SYDNEY & AUCKLAND, New Zealand--(Living Cell Technologies Limited (ASX:LCT) (OTCQX:LVCLY), a global company pioneering the development of a cell implant to treat diabetes, has received a grant of US$500,000 for its on-going Phase II clinical trial of DIABECELL® in New Zealand from the Juvenile Diabetes Research Foundation International (JDRF), a world leader in setting the agenda for diabetes research and the largest charitable funder and advocate for research in type 1 diabetes.)--
“We are delighted that the JDRF, the world’s largest charitable funder and advocate of diabetes science worldwide, is supporting the progress we are making to advance DIABECELL® towards normalising the lives of people with unstable diabetes.”
The first four patients have already received implants and early observations show clinical benefit without remarkable adverse events to date. The Data Safety Monitoring Board has approved proceeding with implants of a higher dose for the next four patients. The JDRF grant will contribute to the second portion of the Phase II trial, which will test the safety and efficacy of DIABECELL® given in higher amounts in patients with type 1 diabetes.
“The initial results from the first phase of the trial showed us a significant feature of LCT’s product in its ability to protect the cells from immune rejection without the use of immunosuppressive anti-rejection drugs,” said Dr Julia Greenstein, Ph.D., Director of Beta Cell Therapies at JDRF. “Encapsulation for immuno-protection is one of JDRF’s research priorities, and the success of this trial could have an important impact on this field of research and the development of a commercially-viable cell replacement therapy for people with type 1 diabetes.”
Professor Bob Elliott, medical director of LCT, said, “At this early stage, we have seen the abolition of unaware hypoglycaemia in the first patient. This diabetes complication occurs in up to 17 percent of long term type 1 diabetic people, and is responsible for up to 8 percent of all deaths in type 1 diabetes. The grant from the JDRF is most welcome as we share the same concerns for diabetes patients who endure life threatening episodes of low blood glucose without warning symptoms.”
Dr Paul Tan, Chief Executive Officer for LCT, said, “We are delighted that the JDRF, the world’s largest charitable funder and advocate of diabetes science worldwide, is supporting the progress we are making to advance DIABECELL® towards normalising the lives of people with unstable diabetes.”
The collaboration with JDRF and LCT for the Phase II trial of DIABECELL® is part of JDRF’s innovative Industry and Discovery and Development Partnership program. Through the program, JDRF partners with pharmaceutical, biotech, and medical device businesses that seek to develop drugs, treatments, technologies, and other therapeutics leading to a cure, reversal, or prevention of type 1 diabetes and its complications. To date, JDRF has made 27 industry grant awards to support a variety of strategic type 1 diabetes research projects since the IDDP program was established in 2004.
Type 1 diabetes is an autoimmune disease in which a person’s pancreas stops producing insulin, a hormone that enables people to get energy from food. Type 1 diabetes strikes children and adults suddenly, and lasts a lifetime. People with type 1 diabetes must take multiple injections of insulin daily or continuous infusion of insulin through a pump to survive. Intensive insulin treatment to normalize blood glucose and prevent future eye, kidney, nervous system and cardiovascular complications can sometimes result in hypoglycaemic unawareness, a loss of the normal stress response to low blood glucose levels. People with type 1 diabetes and hypoglycaemic unawareness feel no warning symptoms when their blood glucose levels drop to low levels that can impair consciousness and lead to accidents and coma. (www.diabetesnet.com and www.diabetesselfmanagement.com)
DIABECELL® is LCT’s treatment designed to normalise the lives of people with insulin-dependent diabetes. DIABECELL®comprises encapsulated porcine insulin-producing cells (islets) that are implanted into the abdomen of patients using a simple laparoscopic procedure, and work by self-regulating and efficiently secreting insulin in the patient’s body. LCT's breakthrough proprietary encapsulation technology means that patients receiving DIABECELL® treatment do not require immunosuppressant drugs after implantation.
About Living Cell Technologies - www.lctglobal.com
Living Cell Technologies (LCT) is developing cell-based products to treat life threatening human diseases. LCT’s technology enables healthy living cells to be injected into patients to replace or repair damaged tissue without requiring the use of immunosuppressant 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.
The Company owns a bio-certified pig herd that is a source of cells for treating diabetes and neurological disorders. For patients with type 1 diabetes, the Company implants 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. 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.
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.
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