LPath inc (NASDAQ:LPTN) investors were given a pleasant surprise last week when the company released positive news on its phase IIa trial for ASONEP. With this positive development in mind, it will be important to update the investment community on why these results will be important to LPath's future, and to update my previous article based on the information that we now have.
The interim data suggests that up to this point the drug has been rather effective on a progression free survival basis. The drug is being tested at two different dosage levels (this will be important when moving the drug into possible phase III testing), the 15 mg/kg dose and the 24 mg/kg dose. At this point, it appears as though the 24 mg dose is the more effective dose, however, we have not seen as many patients complete the requirements for the 24 mg dose. Some of the highlights in the trial include that for each of the groups there is one partial responder (in the 15 mg group we have also seen that eight patients are marked as stable or better, one of which is in their thirteenth month of treatment). We have also seen rather impressive results up to this point in the 24 mg dosage, of the nine patients at this dosage, we only have information at this point for six. Four have, unfortunately, seen their disease progress, but we have one partial response and one stable disease. The most common side effects appeared to be relatively minor in both dosage cohorts.
Why is this important?
These results should help to give the investor community confidence moving forward as to the ability of Asonep to pass clinical muster. The expansion of the trial will help to make sure that investors have a full picture of the activity of ASONEP. More importantly, by allowing for the expansion it will be important to see if the higher dosage is logically able to get more partial responses. Remember, that these are patients who have likely failed multiple other treatment options, and are therefore looking for anything that works. This makes it rather hard to treat these patients, and doctors will likely latch onto any treatment that they can get their hands on for this group.
It is also important to recall that Pfizer has the right of first refusal towards ASONEP development, should the results continue to be impressive it is possible that Pfizer will choose to exercise this option. That would be very lucrative from a financial standpoint for LPath, as it would lower clinical trial costs and set the company up for milestone payments and royalties down the road. It is important to note that Pfizer seems intent on selling the rights. They have not yet found another company to purchase the rights, so the partnership is for right now in limbo for LPath. I reiterate my previous article and still believe LPath to be a buy. Should the company continue to progress its pipeline in the manner that we have seen, it will be a positive for shareholders. This update only helps to strengthen investor confidence in the ability of LPath to execute its strategic vision.
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