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Tuesday, October 08, 2013 6:06:50 PM
Dear Mr. Ehrlich,
Although this is my first time writing to you I have been an investor in Cellceutix since March of 2013 and currently hold approximately 100,000 shares, which is a substantial position for me. On a personal note I am a great admirer of both you and Dr. Menon. However, there has always been one question on my mind that has been a source of uncertainty and that is the expected dosage of Kevetrin for efficacy in humans. Specifically, I would like to understand better if possible the basis for the statement in your October 2nd press release that 100mg/m2 has always been an important dose.
My confusion stems from my review of your past poster presentations (including ASCO 2013) containing your mouse response data that showed no clinical response at 50mg/kg in mice (specifically the yellow treatment line lines up almost exactly with the control in the A549 lung carcinoma mouse study) and some signs of efficacy beginning at 100mg/kg. Although I unfortunately do not have a clinical background there does appear to be an established conversion matrix for mouse to human mg/kg dosing and from mg/kg to mg/m2 dosing in humans (per this link to ACUC tables http://ncifrederick.cancer.gov/Lasp/Acuc/Frederick/Media/Documents/ACUC42.pdf).
Following the metrics in that table, 50mg/kg in a mouse is equal to 4.16mg/kg in a human which is equal to approximately 154mg/m2 in a human (50 divided by 12 and then multiplied by 37 per the table and its examples). Therefore according to the mouse model even at 150mg/m2 dosing one would not expect to observe a meaningful clinical response. According to this same calculation the first signs of efficacy in the mouse studies that are graphed were at 100mg/kg in a mouse which is equal to 8.3mg/kg in a human which is equal to approximately 308mg/m2 in a human (100 divided by 12 and then multiplied by 37).
This discrepancy has caused me some sleepless nights and therefore I would greatly appreciate any clarity you may be able to offer. Is the Company's expectations regarding expected signs of efficacy based on something other than the mouse studies and if so what is the basis? Are my calculations above inaccurate in some way (though the converstion factor from mg/kg to mg/m2 in a human may vary it seems any variance would be to a factor higher than 37)?
Does the Company believe that the range of efficacy is expected to be between 100mg/m2 and 200mg/m2 and if so what is the basis for the Company's conclusion? What type of efficacy would you expect to observe at these levels?
Any answers you may be able to provide are very much appreciated.
Many thanks for your efforts to improve the lives of all.
Sincerely,
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