JoeC
09-12-2007, 08:43 AM
Living Cell Technologies Ltd
PO Box 3014, Auburn VIC 3123
ABN: 14 104 028 042
COMPANY ANNOUNCEMENT
LCT Receives Approval for DiabeCell® Clinical Trial in NZ
12 September 2007, Auckland, New Zealand and Melbourne, Australia:
Key Points:
• LCT receives Regional Ethics Committee approval for diabetes clinical trial in NZ
• LCT pig cell transplant diabetes phase I/IIa trial on track to start by end of 2007
• LCT is the only company world-wide to obtain clinical trial approval for a pig cell transplant
without immunosuppression under current regulatory guidelines
• DiabeCell® product targets the type 1 diabetes market – with 24 million sufferers globally
Living Cell Technologies Ltd (ASX:LCT, OTC:LVCLY) is pleased to announce that it has obtained
all the regulatory and ethics approvals required by the NZ Minister of Health before proceeding
with its type 1 diabetes phase I/IIa clinical trial in New Zealand.
The Regional Ethics Committee has now approved LCT’s clinical trial protocols and this is the final
of successful regulatory applications the Company has assembled to become the leading pig cell
therapy company in clinical phase.
The Ethics review considered key areas such as adequate patient consent, the contribution to
knowledge and risk/benefit ratio of the trial, rare adverse events and LCT’s unique system for
managing potential perceived risk to recipients and the community using guidelines released by
the US Food and Drug Administration (FDA).
Dr Paul Tan Chief Executive Officer of LCT, said: “LCT has worked closely with the regulatory
authorities to establish the framework for conducting clinical trials with pig cells to a new
benchmark. In doing so, LCT has built up considerable commercialisation capability and knowhow
that are essential for taking DiabeCell® to the clinic and market.”
Earlier this year, LCT received regulatory approvals from Medsafe and the Gene Technology
Advisory Committee - the regulatory bodies that led the international review of the health status
of LCT’s unique pig herd and certified its DiabeCell® manufacturing plant to Good Manufacturing
Practice (GMP) standards for supplying medical grade pig cells for use in humans.
In May this year, LCT became the first company to have an internationally accredited diagnostic
facility with the suite of tests for ensuring the absence of infectious viruses and micro-organisms
in pig tissue and a system for monitoring recipients of pig cell implants. To progress the trial,
LCT has been working with Medsafe, Ministry of Health on the database for a register of
transplant recipients and an archive for biological samples, as recommended by the Ethics
Committee.
LCT anticipates the NZ Minister of Health will accept the approvals from the regulatory bodies in
the next few weeks, which will enable clinical trials of DiabeCell® in type I diabetes patients to
commence in NZ in the last quarter of the 2007 calendar year.
Further information: www.lctglobal.com
Paul Tan - CEO
Mob: 0402 716 984 (AUS)
021 608 784 (NZ)
Prof Bob Elliott - Medical
Director
Tel: +64 9 270 7943 (NZ)
Mob: +64 272 924 177
About DiabeCell® clinical trial in New Zealand
Supported by a grant from New Zealand Trade & Enterprise, the 12 month phase I/IIa trial is to
be conducted at a New Zealand hospital and involves the simple injection of LCT’s DiabeCell®
product into the peritoneal cavity (abdomen) of eight insulin-dependent diabetes patients, who
will receive these cells in a dose escalation, to establish both safety and preliminary evidence of
efficacy.
DiabeCell® is a natural pig pancreatic islet cell product for the treatment of insulin-dependent
diabetes. DiabeCell® contains pig islet cells wrapped inside a protective alginate gel microcapsule.
DiabeCell® is injected into the body without any immunosuppression and produces
insulin to help regulate blood glucose levels appropriate to the amount of glucose detected in the
blood stream of the diabetic recipient.
Diabetes globally affects over 240 million people, 24 million of which have type I diabetes (2010
projections, WHO). The direct and indirect costs of diabetes account for up to 20% of
government healthcare expenditures. In NZ alone, over $341 million per annum is spent on
treating diabetes, with six times more people dying from diabetes related complications than in
the annual road toll (NZ Ministry of Health, Diabetes NZ). Human islet cell transplants are
currently available for around US$300k per patient, but there are not enough human cadavers for
this to be a viable treatment.
About Living Cell Technologies: www.lctglobal.com
Living Cell is developing live cell therapy 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 also offers
medical-grade porcine-derived products for the repair and replacement of damaged tissues, as
well as for research and other purposes.
LCT has a US American Depositary Receipt program, enabling US residents to
purchase LCT stock. To purchase ADRs in LCT, please contact your broker (OTC: LVCLY,
CUSIP Number: 53838R107). More information about investing in the LCT ADR program can be
obtained directly from Violet Pagan, Vice President Depositary Receipts at the Bank of New York,
by email : vpagan@bankofny.com .
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, 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. In particular, management’s expectations
regarding the approval and commercialization of product candidates could be affected by, among other things,
unexpected clinical trial results; 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.
