BOSTON H A patient who underwent thora-coabdominalsurgery Wednesday at Deaconess Hospital was shielded againstpost-operative infection by Betafectin, a genetically engineeredcarbohydrate.
The patient was the first of 40 who will receive thecarbohydrate in a Phase II clinical trial, said Spiros Jamas,president and chief executive of Alpha-Beta Technology Inc.,which developed and supplied it. Half will get their Betafectininfusions at the University of Massachusetts Medical School inWorcester, where Alpha-Beta is located.
On Aug. 24 in Budapest, Jamas will report to the EighthInternational Congress of Immunology on the Phase I clinicaltrial of Betafectin earlier this year. In that study, 24 healthyvolunteers received graduated doses of the anti-infective andexperienced no significant adverse effects, Jamas said.
He said he will tell the Budapest audience that "a clear increasewas noted in absolute neutrophil and monocyte counts on adose-response basis."
Neutrophils and monocytes are the white blood cells (WBCs)that attack, engulf and destroy pathogenic microorganisms.Betafectin makes these front-line phagocytic cells multiply atthe scene of an infection, but without spawning often-toxicimmune mediators, such as interleukin-1, tumor necrosis factorand leukotrienes.
Alpha-Beta this month expects to come to terms with theeconomic development departments of Massachusetts or RhodeIsland. Financial support from either will determine where thecompany builds its $20 million to $30 million, 40,000-square-foot commercial manufacturing plant for Betafectin.
Alpha-Beta's board chairman, Gustav A. Christensen, toldBioWorld during a recent site visit that che company intends tomake enough clinical material to supply our impending PhaseIII trials and the first two years of commercial, worldwidemarketing.
"We now have $12 million in the bank," Christensen said. "Sofar, we've spent only $6.5 million getting Betafectin throughthe investigational new drug (IND) permit procedure at theFDA, and building a pilot plant."
Alpha-Beta's management hopes to impress potential investorswith the trials and state financial support. Alpha-Betapostponed a planned IPO last March of 2 million shares ofcommon stock at $14 to $16 because of adverse stock marketconditions.
"We have not withdrawn our registration," Christensen said."We will update it and try to go in the fall for $20 million to$30 million." Alex. Brown & Sons and Vector SecuritiesInternational are lead underwriters.
Betafectin is not just a new antibiotic, Jamas stressed. In fact,the infection-fighting agent is not an antibiotic at all, but a six-carbon sugar polymer H b-glucan H a complex carbohydrate."
Betafectin, Jamas explained, has many medical indications, allrelated to prevention or treatment of infection.
The primary objective of the new Phase II trial, Jamas added,is to establish safety in the post-surgery patient group. Itssecondary goal is to measure infection rate, cure rate andduration of hospital stay. He expects the study to be completedby the end of this year.
Alpha-Beta in October plans to initiate a trial in victims ofsecond- and third-degree burns, who are particularlyvulnerable to bacterial assault.
A single carbohydrate, b-glucan, is the starting material forAlpha-Beta's product line, which also includes a cholesterol-reducing drug, Cholestran, and a high-fiber nutritionalsupplement, Fibercel.
All derive from manipulation of the b-glucan molecule.Immunochemist Joyce K. Czop at Boston's Brigham andWomen's Hospital discovered the b-glucan receptor onneutrophils and monocytes. The hospital granted Alpha-Betaexclusive licensure to its patents covering Czop's discoveries.The company holds similar intellectual property rights fromthe Massachusetts Institute of Technology.
Once over the clinical and regulatory hurdles, the companymay seek assistance. Christensen foresees that "we cannotcommercialize our own products worldwide; we're simply toosmall. I think we'll have corporate partners, for marketing, notfor manufacturing."
-- David N. Leff Science Editor
(c) 1997 American Health Consultants. All rights reserved.