By Kim Coghill
Alexion Pharmaceuticals Inc. said Tuesday that the FDA has given it clearance to commence Phase III pivotal trials of pexelizumab, for acute cardiovascular indications.
Pexelizumab, formerly known as 5G1.1-SC, is an anti-inflammatory C5 inhibitor monoclonal antibody fragment being developed by Alexion, of Cheshire, Conn., in collaboration with Procter & Gamble Pharmaceuticals, an affiliate of Procter & Gamble Co., of Cincinnati.
The 3,000-patient pivotal Phase III trial will look at the safety and efficacy of pexelizumab in reducing death and myocardial infarction in bypass patients. The trial will be called ¿Pexelizumab for Reduction in Infarction and Mortality in Coronary Artery Bypass Graft Surgery,¿ or ¿PRIMO-CABG.¿
Leonard Bell, Alexion¿s president and CEO, told BioWorld Today that although P&G will determine when Phase III trials begin, he expects the date to be sometime late this year or early next year. The trials likely will take 12 to 18 months and upon their start, Bell said the companies will have a better timeline on anticipated regulatory filing dates.
Altogether, Bell said Alexion released positive data on three fronts at the 2001 Scientific Sessions of the American Heart Association in Anaheim, Calif.
¿We are very excited about the three different events, but most importantly, the authorization from the FDA to go forward with a single CABG trial,¿ he said. ¿The results of the Phase II trials are encouraging and this is the first time there has been demonstration of cognitive benefits with an anti-inflammatory drug in bypass patients.¿
Bell said pexelizumab would be extremely significant in the marketplace because there are no other products for bypass patients that reduce inflammation, which results in the reduction of death or heart attack.
Alexion got its first insight into the potential success of pexelizumab back in January when it released positive preliminary data from the Phase II trials. The company¿s stock jumped 25 percent (up $14.25) to close at $71.375 when the data were released showing association between the use of pexelizumab and a reduced rate of death and myocardial infarctions. (See BioWorld Today, Jan. 24, 2001.)
Final data from the Phase IIb trials were released from the study of 914 patients at 65 U.S. sites, indicating that pexelizumab is linked to reduction of accelerated cognitive dysfunction usually noted after coronary artery bypass graft surgery.
Compared to the placebo group, fewer pexelizumab patients appeared to have suffered loss of their visual and spatial recognition and integration skills, which usually decline after CABG surgery, the company said.
According to the American Heart Association, about 550,000 coronary artery bypass graft surgery procedures were performed in 1998.
Alexion and P&G signed the multimillion-dollar deal in January 1999 to develop and commercialize pexelizumab. Alexion may receive up to $95 million in payments, including an up-front license fee, milestone payments and research and development support. P&G will pay for all clinical, manufacturing and other development costs associated with the drugs, according to Alexion. In February 1999, Alexion received a $10 million up-front payment.
Alexion¿s stock (NASDAQ:ALXN) closed Tuesday at $21.70, up $1.40.
In other news from the meeting:
¿ COR Therapeutics Inc., of South San Francisco, said that use of Integrilin is highly cost effective at $1,407 per year of life saved in patients undergoing an intracoronary stent procedure. Integrilin¿s cost effectiveness was evaluated as part of the long-term, follow-up phase of the ESPRIT study in 2,064 patients undergoing coronary stent procedures. The economic analysis showed Integrilin increased costs by less than $300 per patient lower than the drug¿s acquisition cost of $495. At the end of the first year follow-up, the net cost of Integrilin to the health care system was only $146, COR said.
¿ CV Therapeutics Inc., of Palo Alto, Calif., reported retrospective data showing that after termination of paroxysmal supraventricular tachycardia (PSVT), an atrial arrhythmia, with either adenosine or CVT-510, the use of CVT-510 revealed fewer abnormal ventricular beats and fewer post-arrhythmia pauses. The analysis culled data from 14 patients who converted to sinus rhythm after receiving CVT-510 at two centers and from 12 patients who converted to sinus rhythm after receiving adenosine at one of the centers. Current CVT-510 studies include a Phase III trial in patients with PSVT and a Phase II trial in patients with atrial fibrillation.
¿ Vascular Genetics Inc., of Waltham, Mass., is the exclusive licensee of the VEGF-2 gene from one of its investors, Human Genome Sciences Inc., of Rockville, Md. According to four related papers presented at the conference, injecting VEGF-2, an angiogenic growth-factor, into oxygen-deprived hearts has been shown to promote new blood vessel development and improve blood flow in desperately ill patients. Studies showed marked improvement in angina, increased blood flow to the heart, that ischemic areas were dramatically smaller and an increase in exercise tolerance.