vitrogro analysis

Hey everyone,

I am a big Tissue Therapies fan and have loaded up as much as possible. I am pretty sure most here would know about the VitroGro back to front and more over. If not I have done some research on the product and provide a written analysis below. I also have summed up the clinical results to date and written a partnership analysis that I have on hand if anyone would like to have a read, let me know and I will post.



Summary and background

Principal Activities

Tissue Therapies Limited (TIS) is an Australian company developing biomedical technologies for wound healing, tissue repair and various cell culture applications. Tissue Therapies is listed on both the Australian Stock Exchange and Frankfurt Stock Exchange. The Company has worldwide exclusive rights to commercialise VitroGro® ECM (a technology developed by cell biology, tissue engineering and protein engineering experts) which has particular commercial applications in wound healing, tissue regeneration, cell-based therapies and cell culture. Through VitroGro® ECM, the company has a proven, unprecedented product for the definitive treatment of diabetic and venous ulcers. VitroGro® ECM offers for the first time ever, consistent healing as well as better price performance than any product previously available to treat these debilitating (venous ulcers have a habit of growing back and current treatment methods can cost up to tens of thousands of dollars) and sometimes fatal wounds. Patent applications for VitroGro® ECM have been filed in the USA, Canada, Europe, Australia, New Zealand, South Korea, China, Hong Kong, India, South Africa and Japan, with patents already granted in the USA, Europe, South Korea, Japan, South Africa, Australia and New Zealand.

The company is on track for the start of VitroGro® ECM sales in early June 2012 in the UK and Europe; in conjunction, the company is currently in the final process of securing FDA testing approval for the VitroGro® ECM – this will open the doors for VitroGro® ECM development in the world’s largest pharmaceutical market. Recently, the company announced to the market that commercial partnership agreements were signed with Quintiles (has capabilities equivalent to a large international healthcare company including sales and marketing, regulatory submission, pricing and reimbursement and medical affairs) and Movianto (Large, integrated logistics partner specialising in health care); this is unlike other commercial partnerships in the industry whereby the developer, Tissue Therapies, is able retain the VitroGro® ECM rights and in the long-term will be able to hold a significantly higher proportion of the VitroGro® ECM‘s long-term NPV.


Background to VitroGro® ECM

Growing up as a child – from falling while climbing trees to falling off bikes onto the gravel road – everyone has scraped a knee on some asphalt which has resulted in an injury involving wounds during our lives. Normally as a consequence of our careless actions, our bodies go through a painful, genetic and autonomous healing process. However, this is not always the case because our bodies are unique and this healing process is not only complex but fragile and often susceptible to interruption or failure. It is the failure of the healing process that often results to the formation of what is acknowledged as chronic (non-healing) wounds. It is not always the case that chronic wounds originate from injury. There are many factors that contribute to an interrupted healing process such as diabetes, venous or arterial disease and infection or commonly and simply, old age.

Chronic wounds can take years to heal or in the worst case scenario, sometimes never heal at all. This foundation often inflicts severe emotional and physical distress on patients as whilst forming a significant overhanging financial burden on the healthcare system. The matrix scaffold, which is realised in the normal autonomous healing process and known as the extracellular matrix (ECM), is degraded in chronic wounds. Deprived of this ECM, the normal healing process will become distorted and instead, a repetitive cycle of self-augmentation inflammation occurs; this often results in the wound become chronic (non-healing). Tissue Therapies VitroGro® ECM was discovered, developed and successfully tested as a treatment for chronic wounds. The treatment was applied and tested to chronic wounds originally because of the severity of the injury and it is expected that VitroGro® ECM will be used as a multi-purpose treatment in the future; for example, though not limited to, VitroGro® ECM is expected to be further utilised on the application of burns and diabetic ulcers. In an interview with Professor Zee Upton she stated: “I hope VitroGro® ECM will eventually be used as a tool to maintain skin integrity. Perhaps one day you’ll get up in the morning and put on your moisturiser which contains VitroGro® ECM, while you’ll be able to find bio-active bandages that actively assist in healing wounds on the shelves in pharmacies.”


What is VitroGro® ECM?

