To: seminole who wrote (1003 ) 5/20/1998 12:35:00 PM From: David Cathcart Read Replies (1) | Respond to of 1826
Richard, Yesterday's news release did not do much for me either. It seems to me that the phase I trials for MGI 114 have not revealed significant signs of efficacy since the early stages. While I'm not sure of this, it is likely that the company would be announcing additional signs of efficacy if there were some to talk about. Assuming there are no additional signs of efficacy, just what does this mean? In December, Blitzer responded to this question at the presentation. He pointed out that the tumors they are treating in phase I are too large and extensive to be effected by the dose levels of the drug. I suppose one should also consider the fact that these large and extensive tumors, even when they were smaller and more treatable, had already resisted every other drug that was thrown at them during earlier treatments. I am not knowledgeable in this area though and I do not know what should be expected. One encouraging fact is the continued commitment of the NCI to fund multiple phase II trials. On February 11, 1998, Blitzer said: "In early January we held another advisory panel meeting for MGI 114 and were encouraged by the enthusiasm for the drug's development. The oncologists who attended are all as anxious as we are to move into phase II due to the numerous possibilities this drug has in treating a number of tumor types. The National Cancer Institute also sent a representative to participate in this meeting to insure that they as up to speed on the development of this drug as everyone else." The NCI is well aware of the progress of the trials and the results seen thus far. Assuming that there have been no additional signs of efficacy in phase I, this fact is not holding back the NCI in their willingness to fund many phase II trials for MGI 114. So, all we have really learned in phase I is that patients can tolerate a reasonably high level of MGI 114. From what I understand, that is what we should hope for at this stage. What we should look for in phase II is efficacy. Let's bring on phase II. Let's shrink some tumors! Oh, and let's ship lots, and I mean lots, of Salagen to the Sjogren's market while we are at it. David