Hi Luis,
************* The efficacy of the study will be evaluated as a secondary endpoint with consideration for an expanded trial. The study design called for three groups of six patients. The
patients in each group received three monthly injections at one of three dose levels, with each patient being followed for a total of four months. LP2307 at all of the dose levels was well tolerated and five of the patients in the study continued treatment beyond the four month initial phase. LIDAK anticipates having a final analysis of all of the study endpoints by the end of the third quarter of 1997.""""
If you read the first sentence, they say they will evaluate the efficacy.....with consideration for an expanded trial. You can follow tumors with CT or MRI and see if they stop growing or regress. You can biopsy to see if a cytotoxic T-cell response occurs or is enhanced. This is a phase 1-2 study so they are attempting to see if patients have some sort of response. Even if LMI doesn't work with this tumor type, it does not mean that it might not work in conjunction with chemotherapy, I read a paper than claims that LMI with a chemotherapy agent has good results, but that LMI alone did not work (in mice,,,I forget the tumor type).
Really, I think that Lidakol is what gives LDAKA it's price at this point. With a market cap under 80 million and a potential 500 million antiherpes drug about to release phase 3 data in the nest month, one would think that there would be more interest. But there is reasonible caution after the last blown phase 3 trials. On the other hand, when you look at what happened and the natural history of a herpes outbreak, it's hard to believe that the drug does not work. Testing on the placebo is supposed to show that it does have antiherpes activity that was not detected because when the company that made the placebo for them first made it up, they made it incorrectly (and this incorrect version did not show antiherpes effects). During the phase 3 studies, this hired company made the placebo CORRECTLY and then it had antiviral effects. This has been confirmed in further lab studies. (It was not initally picked up because they tested the incorrect version). |
