Regeneus (ASX: RGS) should trade firmer after revealing further results from the joint registry used to track the safety and effectiveness of its innovative cell therapy, HiQCell®, in the treatment of osteoarthritis.
The interim report of 305 patients as at 23 January 2014 has found that patients reported continued improvements at 12 months post-treatment, and the small number of patients that had reached 24 months post-treatment also show continued improvements.
Patients reported significant improvements in pain, function, sleep quality and reduced usage of pain medications, with 73% of patients experiencing a significant reduction in pain.
The HiQCell Joint Registry is the first of its kind in the long-term follow-up of patients undergoing stem cell therapy using the patient’s own fat-derived stem cells.
Patients in the Registry will continue to be followed for up to 5 years with analyses updated regularly.
Within the registry a patient is classified as a responder if they report a greater than 30% reduction in pain; 12 months post treatment 56 of 77 patients were responders and at 24 months post treatment 6 of 7 patients were responders.
Professor Graham Vesey, CEO of Regeneus, commented:
“The Joint Registry is an important part of the company’s commitment to quality. It is exciting that we have registry data available for 12 months and beyond post-treatment for patients.
We anticipate that it will also help us to build a case for permitting medical reimbursement to patients.”
The Joint Registry is a voluntary observational registry and all patients treated with HiQCell are eligible for inclusion.
Patients are tracked from a pre-treatment baseline, at two weeks, at six months and then annually.
Timing of the report coincides with the milestone of treating the 1,000th joint with HiQCell, comprising knees, hips, ankles, wrists, shoulders and digits across a cohort of over 450 patients.
Dr Donald Kuah, a leading Treating Medical Practitioner of HiQCell and specialist sports and exercise physician was also very interested in the results.
He added:
“This Registry is extremely valuable as it allows me to track specific outcomes of my own patients as well as being able to observe the treatment effect across all other patients enrolled in the registry.”
Cancer Vaccine
Earlier this month, Regeneus received support for the efficacy and safety of its licensed Kvax cancer vaccine with a paper showing it led to remission rates of 30%-60% in rats with brain tumour.
Kvax uses the removal of a tumour or biopsy from the patient as source material to produce a personalised vaccine that stimulates the patient’s immune system to see the cancer cells as foreign.
Regeneus has an exclusive worldwide licence for commercialisation of the technology for veterinary applications and an option over all human applications.
The paper “Streptavidin: A novel immunostimulant for the selection and delivery of autologous and syngeneic tumor vaccines”, was published in the peer-reviewed journal Cancer Immunology Research.
Besides showing that Kvax led to remission rates of 30%-60%, upon challenge these animals did not get the disease, which indicates acquired immunity.
The paper also described the treatment of 25 dogs that had a range of advanced cancers.
The study in dogs demonstrated that there were no safety issues with the vaccine and that the dogs often survived longer than expected indicating that the vaccine can slow tumour growth and recurrence.
Regeneus Veterinary Business Unit head Duncan Thomson said the work in dogs suggests that the vaccine is effective in a wide range of tumour types, making it a significant commercial opportunity.
The company had in November 2013 received the green light to commercialise the canine vaccine in the U.S. through the Centre for Veterinary Biologics at the U.S. Department of Agriculture.
It will now focus on setting up a vaccine manufacturing site in the U.S. and beginning a marketing trial with key opinion leaders in the US.
CryoShot Canine
Lonza, the world’s largest manufacturer of stem cells, will produce Regeneus’ off-the-shelf cell therapy, CryoShot® Canine, for registration in the U.S.
CryoShot Canine is for the treatment of musculoskeletal conditions in dogs and is currently under pre-registration trial in Australia.
The cell therapy is produced from a small amount of fat tissue derived from a donor animal. The tissue is processed and cultured to isolate and increase the regenerative cells before being cryogenically frozen and stored in liquid nitrogen.
It is delivered to veterinary clinics cryogenically frozen and then thawed for injection by the treating veterinarian.
Analysis
In Proactive Investors’ view, Regeneus is at the forefront of a massive growth in the regenerative medicine and cell technology industry, currently in its infancy.
A marker is that its core HiQCell® stem cell knee osteoarthritis treatment initially targets Australia’s top chronic disease that current affects 4 million people.
Osteoarthritis, which was incurable, usually resulted in the need for a hip replacement so there is a real treatment gap and need.
Regeneus is already earning revenues with fast growth – $1.77 million in 2013, up from $1.25 million in 2012 and $0.785 million in 2011.
Investors certainly agree, with the company’s $10 million IPO raising closing oversubscribed in September 2013.
Since then the company’s valuation has risen to $88 million.
The company is also looking to leverage the regulatory advantage offered by HiQCell® being considered a surgical procedure rather than a drug to expand its offering to countries with a similar regime to Australia.
On our initial estimates, Proactive Investors places a valuation of Regeneus within the range of $0.76 – $0.93 per share within 6-9 months.
Comments are closed.