BaroFold Inc. announced that it has initiated a two-stage Phase 1, repeat dosing, single-center, double-blinded study in up to sixty healthy volunteers to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of escalating doses of BaroFeron™ (IFNβ-1b).
In published preclinical studies BaroFeron demonstrated enhanced pharmacological properties, both pharmacokinetics and pharmacodynamics, when compared to commercial interferon beta products. BaroFeron has the potential to offer significant benefits to multiple sclerosis patients as these properties have been demonstrated to correlate with lesion formation by MRI measurements and clinical exacerbations.
"BaroFeron is posed to set a new standard for biologics incorporating our novel PreEMT™ technology that produces a product with biopharmaceutical properties that may be superior to conventionally produced proteins," stated Jeffrey L. Cleland, Ph.D., Vice President of Therapeutic Development. "We believe that MS patients will ultimately benefit from the unique properties of BaroFeron."
"This is the Company's first clinical milestone and demonstrates our ability to advance product programs from concept to the clinic in less than 18 months," stated Lyndal Hesterberg, President and CEO. "The tremendous team at BaroFold, combined with the utilization of our unique technology to improve existing biopharmaceutical products, provides us with the ability to rapidly generate multiple product candidates that address large markets. Our goal is to have BaroFeron for multiple sclerosis in late-stage clinical trials and advance two additional two pipeline products targeting allergic asthma and rheumatoid arthritis in the clinic by the end of 2010."
BaroFeron is a proprietary recombinant human interferon beta being developed for the treatment of multiple sclerosis. Interferon beta products are considered the "gold" standard for first line treatment options for managing the progression of multiple sclerosis. However, clinical evidence and physician surveys indicate the need to improve upon the efficacy and safety of currently available therapies. BaroFeron is produced using BaroFold's proprietary PreEMT™ technology to yield a formulation essentially free of protein aggregates. BaroFeron could potentially be differentiated from other interferon-beta products by improved safety and greater bioavailability enabled by BaroFold's proprietary PreEMTTM technology.
BaroFold's proprietary PreEMT technology incorporates hydrostatic pressure to disaggregate and refold proteins into the biopharmaceutical manufacturing process. The technology improves product quality by producing essentially "aggregate-free" final product that may have superior homogeneity and stability. PreEMT enables the production of new biologics that are difficult to manufacture with conventional methods as well as novel protein structures can be generated by reactions performed with the technology. PreEMT production systems are reliable and scalable using commercially available equipment currently used in the food and chemical industries.
BaroFold is developing improved biopharmaceuticals for patients suffering from chronic immunologic disorders. Utilizing proprietary process technologies, BaroFold creates novel protein therapeutics targeting validated disease pathways with blockbuster potential. BaroFold's development candidates target chronic indications having significant physician and patient demand for therapies that are more tolerable and efficacious than those currently available. BaroFold has leveraged its unique technology to form relationships with several biopharmaceutical companies.
This press release contains forward-looking statements that involve risks and uncertainties, including statements relating to initiation and progress of the Company's clinical trial programs. Actual results could differ materially from those projected and the Company cautions investors not to place undue reliance on the forward-looking statements contained in this release.