“Anavex believes that oxidative stress, not amyloid-beta, is the cause of Alzheimer’s; seeking partners for early-stage compound, executives say”
Anavex Life Sciences (OTCBB: AVXL) believes that oxidative stress, not amyloid-beta, is the cause of Alzheimer’s disease, and is currently seeking partners to develop an early-stage compound, according to Harvey Lalach, co-founder, president, chief financial officer and director.
Lead candidate ANAVEX 1-41 has a synergistic neuroprotective and anti-apoptotic effect in animal models that use amyloid (beta) 25-35 peptide to simulate the condition, according to results presented at the 2008 International Conference on Alzheimer’s Disease.
“If something comes across the table, we’ll address it,” Lalach said about potential partnerships. “The game plan would be to move one compound through Phase I in CNS. And if something comes to the table prior to that, we would seriously look at that.”
There has been “significant interest” from big pharma in both the company and its compounds, he noted, adding that there is a need for capital moving forward, as R&D to develop an Alzheimer’s candidate is very costly. “With additional capital, we can move other compounds into Phase I. We also have oncology compounds at various stages of development,” he said.
Companies developing late-stage candidates in Alzheimer’s include Eli Lilly (NYSE:LLY), Wyeth (NYSE:WYE), Pfizer (NYSE:PFE), GlaxoSmithKline (NYSE:GSK) and Bristol-Myers Squibb (NYSE:BMY). Avanex became publicly listed through a reverse takeover at the beginning of 2007, Lalach noted. The company was funded privately with approximately USD 15m in research capital. “It got to the point where the results were encouraging, and investors wanted to move this compound forward as soon as possible,” he said.
The company’s SIGMACEPTOR-N program involves the discovery and development of drug candidates targeting neurological and neurodegenerative diseases, such as Alzheimer’s, epilepsy and depression.
Sigma-1 receptors have been cloned and shown to be distinct from any known receptor class. In the central nervous system, they have been shown to be involved in the modulation of neurotransmitter receptor function, neurotransmitter release and response, as well as memory and learning processes, demonstrating potential neuroprotective and anti-amnesic properties.
“The lead compound comes from the sigma receptor platform, which is a proprietary platform technology that generates molecules based on sigma ligands and receptors,” Lalach said. There is interest from large pharma, as the platform has a potential to create multiple compounds across a variety of different disease indications, he said. George Kalkanis, Anavex’s co-founder and vice-president for strategic planning, said to the surprise of the Alzheimer’s community, it turns out that the current market leader, Pfizer’s Aricept, also affects sigma ligand. Pre-clinical experiments in mice showed that Anavex’s drug can attain all these synergistic receptors, he noted.
“We don’t care if the neuronal toxicities are coming from amyloid or not,” he said. “It turns out that diluting or reducing amyloid beta protein is not a means of treating Alzheimer’s disease.”
The failure of Neurochem and Myriad Genetics’ Alzheimer’s candidates – which worked to reduce or prevent amyloid build-up – is proof of the fact that targeting the amyloid pathway may be wrong, said Kalkanis. Alzheimer’s is due to oxidative stress, and amyloid beta may be a result of oxidative stress, he noted. The oxidative stress pathway may also activate other undesirable effects. The amyloid plaques can come initially as a defense, which is why they accumulate in the brain, he said.
Anavex plans to conduct a single dose-ascending study, which will include 40 volunteers in Europe. A multiple ascending dose study will include 24 volunteers, according to Kalkanis. “These studies will be able to establish the profile of the drug.”
The company is open to any prospects, said Lalach. “Our strategic initiative is to raise some money from investors and advance our first compound to the end of Phase I and beginning of Phase II trials,” he added. “We don’t exclude any proposals for partnership.”
The company recently appointed Dr Mark Smith – a leading researcher who is executive director of the American Aging Association and editor-in-chief of the Journal of Alzheimer’s Disease – to its scientific advisory board. “We’re in the process of upscaling synthesis of the compound, and selecting the right contract research organization,” Lalach said. Anavex has a market cap of USD 50m.
Source: Pharmawire
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