Product Pipeline Update

Thursday, 31 July 2014

Human Health

First-in-man study for human cancer vaccine

Regeneus will fund a first-in-man trial (safety study) scheduled to commence in the first quarter of 2015. Leading oncologists Professor Stephen Clarke and Associate Professor Nick Pavlakis, from the University of Sydney’s Northern Clinical School at the Kolling Institute, will be the investigators on the trial and good progress is being achieved in preparing for the submission of the ethics approval. The cost of the safety trial is expected to be in the region of $500,000.

Regeneus has secured the exclusive rights for human applications of the cancer vaccine technology from Northern Sydney Local Health District following the success of the canine studies.

The therapeutic cancer vaccine has the potential to target a wide range of hard-to-treat cancers with a single product. As the vaccine uses the patient’s own tumour cells and can be prepared under the supervision of the treating clinician, the local regulatory environment for biological therapies in Australia(and other major markets) may allow for an accelerated clinical pathway for the autologous cancer vaccine removing the need for expensive and time consuming phase III trials.

Launch of new initiatives for HiQCell

Over the last quarter we have put in place new initiatives that are resulting in increased enquiries and HiQCell treatments in Sydney and Melbourne.

These initiatives included:

  • A direct patient engagement strategy that encompasses outbound marketing communications and a dedicated HiQCell website including patient enquiry portal and customer relationship management system;
  • A HiQCell processing centre at the new East Sydney Private Hospital. On 18th June 2014, HiQCell was the first procedure performed at the new state-of-the-art hospital and five HiQCell treating medical practitioners (TMPs) are now accredited at the facility;
  • Three additional Melbourne-based TMPs licensed to perform HiQCell;
  • HiQCell being made available to treat neuropathic pain following the publication of the positive results of the study in the Journal of Pain Research in May 2014;

We are on track for the launch of our Singapore presence with first treatments likely in Q4 2014. We have explored the market opportunity for HiQCell in the UK and are in discussions with potential UK medical partners.

Commenced cell manufacture for pre-clinical study for off-the-shelf stem cell therapy

We are on track for our first-in-man trial (safety study) of our allogeneic (off-the-shelf) adipose-derived cell therapy for osteoarthritis (OA) and other musculoskeletal conditions (Progenza).

After receiving ethics approval, we have procured stem cells from human donors and are producing the cells for our clinical trial to assess initial safety and preliminary efficacy in human volunteers with knee OA. Cell manufacturing takes place at CryoSite Limited’s facility as part of a broader R&D exchange between the companies in relation to tissue handling, cell extraction and manufacturing. This is an important milestone in taking our human allogeneic product for OA through the regulatory approval process.

The first batch of cells have been produced for a pre-clinical study that is now underway in the US. We are on track to have cells manufactured in preparation for the human safety trial in Q2 2015.

We understand that the Japanese regulations to support the new laws passed in November 2013 will be released later this year. This will provide important detail on the new framework for cell therapies which has been specifically designed to fast-track the approval of cell therapies like Progenza without the need for large and expensive phase III trials.

Progress on stem cell cream

Research is underway with the Regeneus laboratory to scale up the secretions manufacturing process to deliver a cost effective product for early commercialization activities.

A pre-clinical safety trial on the secretions will be completed by Q4 2014.

Veterinary Health

CryoShot - initiated placebo controlled trials for US registration trials

In advance of our US registration trial for canine CryoShot, we have initiated placebo-controlled trials in Australia and Canada which will provide initial read outs in Q4 2014.

We are well underway with Lonza in the US on the manufacturing development of the CryoShot product for the registration trial. The product must be manufactured under good manufacturing practice (GMP) that is a standard that governs the manufacture of human and animal drugs and biologics.

Kvax – launch of canine cancer vaccine in Australia

We will launch our autologous cancer vaccine (Kvax) in Australia in Q3 2014. We have established a manufacturing capacity for the vaccine at our facility in Sydney and will commence a marketing trial in connection with the launch of the product.

We are actively exploring our commercial partner options for Kvax in the US market now that we have regulatory clearance to proceed with commercialisation. The US marketing trial for bone cancer will commence in Q4 this year.

We are actively exploring the regulatory pathway for the launch of Kvax in the UK.

Funding Runway until Q2 2015

The company has a cash runway to fund its activities up to Q2 calendar year 2015.

The sources of funds include existing cash resources ($2.5m at 30 June), the receipt of the R&D tax rebate for FY14 which is expected to be received in late September 2014 (estimate $3.3m) and forecast sales revenues for the period.