In the past two years we have completed a package of preclinical testing, toxicology trials and four Phase 1 clinical studies (in healthy volunteers) for Octreolin®. We are investigating Octreolin® first for the treatment of acromegaly. Each of the indications for which Octreolin® is being developed qualifies as an Orphan Drug.
Octreolin® Phase 1 – Baseline Studies for All Potential Octreolin® Indications
Octreolin® successfully completed four clinical studies in healthy volunteers. To date, a total of 74 healthy volunteers received up to three separate doses of Octreolin®. Theses studies were conducted in Israel and in the US as an Investigational New Drug (IND).
Octreolin® Phase 3 – Acromegaly
Pivotal studies (Phase 3) in acromegaly began enrollment in Q4 2011.
ClinicalTrials.gov identifier: NCT01412424.