ImmuCell Corp.'s first potential product for human use, atreatment for diarrhea in immune-compromised patients, hasstumbled at the starting gate and is entering an extendedclinical trial to enhance delivery.
The Portland, Maine, company (NASDAQ:ICCC), supplied itspolyclonal antibody for cryptosporidiosis in AIDS patients toUnivax Biologics Inc. of Rockville, Md., which completed aPhase I/II trial in 40 AIDS patients with chroniccryptosporidiosis. Univax holds marketing rights to theproduct, CryptoGAM.
The trial showed safety and some activity. However, in hisquarterly letter, Thomas Stagnaro, Univax's president and chiefexecutive officer, wrote to shareholders on Wednesday that"the parasite level was reduced; however, diarrhea volumeremained unacceptably high in some patients."
Cryptosporidium infection occurs in 10 to 15 percent of AIDSpatients in the U.S. and causes about a 60 percent mortalityrate from dehydration. Cryptosporidium parasites invade thesmall intestine and cause severe and often debilitatingdiarrhea. There is currently no effective treatment.
CryptoGAM is a hyperimmune gama globulin product derivedfrom milk from the first four or five milkings of cows, whichcontain antibody-rich colostrum. ImmuCell developed a vaccineused to induce these antibodies in cows treated on contract atdairy farms.
The globulins are purified, concentrated and freeze-dried, thenadministered in a powdered milk drink.
With this mode of delivery, said Thomas Hatch, ImmuCell'spresident and chief executive officer, "it is unclear whethersustained concentrations of the drug are getting to the site ofinfection to effectively combat the disease."
ImmuCell plans to work with consultants on improvingdelivery of the antibody to the small intestine, perhaps byusing a coating or higher doses, said Michael Brigham, thecompany's chief financial officer.
Univax will continue enrolling patients at seven medicalcenters as subjects in order to evaluate possible alternatedelivery techniques.
A milestone payment due from Univax on June 30 was changedto four monthly payments of $10,000 each from August throughNovember, with the balance of $260,000 due in December. Alloutstanding payments are subject to a 30-day notice ofcancellation by Univax.
Univax had its first profitable quarter in the first threemonths of this year, Brigham said, with a net gain of $16,000.
Univax entered the license and supply agreement withImmuCell last May, when ImmuCell had just $500,000 in thebank and could not afford to complete clinical testing.ImmuCell retained exclusive manufacturing rights and wasexpected to receive about $2 million to $3 million in researchsupport and milestone payments over two to three years.
-- Nancy Garcia Associate Editor
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