Living Cell Technologies Limited
ACN: 104 028 042
29th August 2013 - Sydney, Australia & Auckland, New Zealand- Living Cell Technologies Limited today announced that a review of recent research and development work performed by Diatranz Otsuka Limited (DOL) indicates that there is a genuine opportunity to develop an improved formulation of DIABECELL which has the potential to be registered globally by 2018.
As a consequence, DOL will no longer use for registration purposes the Dia-12 Phase IIb study of the current DIABECELL formulation in Argentina titled: "An Open-label Investigation of the Safety and Efficacy of DIABECELL [Immunoprotected (Alginate-Encapsulated) Porcine Islets for Xenotransplantation] in Patients with Type 1 Diabetes Mellitus.
DOL will consult with Argentinian regulatory and ethics committees in order to ensure we uphold our safety and ethical commitments to patients already enrolled in the study.
A revised regulatory development pathway for the improved formulation of DIABECELL is in preparation.
For further information: www.lctglobal.com
|At the company:|
Dr Andrea Grant
Tel: +64 9 270 7941
Mobile: +64 21 078 5421
About Living Cell Technologies
Living Cell Technologies (LCT) is an Australasian biotechnology company developing cell therapies to treat diseases with high unmet clinical need. To date, the company has taken two therapeutic candidates into clinical development: DIABECELL® and NTCELL®.
Through a joint venture with international pharmaceutical company Otsuka Pharmaceutical Factory (OPF), LCT has secured funding, based on the achievement of clinical milestones, for the clinical development of DIABECELL and the Phase I clinical trials of NTCELL in Parkinson's disease. LCT retains a 50% share of future profits from DIABECELL and NTCELL and a perpetual, exclusive licence to continue to develop products using intellectual property held outside the joint venture.
LCT's unique, proprietary technology, IMMUPEL™, allows cell therapies to be used without the need for co-treatment with drugs that suppress the immune system, which often have negative sideeffects.
LCT is listed on the Australian (ASX: LCT) and US (OTCQX: LVCLY) stock exchanges. The company is incorporated in Australia, with its research and development, operations and manufacturing facilities based in New Zealand.
LCT disclaimer This document contains certain forward-looking statements, relating to LCT's business, which can be identified by the use of forward-looking terminology such as "promising," "plans," "anticipated," "will," "project," "believe," "forecast," "expected," "estimated," "targeting," "aiming," "set to," "potential", "seeking to," "goal," "could "provide," "intends," "is being developed," "could be," "on track," or similar expressions, or by express or implied discussions regarding potential filings or marketing approvals, or potential future sales of product candidates. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no assurance that any existing or future regulatory filings will satisfy the FDA's and other health authorities' requirements regarding any one or more product candidates nor can there be a y assurance that such product candidates will be approved by any health authorities for sale in any market or that they will reach any particular level of sales. In particular, management's expectations regarding the approval and commercialization of the product candidates could be affected by, among other things, unexpected clinical trial results, including additional analysis of existing clinical data, and new clinical data; unexpected regulatory actions or delays, or government regulation generally; our ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry, and general public pricing pressures; and additional factors that involve significant risks and uncertainties about our products, product candidates, financial results and business prospects. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as an icipated, believed, estimated or expected. LCT is providing this information and does not assume any obligation to update any forward-looking statements contained in this document as a result of new information, future events or developments or otherwise.
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