Bayer bails (though it can opt back in), and NUVO goes on with alfimeprase:
>>Nuvelo Resumes Development of Alfimeprase in Multiple Blood-Clot Related Indications
Tuesday June 26, 4:01 pm ET
- Clinical Proof-of-Concept Stroke Trial, Catheter Occlusion Trial and Preclinical Studies in Acute PAO to Begin in Second Half of 2007 -
- Update to Financial Guidance Provided -
SAN CARLOS, Calif., June 26 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO - News) today announced that it will resume development of alfimeprase, its lead investigational product candidate for the potential treatment of multiple blood clot-related disorders, such as acute ischemic stroke, catheter occlusion (CO) and acute peripheral arterial occlusion (PAO). In addition, Nuvelo and Bayer HealthCare have agreed to terminate their collaboration.
Nuvelo has agreed to waive Bayer's obligation to provide Nuvelo twelve-months' notice of termination in consideration of Bayer's agreement to pay Nuvelo a lump sum of $15 million. Nuvelo has also granted Bayer the one-time option to reacquire rights to alfimeprase upon the initiation of a pivotal stroke trial, on the same terms as the original agreement with the addition of a $15 million option exercise payment from Bayer.
"Based on our review of all clinical data and extensive consultations with Data Safety Monitoring Boards, study steering committees and regulatory authorities, we believe that alfimeprase has the potential to offer many benefits, and we remain committed to its development," said Dr. Ted W. Love, chairman and chief executive officer of Nuvelo. "Therapeutic options for stroke patients are limited, and stroke remains the third leading cause of death in the United States and a leading cause of severe, long-term disability. We believe that a safer, more efficacious intra-arterial therapy can change the treatment paradigm for these patients and that a product candidate such as alfimeprase holds the potential to rapidly restore flow and expand the treatment window beyond the current three-hour time frame."
"Alfimeprase holds the potential to offer direct and rapid dissolution of blood clots while keeping its activity localized to the site of delivery," said Dr. Randy Higashida, clinical professor of radiology, neurosurgery, neurology, and anesthesia, and chief of interventional neuroradiology at the University of California, San Francisco Medical Center. "We look forward to conducting this proof-of-concept trial in stroke to determine whether these novel characteristics will translate into positive study outcomes."
The Phase 2 CARNEROS-1 (Catheter Directed Alfimeprase for Restoration of Neurologic Function and Rapid Opening of Arteries in Stroke) proof-of-concept trial with alfimeprase in acute ischemic stroke is expected to begin in the second half of 2007. CARNEROS-1 is a multi-center, open-label, dose escalation study beginning with doses of 1 mg, 5 mg and 10 mg, that will enroll approximately 100 patients within 3-9 hours of stroke onset.
Catheter Occlusion
Going forward, Nuvelo is investigating whether a single, higher, more concentrated dose of alfimeprase would generate results it believes are necessary for commercial success in CO. Nuvelo therefore plans to re-initiate the SONOMA-3 trial in the second half of 2007 with a modified protocol, evaluating a single, higher dose (10 mg) and concentration (5 mg/mL) of alfimeprase in up to 100 patients.
Data from the first Phase 3 trial in the CO program, SONOMA-2, showed that alfimeprase restored catheter function in patients with occluded catheters within 15 minutes with a p-value of 0.022. It did not, however, meet the more stringent p-value required for a single pivotal trial, less than 0.00125, nor did it meet the company's target product profile for commercial success.
Acute Peripheral Arterial Occlusion
Nuvelo has concluded that the delivery method for alfimeprase in its acute PAO program is suboptimal. Nuvelo will close the suspended NAPA-3 trial and plans to initiate preclinical studies focused on identifying optimized delivery methods in acute PAO in the second half of 2007.
Data from the Phase 3 acute PAO trial, NAPA-2, indicates that efficacy could potentially be enhanced by maintaining alfimeprase longer at the site of thrombus; for example, a greater treatment effect was achieved when treating larger clots and in situations where alfimeprase was able to stay in the clot longer. With regard to safety, the NAPA-3 study, unlike NAPA-2, did not show a difference in overall adverse events, or bleeding, in the alfimeprase arm compared to the placebo arm. In both studies hypotension and peripheral embolism were seen more commonly in the alfimeprase-treated patients.
Update to Financial Guidance
For the first half of 2007, in anticipation of a mid-year update on alfimeprase development, Nuvelo provided guidance that it expected both operating expenses and net cash used in operating activities to be in the range of $30 to $35 million for the six month period. Factoring in the revised development plans for alfimeprase described above and the change in its collaboration with Bayer, Nuvelo expects that both operating expenses and net cash used in operating activities will not exceed this same range for the second half of 2007. The company expects to provide further clarification with respect to operating expenses and use of cash as well as the accounting treatment of the Bayer payments made to Nuvelo on its second quarter earnings release conference call.
About Alfimeprase
Alfimeprase is a recombinant direct acting fibrinolytic (rDAF) that has the potential to rapidly dissolve blood clots through a unique mechanism of action -- it directly degrades fibrin, a protein that provides the scaffolding for blood clots. In addition, alfimeprase's thrombolytic activity appears to be localized to the site of delivery because it is rapidly inactivated by alpha-2 macroglobulin, a naturally occurring protein in the blood, as it moves away from the site of delivery and into the general blood circulation.
Conference Call Information
Nuvelo will hold a conference call today at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss this announcement. To participate in the conference call, please dial 800-659-2056 for domestic callers and 617-614-2714 for international callers and reference conference passcode, 96975177. A telephone replay of the conference call will be available through July 10, 2007. To access the replay, please dial 888-286-8010 for domestic callers and 617-801-6888 for international callers and reference conference passcode, 52668084. In addition, this call is being webcast by Thomson/CCBN and can be accessed at Nuvelo's website at nuvelo.com.
The webcast is also being distributed through the Thomson StreetEvents Network. Individual investors can listen to the call at fulldisclosure.com, Thomson/CCBN's individual investor portal, powered by StreetEvents. Institutional investors can access the call via Thomson StreetEvents (http://www.streetevents.com), a password-protected event management site.<<
snip
This cannot have been unexpected, but the Street doesn't like it. The stock is losing ground after hours. Or maybe the Stret expected NUVO to drop it alfimeprase entirely. Since they are not, they are going to have to be in good touch with the FDA about the endpoints, which were too high a hurdle. If they cannot be changed, I don't see the point in continuing.
Cheers, Tuck |
