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I took your suggestion and spoke to Paul Herron, the investor relations officer for SUNP (904-296-3320). He says that the Warner-Lambert DENSPM Phase 2 trials are going well and have progressed to the second phase in one or two indications. As you may recall, the trial design begins by enrolling 15 patients for each of 6 different solid cancer tumors; if they get enough responders in one or more of the 6 indications, they add another 15 patients (phase 2) in those indications, and then may narrow the process done further in a third phase with another 15 patients per indication. They expect to hear the results of the Phase 2 trial by the end of the second quarter. The successful completion of the Phase 2 trial results in a $1M milestone payment to SUNP, as will the filing of an NDA.
Since the FDA asked for a stronger safety profile for DEHOP as a treatment for refractory diarrhea, SUNP has been deliberating whether to do the additional DEHOP trial or to start over with a later generation drug, DESPM, which showed no adverse effects in animal studies. They are ready, or nearly ready, to file an IND for DESPM.
They also are ready or near ready to file INDs for two metal chelator drugs: HBED for sickle cell or related indications, and PCA for ulcerative colitis.
The are close, but not quite as close, to filing INDs for two new anti-cancer polyamine analogs (like DENSPM), which Paul referred to as DENOHO and DEHOHO.
The company would like to find a partner to collaborate with it in bringing these new drugs into clinical trials, so I'm hoping that we will get lucky and read a press release announcing such a partnership in the not too distant future.
The companies website should be launched sometime next week at www.sunpharm.com. Paul warned me not to expect to find too much on the website the first week, but within a couple weeks after its launch they will be adding information about the technology behind their drugs.
Paul likes to refer to SUNP as a diamond in the rough. I have to agree. The $6.2M market cap does not come close to doing justice to this company's value. |
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