A Medical Device Daily

BioAxone Therapeutic (Montreal) reported that it has completed its targeted patient enrollment of the Phase I/IIa North American clinical trial of Cethrin for the treatment of acute spinal cord injury (SCI).

A recombinant protein-based inhibitor of Rho signaling, Cethrin is co-delivered with a fibrin sealant and administered once directly onto the surface of the spinal cord during spinal decompression surgery.

Results from the trial are expected this fall.

BioAxone's announcement on trial enrollment follows a presentation at the 24th annual National Neurotrauma Symposium in St. Louis by the clinical study's lead investigator, Dr. Michael Fehlings, a professor of neurosurgery at the University of Toronto.

Fehlings, holder of the Krembil Chair in Neural Repair and Regeneration based at Toronto Western Hospital, said Cethrin “offers a novel and promising regenerative approach to enhance functional recovery of patients suffering from spinal cord injury.”

He added: “We have seen no adverse events related to the administration of Cethrin at this stage of the study and clinically the results look interesting.”

The trial is an open-label safety and pharmacokinetic study in which Cethrin was administered to patients with acute thoracic or cervical spinal cord injuries. Conducted with 37 patients in nine centers in the U.S. and Canada, the study is designed to evaluate the safety and tolerability of Cethrin.

The protocol entails four escalating doses and includes patients with complete thoracic or cervical injury. While not placebo-controlled, the trial has an exploratory efficacy component based on the American Spinal Injury Association's classification scale, which is designed to detect improvements in sensory and motor function of patients.

“An acute injury to the spinal cord has a dramatic and sudden impact on the life of a person experiencing it,” said Dr. Frank Bobe, president and CEO of BioAxone. “There is no available treatment for this condition, and Cethrin is currently the leading product candidate in the world undergoing human clinical trials.”

He said that in North America alone, there are 12,000 new patients each year whose only hope is to prevent further damage to their spinal cord. “Cethrin is the first of a new generation of drugs that specifically targets the cellular response to an acute spinal cord injury.”

Cethrin is designed to effectively penetrate into central nervous system tissue, where it has been shown in preclinical research models to elicit the rescue and repair of damaged neurons.

Biosignal cites initial trial results

Biosignal (Sydney, Australia) and the Institute for Eye Research (IER; also Sydney) said they have completed an initial overnight safety trial in humans using their new anti-bacterial coated extended wear contact lenses.

The aim of the study was to compare the safety performance of the anti-bacterial contact lenses developed jointly by Biosignal and the IER with commercially available lenses. The comparison showed no significant difference in ocular health, lens performance on-eye or subjective responses between the test lens and available silicone hydrogel lenses when worn for one night.

The trial involving 10 patients was conducted at the clinical facilities of the IER at the University of New South Wales.

The positive safety result has raised the potential of increasing the concentration of active compounds on lens surfaces. Biosignal and IER said they would conduct a further overnight study with lenses produced using a higher concentration of their active anti-microbial to maximize efficacy.

Michael Oredsson, CEO of Biosignal, said, “Based on this initial positive result, we are now planning a further trial to confirm that the lenses retain anti-bacterial potency during wear.”

Separately, Biosignal and the Institute for Eye Research said they have finalized a material transfer agreement with an unnamed major U.S.-based medical products company to test Biosignal's anti-biofilm compounds as medical device coatings. The objective is to reduce the high infection rates endured by patients exposed to medical devices.

This is Biosignal's fourth collaboration assessing effectiveness of anti-biofilm coatings on medical devices and it is the third devices collaboration with a major company. The tests will occur at the company's U.S. laboratories, where it will test its anti-biofilm compounds for their effectiveness in preventing biofilm formation for a range of device pathogens. The compounds will be tested alone and in combination with chlorhexidine.

“Major medical device companies are very eager to invest in testing Biosignal's anti-biofilm technology as they recognize the substantial value of an innovation that might greatly reduce infections from devices,” said Oredsson.

In another piece of Biosignal news, the company and Japanese Restoration Group (Restoration; Tokyo) reported signing a memorandum of understanding and share subscription agreement regarding a commercial collaboration and an investment of up to $1.6 million by Restoration into Biosignal.

The investment will be made at a share price of 15 cents a share in two tranches, the first up to $450,000 to subscribe for shares in any shortfall from Biosignal's current rights issue and the remainder as a placement. Biosignal has agreed to grant a board position to Restoration on completion of the investment.

The Restoration group has identified the field of biomimicry – a branch of science that studies nature's models and then imitates or takes inspiration from these designs and processes to solve human problems – as a key investment target. Biosignal, whose technology is based on models from marine organisms, is one of Restoration Group's first investments in this field.

Biosignal and Restoration will initially focus Japanese activities on a suite of industrial products aimed at biofilm prevention and removal in different product applications in the housing and construction sector. Restoration and Biosignal also have agreed to assess manufacturing of Biosignal's compounds in Japan.

Biosignal's anti-biofilm technology is based on a discovery that the eastern Australian seaweed Delisea pulchra produces natural furanones that disable bacteria's ability to colonize. Furanones lull bacteria to inaction and appear to avoid the problem of bacterial resistance.

NIMS in Mexican distribution accord

Non-Invasive Monitoring Systems (NIMS; North Bay Village, Florida) said it has entered into an agreement with AG Distributores Internacionales (Queretaro, Mexico) to market and sell NIMS' AT-101 Motion Platform and future home version of the AT-101 throughout Mexico.

Gary Macleod, CEO of NIMS, said, “AG Distributores Internacionales has a highly effective marketing and sales presence in the medical device and hospitality sectors in Mexico City and the metropolitan area of Queretaro, which includes Corregidora, El Marques and Huimilpan.”

In exchange for the right to market and sell the AT-101 Motion Platform, AG Distributores Internacionales has agreed to obtain all necessary approvals at its expense and will pay NIMS royalties arising from all sales in those territories.

The agreement has an initial three-year term and may be renewed for an additional three-year term with mutual agreement of both parties.

NIMS has developed a non-invasive, whole-body, periodic-acceleration, therapeutic vibrator, which has been designated as the AT-101.