Biotech company retracts Parkinson’s treatment study after “possible deviation from protocol”
Living Cell Technologies (LCT), a biotech company headquartered in Australia, has retracted a 2011 paper purporting to show that their product reversed Parkinson’s symptoms in rats after “being unable to reconfirm their reported results and a possible deviation from the protocol.”
LCT is developing NTCELL, which, according to their site:
is a choroid plexus cell product with the potential to treat Parkinson’s disease and other disorders, such as stroke, Huntington’s disease and hearing loss, as well as wound hearing. These cells help produce cerebrospinal fluid as well as a range of neurotrophins (or nerve growth factors) that have been shown to protect against neuron (nerve) cell death in animal models of disease.
(We assume that’s supposed to be “wound healing.”)
Here’s the notice from Regenerative Medicine, which went online yesterday:
Due to the authors being unable to reconfirm their reported results and a possible deviation from the protocol that may have occurred, the following article has been retracted from Regenerative Medicine:
Stephen JM Skinner, Hai Lin, Marilyn S Geaney, Thorsten Gorba, Robert B Elliott & Paul LJ Tan: Restoration of motor control and dopaminergic activity in rats with unilateral 6 hydroxy-dopamine lesions. Regen. Med. 6(3), 319–326 (2011).
The authors and editors of Regenerative Medicine regret any negative consequences this publication might have caused in the scientific and medical communities.
The paper has been cited just once, according to Thomson Scientific’s Web of Knowledge, by a paper that included most of the authors of the now-retracted study.
Because LCT is a publicly traded company, and a retraction is material information that could affect its stock price, this is the rare retraction that was accompanied by a press release. A December 19, 2013, company release about the retraction — which refers in the text, but not a footnote, to the wrong journal — notes that the data will be “withdrawn from all regulatory documentation:”
The publication is being withdrawn following an internal quality assurance (QA) audit which showed that the source data for the study held on file at LCT are incomplete and therefore the efficacy conclusions in the publication cannot be confirmed.
The withdrawal of the rat efficacy data does not in itself present a safety risk with regard to the use
of NTCELL in humans. Nonetheless, as a precautionary measure LCT has placed a hold on any further patient recruitment into the human Phase I/IIa clinical study that is currently underway at Auckland City Hospital. This is to allow the company to work with the New Zealand medicines regulator (Medsafe) and the data safety monitoring board (DSMB) to fully understand the impact of the withdrawal of the rat efficacy data on the Phase I clinical trial.
That hold will cost the company money, at least in the short term:
LCT and Otsuka Pharmaceutical Factory (OPF) are co-developing NTCELL as a treatment for Parkinson’s disease. A second cash payment of A$2m which was due from OPF to LCT as a result of the DSMB authorising the recruitment of the remaining three patients to the study is now not expected to be received until patient recruitment into the trial is recommenced.
The company reported that the subject of the clinical trial “continues to do well since their implant in September 2013.”
Paul Tan, the last author of the paper, retired last week from his post as LCT’s chief science and medical officer. The company’s stock, which has been trading below $1 per share over the past year, fell from 95 cents to 60 cents following the release about the retraction last month. It closed yesterday at 69 cents.
Hat tip: Rolf Degen