WBZ's New England Business

Lexington drug company remains upbeat after depression drug demise

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Play from 1:46[1:46] ..." Now this was a mid stage human clinical trial. Obviously I'm assuming that there was some positive results in the early test."...

Play from 1:54[1:54] ..." Yes that's correct the compound first of all -- very substantial tax in animal models both anxiety and depression it -- very nice result in animal models attention deficit disorder that drug went into phase one safety studies and some say it's too early studies and anxiety. And we get paid three study in generalized anxiety disorder where patients who had significant anxiety came and also pat symptoms of depression so we have patients with diagnosed with anxiety disorder but as most patients with these kinds of diseases have significant what we call crossovers sitcoms for depression. In in that phase"...

Play from 4:16[4:16] ..." along we will -- starting. -- to -- to be studies in alzheimer's disease within the next quarter these these two studies are in patients with alzheimer's disease as I've mentioned will be mild moderate alzheimer's disease "...

Play from 0:00[0:00]" How long was the research continuing and let. The decision."

Play from 0:05[0:05]" so some. PRX triple zero -- three it was the first drug that the company the private company -- pretext pharmaceuticals brought to the clinic up patents were granted in 2000. Six recently they've run out to 2024 this is the compound went into the clinic in 2004 and due to the negative results from our depression study a very good well run study it was a phase two -- study. So the second phase late stage development really designed to be and Kona coast study and we were unable to to show clinically significant all right statistically significant difference between -- drug and -- it is true that the placebo rate in that study was higher than we expected and so that patients with who came into the study who had moderate to severe depression. Actually to get better on placebo quite."

Play from 1:03[1:03]" Actually actually but that's part of the difficult in the depression studies and of course were all pleased that the -- got better but -- the drug can't distinguish itself in this study of this nature especially a small company really have to stop development and be very. Be very disciplined about that. So we decided based on the data from this pays to be studied at the efficacy of the drug wasn't significant enough. To warrant for the development I should say that the safety in the tower -- the drug was excellent and if there were additional indications in the future -- Where this type of product might be useful. -- certainly a drug that could be administered to humans safely."

Play from 1:46[1:46]" Now this was a mid stage human clinical trial. Obviously I'm assuming that there was some positive results in the early test."

Play from 1:54[1:54]" Yes that's correct the compound first of all -- very substantial tax in animal models both anxiety and depression it -- very nice result in animal models attention deficit disorder that drug went into phase one safety studies and some say it's too early studies and anxiety. And we get paid three study in generalized anxiety disorder where patients who had significant anxiety came and also pat symptoms of depression so we have patients with diagnosed with anxiety disorder but as most patients with these kinds of diseases have significant what we call crossovers sitcoms for depression. In in that phase three study on the drug showed a very modest benefit on anxiety it didn't hit statistical significance but it showed very robust clinically and statistically significant reduction in. Symptoms of depression. Those those results had -- been in the depressed population as a result would have been sufficient for this study to be positive. But that study that was in the anxiety patients and so. We eat based on those data. In what was the late stage anxiety steady pace in the data we moved ahead in depression because the effect of the drug seemed to be much more -- on depression symptoms which tend to be about pessimistic -- unfortunately in some cases suicidal thoughts -- anxious thought in this sort."

Play from 3:26[3:26]" Doctor what does this mean. Off financially for the company to make a decision like this."

Play from 3:31[3:31]" Well you know and one sort of ironic that it saves the company money because we stop all development of -- kind and it doesn't cost anymore and so in terms of our budget this year well actually expanding slightly less money than we expected over although obviously we're in the business of making drugs. So this is one of our late stage products is a disappointment in the company but it doesn't actually back the 2008 budget."

Play from 3:59[3:59]" I appreciate your your interest -- Moving forward what other drug development programs are under way and -- what are the prospects of for those drugs."

Play from 4:06[4:06]" Yeah so one of the advantages we have here ethics is that that we actually have prior to this amount that we had five drugs in the clinic we don't have four I'm so we do a lot of things moving along we will -- starting. -- to -- to be studies in alzheimer's disease within the next quarter these these two studies are in patients with alzheimer's disease as I've mentioned will be mild moderate alzheimer's disease "

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[1:54]..." Yes that's correct the compound first of all -- very substantial tax in animal models both anxiety and depression it -- very nice result in animal models attention deficit disorder that drug went into phase one safety studies and some say it's too early studies and anxiety. And we get paid three study in generalized anxiety disorder where patients who had significant anxiety came and also pat symptoms of depression so we have patients with diagnosed with anxiety disorder but as most patients with these kinds of diseases have significant what we call crossovers sitcoms for depression. In in that phase "...

[1:46]..." Now this was a mid stage human clinical trial. Obviously I'm assuming that there was some positive results in the early test. "...

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[1:31]..." Well most -- armor battle pace. And and we developed yet polymer base and under the leadership of the program by cardiologists that the -- Church doctor stacked. And so we help them develop a polymer version or stand. Are fully bio sort after about eighteen months or districts -- global sutures. And now -- fire missiles and there were -- on the clinical trial outside the United States. "...

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[3:57]..." population on and that their diseases where there's a great deal of unmet medical -- that is that we don't have treatment today that really satisfied patients or physicians -- trying to treat these conditions so. So these are big areas I think to get a sense of that we actually have program in alzheimer's disease which we have been able to talk about because that of course was in the clinic. And that program has -- it was in phase one in December of 2006 and is now entering phase two B actually has begun -- to be testing. In in over 400 patients in one of our case to be tests. And in 240 patients in a study that will be starting in this month. For alzheimer's disease or really excited about that. "...

[0:04]..." You know Glaxo Smithkline and and -- signed any large collaboration with the one point two billion dollar potential for us. For epics in announced in December of 2006. Since then we've been to achieve several milestones on discussing that collaboration. And now to answer your question the collaboration included four different programs. One of those programs we kind of collaboration was program and alzheimer's disease which was at the time. In phase one in the clinic. And has since moved into phase two and -- comeback -- "...

[1:17]..." our technology which is primarily relies. On computer based drug design -- computer modeling. And come up with new discovery. Targets since that time as I said they were three of these discoveries its programs we "...

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