goldfinger
- 01 Sep 2004 15:33
This ones a heck of a specualive investment but it seems that the institutions are willing to stomp up the cash to back it in the long term.
Heres the latest news from Killik stocbrokers on the company..........
MEDICAL MARKETING Joint Venture
We recently highlighted Medical Marketing (MMG) as worthy of attention. The company, in which I have a personal share holding, has this morning announced the formation of a joint venture, Genvax, to develop a novel DNA vaccine platform technology.
Human trials have been underway since 2001 in areas such as Lymphoma and Myeloma but the technology has broad applications in cancer, viral and bacterial infections (hence the term platform). The technology works on boosting the immune system by teaching it to identify hard to recognise cancer proteins as foreign and destroy them. Early results from the 25 patient trial in lymphoma are encouraging and evaluation of the result is expected by March 2005. Successful results should mean big pharmaceutical groups will start to take financial and commercial interests around that time.
This looks to be the first of a series of announcements due from Medical Marketing as it has a range of predominantly cancer trials moving into the clinical stage. (news flow could push the price higher)
The stock has made good progress in recent sessions up to the mid-80p level where the company is valued at just under 40 million. ENDS.
Please DYOR
cheers GF.
swseun
- 22 Oct 2005 04:02
- 1919 of 2444
thanks GF, just want to know I am the only one still holding it with a loss.
mitzy
- 22 Oct 2005 09:42
- 1920 of 2444
If it falls sub 100p Im in with a shed full..not that it will fall that low but you never know with this market.
Finns note suggests we wont have long to wait for the Genvax efficacy results out several months ahead of schedule.. great news.
doughboy66
- 22 Oct 2005 10:35
- 1921 of 2444
Good to see you back mitzy,i wondered where you had got to.Early on in the year you were a frequent poster on this board and really seemed to have your finger on the pulse of this company,don`t leave it so long to post again.
swseun i`m holding at a loss after adding to my holding a couple of times during the big rise in sp earlier in the year.
I`m still very confident about MMG ,given that the Prudential have just added to their holding and the appointment of SAFC to manufacture batches of ruthenium cancer therapies.Given the recent turmoil in the markets and the recent placing of shares MMG`s share price is about where it was when i first bought in back in Febuary,not so bad really is it?
Roll on 2006
db66
swseun
- 22 Oct 2005 14:09
- 1922 of 2444
great! so I'm not alone in the boat, thanks guys. :-) I might buy in more while the price gets more stable, as MMI is a great company with too good potential.
swseun
mitzy
- 22 Oct 2005 16:38
- 1923 of 2444
Cheers everyone Ill be buying more when they start to move forward again so it wont be long now.
mickeyskint
- 25 Oct 2005 12:44
- 1924 of 2444
From the other place. Looks like we're on the move.
jofster - 25 Oct'05 - 09:59 - 6507 of 6509
Stock prime for a bounce/rise.....Market flat to short, AGM next Wed, intensive note from Insinger due after AGM, Genvax data late Nov/early Dec and hopefully tie up before year end with big pharma.....big 6 to 8 weeks ahead for MMI. Theres more stuff due now than there was back in March and we saw how the price reacted then......
bhunt1910
- 27 Oct 2005 07:14
- 1925 of 2444
Medical Marketing Int'l Group PLC
27 October 2005
For Immediate Release 27 October 2005
MMI GRANTED FOURTH DNA VACCINE PATENT FOR GENVAX CANCER THERAPY
Medical Marketing International Group plc (MMI), the Cambridge, UK-based
pharmaceutical development company listed on the London Stock Exchange (AIM:MMG)
announces that it has received notification of allowance in Europe for a fourth
patent for its Genvax subsidiary developing DNA vaccines for cancer and
infection.
Mark Burton, Technical Manager at MMI explained 'We already have patents granted
in Europe, the USA and Australia for the 'Stevenson 1' family of patents.
Today's news is important as it is the first notification of allowance for the
'Stevenson 2' family of patents which protects our DNA vaccine technology from a
different angle.'
