CepTor Corp. is hoping to breathe new life into a product aimed at preventing chronic respiratory morbidity in premature newborns.

The Hunt Valley, Md.-based firm signed a letter of intent to purchase recombinant human copper zinc superoxide dismutase (SOD) from Ferring International SA.

The deal is contingent upon reaching an agreement with the FDA regarding the "clinically relevant" endpoints for a Phase IIb trial, said Bill Pursley, chairman and CEO of CepTor.

Pending that agreement, the company would make an exclusive option payment to Lausanne, Switzerland-based Ferring, which will "provide us with a significant period of time to put a program together," before deciding whether to exercise that option, Pursley told BioWorld Today.

A product previously investigated by London-based BTG Israel, SOD hit a development snag in a 302-patient Phase II trial when it missed its predetermined endpoint. In that study, the product was administered intratracheally to intubated premature infants. At the end of the 28-day period, there was no statistically significant difference in pulmonary outcome between SOD and placebo

But further study suggested that the measurement of bronchopulmonary dysplasia at 28 days was "fairly irrelevant," Pursley said.

One of the study's investigators, Norman Barton, who now is executive vice president and chief medical officer at CepTor, decided to keep the Phase II data blinded for a year. Those results led to an independent finding of significant positive results in the infants who received SOD at one year. Those data were published in a 2003 issue of Pediatrics.

In March, another article appeared in Pediatrics, which focused on recommendations from a panel assembled by the FDA and the National Institutes of Health concerning longer-term endpoints for chronic respiratory morbidity in preemies.

That "created a very important paradigm shift from a regulatory standpoint and from a study standpoint," Pursley said. "Bronchopulmonary dysplasia, measured at four or five weeks out, has not been shown to be predictive of what happens to these kids about a year out. So the true effect of this drug, which is an oxygen-free radical scavenger, really isn't known until then."

If it opts to purchase the worldwide rights to SOD, CepTor would pursue the product as an orphan drug.

Chronic respiratory morbidity in premature babies, especially those with extremely low birth weights, stems from being intubated and placed on ventilators, and studies increasingly have shown a connection between that process and a host of "long-term morbid" conditions that affect pulmonary and neural development, causing retinopathy, increased blindness, decreased neural development and pulmonary morbidity, Pursley said.

With the long-term data from BTG's Phase II study showing SOD's promise, the product gained renewed interest from the neonatology community, which became "eager to see this moving forward," he added.

So Ferring, after determining that SOD no longer fit with its strategic focus, set out to divest the program to a company that would develop it to approval. CepTor's connection to SOD, through Barton, as well as Vice President of Clinical Research Theresa Michele - also a BTG alum - made it "a very nice fit for us," Pursley said.

"Our next goal is to try to meet with the FDA, and hopefully, get an agreement on the endpoints," with the aim of getting SOD "back into the clinic in a Phase IIb study around the middle of next year."

In the meantime, CepTor is awaiting word from the FDA on its complete response to an investigational new drug application for Myodur, its compound for Duchenne's muscular dystrophy. The company initially submitted the IND in January, but the agency put it on hold pending a satisfactory response letter. CepTor expects to hear from the FDA by Sept. 30.