unmet medical need. Obviously, we will be exploring this option for Kevetrin, however an application for this type of rapid movement through the regulatory process can only be made after the completion of the phase 1 clinical study.”
- a couple of exciting statements here.
1. Again the P21 reference, including IMO purposely building anticipation ("eager" for info) and excitement by clearly stating that this can be a major breakthrough in cancer research. A statement like this would not be put into a PR unless there is a great deal of confidence in the results to come.
2. The discussion of expediting novel drugs is very promising, especially how its mentioned in the broader context of the discussions across the biotech industry. to me this is subtle but purposeful as it does all but flat out say "we are going for breakthrough designation" when the time is right and the data is there to support it. I cant help but think of PC_C and what that designation has meant for that company so far.
Regarding Prurisol, Dr. Menon and Cellceutix Chief Executive Officer Leo Ehrlich have recently returned from meetings with Dr. Reddy’s Laboratories Ltd., (Dr. Reddy’s”), a New York Stock Exchange listed company, at Dr. Reddy’s state-of-the-art manufacturing facility and headquarters in Hyderabad, India.
Dr. Reddy’s has completed the process development of Prurisol and is now in the formulation stage for the manufacturing of Prurisol for the upcoming clinical trials in Europe planned for the second quarter of 2013.
- another anticipated and now confirmed development for Prurisol, all systems go for production of the final product in preparation of the POC trial coming up soon in Europe
“At our meetings with Dr. Reddy’s, we met with over twenty scientists working on the Prurisol project. I was very impressed with the comprehensive scientific team that they have dedicated to our project,” said Leo Ehrlich. “While they had already informed us that they had reduced the number of manufacturing steps, Dr. Reddy’s has now advised that they have further condensed the process, which is delivering much higher yields than originally anticipated that ultimately will save us valuable time and money in the production of Prurisol.”
- confidence inspiring statement - the supply chain for the final product offers a top level scientific team offering impeccable quality, even further increased efficiency, reduced lead time, and reduced cost of production - something that will have a big implication not only for the company and the upcoming trial, but for product valuation once the trial proves that prurisol works. This is shaping up to be a very attractive, effective, lean and mean product ready to go to the highest bidder when that time comes.
The Company is pleased to report that the recently filed registration statement with the Security and Exchange Commission is now effective, thus concluding the imposed “quiet period”. Additional updates on the planned studies testing Kevetrin against Acute Myelogenous Leukemia at the University of Bologna as well as other corporate developments relating to research on Kevetrin at a world-renowned cancer center in the Southwest United States are forthcoming shortly.
The statements about the quiet period ending and the Euro trial and SW cancer center announcements are also purposely put one after another, to basically make a pre-announcement that further confirmation and info is on the way "shortly", which in my opinion could be as soon as next week or a few weeks at most. We've learned from a prior PR that they've been working on the SW cancer center agreement, so it wouldn't surprise me if they have this lined up and ready to announce very soon now that the quiet period is concluded.
All in all, this is really just a wide ranging and comprehensive update on all fronts, and continues to build on the momentum of the Dana Farber trial, while also continuing to establish the narrative that Cellceutix is rapidly moving out of the realm of the speculative, and into the arena of established hard clinical trial data, upcoming proof of efficacy, and a rapid management execution of a solid business plan that will serve the company and shareholders well when it is time to step up to the plate with the FDA and/or big pharma.
All just my humble opinion of course, but this PR was more than i hoped for and has made my whole weekend! I know we suck at predicting SP as evidenced by the Dec 1st contest, but IMO i think we have enough going on here that its not unreasonable to think we could see double the current SP by spring time possibly? Time will tell, its going to be an interesting ride for us all
