EAGAN, Minn., May 15 /PRNewswire/ -- Biothera announced today that it has successfully completed a Phase I clinical trial for Imprime PGG(TM), its investigational new drug for the treatment of various cancers and the enhancement of white blood cell mobilization and production.
The single-dose, dose-escalating Phase I study examined the safety and tolerability of a single injection of Imprime PGG in 24 healthy volunteers. As anticipated based on previous research, Imprime PGG demonstrated a strong safety profile.
"We are very pleased to have successfully completed our first trial in humans," said Myra Patchen, Ph.D., executive vice president of pharmaceutical development for Biothera. "We are on track for moving quickly to proof of concept Phase II trials."
Biothera plans to initiate a multiple-dose, dose-escalation Phase I clinical study in June. The study is designed to generate additional safety data, including pharmacokinetic and pharmacodynamic data. Biothera is also preparing to launch a Phase II clinical program that will include a series of trials featuring a combination of Imprime PGG and various monoclonal antibodies and growth factors to treat a number of indications.
"Completion of the single-dose Phase I trial is a milestone for Biothera and this platform technology," said Daniel Conners, Biothera founder and chairman. "Our strategy is to complete multiple Phase II trials and then license these specific drug combinations to large biotech or pharmaceutical companies."
Imprime PGG is a soluble/injectable beta 1,3/1,6 glucan derived from a proprietary strain of yeast (Saccharomyces cerevisiae). Imprime PGG binds with specific receptors on neutrophils, the most abundant immune cell in the body, and primes them for heightened immune activity. Preclinical studies demonstrate that Imprime PGG-bound neutrophils attack and kill cancer cells when complement and antibodies are present. In effect, this novel mechanism engages the innate immune system in the fight against cancer.
About Biothera, the Immune Health Company
Biothera is a biotechnology company dedicated to improving immune health. The company's primary focus is developing pharmaceuticals that engage the immune system to fight cancer and that produce white blood cells following chemotherapy or radiation. In addition, Biothera manufactures and markets food-grade ingredients that support healthy immune function to the nutritional supplement, functional food, cosmetic and animal nutrition markets. Website: http://www.biotherapharma.com .
BiotheraCONTACT: David Walsh, VP, Communications of Biothera, the Immune HealthCompany, +1-651-256-4606, dwalsh@biotherapharma.com
Web site: http://www.biotherapharma.com/