David Best, Chairman of MMI Group added 'This additional patent protection has
come at an opportune time. The potential for DNA vaccines in cancer has already
been shown by our previous clinical results. However, there is now recognition
that DNA vaccines also have great potential in infectious diseases such as
pandemic influenza as they can be rapidly developed and manufactured in response
to such threats. This ever strengthening patent portfolio enhances our vaccine
pipeline and similarly provides greater leverage to the current negotiations we
are having with major pharmaceutical companies.'
goldfinger
- 27 Oct 2005 09:28
- 1926 of 2444
More good news. Lets Hope Best gets his finger out with the big boys.
cheers GF.
bhunt1910
- 27 Oct 2005 09:38
- 1927 of 2444
Are we talking George or David !!!
goldfinger
- 27 Oct 2005 10:23
- 1928 of 2444
Both LOL.
cheers GF.
swseun
- 27 Oct 2005 23:40
- 1929 of 2444
just get it from others:
Mike Walters report from the start of this month is available free to view:
http://www.michaelwalters.com/stories/news.phtml?num=2557
goldfinger
- 30 Oct 2005 00:46
- 1930 of 2444
Opened out as it is free.....
A Global First
3/10/2005 (119264)
A Global First
Do not rely upon the preliminary results statement released by Medical Marketing International (MMG) on September 29. It contains a long report from executive chairman David Best, plus a detailed financial review, and much more. But it falls far short of conveying the real potential of this business.
The real impact of what is happening at MMI is in the annual report and accounts, a nicely produced document which goes to considerable lengths to seek to explain what is going on in the company, with particular emphasis on the three bio-babies, each of which has terrific potential.
Many of us hold our shares in nominee accounts, which means that we probably do not receive actual documents from the companies we back with our money. Such accounts have their uses, but are typical of the sloppy government and Stock Exchange thinking which has put in place a system which effectively divorces shareholders from their investments, depriving them of information, the chance to vote and speak at meetings, and much else.
In this instance, it is important that anyone who holds shares in MMI, or who might be thinking of buying some and you should - should make the effort to obtain a copy of the report and accounts. They should be available soon on the website at www.mmigroup.co.uk, but you can get a glossy copy via sites like www.ftannualreports.com.
You will simply have to take my word for what is in the report until you get it. But there are some remarkably confident comments. Perhaps the most eye-catching concerns Genvax, the companys 50% owned research project into DNA vaccines. It says Genvax has achieved a global first in DNA vaccines in a therapeutic clinical setting. (page 13)
Or maybe you might prefer a fragment from the smaller print a strong and targeted immune response against cancer has now been achieved. (page 13).
Or possibly Genvax is either working with, or is in discussions with, the major players in this field. (page 15)
Perhaps Several global leading pharmaceutical companies have recognised the importance of the Genvax breakthrough and discussions are ongoing. (page 15)
Maybe you would prefer We have shown that DNA vaccines can be made to work and this fact has been recognised by major pharmaceutical companies. (page 15)
Or what about progress with ruthenium in Oncosense, MMIs wholly-owned cancer therapy subsidiary? Try The data all indicates that ruthenium has the potential to be a blockbuster, or a series of blockbuster cancer therapies provided that this data is reproduced in the clinical trials. (page19)
Then there is the basic, wrap-around conclusion by Best I look forwardto seeing the full potential of MMI being realised as we stand poised on the edge of a new era for the company. (page 10)
Going through it, you might be tempted to conclude that this is a business which might be on the brink of creating several potential cures for cancer, and much else besides. That, you might think, could be extremely valuable. And you would be right.
There is much to digest in the long and detailed explanations of the various therapies on which the company is working, which is why you should read the report yourself. It has been produced not merely to help shareholders, but to introduce the business to a variety of audiences, and so sets out the complex progress of the science in a relatively simple way for most to follow.
At this point, it is important to point out that the information and comments in the report and accounts should be taken seriously. This is not some half-baked report put together with eyes closed, fingers crossed and a dash of good cheer after a good lunch.
