From this I see a multimillion share day coming A
Post# of 72440
From this I see a multimillion share day coming
As per the clinical protocol, the Safety Committee will now meet to approve continuation of dose administration for the benefit of that group of patients
Very interesting wording here. Usually any report of such a request is phrased something closer to ..."the safety Committee will meet to determine whether continuation of dose administration would be of any benefit...", and such statements come later after several escalations and following a complete PK/PD and confirmation of some benefit in a later cohort. To me this signals something very positive happened. Previous statements from the company regarding starting doses at significantly higher levels than usual would support this interpretation.
and to approve increasing the dose for the next group of patients, which the Company expects to begin in mid-December.
Review is two-fold, continuation of treatment and approval for escalation for the next cohort. The company is flat out stating that they have no reason to think there will be any other decision than approval from the Safety Committee.
“The clinical trials are progressing extremely well and right on schedule,” commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “As we await the lab reports, it’s very encouraging that we have not seen any of the toxic side effects that are commonly associated with chemotherapy at this point. Many new drugs demonstrate toxicity immediately, so I interpret the information on Kevetrin™ with a great deal of optimism.
From the Big Guy himself, reconfirming much of what was implied through a very positive interpretation of data, including confirmation of no adverse events in the subjects. We are not talking the "well-tolerated" statements of nearly all other anti-cancer agents, where well-tolerated can include minor dizziness, vomiting, diarrhea, minor and temporary loss of appetite, etc. Is is flat out no indications of toxicity after beginning doses significantly higher than usual.
We are excited for the upcoming weeks when the next cohort, in which dosing levels will be doubled, may provide us even greater insight on what we believe is the most exciting oncologic drug in development today.”
The dose will be doubled for the next round. A doubling is most unusual. More commonly the dose is increased by 1/3 to 1/2.
Regarding Prurisol™, the Company’s drug in development as a new therapy for psoriasis, Dr. Reddy’s Laboratories Ltd. (“Dr. Reddy’s”) has advised the Company that scale-up manufacturing is underway. During the pilot developmental studies, Dr. Reddy’s was able to improve the yield and purity and reduced the synthetic steps required. This will save Cellceutix valuable time and money in the manufacturing of Prurisol for the planned Phase 2 / 3 clinical trials.”
By end of March CTIX will have two drugs in human testing. By end of May or early June, the company will know that Prurisol acts exactly as it did in the xenograph studies. Also, confirmation that the study will be a Phase 2 and Phase 3 combined. If Prurisol works, by Christmas of next year there should by a license agreement in place. This last sentence is my opinion.