Apologize if this was already posted but below is
Post# of 72446
Posted On: 12/01/2012 6:17:35 PM
Apologize if this was already posted but below is Dr Feelgood's assessment of PR :
CTIX PR: Line by line opinion and critique
Cellceutix Anti-Cancer Drug Kevetrin Completes Dosing Cycle, Ready for Next Cohort
Means what it says, all dosing is finished for the first round in the standard 3X3 protocol. Preparations are underway for the next 3 patients in the 2nd round of dosing.
BEVERLY, MA – December 3, 2012–Cellceutix Corporation (OTCBB: CTIX) (the “Company”), a clinical stage biopharmaceutical company focused on discovering small molecule drugs to treat unmet medical conditions, including drug-resistant cancers and autoimmune diseases, is pleased to report that clinical trials for Kevetrin™, the Company’s flagship anti-cancer drug, are progressing smoothly.
In the first 3 weeks, and for the week following the 3rd dose, no adverse effects were observed or recorded outside those already anticipated. The protocol included procedures and measures for outcomes based on anticipated results attained during animal testing. Nothing outside predicted parameters occurred. No hitches.
In the clinical trials, being conducted at Harvard University’s Dana-Farber Cancer Institute and partner Beth Israel Deaconess Medical Center, the cohort which began treatment with Kevetrin early in November has completed the initial cycle.
Rephrases the title, and reiterates previously released information dealing with the study being conducted at two of the world's premier oncological research clinics.
To date, the group of subjects has been reported to be within normal parameters of the clinical protocol.
Elaboration, directly states what was implied in a previous line and confirms that interpretation.
A total of 84 blood samples from the patients have just been sent to the laboratory for pharmacokinetics analysis.
Pharmacokinetics (PK) "PK is the quantitative study of drug movement in, through and out of the body, includes the study of the mechanisms of absorption and distribution of an administered drug, the chemical changes of the substance in the body (e.g. by metabolic enzymes such as CYP or UGT enzymes), and the effects and routes of excretion of the metabolites of the drug. --Wikipedia definition (for dummies like me) What the body does to the drug from administration of dose to elimination.
Since there is no mention, one can assume the Pharmakodynamics (PD) will not yet be examined. PD simply put is what the drug does and how it acts on the body, including its mechanism of action.
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.
GO CTIX !
CTIX PR: Line by line opinion and critique
Cellceutix Anti-Cancer Drug Kevetrin Completes Dosing Cycle, Ready for Next Cohort
Means what it says, all dosing is finished for the first round in the standard 3X3 protocol. Preparations are underway for the next 3 patients in the 2nd round of dosing.
BEVERLY, MA – December 3, 2012–Cellceutix Corporation (OTCBB: CTIX) (the “Company”), a clinical stage biopharmaceutical company focused on discovering small molecule drugs to treat unmet medical conditions, including drug-resistant cancers and autoimmune diseases, is pleased to report that clinical trials for Kevetrin™, the Company’s flagship anti-cancer drug, are progressing smoothly.
In the first 3 weeks, and for the week following the 3rd dose, no adverse effects were observed or recorded outside those already anticipated. The protocol included procedures and measures for outcomes based on anticipated results attained during animal testing. Nothing outside predicted parameters occurred. No hitches.
In the clinical trials, being conducted at Harvard University’s Dana-Farber Cancer Institute and partner Beth Israel Deaconess Medical Center, the cohort which began treatment with Kevetrin early in November has completed the initial cycle.
Rephrases the title, and reiterates previously released information dealing with the study being conducted at two of the world's premier oncological research clinics.
To date, the group of subjects has been reported to be within normal parameters of the clinical protocol.
Elaboration, directly states what was implied in a previous line and confirms that interpretation.
A total of 84 blood samples from the patients have just been sent to the laboratory for pharmacokinetics analysis.
Pharmacokinetics (PK) "PK is the quantitative study of drug movement in, through and out of the body, includes the study of the mechanisms of absorption and distribution of an administered drug, the chemical changes of the substance in the body (e.g. by metabolic enzymes such as CYP or UGT enzymes), and the effects and routes of excretion of the metabolites of the drug. --Wikipedia definition (for dummies like me) What the body does to the drug from administration of dose to elimination.
Since there is no mention, one can assume the Pharmakodynamics (PD) will not yet be examined. PD simply put is what the drug does and how it acts on the body, including its mechanism of action.
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.
GO CTIX !
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