I'm reposting the email conversation I had with Leo.Notice I asked about the first cohort and the dosing.
Read bottom to top.
Kelt
Rules of the trial.
On Dec 2, 2012 3:22 PM, "James Maffei , Sr." <lmaffei@roadrunner.com> wrote:
Thank you.How then is the purpose served by having the 1st cohort remain on the low dose regimin as opposed to elevating them as well?Jim----- Original Message -----From: Leo EhrlichSent: Sunday, December 02, 2012 11:04 AMSubject: Re: PR yesterdayHi,Actually the standard lab results have not been made available to us. We hope to see them after they are prepared for the safety board. This is clearly stated in the press release. “As we await the lab reports.....Please remember the protocol is strictly followed. The primary reason for the trial and its title isA Safety, Pharmacokinetic and Pharmacodynamic Study of Kevetrin in Patients With Advanced Solid Tumors
When Dr. Menon says “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. 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.”That is based on the minutes of the teleconference meeting with the hospital who of course have access to all records and the care givers who dose and see the patients.We are very pleased that the Harvard lab has now decided to do PK work. It was actually unexpected so soon in the study. As far as the lab tests for the p21 biomarker, we have not received word on the timing of these tests. As per the title of the study, p21 (biomarker for p53) is a secondary goal. We dont know when they will do such.Remember these patients have only a few months to live when they began this trial. Now that a month has passed its nice to hear this report from the hospital. Remember that the dose given is very low as per the clinical protocol, and dosing escalates on every future cohort.I too am impatient. However as the trials moves forward, all our questions will be answered.Best regardsLeo
On Sat, Dec 1, 2012 at 11:51 AM, James Maffei , Sr. <lmaffei@roadrunner.com> wrote:
Hi Leo.This is probably a dumb question but I saw that 84 blood samples were just sent to the lab.Assuming they have been testing over the previous 4 weeks right along,is there anything these latest samples could reveal that earlier samples might not?Thanks , Jim
