Living Cell Technologies Announces Positive Preliminary Data From DiabeCell Phase I/IIa Trial in Type I Diabetes
Initial Safety and Efficacy Demonstrated in First Two Patients
MELBOURNE, AUSTRALIA and AUCKLAND, NEW ZEALAND - Living Cell Technologies Limited today released positive preliminary results for its Phase I/IIa clinical trial of the company's proprietary DiabeCellÂ® porcine islet cell implant for the treatment of type 1 diabetes.
The clinical trial is being conducted in six type 1 (insulin-dependent) diabetic patients. Participants in this trial are first administered the lowest clinically effective dose and then given additional treatments to achieve additional clinical benefit. Patients receive an initial dose equivalent to 5,000 IEQ (islet equivalents/kg) administered by injection into the peritoneal cavity, followed by a second dose six months later. Follow up monitoring continues for 12 months after the conclusion of the trial.
The primary efficacy endpoint for the trial is reduction in hemoglobin A1C (HbA1C) levels during the 12-month post-transplant period compared with baseline (week-1) levels. Secondary efficacy endpoints include glucose lability, reductions in hypoglycemia and nocturnal hypoglycemia, reductions in the average daily insulin dose of > 25%, changes in endogenous insulin secretion, and quality-of-life changes.
As of the date of this announcement, two of the six patients planned for the trial have been implanted with DiabeCellÂ®. The first patient received the first dose in June 2007, and the second patient received the first dose in September 2007 at the Sklifasovsky Institute in Moscow. The clinical trial monitor, Geny Research Group Inc., a Boston based Clinical Research Organization, has indicated that both patients appear to be well and have shown no adverse effects. Each of them achieved much greater than the 25% minimum target reduction in daily insulin requirements at the three-month and one-month follow-ups, respectively.
Dr Paul Tan, LCT CEO stated, "This early indication of success is heartening for the prospects of the trial and development of a commercially available product. Our goal is to provide type 1 diabetics with more control over their blood glucose levels and increased independence from the need for insulin injections." The Company cautioned that the data is very preliminary and should be interpreted in the context of complete data that will be accrued from the remainder of the trial.
LCT intends to conduct a second Phase I/IIa clinical trial of 12 months duration in New Zealand of its DiabeCellÂ® product with a patient cohort composed of eight long-standing type 1 diabetics. Patients will receive higher doses of DiabeCellÂ® than in the trial currently underway. It is anticipated that this trial will start in late 2007 and then will be followed by a larger pivotal trial.
About Living Cell Technologies: www.lctglobal.com
Living Cell is developing cell-based products to treat life threatening human diseases. The Company owns a biocertified pig herd that it uses as a source of cells for treating diabetes and neurological disorders. For patients with Type 1 diabetes, the Company transplants microencapsulated islet cells so that near-normal blood glucose levels may be achieved without the need for administration of insulin or at significantly reduced levels. The company entered clinical trials for its diabetes product in 2007. For the treatment of Huntington's disease and other neurological disorders, the company transplants microencapsulated choroid plexus cells that deliver beneficial proteins and neurotrophic factors to the brain. Living Cell's technology enables healthy living cells to be injected into patients to replace or repair damaged tissue without requiring the use of immunosuppressive drugs to prevent rejection. Living Cell also offers medical-grade porcine-derived products for the repair and replacement of damaged tissues, as well as for research and other purposes.
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 any 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 anticipated, believed, estimated or expected. LCT is providing this information as of October 9, 2007 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.