BioWorld International Correspondent
LONDON ReGen Therapeutics plc released interim data from the first phase of a Phase IIa trial of Colostrinin in the treatment of Alzheimer’s disease, showing that the rate of deterioration in patients in the treated arm was slower than in the placebo group.
The findings did not achieve statistical significance at the interim stage; however, results were consistent across all seven variables measured. The greatest effects were seen in the ADAS-cog measurement of cognitive function and the IADL measurement of the ability to perform everyday activities. There were no concerns over safety, toxicity or side effects.
Shares in the company, which is quoted on London’s Alternative Investment Market, fell by more than 20 percent to 13 pence, following the announcement on March 22.
However, CEO Mike Harvey said the results were very encouraging.
“If the safety and efficacy profile shown in the first phase of this trial is maintained in its final phase, then Colostrinin has the potential to be one of the first therapies for Alzheimer’s disease that will offer long-term benefits as opposed to symptomatic relief,” he said.
The trial, which is due to run until May, involves 106 patients at six centers in Poland. The first phase involved half the patients receiving Colostrinin for 15 weeks in a double-blind, placebo-controlled study. Colostrinin, an orally available, proline-rich polypeptide complex derived from ovine colostrum, has shown positive results in a number of previous studies in Poland. Regulators there required that all patients should receive the active drug in the second 15-week phase of the trial.
ReGen, based in London, was set up in November 1998 to commercialize Colostrinin, which was developed over a span of 20 years at the Institute of Immunology at the Academy of Science in Wroclaw, Poland. It remains the only compound in ReGen’s portfolio. Studies by ReGen and its scientific collaborators at the University of Texas Medical Branch suggest Colostrinin may act as an antioxidant, may prevent the formation of, or dissolve, amyloid plaques, and may modulate the immune system.
In double-blind trials conducted before ReGen acquired the compound, the progression of Alzheimer’s disease was halted in all cases. Also, some patients showed significant improvement in social functioning and short-term memory. There were no deaths among the 16 patients in the treated group during the three-and-a-half-year trial, and there were no side effects.
ReGen raised £1.45 million (US$2.07 million) when it was founded in 1998, and £300,000 the following year. In March 2000 it moved onto London’s Alternative Investment Market, raising £5 million in the process, and in November 2001 subsequently raised £1 million from existing investors.
If the final results of the current trial are successful, ReGen said it may seek a commercial partner. The company also hopes to sell the drug in Poland before seeking registration elsewhere.