First clinical Results Confirm Potential New Application of Key Product in AM-Pharma's Pipeline
BUNNIK, The Netherlands, July 9, 2007-AM-Pharma B.V., the biopharmaceutical company developing novel therapeutics to treat infectious and inflammatory diseases, today announced the positive clinical results of its Phase IIa Alkaline Phosphatase (AP) trial for patients with ulcerative colitis, a chronic and relapsing inflammatory bowel disease affecting the colon.
In this recent trial, AP was used in the treatment of 21 hospitalised patients suffering from moderate to severe ulcerative colitis, who had failed to show improvement using existing treatments of steroids and immunosuppressants. The AP therapy was administered through a duodenal drip at a dose of 10mg AP per day.
In the trial, patients showed clinically relevant improvement after the seven day treatment period, in the two main clinical parameters (Truelove-Witts and Mayo scores) measured three weeks after starting the AP trial.
Patient response rates after three weeks were 63% on the Truelove-Witts score and 47% on the Mayo score. Complete remission after three weeks was reached by 21% of patients on the Truelove-Witts score and by 5% of patients on the Mayo score. After 63 days, 79% of patients showed a response and 26% of patients were in complete remission according to the Truelove-Witts score. No serious adverse effects or treatment-related withdrawals were reported.
AP is a unique therapy for ulcerative colitis based on the dephosphorylation and detoxification of a group of bacterial endotoxins called lipopolysaccharides, which can cause inflammation in the colon. AM-Pharma's patented AP treatment has already shown positive results in trials for treatment of acute renal failure and sepsis.
Bart Wuurman, CEO commented: "It's fantastic that this first AP study for ulcerative colitis revealed our treatment to be clinically active, despite the short seven day treatment period and the severity of the patients' disease. These results are very promising for the future development of AP for ulcerative colitis, where we plan to administer AP treatment for longer periods. Also importantly, results from this trial revealed that the treatment is very well tolerated. This is potentially good news for ulcerative colitis sufferers, who are looking for safe and effective treatment options."
AM-Pharma will continue to study the oral use of AP for ulcerative colitis in a further Phase II clinical study. Once safety and efficacy have been confirmed in a larger group of patients, AM-Pharma intends to license the product to a partner who will take on the late-stage development and worldwide commercialisation of AP.
Notes to editors:
About AM-Pharma www.am-pharma.com AM-Pharma is a biopharmaceutical company focused on the preclinical and clinical development of novel compounds in the field of severe infectious diseases and inflammatory diseases. All its products are based on endogenous molecules which have been optimised to combat disease.
AM-Pharma is currently conducting Phase II clinical trials for two products; Alkaline Phosphatase for sepsis, acute renal failure and ulcerative colitis; and Anti-microbial Peptide hLF1-11 for the prevention of infections in hemopoietic stem cell transplant patients.
AM-Pharma is based in Bunnik, The Netherlands with a staff of 20. The company is financed by, amongst others, Forbion Capital Partners, Inventages Venture Capital and Theratase plc. Once product safety and efficacy have been established, AM-Pharma will look for world-wide development and marketing partners for its products.
About Alkaline Phosphatase (AP)
The endogenous enzyme Alkaline Phosphatase is expr essed in various tissues throughout the human body including the kidney and GI tract. AP has been shown to dephosphorylate lipopolysaccharides to a non-toxic form that acts as a partial antagonist on the lipopolysaccharide receptor complex. In addition to lipopolysaccharides, AP can dephosphorylate different other substrates e.g. ATP and through this dephosphorylation interfere with several diseases, including ulcerative colitis, sepsis and acute renal failure.
About Ulcerative Colitis Ulcerative colitis (UC) is a chronic, relapsing inflammatory bowel disease affecting the colon, which usually starts between the age of 15 and 25. UC incidence in the US, Europe and Japan is around 1 million patients. Only around 650,000 of these patients, however, receive medical treatment. Around 20% of UC patients (200,000 patients) have a severe and debilitating form of the disease. Ulcerative colitis usually involves the rectum but may extend proximally to involve a portion of or the entire colon. Until recently, sales of UC drugs were around US$1bn, dominated by 5-ASA drugs, corticosteroids and immunosuppressants. However, with the introduction of the marketed drug Remicade(r), total sales in this market segment have been growing substantially.
About the Truelove-Witts and the Mayo scores The Truelove-Witts (TLW) score measures disease activity composed of 6 variables: number of stools per day; blood in stools; temperature; pulse; haemoglobin; and erythrocyte sedimentation (ESR) rate. Response is defined as a TLW score of less than 10 and by a decrease of 3 points or more. Clinical remission was defined as a TLW score of less than 3, which means 1 or 2 stools per day without blood, absence of fever or tachycardia, a normal haemoglobin or "returning towards normal", a normal ESR or "returning towards normal", and gaining weight.
The Mayo score looks at stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy, and Physician Global Assessment (PGA). Scores range from 0 to 12 points. Response is defined as a Mayo score of less than 3 and requires improvement (a minimum 1-point decrease from baseline) in the PGA score and improvement in at least one other clinical assessment (stool frequency, rectal bleeding, patient's functional assessment, endoscopy findings) and no worsening in any other clinical parameter. Clinical remission is defined as complete resolution of stool frequency (normal stool frequency), rectal bleeding (no rectal bleeding), patient's functional assessment score (generally well), endoscopy findings (normal), and a PGA score of 0.
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