It has had to withstand proper scrutiny by lawyers and accountants in an advisory team which demands proper legally-enforceable standards. MMI has just raised 10m by a share placing at 135p. That involved justifying every word, every line, way back to proving how and when the business was established, and producing the detailed research upon which every scientific conclusion was based. The directors who signed warranties are on the hook, liable to be sued for sums which amount to several times their salaries if they have not told the truth.
So when there is talk of a global first, or safer than , or promising results you can be sure there is proper evidence to justify such a statement.
When page three talks of an exciting portfolio of potential blockbusters, some of which are already showing promising clinical result and these have resulted in discussions with potential global marketing partners you can bet that chairman Best has been talking to the biggest names in the business.
Look around for those interested in vaccine development, and you will find people like GSK, Merck, Novartis/Chiron and Aventis. Please note, though, that the company has given no specific names and no deal has been concluded with any such people. It is possible that there will be no deal with anyone. But those are the sort of people who must be watching and some will be talking to MMI.
Both the DNA vaccines in Genvax and the ruthenium developments in Oncosense have attracted the main attention. My report Vaccine Action on September 2 spotlighted the growing interest from big pharma in vaccines.
The countless dire predictions of a bird flu pandemic have highlighted the importance of vaccines. If it happens, the world is likely to be left floundering. There are too few vaccines already made, too little world capacity to make more, and with each vaccine taking maybe nine months to create, the situation is not encouraging. It is 50 year-old technology, producing vaccines which might work half of the time.
That is why all of the big players are so interested in DNA vaccines. So far, most results have been disappointing. Until, that is, the global first achieved by Dr Freda Stevenson and the team at the University of Southampton. MMI owns half of this, rising to 58% over two years.
The way in which DNA vaccines work by injecting as protein found on the surface of tumours into the muscles of the patient is explained in the report. There is much about it in earlier reports in my archives.
Suffice it to say here that Professor Stevenson has achieved impressive results using tetanus toxin, which is strong enough to activate the human immune response system against cancer.
Trials in humans are being funded by cancer charities, and initial results were presented in March 2005. There are no toxic effects, and the side effects are mild flu-like symptoms which probably simply signify that the vaccine is working. None of the 25 patients suffering from follicular lymphoma in the initial trial have had to withdraw, and the vaccines have caused a significant and sustained elevation of immune factors, which in turn can be shown to have caused the cancer to remain in remission.
There are actually trials at three different centres. They involve many different factors and require an enormous amount of analysis. Not all results are in from all three centres. The tests are safe, and immune responses are good at low dosages. But dosages are being stepped up, and full efficacy results at higher dosages are not yet available.
The regulators link all trials, and have allowed two to go ahead in myeloma (cancer of the bone marrow). This involves treating healthy bone marrow donors. It is clear that progress is encouraging. Otherwise the regulator would not have allowed a second trial, or the involvement of healthy donors.
Lymphoma and myeloma both involve vaccines tailor-made to each patient. That creates some issues over manufacturing, but MMI believes these can be overcome.
A trial in men with prostate cancer has been under way since February 2005. It is progressing well, with no toxicity and low side effects. Crucially, it is possible to use an antigen common to most men, so we have pretty much a one size fits all solution, which does not require specific formulation for each patient.
There are relatively simple methods of measuring progress quickly. Medical ethics dictates that the company cannot publish results while further patients are still being recruited, but it appears that the tests are already being allowed to move to using a higher dosage. That would not be permitted if there were real problems.
Regulatory approval has been granted to start trials for colon cancer this month, again using an antigen which should be common to all sufferers. More trials for other solid tumours like lung and stomach cancer should start soon. Had there been any sign of problems thus far, the regulator would not have given permission.
In the annual report, MMI technical manager Mark Burton says that patents are being granted, and Genvax is working with or talking to, major players over the form of delivery mechanism which would allow the vaccines to be given to patients. And several global-leading pharmaceutical companies are in talks about the Genvax breakthrough.
As well as in tackling various forms of cancer, DNA vaccines also have applications in viral and bacterial infections. They are likely to be more effective with fewer side effects than traditional vaccines, and are cheaper and easier to make. Market potential is very significant and major pharmaceutical companies have recognised that Genvax has shown DNA vaccines can be made to work.
