Alseres

(from January 2009)

Alseres made a bold move early in 2008, when they licensed BioAxone's Cethrin, a Rho-antagonist which has showed promise in its early spinal cord injury PhII. They also brought BioAxone's CEO on board, and are now devising a blinded, placebo-controlled Phase IIb. Cethrin looms large in quality and pace in contrast to the seemingly interminable sagas of Altropane, and their program for a second-generation imaging agent (technetium). The problem is money, they cannot run even a modest Phase II for Cethrin. They now are down to a month or two of operating capital, though we suspect that their longterm investors will sustain them.

(from January 2008)

Besides changing their name, which in this situation was a good thing, Alseres made a bold and potentially vital move early in 2007, when they licensed BioAxone's Cethrin, a Rho-antagonist which showed promise in its early spinal cord injury PhII. They also brought BioAxone's CEO on board, and are now devising a blinded, placebo-controlled Phase IIb. Alseres is also about to run an inhouse competition amongst its various preclinical regenerative programs (e.g. oncomodulin, inosine). Cethrin looms large in quality and pace in contrast to the seemingly interminable sagas of Altropane, and their program for a second-generation imaging agent (technetium). They have been able to raise money, but they could use a partner with resources.

(from July-August 2006)

After two years of negotiation and renegotiation with the FDA, BLSI had launched the pivotal trials for Altropane imaging in PD, expecting to enroll 322 patients--the SPA meaning approval was guaranteed if they met the endpoints. A little more than halfway through, in March 2006, BLSI terminated the SPA and announced that they would analyze the data. The premise is that they now believe that GPs assessing PD have a higher rate of diagnostic inaccuracy than they had expected, which would, in their view, mean that Altropane has a lower hurdle to surmount, and enough patients had already enrolled to do so. Of course, now there is no SPA, and the FDA has no commitment to give its OK. They claim that they will receive and analyze the data during 3Q. While we have not been enthused about the commercial prospects for Altropane, given that so much importance has been assigned the Phase III by BLSI, it seems ill-considered to cut it in half and lose the assurance of their SPA. BLSI signed an expanded R&D contract with Children's Hospital (Boston), regarding axon regeneration techniques. But that same relationship has not so much as generated a clinical trial in ten years, thus it is hard to know if BLSI is accruing any value for its money. If Altropane fails, it will not matter, BLSI will not survive.