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daydreaming2

01/25/15 3:10 PM

#89173 RE: frrol #89168

With the fact that Dr. M said it is working like in the mouse studies, and the fact that they have more access to infirmarormation than they are allowed to share until DF gives the ok.... I would say K is on track. IMHO of course.

GLTA

Chemdeps

01/25/15 4:47 PM

#89178 RE: frrol #89168

If the results are not positive and CTIX clearly has more information about how well K is working in the trial, why would they include the request for an article in the PR? Does not make sense to me...if the results are not stellar, then just leave the article request out of the PR....something tells me they know that K is behaving as everyone had hoped...IMO of course.

farrell90

01/25/15 6:19 PM

#89188 RE: frrol #89168

You seemed to have your studies and PRs confused. Review the quotes below and you should be much more positive about CTIX's drugs, Kevetrin and Brilacidin.

The researchers at Dana Farber requested the following:

"Additionally, the Principal Investigators for the Kevetrin trial have requested that the Company start preparing a presentation to be used for an article on the safety and pharmacological effect of Kevetrin on multiple cancer lines as demonstrated in the clinical trial. Cellceutix interprets this recommendation as a very optimistic sign regarding anticipated outcomes for the trial and clinical advancement of Kevetrin."

It is hard to spin that request as a negative. In effect you have the principal researchers from one of the worlds premier cancer research centers asking CTIX to report on the Kevetrin FDA stage 1 study which has been an astounding success.



http://cellceutix.com/cellceutix-reports-spleen-lesion-disappears-in-patient-with-metastatic-stage-4-ovarian-cancer-in-clinical-trial-of-anti-cancer-drug-kevetrin/#sthash.FVdlRYj0.dpuf

The FDA rquested pharmacokinetic data for Beilacidin:

'In communication with the FDA last week, Cellceutix was encouraged to submit additional information from the Phase 2b study, including analyses of the recently obtained pharmacokinetic (PK) data. The Company has requested its vendors to assist in preparation of this information for submission as soon as possible. Thereafter, the Company will meet with the FDA to discuss the completed Phase 2b study and to discuss the plans for Phase 3 studies. -"

IMO the importance of this communication is to show CTIX and the FDA are planning the nuts and bolts of the Brilacidin FDA stage 3 trial. Again I do not see how that can be understood as anything but a positive as it IMO certainly presages the announcement of the stage 3 FDA trial

http://cellceutix.com/cellceutix-reports-positive-results-of-brilacidin-in-microbiological-intent-to-treat-population-in-phase-2b-absssi-trial-additional-pharmacokinetic-information-to-be-submitted/#sthash.OOTJ9FrE.dpuf

Good luck, Farrell

sox040713

01/25/15 8:41 PM

#89203 RE: frrol #89168

I agree that sponsor should publish clinical data, good or bad. But if Kevetrin is not working at all, Leo would not mention the request for a presentation in a PR. CTIX would do it quietly instead. To me the most telling part of the PR is:

“With that in mind, we are analyzing the collective preliminary data from the trial to date showing a strong safety profile for Kevetrin, an effect on p53 and data seeming to indicate that ovarian, pancreatic and other FDA designated orphan cancers would be ideal mid-stage clinical trial targets as we plan to move forward.”

I am expecting at least three Phase 2 trials of K against different solid tumors. Just my two cents.

And the fact that DF asked the company for an article on K's PK/PD is not definitively bullish to me. Researchers want trial results published, period.