The Montreal-based biopharmaceutical company has developed a prolonged release formulation of octreotide (C2L), which is the active pharmaceutical ingredient in Novartis' Sandostatin LAR (octreotide acetate for injectable suspension) for the treatment of acromegaly.
Results from the Phase II study suggest Ambrilia's C2L would provide fewer injections per year than Sandostatin - up to nine injections for C2L versus 13 for Sandostatin (SLAR).
"[This would] improve patient convenience and reduce cost of treatment . . .
Also, C2L is easily reconstituted thus easier to use than SLAR," Ambrilia senior executive vice president and chief scientific officer Dr Bonabes de Rouge told US-PharmaTechnologist.com.
The study suggested a 42-day dosing interval with C2L was possible in comparison to Sandostatin LAR's 28-day dosing interval because of the prolonged release action of the drug formulation.
"Considering this was a single dose study and thus there is no carry over from the previous injections, I think this is extremely encouraging.
Although the patient population is still small, I would agree that it supports a 42-day dosing interval," C2L principal consultant and investigator Professor Stafford Lightman said in a statement.
"I was impressed with the evidence that there is actually continued effect even beyond the 42-days, which suggests that when you give C2L at 42-day intervals, there should not be any significant breakthrough in the run up to the next injection," said Lightman, who is a professor of medicine at the University of Bristol and Henry Welcome Center for Integrative Neuroscience and Endocrinology, UK.
The formulation incorporates biodegradable microspheres which release the drug at a constant rate over an extended period of time.
The formulation was developed by Ambrilia using a patented technology under license from Brookwood Pharmaceuticals.
Beside the reduced dosing interval, other data from the Phase II study showed a single dose administration of octreotide (C2L) in 8 patients indicated that C2L normalized the major marker for acromegaly, the insulin-like Growth Factor 1 (IGF-1), and suppresses high Growth Hormone (GH) plasma levels, with no serious adverse events reported.
Ambrilia's prolonged release formulation is now in Phase III trials which will compare 30mg of C2L and 30mg of Sandostatin LAR based on the changes in the mean IGF-1 and GH plasma levels in acromegalic patients.
C2L would be administered every 42 days for 84 days and Sandostatin LAR administered every 28 days for 84 days - 2 injections of C2L versus 3 injections of Sandostatin LAR in a 3-month period.
The study is expected to be finished by the end of this year.
Acromegaly is a serious chronic condition related to a permanent hypersecretion of GH by the pituitary gland, generally caused by a tumor.
The flow-on effect is an excessive production of IGF-1.
Together, the excess hormones result in uncontrolled growth of various organs and debilitating symptoms.
Octreotide, a peptide made up of eight amino acids, mimics the action of the naturally occurring endocrine system regulator somatostatin by inhibiting naturally produced hormones such as GH and IGF-1.
Novartis reported $900m in total sales of Sandostatin in 2005.
Ambrilia's prolonged release formulation of octreotide comes from the merger with Cellpep in 2006, a private French biotech company specialized in tumor targeted peptides and antivirals.