This is staggering stuff. It shows that, all being well, MMI could have block-buster products able to address multi-billion pound world markets. It is not there yet, but progress is encouraging.
At 138p, MMI is capitalised at 80m. Most of that is hope value hope that the current research will continue to succeed. Clearly it is impossible to rule out the chances of failure, but if all continues to go well, MMI could be worth many times the current value. And it is important to reflect that current Genvax trials are in human patients.
It is possible that Oncosense, the wholly-owned subsidiary developing ruthenium as a superior alternative to platinum in fighting cancer is worth even more than Genvax. Once again, it is important to recognise that there is many a slip, and ruthenium is not yet ready for market. It could all go wrong, but
Burton explains in the annual report that there are three different technologies aimed at the $40bn cancer therapy market. The potential drugs in development may be broadly compared to the market leading platinum based drugs cisplatin, carboplatin and oxaliplatin - in the mode of action and intended market. Laboratory data indicates that the ruthenium compounds have major advantages over platinum in terms of efficacy and safety along with lack of resistance and allergy.
Working with the team led by Professor Peter Sadler at the University of Edinburgh, the company has established a portfolio of some 8,000 compounds protected by a series of patents. Different compounds act against individual tumor types, raising the prospect of not one, but a while new class of cancer drugs.
There appears to be less resistance to ruthenium from some cancers, and fewer allergic reactions. Highly encouraging efficacy success with the lead ruthenium compound prompted the company to commission an independent test for certain toxicity. It appears that ruthenium is safer than tamoxifen, the leading breast cancer drug, which has been in use for decades.
Burton reports that the data all indicates ruthenium has the potential to be a blockbuster, or a series of blockbuster cancer therapies provided that this data is reproduced in the clinical trials.
Clinical trials are crucial, and a slightly sensitive issue. The company was promising to have ruthenium compounds in clinical trails before the end of this year. That is not likely to happen now. The target date is early next year.
It is important to understand this change of plan, which is what it is. It would have been possible to make small quantities of the lead compounds and to take them into clinical trials earlier this year. Instead it was decided to find a manufacturer who could make the compounds to the required standard on a commercial basis, and then to take them into the clinic.
This means that if the compounds are successful in the clinic, they could be marketed in the same form without the need for further development or re-testing. Inevitably, had small quantities passed clinical trials, a subsequent bigger production run would have had to be tested again so the current plan avoids duplication at the expense of some delay.
It also means that MMI can retain ownership of the manufacturing process, an important step in retaining more value. It has taken time to find a manufacturer not a big pharma name who can satisfy all of the MMI requirements, and who will ensure that there is no leakage of intellectual property or conflict of interest.
A decision on a manufacturer has been reached, and could be announced in the next few weeks.
Once all is signed, it should take 12 weeks to make two of the three lead compounds. A brief test period will follow, and the first two compounds could go into clinical trials early next year.
Ruthenium is related to platinum, and has many of the same characteristics. In some cases, it is 100 times more efficient. But because the general chemical qualities are already known, the possibility of unexpected problems is reduced though it still exists.
What next? Best remarks that the companys market value was 120m during the year, though it ha since fallen back. He believes there is a considerable way to go until the significant potential of the company is realised. Further clinical trials and licensing agreements should have an impact on this valuation.
He is not being rushed, nor is he a small company boss in pursuit of fast personal wealth. He and his wife, director Margaret Mitchell, still hold around 40% of the company. But in April 2004, they sold a chunk of the equity to M & G at 58p a share to realise 3.85m. The idea was not to cash in, but to bring in an important institutional shareholder. M & G (part of the Pru) had done plenty of homework and was excited by the prospects. M & G remains a large, supportive investor. That deal prompted me to recommend the shares at 67.5p (Best Bet, April 19, 2004).
Best has deliberately chosen no to rush ruthenium into the clinic, and instead consulted his bigger shareholders over how early he should conclude deals with big pharma.
He faced the classic small company dilemma. The earlier he went to a big company for backing, the greater the portion of future value that company would take. Yet holding on to advance the science and realise more value required extra cash.
