Video | Business Headlines | Internet | Science | Scientific Ethics | Technology | Search

 


Sustained Benefit with DIABECELL® Implants

Living Cell Technologies Reports Interim Results Showing Sustained Benefit with DIABECELL® Implants for Insulin Dependent Diabetes

February 11, 2009 – Sydney, Australia, Auckland, New Zealand– Living Cell Technologies Limited (ASX: LCT; OTCQX: LVCLY) reports positive interim results from the long term follow-up of insulin dependent diabetes patients in the Phase I/IIa clinical trial of its lead product, DIABECELL®.

A total of seven patients have received DIABECELL® implants, five of whom have had two low dose (5,000 islet equivalents (IEQs) per kg body weight) implants at least six months apart. There have been no remarkable adverse events attributed to double implants. Two patients have received a single higher dose (10,000 IEQs/kg) with no safety concerns to date.

The results of 36 to 68 weeks follow-up from the first four patients showed that good blood glucose control was maintained as reflected by a reduction in glycated hemoglogin (% HbA1c) levels from a mean of 8% pre-enrolment to 6.8% at time of clinical review. The American Diabetes Association target for good blood glucose control is HbA1c below 7% and the normal is less than 6.2%. This control was attained despite a reduction of 10% - 38% in the required daily insulin dose.

It is too early to assess the second implant for the fifth patient. However, the patient’s HbA1c improved markedly from 9.8% before enrolment to 7.2% accompanied with a small reduction in the average daily insulin dose of 6%.

LCT Medical Director, Professor Bob Elliott said, “The patients clearly benefited from the implants administered at the lowest dose. The second implant maintained this benefit. Remarkably none of the patients have had problems with clinically relevant episodes of low blood glucose. Most people with diabetes cannot attain this degree of blood glucose control shown by these patients without large swings of very low or high blood glucose levels that are often fatal.”

Two more patients have received the higher dose of DIABECELL®. Patient six declined further follow-up at 20 weeks after the first implant when there was no change in glucose control or insulin dose. To improve consistency, LCT narrowed product quality release specifications for all subsequent implants. Patient seven has been followed up for only four weeks at which time HbA1c improved dramatically from 8.3% to 4.8% and daily insulin requirement dropped by 60%.

Professor Elliott further stated, “We can expect better outcomes with higher doses. The encapsulated cells offer not only an alternative but a physiological replacement therapy to provide new hope and improved lifestyles for people with diabetes.”

Dr Paul Tan, LCT Chief Executive Officer, said, “The next three patients in Russia are scheduled to receive the 10,000 IEQ/kg dose by April this year before testing the top dose of 15,000 IEQs/kg. Steps to initiate a pivotal trial and a commercialization strategy in Russia have been taken.”

DIABECELL® is LCT’s encapsulated porcine insulin-producing cell product designed for the treatment of type 1 diabetes without the use of immunosuppressive drugs.

-Ends-


About Living Cell Technologies: www.lctglobal.com
Living Cell Technologies (LCT) 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. LCT’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. LCT also offers medical-grade porcine-derived products for the repair and replacement of damaged tissues, as well as for research and other purposes.

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 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 commercialisation 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 materialise, 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 December 2008 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.


© Scoop Media

 
 
 
 
 
Business Headlines | Sci-Tech Headlines

 

Insurers Up For More Payouts: Chch Property Investor Wins Policy Appeal In Supreme Court

Ridgecrest NZ, a property investor, has won an appeal in the Supreme Court over insurance cover provided by IAG New Zealand for a Christchurch building damaged in four successive earthquakes. More>>

ALSO:

Other Cases:

Royal Society: Review Finds Community Water Fluoridation Safe And Effective

A review of the scientific evidence for and against the efficacy and safety of fluoridation of public water supplies has found that the levels of fluoridation used in New Zealand create no health risks and provide protection against tooth decay. More>>

ALSO:

Scoop Business: Croxley Calls Time On NZ Production In Face Of Cheap Imports

Croxley Stationery, whose stationery brands include Olympic, Warwick and Collins, plans to cease manufacturing in New Zealand because it has struggled to compete with lower-cost imports in a market where the printed word is giving way to electronic communications. More>>

ALSO:

Prefu Roundup: Forecasts Revised, Surplus Intact

The National government heads into the election with its Budget surplus target broadly intact, delivering a set of economic and fiscal forecasts marginally revised from May to reflect weaker commodity prices and a lower tax take. More>>

ALSO:

Convention Centre: Major New SkyCity Hotel And Laneway For Auckland

Today SKYCITY Entertainment Group Limited revealed plans to build a new hotel and pedestrian laneway of bars, restaurants and boutique shopping on land it owns in the Nelson and Hobson Streets block, expanding the SKYCITY Entertainment Precinct. More>>

ALSO:

Igniting The Spark: Bringing The Digital Enabler To Life

Changing a name is, relatively speaking, the easy part of a re-invention. Changing a culture, getting all the ducks in a row, turning yourself inside-out to become customer-inspired is a much bigger challenge. More>>

ALSO:

Get More From Scoop

 
 
Computer Power Plus

Standards New Zealand

Standards New Zealand
 
 
 
 
 
 
 
 
Sci-Tech
Search Scoop  
 
 
Powered by Vodafone
NZ independent news