Biotech Values

[Praveen]

KERX: Hi Dew and Board,

I respectfully disagree with you on some issues with kerx.So please don't take anything personal.

Q:First thing I found is that you thought releasing results on a friday evening is trying to cover up the bad results.

A:Might be true but not in this case.

Q:Reg M.weiss can sell ice to eskimos and can manipulate the share price temp.

A:I heard him a few times. Might not be the greatest CEO. But certainly not pure hype and he is not manipulating.

Q: Why the diff in inevaluable pts:
A: Because this is a pilot trial, they allowed pts who first satisfied the criteria but after a month when they didn't fit the criteria, they still allowed them because of sympathy towards the disease and also to encourage the doctors to use the drug. But they are going to stick to the criteria strictly in ph 3 & 4.

Q: P value
A: You know it from first about the trial.
In this Phase 2 study, the primary endpoint for the study was the percentage of patients achieving "Therapeutic Success" at six months. This is also the endpoint in the protocol for the KRX-101 Phase 3 clinical trial now recruiting patients, and which was agreed to with the FDA under a SPA. A patient is considered a "Therapeutic Success" if they achieve one of the following outcomes following 6 months on study:


(1) 50% reduction in albumin to creatinine ratio or "ACR" -- ACR is a
standard measurement used to assess the level of kidney disease in
these patients. ACR measures the level of albumin protein in urine,
also referred to as "albuminuria," or

(2) Normalization of ACR with at least a 25% reduction in ACR -- in this
study the normal laboratory range for albuminuria was defined as less
than 20mg of albumin to 1g of creatinine.

Also the p value is 0.045 which is not bad. further the trial is only 16.7% powered. When the trial 3 reaches 1000 pts, it will be 90% powered and we can evaluate the p value then.
(plus or minus a few zero's)

Q) why the descent in the curve with 400mg?
A) L shaped dose curve as it is common with heparinoids and enzyme inhibitors. I don't think it is due to nephrotoxicity.
You see similar curve with ACE inhibitor captopril at 25mg dose and increased dose and the results were published in Lancet. Might be when the pt no's increase to 1000, you might see a plateau phase. also 200mg is the fda recd dose for phase 3 and 4. The drug is of a mixed physiology with both agonist and antagonist action.

Q: reg efficacy:

A:placebo:11% 200mg dose: 33%. Also if you see the graphs in the powerpt presentation, efficay is clear with 200mg dose and one can't deny it. They were 20 trials done in the process which proved the drug works. Also there were no sig side effects and no dose toxicities.

Q: Do I think this is a blockbuster drug?
A: It's a bit like flurizan. It works to a certain extent and certainly diab nephro affects 8-9 Million people and i think it will be approved. But the cancer drug krx 401 might be a blockbuster like mygn's mpc 6827.

I would like to hear your opinion too guys...

Dr.Praveen