Alseres: Commentary
(NASDAQ: ALSE)

(from January 2008)

Cethrin continues to stand out as a promising treatment for spinal cord injury. Twelve-month data from the Cethrin Phase IIa trial showed that 38% achieved clinically relevant improvement in functioning. A Phase IIb trial using the most efficacious dosing will begin during 2H:08, using an adaptive design that could reach a 100pt enrollment. Alseres just raised another $5 million to get underway with this ambitious program. That is by far their most important asset, the imaging agent Altropane, scheduled to enter a pivotal trial, has yet to establish its commercial potential in our eyes, and the early stage neuroprotective/regenerative agents (inosine, EGF-R inhibitors) remain essentially static. But we do believe that the data for Cethrin obtained thus far puts it ahead of any other clinical-stage therapeutic for SCI, and we still think that this would be a valuable partnership asset.

(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.