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TheHound

11/23/14 10:59 AM

#79273 RE: georgejjl #79270

Monotherapy could be more effective against certain types of cancers. Combination therapy could be more effective against others. Here's a few facts that support my position.

Kevetrin was studied in two cell lines of multi-drug resistant lung cancer. In two studies with the multi-drug resistant non-small cell lung carcinoma human cell line, A549, Kevetrin showed average tumor growth delay of 72% and average tumor volume reduction of 81% compared to controls. Both tumor growth delay and tumor volume reduction were also significantly greater with Kevetrin than with paclitaxel. (p<0.001). http://cellceutix.com/wp-content/upl...ancer-A549.pdf

In two studies with the NCI-H1975 non-small cell lung carcinoma multi-drug resistant lung cancer, Kevetrin showed average tumor growth delay of 149% and tumor volume reduction of 94% compared to controls. Both tumor growth delay and tumor volume reduction were greater with Kevetrin than with paclitaxel (p<0.001). http://cellceutix.com/wp-content/upl...-NCI-H1975.pdf

In animal model testing on a taxane-resistant, estrogen receptor-negative breast cancer human cell line, MDA-MB-435s, tumor volume was reduced by 72% and tumor growth was delayed by more than 52% with Kevetrin when compared with paclitaxel. In a study with the MDA-MB-231 breast cancer cell line, Kevetrin demonstrated tumor growth delay of 90% compared to controls. http://cellceutix.com/wp-content/upl...DA-MB-435S.pdf

Colon Cancer Kevetrin showed tumor growth delay of 43% compared to controls and paclitaxel when tested on animals with HCT-15 P-glycoprotein drug resistant colon cancer. Kevetrin was studied in two experiments alone and in combination with 5-FU against the HT-29 cell line of colon cancer. Kevetrin alone demonstrated average tumor growth delay of 43% compared to controls. 5-FU alone showed an average tumor growth delay of 20%. The combination of Kevetrin and 5-FU resulted in an average tumor growth delay of 97%. http://cellceutix.com/wp-content/upl...oma-HCT-15.pdf

Kevetrin was studied in multiple experiments alone and in conjunction with radiation against the SCC-15 cell line of head and neck cancer. Kevetrin alone showed an average tumor growth delay of 45% compared to controls, similar to radiation alone. When administered in conjunction with radiation, Kevetrin showed an average tumor growth delay of 116%. http://cellceutix.com/wp-content/upl...ation-with.pdf

Kevetrin was studied against the PC-3 cell line of prostate cancer. In two studies, Kevetrin demonstrated an average tumor growth delay of 54% compared to controls, while cisplatin showed an average tumor growth delay of 49%.

The Company conducted pre-clinical studies using human retinoblastoma cells (WERI-Rb-1) in nude mice that were implanted either subcutaneously or directly into the eye, intravitreally. Treatment with Kevetrin significantly reduced the tumor volume by more than half in the subcutaneous tumor model and showed a significant improvement in the clarity of the eye in mice treated with Kevetrin.

TheHound

11/23/14 11:20 AM

#79277 RE: georgejjl #79270

Apparently no one here agrees with you're position that monotherapy can be scientifically ruled out against certain types of cancers given the current data. Not even Dr. Jerry. You're all alone. Doesn't that tell you anything?

MinnieM

11/23/14 12:16 PM

#79290 RE: georgejjl #79270

I think I'm simply going to wait for full Kevetrin trial results before making any statements about whether or not Kevetrin will be best as a single treating agent or in combo with various cancers. Various cancer are currently being tested with Kevetrin as a single agent. The upcoming trial in Italy will test it as a combination therapy.

Without results I wouldn't begin to say which way Kevetrin will be more effective. Especially, since the answer will differ dependent upon the cancer being tested.

The same goes for Prurisol. We don't know the answers until trial results are in.

It's a good thing we have Brilacidin to discuss.

Have a great weekend all. ;)




biodoc

11/23/14 12:19 PM

#79291 RE: georgejjl #79270

George, it's a silly argument. Kevetrin is nearing the end of a Phase I trial. The primary endpoints of defining MTD and DLT will soon be defined. Secondary outcome measures including pharmacokinetic profile, change in tumor size, change in tumor markers, and changes in P21 biomarker will be achieved. It's a lot of information that will allow for Phase II strategy to optimize dosing, better define target patient population, and allow better insight into Kevetrin's potential as an anti-cancer agent.

Do you believe that eventual use of Kevetrin as monotherapy or in combination therapy impacts Cellceutix's valuation at this time? IMO, Kevetrin as a single agent would be great and I'd be very happy. And if another agent can be combined with Kevetrin to give even a slight benefit to a cancer patient, I'm all for it. It's no longer monotherapy but it's better for the patient. If Kevetrin can be used in combination with other agents for a wide variety of cancers then I'm thrilled. What's best for investors? If Kevetrin is eventually approved, they're all homeruns.

We have a long way to go in clinical trials and its eventual use as monotherapy or in combination does not impact my investment decision in any way. I'd be surprised if monotherapy vs. combination therapy for Kevetrin impacts the decisions of any investors at this stage.

Declaring an opinion over and over again does not make it fact.

btw, I note that you still haven't answered DrBones question about p21 levels that are necessary for substantial benefit. Good luck finding the answer and please let us know.