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Press Release

ALIZYME ANNOUNCES SUCCESSFUL PRELIMINARY RESULTS FROM ITS PHASE IIa CLINICAL TRIAL OF ATL-104 FOR MUCOSITIS

Alizyme plc
Posted on: 06 Mar 06

Immediate Release

02 March 2006

 

ALIZYME ANNOUNCES SUCCESSFUL PRELIMINARY RESULTS FROM ITS PHASE IIa CLINICAL TRIAL OF ATL-104 FOR MUCOSITIS

 

Cambridge UK, 02 March 2006: Alizyme plc (LSE:AZM) is pleased to announce successful preliminary results of its Phase IIa clinical trial to evaluate ATL-104 for the treatment of mucositis, which demonstrated positive responses in patients.

 

The multi-centre pilot clinical trial used a randomised, double-blind design, comparing three doses of ATL-104 with placebo on the incidence and severity of mucositis in patients undergoing chemotherapy, prior to autologous peripheral blood stem cell transplantation for the treatment of myeloma and/or lymphoma. The trial enrolled 64 patients and was conducted at 8 centres in the United Kingdom. This trial was a pilot proof of concept study, and was not designed to demonstrate statistical significant differences between the three doses of ATL-104 and placebo.

 

The objectives of the study were to determine the effect of ATL-104, administered as a swallowable mouthwash, on a number of parameters associated with chemotherapy-induced mucositis, including duration of mucositis, as well as safety and tolerability. Patients were treated for three days prior to and three days following the chemotherapy used to destroy their cancer and bone marrow.

 

The duration of mucositis was consistently reduced across all actively treated groups. In the total population of patients treated with ATL-104 there was a shorter mean duration of WHO Grade 2-4 mucositis at all doses (50, 100, 150 mg/day; 3.5, 4.5, 3.2 days respectively) compared to placebo (5.9 days). In those patients with WHO Grade 3 or 4 mucositis, the mean duration was 2.4, 2.8, 3.1 days for the ATL-104 groups respectively, and was 5.4 days for the placebo group. When measured by the WCCNR scale, the duration of mucositis was also similarly reduced (8.1, 7.2, 7.2 days in the active groups, compared to 11.2 days in the placebo group). The duration of oral ulceration and pain was also reduced compared to placebo, across all three ATL-104 groups. The number of days when a patient was unable to take solids by mouth was also reduced by ATL-104 treatment (2.7, 2.8, 3.1 days respectively) compared to placebo (6.7 days). The incidence of mucositis, measured by WHO or WCCNR scales (see Editors Notes) was not notably affected.

 

ATL-104 did not appreciably alter the adverse event profile attributed to the chemotherapy regimens.

 

Dr. Robert Marcus, Principal Investigator, commented:

 

“The results of this pilot study provide encouraging early data on the activity of ATL-104 in the management of mucositis, which now merits further investigation in larger randomised trials.”

 

Dr Richard Palmer, Chief Executive Officer commented:

 

“We are very pleased to have obtained positive responses in patients of the activity of ATL-104 by a number of criteria in this challenging indication. We will now evaluate the details of the results further, in preparation for discussions with regulatory authorities on the future development strategy for this compound. We will also share these encouraging data with potential licensing partners, and will be presenting them at a scientific meeting at the earliest appropriate opportunity.”

 

For further information, please contact:

Dr Richard Palmer, Chief Executive Officer

 

Tim McCarthy, Finance Director

 

ALIZYME plc

+44 (0) 1223 896000

 

 

Lisa Baderoon/Rebecca Skye Dietrich

 

BUCHANAN COMMUNICATIONS

+44 (0) 20 7466 5000

 

Further information on Alizyme can be found on the Company’s website: www.alizyme.com


 

Editors Notes

 

Alizyme plc

Alizyme is a speciality pharmaceutical development company, based in Cambridge, UK, targeting the treatment and management of gastrointestinal disorders, obesity and diabetes. It has a portfolio of products which, in addition to ATL-104, includes cetilistat (completed Phase IIb, currently being prepared for Phase III clinical development), renzapride (Phase III for the treatment of constipation-predominant irritable bowel syndrome in the US), and COLAL-PREDÒ (Phase III for the treatment of acute ulcerative colitis in Europe).

 

Mucositis

Treatment of cancer with chemotherapy or radiotherapy can result in mucositis, a condition in which the cells lining the mouth and gastrointestinal tract are damaged leading to inflammation, ulceration, pain, diarrhoea and difficulty in eating and drinking.

 

An effective drug would greatly improve the quality of life for those receiving cancer treatment. Also, by reducing the incidence and/or severity of mucositis, this would allow higher therapeutic doses to be administered and lead to more effective treatment. Over one million of the cancer patients treated each year suffer from mucositis and the potential market for drugs to prevent/treat mucositis effectively is estimated to be in excess of  $500 million per annum.

 

WHO (World Health Organisation) Oral Mucositis Grades

The WHO is a 5 point scale ranging from 0 (no mucositis) to Grade 4 (unable to take fluids or solids by mouth). Intermediate points on the scale include other components, such as: ulceration, pain and bleeding.

 

Western Consortium for Cancer Nursing Research (WCCNR) Grades

The WCCNR is a 4 point scale, ranging from 0 (no mucositis), to Grade 3 (includes: ulceration, bleeding, infection, inability to take fluids and solids by mouth, and pain). Intermediate points include all these symptoms, but with lower degrees of severity.

 

Autologous Peripheral Blood Stem Cell Transplantation (PBSCT)

Autologous PBSCT involves removal of some stem cells from the blood of a cancer patient, followed by intensive chemotherapy to destroy their leukaemia and/or lymphoma, which also results in the destruction of the remaining blood and bone marrow cells. The stem cells are then returned to the patient’s circulation to recolonise the bone marrow. This intensive cancer treatment results in a very high (around 90%) proportion of patients experiencing mucositis, such that they require strong pain-killing drugs and sometimes have to be fed via a tube, as well as severe effects on the bowel and increased risk of septicaemia.

 

ATL-104

ATL-104 is a plant protein, which is manufactured by a recombinant process. It has been developed by Alizyme following an agreement in 1996 with Rowett Research Institute, which gave Alizyme ownership of all their intellectual property involving drugs based on plant lectin proteins.

 

The effectiveness of ATL-104 in preventing and treating mucositis has been demonstrated in laboratory models. By stimulating the growth of cells that line the gastrointestinal tract, ATL-104 acts in a similar way to Amgen’s KepivanceTM, which has been approved for the treatment of mucositis of the mouth. ATL-104 should be well differentiated from KepivanceTM since it can be administered orally, rather than having to be injected to act systemically, and is expected to act locally in both the mouth and gut.

 

 

 

 

 

 

 

 

 

 

 

(Note: COLAL-PRED® is a registered trademark of Alizyme Therapeutics Limited)

 

 

The identification of compounds for successful research, their progress through development and the obtaining of regulatory approvals or authorisations before marketing, manufacture and/or distribution of products is not certain or a formality.

For more information:
http://www.alizyme.com

Editor's Details

David Campbell
david.campbell@alizyme.com

Last updated on: 27/08/2010

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