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Chiasma Reports Successful Oral Delivery Of A Peptide In Clinical Study
Date:6/13/2010

  • No serious adverse events among the Octreolin-treated subjects
  • Octreolin was well tolerated by all subjects
  • Measurable drug levels were noted in all subjects at all 3 doses of Octreolin
  • Linear ratio between Octreolin doses and exposure (AUC) was established
  • Drug levels and PK profiles were comparable between Octreolin and the injected reference drug
  • Similar elimination half life (T(1/2)) of octreotide regardless of route of administration or dose
  • Significant octreotide absorption within the first 40 minutes from capsule administration in all subjects for all 3 doses

Therapeutically relevant blood levels of octreotide, known to induce maximal inhibition of GH in acromegaly patients, were achieved and were maintained for a longer time with Octreolin than after Sandostatin subcutaneous injection. The effective blood levels of octreotide (as measured by maximal GH inhibition) are well established clinically based on data from decades of octreotide injections.

The study outcomes support advancement of clinical development of Octreolin and allow dose selection for the pivotal study in which the clinical efficacy of Octreolin will be tested in acromegaly patients.

Shlomo Melmed, MD, Senior Vice President, Academic Affairs & Dean of the Medical Faculty at Cedars-Sinai Medical Center and Professor and Associate Dean of the University of California, Los Angeles (UCLA) School of Medicine, said, "Chiasma has demonstrated achievement of an important first clinical step in the process of developing a safe and effective oral therapy for acromegaly patients who would prefer the convenience of oral therapy and the avoidance of the side effects associated with injectable forms of somatostat
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SOURCE Chiasma, Inc.
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