PipelineReview.com - Biotech News & Online Store - Camurus starts phase I clinical trial with CAM2029

Camurus starts phase I clinical trial with CAM2029 – a new long-acting octreotide depot

21 Apr 2006

LUND, Sweden | Apr 20, 2006 | The Swedish Medical Products Agency has approved Camurus’ Clinical Trial Application (CTA) for Phase I trials of CAM2029,

the company's product candidate for the treatment of acromegaly and carcinoid tumours. The study starts in April 2006.

Acromegaly is a rare chronic and insidious hormonal disorder that occurs when the pituitary gland produces excess growth hormone (GH) leading to the subsequent elevation of insulin-like growth factor-1 levels (IGF-1). It most commonly affects middle-aged adults and may lead to premature death. Symptoms of this condition include abnormal skeletal growth deformities (particularly of the hands, feet, and face) cardiovascular disease, neuropathy, respiratory disease, and malignancy.

Carcinoid tumour is an intestinal tumour which arises from specialised cells with paracrine functions. The primary tumour is commonly in the appendix, where it is clinically benign. Secondary, metastatic, intestinal carcinoid tumours secrete excessive amounts of vasoactive substances and polypeptide hormones. These tumours may grow anywhere in the gastrointestinal tract, and in the lungs, with approximately 90% in the appendix. The clinical condition is Carcinoid Syndrome which is manifested by symptoms of episodic cutaneous flushing, abdominal cramps and diarrhoea, heart valvular lesions, peripheral edema, wheezing, cyanosis, and arthritis.

The new product, denoted CAM2029, is a long-acting injectable depot of octreotide acetate based on Camurus’ in-situ forming, liquid crystal (LC) gel technology, which facilitates time-release injectable depots that slowly deliver drugs to plasma to improve compliance and create a more therapeutic profile. Octreotide is a synthetic analogue of somatostatin, a naturally occurring hormone peptide that signals to the pituitary to reduce growth hormone production. In clinical practice the compound is used to treat acromegaly and the carcinoid syndrome by controlling hormonal hypersecretion.

CAM2029 is a sustained release formulation of octreotide designed to give a fast and controlled onset of action without the need for supplementary daily dosing during initial depot treatment. The product will be provided in ready-to-use form thus also facilitating ease of handling and administration.

The clinical study, which will enrol 32 healthy volunteers, has been designed for assessment of tolerability, pharmacokinetics, and pharmacodynamics. This is a double-blind, randomised, placebo-controlled, single dose study of three different dose volumes of octreotide, given by subcutaneous injection, and one dose volume by intramuscular injection.

CAMURUS is a leading provider of drug delivery systems for peptides, proteins, and insoluble drugs. Working closely with pharmaceutical manufacturers the company's proprietary technologies make it possible to introduce new therapeutic products, improve the efficacy of existing products, and to revive stalled pipeline projects.

For further information, please contact:
Fredrik Tiberg, President & CEO, Head of R&D, +46 (0)46 286 3863, This e-mail address is being protected from spam bots, you need JavaScript enabled to view it

SOURCE: CAMURUS

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