LCT reports positive results from NZ Diabecell trial

Living Cell Technologies (LCT), the Australian biotech developing a porcine-based cell implant to combat diabetes, today reported that 10 of the 12 insulin-dependent diabetes patients taking part in the clinical trial of its Diabecell product in New Zealand have shown marked improvement.

The first group of four patients have each received one implant of DIABECELL at the dose of 10,000 islet equivalents per kilogram body weight (IEQ/kg).

In all cases, patients experienced a dramatic fall in the number and severity of hypoglycaemic events, which occur when blood glucose reaches very low levels, often resulting in unexpected convulsions and / or loss of consciousness.

At the 24-week mark, these four patients averaged together experienced a 64 percent reduction in low glucose events.

More importantly, this group saw an average decline in life-threatening unaware low blood glucose events of 76 percent. One of the patients, whose progress has been followed now for 52 weeks, has experienced no unaware evens since week five.

By week 24 all patients in group one saw their insulin doses reduced by an average of 32 percent.

LCT Medical Director Professor Bob Elliott said that hypoglycaemic unawareness is a dangerous complication which occurs in about 20 percent of insulin dependent diabetic people and is responsible for up to 8 percent of deaths in this group.

“The ability to reduce the likelihood of these dangerous events is a significant step toward normalising the lives of our patients.” It also promises to alleviate the heavy burden shouldered by their families.

LCT reported that the second group of four kiwi patients each received a dose of 15,000 IEQ/kg with “no significant adverse events attributed to the treatment”.

These patients have each been observed for at least 12 weeks, and showed an average reduction in the severity of low blood glucose events of eight percent with unaware blood glucose events down by an average of 30 percent.

This data are significant for the fact that hypoglycaemic episodes did not reduce at a greater rate compared with patients treated at the lower level dose of 10,000 islet equivalents per kilogram body weight (IEQ/kg), helping to inform researchers as they try to find the target product profile.

In the third group of four patients, two have received a higher dose of 20,000 IEQ/kg. No significant adverse events have been recorded at this stage although it is too early to conduct a full assessment. “We expect the dose seeking studies to continue delivering positive results and important information,” said LCT CEO Dr Ross Macdonald. “With consistent benefit in the form of reduction or elimination of hypoglycaemic events, LCT is planning to expand clinical trials of DIABECELL to obtain the necessary pivotal data for the treatment to be approved.”

LCT’s lead product Diabecell comprises encapsulated porcine insulin-producing cells (islets) that are implanted into the abdomen of patients using a simple laparoscopic procedure. They work by self-regulating and efficiently secreting insulin in the patient’s body. The company adds that due to its proprietary encapsulation technology, patients receiving Diabecell do not require immunosuppression after implantation.