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Biotech / Medical : Pharmacyclics (PCYC) -- Ignore unavailable to you. Want to Upgrade?


To: Biomaven who wrote (495)8/27/1999 2:28:00 PM
From: scaram(o)uche  Read Replies (1) | Respond to of 717
 
35, new 52 week high (eom)



To: Biomaven who wrote (495)8/29/1999 9:49:00 PM
From: chirodoc  Read Replies (1) | Respond to of 717
 
anyone have info on hyperthermia?????
i am checking out CELN and BSDM

seems that there is quite a bit of research using thermal with radiation and chemo and it seems to help.

i am asking because i know that it could be a treatment used in conjunction with some of pcyc's compounds.

any ideas?

curtis




To: Biomaven who wrote (495)8/30/1999 5:34:00 PM
From: Gordon James  Read Replies (2) | Respond to of 717
 
A cursory roto-rooter recap...

Seems we had some sell-on-the-news, and perhaps some disappointment that there didn't seem to be much obvious improvement in the full-study results vs. the earlier results, much less an indication of the imminent demise of balloon angioplasty. I haven't been of the impression that out-and-out replacement of balloon angioplasty would be necessary for ANTRIN to do well, and the early results didn't lead one to believe that this was in the cards, but perhaps some folks were speculating on a move closer to that direction. However, it still seems to me the results are promising, and it's good to see development progress to a big PhaseII study. IMO, ANTRIN brings some important features to the table, probably as an important companion treatment to balloon angioplasty. In particular, the noted characteristics of limited vessel wall injury and restenosis vs. balloon angioplasty, and ability to treat long sections of artery vs. the point attack of balloon angioplasty. Even with stents, I understand that we still have significant incidence of restenosis with balloon angioplasty, opening the door for companion treatments.

A few questions that the press release raised for me...

Did we experience a reported decrease in response rates versus the early results? Early results seemed to indicate an almost 100% response, 12 of 14 with a greater than 10% increase in MLD, from the March press release:

Patients were evaluated for toxicity and local arterial responses by follow-up angiograms and intravascular ultrasound (IVUS) performed either 14 days or 28 days following photoangioplasty...

Sixteen patients were treated and evaluated with IVUS and/or angiograms in the study reported by Mahmood Razavi, M.D., a cardiovascular interventional radiologist at Stanford. In the 14 patients receiving follow-up IVUS, 12 responded to treatment, defined as an increase of greater than 10% in the blood vessel opening or minimal luminal diameter (MLD).


Now in the results just reported, doesn't look as good:

Baseline and day-28 paired angiograms were available for 43 patients. Overall, these indicated improvement in minimal luminal diameter (MLD) on day 28 compared to baseline. Of the 19 patients with MLD improvement, 14 had improvement of 10 to 112 percent (mean = 35.6 percent).

Looks like we now only have 14 of 43 responders with over 10% improvement in MLD. Perhaps this is due to consistent use of 28-day followup here versus 14 or 28-day in the earlier results. Does look like we got a higher top improvement of 112% versus earlier reported top of 76%. Looks like the mean 35% improvement among responders remained steady.

I suppose there may have been some disappointment as well with Miller's characterization of the results. If people were expecting some bold statements about displacing balloon angioplasty, they instead got a somewhat noncommittal:

``We look forward to building on these results and better defining the clinical activity and role of Antrin photoangioplasty in the treatment of atherosclerosis in the Phase II trial now underway.'

Another possible disappointment for some - it appears they are not yet satisfied with the dosing regimen, and intend to work on it more in the PhaseII. From the current press release:

Patients will be randomized into one of three arms: two treatment arms and a control arm. The two treatment arms will evaluate different dosing regimens.

On the bright side, I suppose we can look forward to the possibility of future improvements in efficacy, given that they don't seem to have finished tweaking the dosing regimen.

Overall, looks quite promising to me, perhaps some folks were expecting too much from this at this point. Looking forward to further analysis of this by the biocognoscenti who frequent this thread...

GJ