In addition, the efficacy as measured by the mean insulin-like growth factor 1 (IGF-1) and growth hormone (GH) plasma levels is maintained at the same level throughout the study period. It further confirms that octreotide C2L 30mg every six weeks can replace Sandostatin LAR (SLAR) 30mg every four weeks in acromegalic patients, with the same clinical benefit and no unexpected or serious adverse effects, said Ambrilia Biopharma.
This open-label 24-week extension study evaluated the safety, clinical and biological activity of C2L 30mg in acromegalic patients. Mean efficacy on IGF-1 was identical, throughout Study 302, to what it was after 84 days (12 weeks) of treatment in the first part of Study 301 with either C2L or SLAR. This suggests that switching from SLAR every four weeks to C2L every six weeks does not induce a decrease in IGF-1 response, even after 36 additional weeks follow-up.
Efficacy on GH was also maintained throughout Study 302, again supporting that switching from SLAR every four weeks to C2L every six weeks at the same dose yields the same efficacy on GH control in acromegalics over an extended period of time. The number of patients with normalized IGF-1 or GH levels was identical or slightly higher (though not significantly) after treatment with C2L as compared to SLAR.
Overall, the top-line analysis of the results supports the ability of C2L 30mg given every six weeks to replace SLAR given every four weeks at the same dose, with mean efficacy and safety maintained over an additional six months treatment. The company expects regulatory filings to be initiated before the end of 2008.
Philippe Calais, president and CEO of Ambrilia, said: “These new data further validate C2L’s potential to be a safe, effective and cost-effective therapy, well positioned to capture a sizeable portion of the $1 billion-plus SLAR market. Again, we are progressing well toward our year-end divestment goal for C2L which could alleviate the company’s financial overhang by bringing non-dilutive funding.”