Apex Bioscience Inc. has been issued a broad patent (U.S. Patent No.5,296,466) covering the use of hemoglobin and other iron-containingproteins to treat hypotension induced by septic shock. The company isdeveloping a recombinant hemoglobin product for shock-inducedhypotension, and expects to begin clinical trials in patients within twoyears.Apex has exclusive rights to this patent, which is based on work bycompany scientists and researchers at the M.D. Anderson CancerCenter at the University of Texas and at Duke University."Excess nitric oxide is strongly implicated in the acute blood pressuredrop that takes place during shock pressure," said John Irick, thecompany's president and chief executive officer. "The patent is basedon the discovery that lowering nitric oxide levels with hemoproteinssuch as hemoglobin restores normal blood. The hemoglobin isadministered in very low doses to achieve a therapeutic effect and actsas a nitric-oxide scavenger.' It is now undergoing pre-clinical testingand has been found to reverse shock-induced hypotension in animalmodels."Irick said that in addition to its recombinant hemoglobin product, Apexis also looking at the application of nitric oxide blockers that wouldprevent the synthesis of nitric oxide
Deplete Sources of Arginine"We are looking at arginine, an essential amino acid needed for thesynthesis of nitric oxide," Irick said. "The primary source of arginine isthe diet. We would like to deplete the exogenous sources of arginine bycontrolling the absorption of arginine in people at risk for shock, manyof whom receive supplemental amino acid feedings. We are developinga proprietary, arginine-free amino-acid based product that would be fedto them, excluding the arginine in this diet. In this way, their bodies'resources of arginine would be depleted."Irick noted that the hemoglobin treatment would be used for patientsalready in septic shock. He said these patients are usually treated withfluids. "Statistics indicate that about one-third respond to fluid therapy.Those who don't receive pressors; but a substantial number in thisgroup don't respond to pressors. The arginine product could be used inthese cases, either alone or in conjunction with pressors. Patients whoare at high risk for shock would receive the arginine-depletion productin hospital prophylactically to lower the risk of septic shock," Iricksaid.Irick noted that the arginine-free product is now undergoing afeasibility study at the M.D. Anderson Center. The company hopes tobegin Phase I testing as early as 1995.Based in Research Triangle Park, N.C., Apex Bioscience was foundedin 1993 as the successor to Strohtech Inc. It is a privately heldbiotherapeutics company engaged in the discovery, development andcommercialization of proprietary therapeutic products based on themodulation of reactive nitrogen intermediates and reactive oxygenspecies, the company's RNO technology.
-- Philippa Maister
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