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ALT-711 was one of the most promising products for the same type of long-term, low-dose usage that seligilene (trade name Deprynl, a parkinsons medication with a 70 year history of medical use) and Metformin (a medication often given for Type II diabetes. Rather than working on insulin release, it works to maintain glucose tolerance, diabetes being a case of extreme glucose intolerance.)that became popular amongst anti-aging aficianados.
In the case of these two other meds, both the diseases they are used upon are among the groups that we all get eventually. Some of us die before we manifest symptoms, some of us manifest symptoms before we die. In either case, the oxidation of glial brain cells (parkinson's) and progressive glucose intolerance (diabetes) are inevitable. In both cases, these meds, formerly used for treatment, have proven useful as prophylactics against the diseases. They are both off-patent, and available inexpensively. Good.
In the case of ALT-711, the chemical compound had been discovered many years ago, and had traveled a circuitous route through academia, research firms, and finally, Alteon. There are two prominent attributes to Alagebrium (as Alteon renamed it). The first is that it is not a difficult compound to sysnthesize. An active black market rose very quickly after the early Phase I and II tests came in. Independent, lab-tested, certified for purity product was available for a short time on the grey market at about $3 per gram.
Now the issues for these small pharma-development firms are a)can they bring a blockbuster medication through the approval process with proven efficacy and safety in a time frame short enough to keep drawing venture capital until they have an approved product. Alteon, having a huge amount of convertible preferred stock hanging over it's head (held by Genentech), had increasing difficulty raising subsequent levels of venture capital until finally, it was unavailable at any price. At that time, Alteon was essentially bought for it's corporate shell by a three-man operation developing another medication that needed a corporate shell in order to move fast. The company now has perhaps three employees here in the states, and outsources it's research, (probably non of it on ALT-711, despite the websits assertions).
A central issue to the difficulty of approving the medication was that the patents were of questionable worth. First, the molecule is not difficult to replicate, and that's a negative vis-a-vis obtaining approval and also satisfying investors that they are buying into an exclusivively owned product. According to some, and I though I have read parts of the patent application, I am no expert on that subject, the patent was only a "use" patent. For treatment of severe heart failure. And the medication had dramatic positive results in the tests for efficacy in that field. But again, lack of patent protection, and ease of replication by others, obviously made the venture investment community lose faith before an approved product arrived.
Counterintuitively, this end result may be the optimal outcome for those interested in anti-aging compounds that reverse some of the inevitable processes associated with aging.
The early interest in, and black market for Alagebrium was based on the perception, probably accurate, that at lower long-term dosing, the medication would prove not only restorative of an earlier state regarding heart health, but would also act, again in low doses, as a prophylactic against glcoslylation, or cross-linking of cells, wherein they become stiff and cease to function well vis-a-vis water and nutrient exchange and other functions. One conclusion that could easily be derived from the published research was that Alagebrium worked first and fastest on those areas with the most blood-to-surface coverage and that were constantly in a state of higher levels of hemodynamic pressure. I.E. the large and small chambers of the heart, as well as the atriums, and potentially, the valves. Because testing for approval such as Alteon engaged in, looks for quick answers for severe problems in order to meet the "need" hurdles of the FDA, and the impatience of the venture capital markets, Alteon never engaged in long-term tests seeking FDA approval of the medication for other conditions. Given the relationship between surface-area coverage under pressure and short-terms results, testing for conditions such as diabetic neuropathy, or long-term low-dose prohylactic use for aging hearts, which would have taken years, was never an option for Alteon.
For those who read such research regularly, and are agressive about finding answers to their anti-aging goals, the failure of Alteon is not all bad. One can find small chemical labs and chemists who can replicate the molecule using existing, readily available information. Production of such medications for personal use does not violate any patents or laws (excluding of course, scheduled substances). Third party testing of the end product is also avialable.
So, while the drug industry environment in this country failed to produce a good product, readily available, probably at high cost, the news is not all bad for the knowledgeable and determined.
Although I have not seen Alagebrium available on the "grey market" since the Alteon became an obvious near-term casualty, those who seek, will find. And probably much, much cheaper than if the medication had been approved.
The research is there. The results were excellent. One could draw reasonable conclusions about long-term low dose usage. And the mechanisms are out there to obtain the product.
Not a perfect outcome, but not a disaster, either.
[Posted by: frank at April 20, 2007 6:21 AM]
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