PO Box 3014, Auburn VIC 3123
ABN: 14 104 028 042
COMPANY ANNOUNCEMENT
LCT Receives Approval for DiabeCell® Clinical Trial in NZ
12 September 2007, Auckland, New Zealand and Melbourne, Australia:
Key Points:
• LCT receives Regional Ethics Committee approval for diabetes clinical trial in NZ
• LCT pig cell transplant diabetes phase I/IIa trial on track to start by end of 2007
• LCT is the only company world-wide to obtain clinical trial approval for a pig cell transplant
without immunosuppression under current regulatory guidelines
• DiabeCell® product targets the type 1 diabetes market – with 24 million sufferers globally
Living Cell Technologies Ltd (ASX:LCT, OTC:LVCLY) is pleased to announce that it has obtained
all the regulatory and ethics approvals required by the NZ Minister of Health before proceeding
with its type 1 diabetes phase I/IIa clinical trial in New Zealand.
The Regional Ethics Committee has now approved LCT’s clinical trial protocols and this is the final
of successful regulatory applications the Company has assembled to become the leading pig cell
therapy company in clinical phase.
The Ethics review considered key areas such as adequate patient consent, the contribution to
knowledge and risk/benefit ratio of the trial, rare adverse events and LCT’s unique system for
managing potential perceived risk to recipients and the community using guidelines released by
the US Food and Drug Administration (FDA).
Dr Paul Tan Chief Executive Officer of LCT, said: “LCT has worked closely with the regulatory
authorities to establish the framework for conducting clinical trials with pig cells to a new
benchmark. In doing so, LCT has built up considerable commercialisation capability and knowhow
that are essential for taking DiabeCell® to the clinic and market.”
Earlier this year, LCT received regulatory approvals from Medsafe and the Gene Technology
Advisory Committee - the regulatory bodies that led the international review of the health status
of LCT’s unique pig herd and certified its DiabeCell® manufacturing plant to Good Manufacturing
Practice (GMP) standards for supplying medical grade pig cells for use in humans.
In May this year, LCT became the first company to have an internationally accredited diagnostic
facility with the suite of tests for ensuring the absence of infectious viruses and micro-organisms
in pig tissue and a system for monitoring recipients of pig cell implants. To progress the trial,
LCT has been working with Medsafe, Ministry of Health on the database for a register of
transplant recipients and an archive for biological samples, as recommended by the Ethics
Committee.
LCT anticipates the NZ Minister of Health will accept the approvals from the regulatory bodies in
the next few weeks, which will enable clinical trials of DiabeCell® in type I diabetes patients to
commence in NZ in the last quarter of the 2007 calendar year.
Further information: www.lctglobal.com
Paul Tan - CEO
Mob: 0402 716 984 (AUS)
021 608 784 (NZ)
Prof Bob Elliott - Medical
Director
Tel: +64 9 270 7943 (NZ)
Mob: +64 272 924 177
About DiabeCell® clinical trial in New Zealand
Supported by a grant from New Zealand Trade & Enterprise, the 12 month phase I/IIa trial is to
be conducted at a New Zealand hospital and involves the simple injection of LCT’s DiabeCell®
product into the peritoneal cavity (abdomen) of eight insulin-dependent diabetes patients, who
will receive these cells in a dose escalation, to establish both safety and preliminary evidence of
efficacy.
DiabeCell® is a natural pig pancreatic islet cell product for the treatment of insulin-dependent
diabetes. DiabeCell® contains pig islet cells wrapped inside a protective alginate gel microcapsule.
DiabeCell® is injected into the body without any immunosuppression and produces
insulin to help regulate blood glucose levels appropriate to the amount of glucose detected in the
blood stream of the diabetic recipient.
Diabetes globally affects over 240 million people, 24 million of which have type I diabetes (2010
projections, WHO). The direct and indirect costs of diabetes account for up to 20% of
government healthcare expenditures. In NZ alone, over $341 million per annum is spent on
treating diabetes, with six times more people dying from diabetes related complications than in
the annual road toll (NZ Ministry of Health, Diabetes NZ). Human islet cell transplants are
currently available for around US$300k per patient, but there are not enough human cadavers for
this to be a viable treatment.
About Living Cell Technologies: www.lctglobal.com
Living Cell is developing live cell therapy 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 also offers
medical-grade porcine-derived products for the repair and replacement of damaged tissues, as
well as for research and other purposes.
LCT has a US American Depositary Receipt program, enabling US residents to
purchase LCT stock. To purchase ADRs in LCT, please contact your broker (OTC: LVCLY,
CUSIP Number: 53838R107). More information about investing in the LCT ADR program can be
obtained directly from Violet Pagan, Vice President Depositary Receipts at the Bank of New York,
by email : vpagan@bankofny.com .
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, 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. In particular, management’s expectations
regarding the approval and commercialization of product candidates could be affected by, among other things,
unexpected clinical trial results; 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.