In this case, Best and his advisers opted to go for final production quality on ruthenium, and keep full ownership of the product and the production method. That should eventually allow him to get a better deal from big pharma.
As official notifications come in probably this week it should become clear that the 10m fund-raising has attracted support from specialist bio-tech institutions. It appears that some would happily have subscribed for new shares at 175p, close to the price when talks started.
The way the City works can be cruel. MMI shares touched 300p briefly earlier this year, and were then hampered by a combination of short selling and an ill-informed note suggesting a ludicrously low value for the shares, written by an analyst who never took the trouble to talk with the company first. He later quietly corrected many of his errors.
That meant this latest funding has been done at a much lower price than might have been good news for the institutions who took the shares, but bad for small shareholders. The sheer burden of red tape time and cost stopped the company from offering the placing shares to all.
The price was reduced in the short term by the need to make insiders of all prospective buyers of the new shares. That meant all natural buyers were kept out of the market for three or four weeks. The price declined in the face of some rumoured short selling (never take such stories at face value), and the usual nasty nonsense where some institutions spread the word of a potential placing. Others sell short against the stock they might receive, thus making a quick profit and pushing down the price of the placing (and cost to them). Nasty, but all too predictable.
All of this is the trickier because MMI has modest revenues, and little in the way of a conventional asset backing. It has vast potential, but the current value can legitimately be debated and can be trashed by those either ignorant or setting out deliberately to mislead.
The success of the 10m placing with highly-informed investors at 135p makes a nonsense of the absurdly low analyst projection of value earlier in the year. Analyst Alex Isaac at Insinger de Beaufort has tentatively put a price of 275p on the shares.
That looks a modest target for those ready to gamble that the current progress- all properly authenticated in the report will continue. The report talks of discussions with potential global marketing partners, and Best mentions licensing agreements.
At this stage, he is unlikely to leap into bed with any of the pharma big boys. But he might be ready to contemplate licensing some of the technology for particular tasks perhaps applying it to a particular vaccine. That sort of thing might bring in an endorsement of sorts from a big name, plus extra cash.
The real game, though, is to hold on and to continue to develop the potential blockbusters for as long as possible. The further down the road to market, the greater the proof of efficacy, the greater the value MMI can retain. That does risk something going wrong, so you should never treat MMI shares as a sure thing but if progress continues as it has been going, then the numbers could eventually get very much bigger.
I hold shares in Medical Marketing.
Ends
Previous Stories
cheers Gf.
doughboy66
- 30 Oct 2005 09:33
- 1931 of 2444
Thanks goldfinger,i have become attached to these for personal as well as financial reasons.
I just hope Evil doesn`t get some inside information and get the chance to close his short if these really do take off ,which i`m sure they will !!
db66
goldfinger
- 30 Oct 2005 23:54
- 1932 of 2444
DB never ever become attached emotionally to a stock. Its the worst senario going.
Just a few words of experience. Dont mean to be hard or bossy but love and finance never ever go together. In fact enthusiasm and liquidity have an inverse relationship.
cheers GF.
mickeyskint
- 31 Oct 2005 10:29
- 1933 of 2444
It's the AGM on Wednesday so any good news and we could have a rise. EK is trying to kick the price down but is not having a lot of luck. I think his short must be going against him. Don't you just feel for him. Hang on to your shares.
MS
goldfinger
- 31 Oct 2005 22:35
- 1934 of 2444
Yup I think their could be good news but please lets not forget if there was concrete news a RNS would be out. So lets keep it cool for the moment.
cheers Gf.
bhunt1910
- 02 Nov 2005 11:14
- 1935 of 2444
Medical Marketing Int'l Group PLC
02 November 2005
Immediate Release 2 November 2005
MMI AGM UPDATE
At the Annual General Meeting of Medical Marketing International Group plc (AIM:
MMG), the Cambridge, UK-based pharmaceutical development company focussed on
cancer and infection, all resolutions were approved.
