By Mary Welch
Cypros Pharmaceutical Corp. achieved statistical significance in its Phase II trial of Ceresine in adult ischemic stroke patients, confirming results found in an earlier Phase II trial of the same drug in patients with traumatic brain injury.
The most recent trial, conducted with 31 patients at five centers, aimed at reducing the accumulation of lactic acid in the brain. Patients were evaluated within 24 hours after having a stroke, using a magnetic resonance spectroscopy (MRS) that visualized the amount of lactic acid (which destroys tissue) in the brain, quantifying lactate in the conscious patient in real time. After an initial MRS, patients were given Ceresine, and a second MRS was conducted about a half-hour later.
The study showed that the higher the dose of the drug, the greater the reduction of lactic acid.
¿We evaluated the patients less than an hour after dosage and we still had statistical significance in the reduction,¿ said Paul Marangos, president and CEO of the Carlsbad, Calif.-based company. ¿With the trial for traumatic brain injuries, we were able to get a look at the cerebral spinal fluid at one, two, five [and] 10 hours. It was a serial look. With the MRS, it¿s different. For one thing, the patients have to be totally still, and the patients were getting antsy. Even so, it was enough time to show the effects of the drug.¿
The trial proved two things, Marangos said. The first is that Ceresine ¿gets into the brain,¿ and the second is that it can lower lactic acid in stroke and brain-injured patients.
¿There have been several neuroprotection drugs using different mechanisms and a couple of them recently failed in Phase III trials,¿ he said. ¿This lactate-reducing approach has never been tried before. It works by a totally different mechanism.¿
Ceresine, Cordox Vying For Resources
What to do next is the problem facing the company. It wants to start a Phase III trial of Ceresine in brain-injured patients, and a possible one for the ischemic stroke indication now that the Phase II results came in positive, Marangos said.
However, the company would also like to intensify its Phase III trials for Cordox for the treatment of painful episodes of sickle cell anemia.
Cordox, a naturally occurring intermediate of energy metabolism, helps red blood cells maintain their normal shape and improves overall blood flow. Cordox works by supplying energy in the form of adenosine triphosphate to sickled red blood cells, allowing them to become more pliable by depolymerizing hemoglobin and improving overall blood flow. It also provides energy to oxygen-starved tissues, preventing damage to those tissues and to blood-vessel walls. (See BioWorld Today, June 18, 1998, p. 1.)
Cypros intends to conduct a Phase III trial with Cordox with 280 patients at approximately 30 sites. So far, 12 centers are operational, and another 15 are ready to go next month, Marangos said. He expects a new drug application to be filed in 2001. ¿We¿re trying to decide and prioritize,¿ he said. ¿One strategy is to partner these drugs to help fund a $25 million trial; another is to start a pivotal trial in a small way, and grow it,¿ he said. ¿We have an abundance of opportunity, and not the resources. It¿s the mantra of biotechnology companies.¿
The FDA has granted Ceresine expedited development status in both indications. ¿We¿d like to do pivotal trials in both indications, obviously,¿ Marangos said. ¿We are still working on it and we have an open mind.¿
Cypros is looking to co-partner Ceresine, but to say the company is ¿actively looking¿ would be an exaggeration, Marangos said. ¿We¿d rather not do a licensing deal; instead we¿d prefer to co-promote the drug,¿ he added.
The company¿s stock (AMEX:CYP) closed Thursday at $2.937, up $0.125. n