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Alizyme announces that Prometheus Laboratories Inc.has initiated the clinical development of COLAL-PRED(R) in the US with a Phase II study for the treatment of ulcerative colitis
Cambridge UK | May 20, 2008 | Alizyme plc (LSE: AZM) (“Alizyme”) announces that Prometheus Laboratories Inc. (“Prometheus”), its partner in North America for COLAL-PRED(R), has initiated the clinical development of COLAL-PRED(R) in the US with a Phase II study for the treatment of ulcerative colitis.
The trial is a multi-centre, randomized, double-blind, placebo-controlled, parallel-design, dose-ranging study of COLAL-PRED(R) for the treatment of ulcerative colitis in approximately 200 patients. Patients will be randomized to placebo or one of four doses of COLAL-PRED(R) (equivalent to 40, 60, 80, or 120 mg of prednisolone) for a treatment period of 4 weeks.
Alizyme is currently developing COLAL-PRED(R) for the treatment of ulcerative colitis in Europe. Recruitment into the current EU Phase III registration clinical trial in approximately 800 patients with active moderate-to-severe ulcerative colitis completed in 2007 and headline results are expected to be reported in July 2008. Successful results from this EU Phase III trial would allow a Marketing Authorisation Application (“MAA”) to be submitted for the EU in Q4 2008.
Commenting on today’s announcement, Tim McCarthy, Alizyme’s Chief Executive Officer said:
“We are delighted with the news that Prometheus has initiated recruitment into their Phase II study for COLAL-PRED(R) in the US, a significant market for this product. The commencement of clinical activity in the US for COLAL-PRED(R) is a key milestone in the development and commercialisation of this product for the global market.
Editor’s Note
Alizyme plc
Alizyme is a speciality biopharmaceutical development company, focused on the therapeutic areas of metabolic disorders, gastrointestinal disorders and cancer supportive care. In addition to COLAL-PRED(R), it is developing cetilistat for the treatment and management of obesity and related diseases, such as type 2 diabetes and ATL-104 for the treatment of mucositis, a side effect of cancer therapy.
Prometheus Laboratories Inc.
Prometheus is a privately owned US specialty pharmaceutical company committed to developing new ways to help physicians individualize patient care. Prometheus focuses on the treatment, diagnosis and detection of gastrointestinal, autoimmune and inflammatory diseases and disorders. Prometheus' strategy includes the marketing and delivery of pharmaceutical products complemented by its proprietary, high-value diagnostic testing services. By integrating therapeutics and diagnostic services, Prometheus addresses the continuum of patient care, thereby providing physicians with a comprehensive solution to treat chronic diseases. Prometheus' corporate offices are located in San Diego, California.
Additional information about Prometheus can be found at www.prometheuslabs.com.
Ulcerative colitis
Ulcerative colitis is an inflammatory disease of the colon that causes symptoms such as abdominal pain, bleeding, cramping, fatigue and diarrhoea. These conditions are characterised by episodes of acute flare of the inflammation, followed by periods of remission. In severe cases, surgery may be required to remove the diseased tissue.
The ulcerative colitis market is currently dominated by anti-inflammatory steroids and 5-ASA products, which have safety and/or efficacy issues. COLAL-PRED(R) has a unique competitive profile based on Alizyme’s proprietary drug delivery technology, COLAL(R), which clinical trials to date have shown to enable targeted delivery of the active drug to the colon, making possible the effective treatment of ulcerative colitis with an anti-inflammatory steroid without the usual debilitating side effects typically associated with such steroids.
Currently around 2 million people in major territories suffer from ulcerative colitis, of which an estimated 700,000 are in the US. Current projections of sales of COLAL-PRED(R) in the major territories are in excess of US$250 million per annum.
COLAL-PRED(R)
COLAL-PRED(R) is a proprietary gastrointestinal product developed by Alizyme for the treatment of ulcerative colitis. It is the combination of Alizyme’s proprietary colonic drug delivery system, COLAL(R), and prednisolone metasulfobenzoate sodium (“PMSBS”), an approved steroid in Europe. COLAL-PRED(R) has a coating that is broken down only in the colon, by locally occurring bacteria. This leads to topical delivery of PMSBS to the colon, rather than systemic delivery. It has been shown in a Phase II clinical trial to provide levels of efficacy comparable to that reported for conventional oral prednisolone, but without the side effects of steroids.
COLAL(R)
COLAL(R) is a drug delivery technology which enables drugs to be taken orally and then be specifically released when the preparation reaches the colon. Achieving colonic release with conventional oral dosage forms has proved difficult because of the variation between individuals in transit times and conditions within the gastrointestinal tract. COLAL(R) overcomes this difficulty by covering small pellets containing the drug with a coating of ethylcellulose and a specific form of amylose (derived from starch). This coating prevents drug release in the stomach and small intestine. When the pellets reach the colon, the amylose in the coating is broken down by bacterial enzymes and the drug is released.
(Note: COLAL(R) and COLAL-PRED(R) are registered trademarks of Alizyme Therapeutics Limited)
SOURCE: Alizyme plc |
