Unigene Releases PTH Clinical Study Results

Thu. March 19, 2009; Posted: 11:21 AM

Mar 17, 2009 (Close-Up Media via COMTEX) -- UGNEE | Quote | Chart | News | PowerRating -- Unigene Laboratories, Inc. reported that its improved Enteripep PTH tablets were able to consistently deliver therapeutic blood levels of the drug with significantly reduced variability in a Phase I study involving twenty-four postmenopausal women.

In a release, the company noted:

The resulting average blood levels exceeded those that have been shown in third party studies using injectable PTH to stimulate bone growth in osteoporotic women. No serious or unexpected adverse events were reported.

The same improved solid dosage form used in this PTH study was successfully tested by Unigene in clinical studies with oral calcitonin conducted last year, and in those trials it also demonstrated performance when compared with earlier calcitonin studies that utilized Unigene's original oral delivery technology.

"We have learned a tremendous amount about our delivery system and the PTH molecule over the past two years, and the performance of these tablets has justified our diligence in building that database," said Dr. Ronald S. Levy, Executive Vice President of Unigene. "Currently PTH is the only FDA-approved bone anabolic therapy and it is sold as an injectable product. These results are a major step forward in the development of an oral PTH product and we believe that this valuable know-how will make it easier for us to adapt our technology to orally deliver other peptides as well."

Unigene Laboratories, Inc. is a biopharmaceutical company focusing on the oral and nasal delivery of large-market peptide drugs.

((Comments on this story may be sent to health@closeupmedia.com))

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