The profesional consensus appears to be that healing rates for chronic venous ulcers ranges between 30 and 60% for the first six months of treatment. There's a great deal of variation in this consensus because of the sheer variation in patients analysed in various studies. Variations in healing rates will be affected by age, underlying health status, initial ulcer size, treatment issued and compliance with that treatment to name but a few factors affecting healing rates.
Tissue therapies have conducted trials so far on both venous and diabetic ulcers. Specifically the venous ulcer trial was conducted on patients who had venous ulcers for an average time of 11 months and who had undergone compression therapy for an average period of nine months prior to the Vitrogro trial.
The trial period was for 24 days with complete healing occurring in 16.7% of the patients and an average reduction in ulcer size of 43% in that 24 day period.
The first point to make is that you can't compare healing rates in those with ulcers for almost a year to those who have had an ulcer for a week or two. The amount of tissue damage that can be done by a venous ulcer over 12 months is incomparable for starters.
To make a meaningful comparison (conclusion) you would have to compare Vitrogro's healing rates to compression therapy healing rates as experienced by those with ulcers of similar duration and size for example. What the comparison healing rate for these "hard to treat" ulcers TIS haven't mentioned (a phone call perhaps to find this out??) though they would have had to have one in mind given that they've presented a result indicating the Vitrogro healing rates were highly statistically significant. The "comparison" rate is unlikely to have been 30-60% though. For 12 month old ulcers treated for 24 days by standard compression therapy it may have been in the low single digits.
I think the first market Vitrogro will be targeted at will be the "failure to respond" market. It's certainly a market that will be willing to at least try something new given the misery that a chronic ulcer over an extended period of time can induce.
The second point to make is that within the first six months of treatment not all ulcers are created equal. Some patients will present with an ulcer the size of a five cent coin and it's highly likely the six month healing rate for these are in the 80-90% range or more. This would be an unlikely market for Vitrogro. Conversely, a patient could present with an ulcer the size of your palm or have one that quickly develops that way in which case you can forget the 30-60% healing rate within six months idea. Again physicians are likely to be highly receptive to a second line of treatment for this class of ulcers.
Third, neither compression therapy nor for that matter Vitrogro is capable of dealing with the underlying problem causing the ulcer in the first place, in this case venous insufficiency. This means that many patients will experience second, third and fourth ulcers and are sure to be requesting a bit more than some bandaging, a compression stocking and keep your feet elevated type of advice should they experience ulcer recurrence. Again a market Vitrogro may be able to explore.
Increasingly big pharmas are asking for global licensing type deals (principally for full price control) and if you're a hopeful (as TIS is) than it's pretty much standard that you will be advised to get your legal, regulatory and manufacturing operations into order before a big pharma will even consider entering and putting a price on any deal. And unless you have a cure for aging or something similar you're going to have to pay for most if not all of these pre-commercialisation arrangements.
But you'll do so because if you can plug your product into a global pipeline there's an awful lot of benefits should you achieve market success.
TIS is high risk-high reward stuff. It's a biotech...that's how it works. There's a lot of potential here because Vitrogro tackles a large and growing need that quite simply hasn't or isn't being addressed adequately. It has the opportunity to be first into untapped market space so the potential for high rewards is there.
But it's risky stuff. It always has been and it always will be. Make your buy/sell/hold decisions accordingly.
Good luck.
TIS Price at posting:
53.0¢ Sentiment: LT Buy Disclosure: Held
