Nuvelo/NASDAQ: NUVO is in discussions with clinical advisors and partner Bayer, to provide details on the go-forward plan for alfimeprase in the second quarter of 2007. As a reminder, on December 11, 2006, Nuvelo and partner Bayer had suspended the alfimeprase development in catheter occlusion (CO) and peripheral arterial occlusion (PAO) following failure to reach its primary endpoints in Phase III NAPA-2 and SONOMA-2 trials. Key secondary endpoints were also not achieved. Despite alfimeprase’s failure in CO and PAO trials, Nuvelo indicated that all options are still open, including, potentially, stroke and deep vein thrombosis. We believe the drug’s intravascular delivery is a key challenge that Nuvelo must address. Should delivery challenges be overcome, we believe that given its mechanism of action, alfimeprase could potentially offer a lower risk of bleeding versus other thrombolytics in stroke.However, Nuvelo’s progress with its early-stage pipeline will be a key theme in 2007. rNAPc2 is also being developed for acute coronary syndrome and Phase IIb data were presented at the World Congress of Cardiology in September 2006. The results showed promising efficacy trends but additional clinical results will be required to better define the drug’s therapeutic window and potential for side effects. It is difficult to handicap how these results will translate into clinical benefit in later-stage trials.
A Phase II trial of rNAPc2 in metastatic colorectal cancer is under way; efficacy endpoints include progression-free survival, metastasis-free survival, and overall survival as well as additional trials in other tumors. The company will give guidance on timelines for that trial when enrollment is further along and in late March, rNAPc2 received fast track designation from the FDA. Nuvelo’s share price rose on the news. Nuvelo is also considering trials in additional cancer indications with the start of additional trial(s) this year a possibility. The company also reiterated plans to begin a Phase I trial for NU206, a stem cell growth factor, in the first half of 2007 and a Phase I trial for NU172, a thrombin inhibitor, in the fourth quarter of 2007 or the first quarter of 2008. NU206, a growth factor for GI-related disorders, will enter Phase I trials in the first half of 2007. NU172 will enter a Phase I trial in the fourth quarter of 2007/first quarter of 2008 to inhibit blood clots. Nuvelo is clearly shifting focus toward earlier stage candidates that may have promise. However, the programs are early, and key clinical data won’t be available until 2008.
Nuvelo will trade in-line pending additional clarity on the alfimeprase program or new pipeline initiatives. But once the status of alfimeprase is known and Nuvelo initiates its early stage pipeline, investors’ optimism in the company’s outlook could revive.
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