Graham Kelly
With the MSHL annual shareholders meeting out of the way, I have a few comments. I also note some comments on the Yahoo message board following the recent presentation which I will follow up on here.
1. On the departure of Chris Naughton, as I have said previously, I have no inside knowledge on the background to this. It appears, however, that at least part of it has to do with a shift of corporate emphasis to the US. Both NVGN and MSHL are owned predominantly by US investors and that has been the case now for about 8 years. The US also has been the greatest source of capital raising since day 1, and the only source of analyst following, limited as that has been. It has made good sense for the past 8 years to domicile both companies in the US, which is why I spent so much time in the US and it is a barrow that I pushed hard for a number of years, regrettably to no avail. Trying to get attention in the US marketplace with virtually no full-time presence and the occcasional visit of the CEO to NYC is futile in the extreme.
If the departure of Chris Naughton represents finally an acceptance of that position, with th eintention of appointing a US-centric CEO, then it is the second-best thing that the Board could do for the Company.
But the best thing that the Board could do is to exit Australia and domicile both companies in the US. There is no justifiable argument in favour of retaining the ASX as NVGN’s primary listing, or for having both companies run out of Sydney. That is an historical situation that is long past its use-by date. The only reason it hasn’t happened to date is that the bulk of of the two Boards live in Australia. Some years ago, Fortune magazine (or one of the big business mags) conducted a poll of the top 50 major corporations in the US. They asked the question of what were the main drivers in deciding where to locate the company headquarters. Factors such as access to a workforce, transport hubs etc seemed the most likely responses. In fact, the dominant reason came down to where the President’s partner wanted to live. Novogen and MEI are based in Australia because that is where the bulk of directors and executives live and choose to remain.
The answer is to relocate by puting a broom through the two boards and pass the baton over to a handful of US directors who have the best interests of the two companies at heart. A couple of names of high profile investors associated with NVGN come immediately to mind.
There are no sour grapes here, just the practicalities of the marketplace. On the public record, I want to express my gratitude in particular to Professor Paul Nestel, a long-serving Novogen director whose opinion, advice, involvement, insight and friendship I greatly valued. I was saddened to see the votes against his recent re-election. He is the only director I would retain if continuity is required as part of a hand-over.
For those who might be concerned about the companies being in something of a void, I have no particular concerns about this interim period. David Seaton is perfectly capable of managing the day-to-dayaffairs of the Company on a temporary basis.
2. It was disappointing to not have any OVATURE data released. Some months ago the Company indicated that it expected to have the data crunched by the end of this year. Despite everybody’s understandable frustration at the delay, I urge patience and in particular not to read anything troubling into the delay. The volume of data will be considerable. The change in the CRO earlier this year, and the time it would have taken for the new CRO to get up to speed on the trial, will have delayed matters by some months.
3. No new data released about the Yale/Harvard prostate cancer study with PXD. According to the interim data released by Dr Kevin Kelly earlier this year, PXD was looking promising for the androgen-dependant group, but not showing any stand-out effect in the more advanced androgen-refractory group. That fits in exactly with what we know about the mechanism of action of this drug. Speaking from personal experience, the availability of a drug with an anticancer effect at this stage of the disease would be a godsend. With aggressive prostate cancer, once local therapy fails as indicated by a rising PSA, the only option is surgical or chemical castration. This is not curative, serving only to deny the ability of testosterone to fuel cancer growth. But that eventually (after about 12-18 months) fails when the cancer becomes androgen-independent. Castration is not a pleasant option – loss of libido, severe mood swings, gynecomastia being just some of the side-effects. If PXD can achieve a significant delay in the need for androgen ablation therapy, or even complete avoidance of it, then it will be a major development.
There was no update about this study, in particular on where recruitment stands. It may be that the next update (or final analysis) will be AACR or the like next year.
4. It was announced that analysis of the PXD + docetaxel trial in ovarian cancer patients is underway. I’m not getting too excited about this study. I don’t think its design reflects the optimal way to use the two drugs in combination. Professor Jim Morre at Purdue did some work a few years ago that provided the clues to the right combination. It is a pity that the trial designers didn’t take notice of it. One of my ongoing frustrations.
5. Triphendiol. The animal data with pancreatic carcinoma is impressive. People need to appreciate the chemo-refractory nature of this cancer to understand just how impressive the PXD + gemcitabine data is. Potent cytotoxics like cisplatin and docetaxel have little or no effect on this cancer.
It is interesting that the focus for the Phase 1b study has shifted away from the US and the FDA to Australia. I imagine that this has something to do with lowering both cost and time. The focus also now is on pancreatic cancer and away from cholangiocarcinoma, probably reflecting the considerably greater ease of recruitment of pancreatic cancer patients.
6. The NV-128 data continues to impress. It really is a considerably stronger anticancer drug than PXD. I am not sure why it is going to take another 12 months to commence a Phase 1a study. It might simply be a matter of resource allocation, or the need to complete animal toxicology studies, or the challenge of manufacturing sufficient drug.