Diabecell--Latest Update

Anyone want to join me in a trip to Russia:)

"Living Cell Technologies Limited today announced the formation of a subsidiary, LCT Biomedical Limited in Russia, to facilitate the commercial development of DIABECELL®, its lead product for the treatment of type 1 diabetes.

Natalia Dolgova, who is based in Moscow, has been appointed the first director of LCT Biomedical.

Mrs. Dolgova has 17 years experience in the medical products market in Russia. Her objectives are to obtain regulatory approval for a pivotal clinical study of DIABECELL® in at least two centres in Russia and register the product so that the treatment is available for people with diabetes in Russia.

Dr Olga Garkavenko, LCT’s New Zealand based Regional Director for Russia said,
“The regulatory process has already been initiated and it is envisaged that the pivotal study and product would be registrable by October 2011.”

Prof Bob Elliott, Medical Director of LCT, said, “This subsidiary is a timely development to advance positive preliminary results from the first trial in Moscow. We have now implanted 8 patients with DIABECELL®, the most recent on 22 June 2009 in a 33 year old man with type 1 diabetes. To date, there have been no untoward adverse events. Two patients remain off insulin injections at their last clinical review. All patients followed up have said they are pleased with how the implants have improved control of their blood sugar levels and this is supported by their normalized %HbA1c (glycated hemoglobin measurements) and reduced daily insulin doses.”

Dr Paul Tan CEO LCT said, “The establishment of this company with local business and regulatory expertise aims to accelerate commercial development. DIABECELL® will be supplied from New Zealand for the foreseeable future. This is the quickest development pathway to get this innovative treatment available to the wider diabetic community.”

DIABECELL® is designed to normalize blood glucose levels in type 1 diabetes sufferers. DIABECELL® comprises encapsulated porcine insulin-producing cells which can be administered without the need to use immunosuppressive drugs.

Type 1 diabetes occurs when the body’s own immune system destroys the insulin-producing cells of the pancreas (called beta cells). Five to 10 percent of the more than 200 million diabetics worldwide have insulin dependent type 1 diabetes. Type 1 diabetes is associated with kidney failure, blindness, nerve damage, life-threatening cardiovascular disease and limb amputations. Current treatment options include multiple daily injections of insulin.

LCT in St Petersburg, Russia, June 2009

Potential new clinical trial site, St Petersburg, Russia

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 Parkinson’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 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 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."

Living Cell Technologies Ltd
PO Box 23 566
Hunters Corner
+64 9 276 2690

hmmm, this is interesting, but am sure it is not approved by the FDA. Since as what I know they take 10 years to prove something after making sure that all the side effects are known.

However going through there site:
The long term safety of DIABECELL has been demonstrated in at least one patient whose implanted cells are still producing insulin after 10 years

I wonder if we can pass this to the FDA!! :slight_smile:

Thanks for sharing, you are an angel gave us another hope

Will be forever for FDA approval. It’s off to Russia!

I’ll catch a ride with you Gerri! Did you make any granola?

You come with me to Russia & I’ll make you all the granola you want! Many, many decades since my family left Russia in fear of their lives. Never thought I’d want to go there.