Alzheimer's disease is a devastating, incurable disease for which there is currently no effective treatment. As such, it presents a drug development target that small companies with somewhat offbeat drug candidates can tackle, maybe dodging the pharmaceutical giants in the process.

A case in point is London-based ReGen Therapeutics, which is developing colostrinin, derived from sheep's milk, as a drug to stabilize and improve cognitive function in Alzheimer's patients through the control of plaque formation.

ReGen, of course, is not alone. Other firms hoping to tap that market through plaque formation control include Sanofi Synthélabo, Eli Lilly, and Merck. And other companies--ranging from giants like Pfizer, GlaxoSmithKline, Aventis, and AstraZeneca to smaller biotechnology companies--are exploring a variety of chemical approaches to Alzheimer's control.

ReGen was formed in 1997 to develop its unusual drug candidate. Colostrinin is a complex comprising -casein-derived peptides, -casein-homolog-derived peptides, annexin-derived peptides, and a variety of other peptides from unknown precursors. It was first isolated from ovine colostrum in 1974 by Polish scientists.

Chief Executive Officer Michael Harvey calls ReGen "a virtual company": nothing more than a six-person administrative office in London; a small office in Warsaw, Poland; and a chief scientist in Houston. "Basically what we do is manage other people," Harvey explains. "We find the people to do the work, contract with them, and monitor the work to conclusion."

As a company, Harvey adds, "we are based on networking. We've brought together a diverse group of people with different skills and backgrounds."

ReGen's financial accounts for 2001 are due out at the end of March; for 2000, it reported administrative expenses of roughly $1.8 million and net losses of $1.4 million.

Colostrinin is now in clinical trials in Poland. It is being tested there for a series of reasons that go back to the company's executive director and chief scientific officer, Jerzy Georgiades, who spent most of his childhood in Poland.

Georgiades attended university in Gdansk and trained as a doctor there. In the 1960s, he immigrated to the U.S., where he worked for a number of academic institutions, including Rockefeller Institute and the University of Texas. Most of his academic work was in cytokines, particularly -interferon.

After the collapse of the Communist regime in 1989, Georgiades reestablished contact with colleagues in Wrocl/aw who were working with polypeptides, including the ones that have been developed as colostrinin. Early clinical work done there hinted at some efficacy in treating Alzheimer's. That work led to a full, double-blind trial in 1995 that confirmed that the complex had no adverse effects and appeared to show some efficacy.

Georgiades became interested in commercial exploitation of colostrinin at the same time that the Polish government was urging the country's academics to obtain commercial sponsorship.

For the clinical trial under way, Harvey says, the colostrinin is obtained through physical extraction from ewe milk. It is collected and purified in Poland, compounded into tablets in Germany, and sent back to Poland for the trial.

"In the longer term, if this is successful, we will have to move away from Poland--we are starting to look at other sources for colostrum," Harvey notes.

The company is also working to underpin its clinical trials with research into why colostrinin does what it seems to be doing, with much of this work being done at the University of Texas Medical Branch in Galveston. The most likely mechanism is cytokine activity, regulating the metabolism of amyloid- protein deposits, Harvey suggests. However, the colostrinin "could be doing several things in parallel: Because it is a complex, a synergistic effect could be possible."

In the longer term, Harvey adds, because ReGen has identified many of the peptide structures involved, "we could have the opportunity of producing second-generation products."

At the moment, the company is developing current Good Manufacturing Practice production capability and working to optimize dosage forms. Among its objectives are a regulatory package to allow completion of European Union Phase IIB trials and a pivotal mechanisms study. In order to develop the science and intellectual property base, ReGen also aims to collaborate with a development and marketing partner, including investigating other clinical applications for colostrinin peptides.

[Previous Story] [Next Story]

Chemical & Engineering News
Copyright © 2002 American Chemical Society