Lund, Sweden. 26 January, 2010 – Camurus announces that following the approval of its clinical trial application by the German BfArM, dosing has today been initiated in a repeat dose clinical study to further document pharmacokinetics, pharmacodynamics, and safety of its long-acting octreotide chloride drug product (CAM2029). The product is being developed for treatment of acromegaly and carcinoid tumours. The clinical trial, carried out in Germany, involves seventy healthy subjects, and includes the active comparator drug Sandostatin® LAR® from Novartis. The study protocol has been reviewed in a protocol assistance procedure by EMEA; endorsing the study, including the primary as well as all secondary objectives, as part of the overall development program for registration of CAM2029.
Camurus’ CEO Fredrik Tiberg comments: “This is an important study to Camurus. It is our first repeat dose trial featuring CAM2029. The study is designed to demonstrate key features of CAM2029 and the FluidCrystal® Injection depot system (including pharmacokinetics, biomarker effects and local tolerability) and to facilitate comparison with current gold standard treatment. The trial is intended to laying the foundation for a pivotal clinical phase III trial of CAM2029 in acromegaly patients early 2011.”
Acromegaly is a serious and rare hormonal disorder. It is caused by prolonged overproduction of growth hormone by the pituitary gland, in more than 90% of cases originating from a benign pituitary tumor (pituitary adenoma). It is most frequently diagnosed in middle-aged adults and leads to an increased morbidity and mortality if left untreated.
CAM2029 is a new ready-to-use, long-acting octreotide product for treatment of acromegaly and carcinoid tumours (and other gastro-entero-pancreatic neuroendocrine, GEP NE, tumours). The product is based on Camurus’ proprietary FluidCrystal® Injection depot drug delivery system. This system consists of a lipid-based liquid with dissolved drug compound (e.g. octreotide chloride) that can be administered subcutaneously as a low volume injection. Once injected the lipid constituents immediately start to self-assemble into the "active" FluidCrystal® controlled release matrix. This allows a rapid establishment of therapeutic plasma levels which in the case of CAM2029 are maintained during one month following a single injection. Compared to current marketed products CAM2029 offers the advantage of being more convenient to handle and easy administer. The ready-to-use product design, thin needle, small injection volume and room temperature storage stability allows for easier handling and administration, not only by healthcare professionals but also by patients/partners in the home-setting. Based on the potential significant benefits for patients, including improved quality of life, CAM2029 was recently granted orphan drug designation by the EMEA (EU/3/09/645; granted 12/6/2009).
For more information, contact:
President & CEO
Tel: +46 (0)46-286 46 92
Senior Director, Business Development & Alliances
Tel: +46 (0)46-286 57 38
Camurus is a life science company providing innovative, nanoscale drug delivery systems for development of new and improved, high-value therapeutics. Application of the company’s FluidCrystal® gel and nanoparticle delivery technologies range from long-acting in-situ forming depots for small molecules and peptides to lipid nanocarriers designed for intravenous, oral and transdermal delivery. These are used in developments programs with biotech and pharma companies worldwide. Camurus also develops drug products targeting improved performance, safety, and patient compliance of existing drug compounds and currently has four products in clinical development.