Vaccine developer Univax Biologics Inc. has a pipeline ofproducts reaching the clinic.
The Rockville, Md., company derives hyperimmune intravenousimmunoglobulins (IGIVs) from human plasma containingspecific antibodies induced by its vaccines.
Univax recently began Phase I trials in healthy volunteers of avaccine targeted at a bacterium that colonizes the lungs ofchildren with cystic fibrosis.
The mucoid exopolysaccharide pseudomonas vaccine istargeted at a mucus-producing strain of Pseudomonas. As withall of Univax's vaccines, the trials will determine safety andstimulate plasma in donors for use in the preparation of MEPIGIV that can be used to treat children with CF.
Phase I trials of the IGIV in children with CF are scheduled tobegin in September 1992.
The company has received Food and Drug Administrationapproval to begin Phase I trials of a tetravalent group Bstreptococcus (GBS) polysaccharide vaccine. The trials willstimulate production of GBS IGIV to treat neonatal sepsis,which kills about 10,000 newborn infants annually in theUnited States, in future clinical trials.
The company is also conducting Phase I trials of a bivalentStaphylococcus aureus vaccine. Both a Staph vaccination and ahyperimmune IGIV program are planned to prevent catheter-related infections.
Univax last month filed a fourth investigational new drugapplication for Phase I trials of a vaccine for septic shockcaused by gram-negative and positive bacteria. Later in theyear, the company plans another Phase I trial of a lipid Avaccine for septic shock.
The company has orphan drug designation for GBS IGIV to treatneonates with GBS infection, and for MEP IGIV to treat andprevent pulmonary infections due to Pseudomonas aeruginosain patients with CF.
Univax last November signed a marketing agreement withAlpha Therapeutic Corp. to manufacture and distribute theseptic shock IGIV. Los Angeles-based Alpha, a wholly ownedsubsidiary of Green Cross of Japan, is providing developmentfunding totalling $7 million over 5 years. Univax has retainedco-marketing rights in the United States and Europe.
Univax has raised a total of $5.25 million since it was foundedin 1988. Funders include Charter Ventures; Kleiner, Perkins,Caufield & Byers; Domain Associates; and Jacobs EngineeringGroup Inc.
-- Karen Bernstein BioWorld Staff
(c) 1997 American Health Consultants. All rights reserved.