Alteon Updates Investors on Alagebrium Development Status
Wednesday May 4, 9:40 am ET
- Alagebrium Preclinical Toxicity Tests Progressing; Company Intends to Perform SPECTRA Clinical Trial Interim Analysis -
PARSIPPANY, N.J., May 4 /PRNewswire-FirstCall/ -- At the Rodman & Renshaw Techvest 2nd Annual Global Healthcare Conference today, Alteon President and Chief Executive Officer Kenneth I. Moch reported encouraging interim results from preclinical toxicity tests of alagebrium, the company's lead A.G.E. Crosslink Breaker. Results thus far indicate that the liver alterations previously seen in rats, which led to the voluntary suspension of enrollment in the alagebrium clinical trials, are not caused by genotoxicity pathways, but may be a result of the male rat metabolism.
ADVERTISEMENT
Mr. Moch also announced that Alteon intends to perform an interim analysis of the ongoing Phase 2b SPECTRA (Systolic Pressure Efficacy and Safety Trial of Alagebrium) trial of alagebrium in patients with uncontrolled systolic hypertension before resuming enrollment of new patients into this trial. By mid-year 2005, approximately two-thirds of the targeted 250 patients are expected to have completed SPECTRA.
"After careful consideration and discussion with our scientific advisors, Alteon has determined that it is prudent to undertake an interim analysis of SPECTRA," said Mr. Moch. "The results of this analysis, together with the results of the preclinical toxicity tests currently under way, will guide Alteon in determining the next steps for resuming enrollment in this trial and the conditions under which such enrollment could resume. We are using an independent Data Review Committee to preserve the integrity of the final statistical analysis."
"We remain enthusiastic about the compound's potential," Mr. Moch continued. "Alteon's clinical team is actively working with our study sites in preparing to identify additional patients for our clinical trials, pending the toxicity findings and the SPECTRA interim analysis."
The ongoing toxicity tests resulted from findings announced in December 2004 of a two-year preclinical carcinogenicity study indicating that male Sprague Dawley rats exposed to high doses of alagebrium over their natural lifetimes developed dose-related increases in liver cell alterations including hepatocarcinomas, and that the alteration rate was slightly over the expected background rate in this gender and species of rat. The company also initiated a series of preclinical experiments to explore the mechanism by which the liver alterations developed and their relevance to human exposure. In February 2005, as a precautionary measure, the company suspended enrollment of new patients into all ongoing clinical trials of alagebrium based on the initial results from one of the follow-on experiments that suggested the need for further preclinical testing. These more recent preclinical toxicity experiments, for which encouraging news is being announced today, are ongoing and are expected to be completed by mid-year. Decisions regarding resumption of enrollment of patients into the Phase 2 trials will be made at that time.
Mr. Moch further noted that the initial findings in male Sprague Dawley rats occurred at a low level and much later in the rat's 2-year lifetime (~80 human equivalent years), and after long exposures (greater than 40 human equivalent years) of dosing. Additional experiments are being conducted to further explore the role of metabolic and cellular processes and any possible relationship to humans. To date, there is no relation of the findings to any potential human carcinogenic risk associated with alagebrium.
The ongoing testing is thus far consistent with previous evaluations of alagebrium. Earlier preclinical studies found no mutagenic or carcinogenic activity in either rats or mice. In addition, four key genotoxicity studies to help determine potential toxicities of alagebrium in man did not indicate any potential carcinogenic risk. Alteon has reviewed all of the cumulative human safety data and previous preclinical experience of alagebrium, and these data have not demonstrated a relationship to the two-year (lifetime) carcinogenicity study in rats.
The full webcast of Mr. Moch's presentation can be accessed at the company website, alteon.com. In addition, Alteon will be holding an investor update conference call on May 11, 2005. Details will be announced.
[Snip] |
