Innovation Pharmaceuticals Inc (IPIX)

[RJFL]

Hi Govorchin,
I enjoy your posts immensely but wanted to provide some comments on the amount of disclosure investors are receiving on the kevetrin trial vs secrecy and the potential for cures in either the current solid tumor trial or subsequent applications like retinoblastoma.

I believe the amount of information released has been fairly good for a phase I. I don’t believe DF is withholding information because of investigators ego’s or so they can maximize the impact/splash of the data. I believe they are being extra cautious because the data has to be statistically analyzed and fully vetted and the trial is not complete. DF rightfully has to approach it from a scientific standpoint so hopes are not falsely raised on incomplete data. We are dealing with very small patient numbers in our study. I for one, have been very happy (ecstatic) with the information disclosed in conference presentations like ASCO and the recent SF conference. As you have summarized Govorchin, we have multiple participants completing multiple cycles (I have tried to research how common it is but have not been successful) and we know we have had stabilization and now a case of tumor regression. I am thankful for having received these tidbits during the trial as opposed to at trial completion.

I also think it’s prudent to keep in perspective any talk about “cures” at this juncture. For solid tumors it’s typically 5 years cancer free after a complete response, so we cannot accurately claim anyone will be cured, even if they have a complete response, at the end of the Kevetrin phase I. Hopefully down the road those folks will fall in to that category. To provide some perspective, our Kevetrin trial is utilizing CT scans as a measurement of response. Even if there was a complete response and no evidence of a primary or metastatic tumor via CT scan after treatment, this is not a guarantee of cure. The link below illustrates this.

http://jco.ascopubs.org/content/24/24/3939.short

Review of the study, “Complete Response of Colorectal Liver Metastases After Chemotherapy: Does It Mean Cure?” reveals:

“Overall, 66 LMs (liver metastases) disappeared after chemotherapy as seen on CT scan. Persistent macroscopic disease was observed at surgery at the site of 20 of 66 LMs, despite CT scan showing a complete response. The sites of 15 initial LMs that were not visible at surgery were resected. Pathologic examination of these sites of LMs, considered in complete response, showed viable cancer cells present in 12 of 15 cases. The sites of 31 initial LMs that were not visible at surgery were left in place during surgery; after 1 year of follow-up, 23 of 31 LMs considered in complete response had recurred in situ. Overall, persistent macroscopic or microscopic residual disease or early recurrence in situ were observed in 55 (83%) of 66 LMs having a complete response on imaging.”

I want to emphasize, I am not trying to be a wet blanket here, I am just trying to keep things in perspective. The results we have had thus far for kevetrin are great, but it’s still early in the process. The only way to critique the potential efficacy is to let the trial run its course and then review the data. There are many examples where promising preliminary data on new drugs/treatments ultimately proved to be no better, or in some cases worse, than the standard treatment that was in use for a given use at the time. In closing I’ll use the following example. Back in the early 90’s, early data on the efficacy for the use bone marrow transplantation (specifically autologous peripheral stem cell transplants) looked very promising as compared to other standard care methods. After several years of use and study, I believe it was determined that the approach did not offer superior long term benefit in terms of survival. My first wife rightfully tried this treatment based on available data at that time. Unfortunately, despite the extremely aggressive treatment where upon completion she was in complete remission, she subsequently succumbed to the aggressive breast cancer just 6 months after the treatment following relapse at the age of 34. While I own a ton of Cellceutix stock and want to see this succeed for financial reasons, it’s even more important from a from a personal perspective since I have a daughter and I know of several others where Kevetrins success is ultimately much more personal implications.

Govorchin so you know I respect your tenacity to keep pushing for information, keep doing it! I just wanted to express my thoughts. I’ll try to post again later today/tonight on another brillicidin topic that has not been spoken of that excites me.

Best to all, especially to those fighting cancer!