Replies to post #6618 on Biotech Values

[mid_swe]

>>No, that’s not the point. It’s quite plausible that Squalamine could be efficacious in AMD at 40mg but not at 10-20mg.<<

In Post #57 you wrote:

"Slide 52: Efficacy at 4 months stratified by dose. This is an especially important slide because it suggests that the 50mg/m2 dose did not work appreciably better than the 25mg/m2 dose:"

If I compare the result from the 6 pts treated it´s the same as the old trial at 25 and 50mg/m2 dose.

"Preliminary results from six patients treated with 40 mg of squalamine, each of whom suffered from wet AMD in both eyes, demonstrated that of 100% of eyes (n=12) had preserved or improved vision at week three"

As I see it they are more or less confirming the old results but I´m not sure if there is a difference in dose schedule.

[randychub]

"Nevertheless, GENR appears to be in an uncomfortable predicament. On the one hand, today’s PR takes the bloom off the rose about the 10mg data set reported last October being “positive.” (As I noted at the time, it was anything but.) Moreover, since GENR has not disclosed the 20mg data, it is reasonable to infer that the 20mg data are not a whole lot better than the 10mg data"

That could be or perhaps they just want to save something for the presentation or the most likely case is that all patients in that trial have not yet completed the trial or analysis. They had no problems putting out a press release with the 10mg data I expect they also will have no problems releasing the 20mg data when it is available.

On the other hand, there may be reluctance on the part of the post-Vioxx FDA to accept a dose as high as 40mg for an anti-angiogenic drug given systemically over an extended period of time, perhaps as long as two or three years.

Again you could be correct with this guess but you also could wrong. The systemic issues in those other drugs showed up fairly quickly. Why didn't we see those problems in the cancer trials with very large dosage levels? The problems with avastin 2.5 patients out of every 100 patients while bad are probably not bad enough to keep the drug off the market.

How many of those avastin patients actually died from systemic events? WHen did those events occur and is there a way to reduce those already very small numbers. Celebrex is on the market for pain relief with those issues. I would expect to keep from going blind that a higher threshold of systemic events would be permitted.

We can once again talk about improved vision. The only issue remaining is systemic events. To date with cancer and amd patients there has not been a single event with hundreds of treated patients.

If squalamine can show dramatic improvement for a group of patients over a small time frame it is also possible to give squalamine improve their vision and maintain that vision using visudyne alone or smaller dosages of squalamine.

Any idea if their have been issues with thalidomide and systemic events? There is a vegf drug that has been given to thousands of people. I',ll ask that question on the IMCL board. Perhaps MBK will know the answer.

Randy