VitroGro® ECM is the result of more than 10 years of peer reviewed published research by the
scientific group headed by the Tissue Therapies’ Chief Scientist, Professor Zee Upton. VitroGro® ECM is a sterile (germ-free), acellular (single cell – easy to replicate) and flow-able (breathable) biomimetic scaffold that replaces the normal skin extracellular matrix that is degraded or absent in chronic wounds; in this case, VitroGro® ECM forms a physical matrix that replaces the degraded scaffold with a viable scaffold that is able to restore normal wound healing. For restoration of normal wound healing, it is essential to restore a matrix that contains the binding sites to which skin cells must adhere before normal wound healing can proceed

Whilst Professor Zee Upton was undertaking her PhD and studying the evolution of molecules and cells, she came across an arbitrary band on a gel only found in chickens. This band was examined whether it would become a new growth factor in binding protein or to instead, ignore the band because it is an artefact or probably serum albumin. The band was seen as irrelevant to the project at the time and was ignored. Nonetheless, six years later, Professor Upton was allocated $50,000 from the CRC to study and discover what that band was – this was called the “red herring” project.

Initial work was targeted towards chickens but later expanded to humans. Eventually it was discovered that the band that was binding the growth factor was in fact a “sticky” protein called “vitronectin” (human and bovine (cow) blood and other cell tissue vitronectin also bind the growth factors). The “sticky” protein – Vitronectin – is involved in the early stages of normal wound healing, stimulating cell adhesion and cell spreading into the wound area. Upon further research, Professor Upton recognised the potential of vitronectin to become a replacement for the degraded matrix in chronic wounds.

Moreover, the new findings directed the focus of the project to determine whether vitronectin could be applied as a matrix scaffold and in turn, provide degraded cells with the acceleration necessary to restore chronic wounds back to a normal healing process. Early research concluded, on its own merit, that a simple vitronectin scaffold would be insufficient to ignite the healing process towards a normal healing course because the extracellular matrix (ECM) in chronic (non-healing) wound cells is degraded and deprived of important attachment sites known to exist in the “normal ECM”. In this case, for the “sticky” protein to be successful the “replacement ECM” would need to “replicate” the “normal ECM” that is present in the initial wound healing stage.

Further analysis on the early-stage of the wound healing process shows that the “normal ECM” encompasses two elements that provide attachment sites for cells and guide tissue restoration. Respectively, these elements consist of: 1) glycoproteins or “sticky proteins” such as Vitronectin and, 2) growth factors sequestered to the matrix scaffold. Evidently, tailored towards incorporating both elements discovered during the early stages of the normal wound healing process, the VitroGro® ECM is as a synthetic protein developed to “replicate” the “normal ECM” scaffold and acts to restore normal wound healing by replacing the degraded ECM with a scaffold containing attachment sites to guide skin cell replication and migration (the two essential elements of wound healing) that support structural and physiological changes during the different phases of wound healing cycle. VitroGro® ECM is created synthetically and so unlike other wound dressing products, VitroGro® ECM is not derived from animal or human tissues.


Classification

During 2007, Tissue Therapies confirmed that the classification of VitroGro® ECM from Health Canada (the Canadian Health Regulatory Body) and by an EU Notified Body – British Standards Institute – as a ‘topical biologic’ and therefore, the clinical regulatory testing requirements for the product is similar to the acceptance approval process of a medical device, rather than a pharmaceutical drug. This was a major milestone for Tissue Therapies because it means that testing required to bring VitroGro® ECM to market would be considerably faster than those required for a pharmaceutical. In this case, the only means necessary for VitroGro® ECM to successfully complete a single small clinical trial in comparison to the phase trials that applies to pharmaceutical drugs. Furthermore, Dr Mercer said that “The Canadian classification (being mutually recognised), will also provide the opportunity to access the markets of Canada, EU, Switzerland, Australia, New Zealand and Asia, as well as potentially accelerating access into the United States (which requires FDA approval).”

Early in 2011, prior to Tissue Therapies submitted its USA Food and Drug Administration (FDA) Request for Designation (RFD) Application – an application that leads to the classification of VitroGro® ECM – the company announced that it took advantage of an regulatory expert consulting review that includes two former Directors of the FDA. The feedback received by Tissue Therapies was that the consulting group is confident that the RFD will result in a successful device classification by the FDA. In November 2011, the company announced that it had received a formal classification of the VitroGro® ECM from the FDA as a biologic product; this thus, mirrors Health Canada’s classification. Dr Mercer explained, “A biologic classification is much simpler, quicker and cheaper than the approval process required for a product classified as a pharmaceutical.”

Cheers,
UnclePanda