AGM Highlights:
Genvax
Approval to commence colon cancer clinical trial
Final lymphoma trial results expected December 2005
Myeloma and prostate cancer trials ongoing
DNA vaccine clinical trial for CMV (cytomegolovirus) ongoing
DNA vaccine for influenza in development
DNA vaccine for undisclosed bacterial infection in development.
DNA vaccines for pandemics - partner discussions ongoing
ncosense
SAFC pharma now manufacturing ruthenium for clinic
CXR Biosciences appointed to conduct final tests on GMP-grade ruthenium prior
to trials
Viratis
Further applications of ribozyme platform technology identified
David Best, Chairman of MMI Group commenting on these developments said:
'MMI now has a very strong and continuously progressing pipeline, strong patents
and the strongest balance sheet in its history. All these factors, coupled with
the discussions we are having with several major pharmaceutical companies means
that MMI is poised on the edge of a new and exciting era'.
For further information, please contact:
David Best - Chairman
MMI Group
mickeyskint
- 04 Nov 2005 16:06
- 1936 of 2444
Up 9% today, lets hope it continues, though don't expect any major announcements untill 06.
MS
mickeyskint
- 05 Nov 2005 11:51
- 1937 of 2444
Got this from the other side.
el magnifico - 4 Nov'05 - 18:26 - 6568 of 6575
In the Q&A after the AGM, Best noted that MMG was in discussions with "several major pharma" players (he specified that "several" meant more than three, but less than twelve), especially for the Genvax platform and associated anti-virals.
This was interesting, since in previous presentations Best has highlighted the maximum value creation of taking a product all the way through Phase II before partnering. So why talk to Pharma now ? His answer was that a surprising amount of discussions were initiated by the large pharmas knocking on MMG's door, rather than MMG seeking them out. He also suggested that "collaboration" at an earlier stage would be consistent with the model through Phase II, rather than any premature licensing deals which would surrender a good deal of the upside to the pharma name.
Also interesting was the "encouraging" progress of Genvax in the "universal" (as opposed to the "bespoke" ie patient-by-patient trials in lymphoma and myeloma) trial in prostate cancer trial, which commenced in Feb 2005. Here, results on active patients are "open-label" (ie results visible to the sponsors such as Cancer UK)and progressing to ever higher doseage levels, which suggests that the drug is well-tolerated. It was suggested that applications in colon, lung and stomach could soon be trial candidates, with the regulator already having approved a trial for colon cancer. This is not a narrow technology.
MMG has a patented DNA vaccine technology that works. This is revolutionary medicine. Add in ruthenium at Oncosense as a potential replacement for platinum-based cancer therapies and don't write off Viratis (which got a lot of play-time at the AGM for hepatitis as well as HIV)and you are effectively owning a portfolio of leading-edge compounds. MMG's business model, low-cost development of academic excellence) permits shareholders to participate in the tremendous upside.
After the AGM, there were no fireworks. Just as well. Fireworks are for the short term (and tomorrow night). Buy a postion in MMG and hold it.
el
mickeyskint
- 05 Nov 2005 11:58
- 1938 of 2444
This is a long document and a must read if you hold these. If you don't hold and still read the document how can you not afford to buy. The potential here is massive. I'm not ramping just read and make your own mind up. From the other side courtesy of Mike Walters.
049balt - 5 Nov'05 - 03:43 - 6574 of 6575
This was posted by Mike on the free section, on his site tonight.
The MMI Meeting
This is mostly an edited version of the presentation by MMI chairman David Best at the agm. It seems fair to make it available to all shareholders. If you reproduce it, or part of it, please attribute it to www.michaelwalters.com. It does not include comments on the statement posted on www.michaelwalters on Friday.
Are you worried about Medical Marketing International (MMG)? Do you wonder why I write so much about it?
Perhaps this will help any doubters to understand. It is not my work, merely a fairly lightly edited version of the presentation by chairman David Best at the annual meeting on November 2. Remember - any such statement from Best has to be verified by all sorts of advisers before he makes it. We are not talking top-of-the-head gossip here.
As suggested, he came up with no startling new announcement. That was always unlikely. But because a few had hoped there would be something, they have tossed out a few shares and the price has slipped a few pence since.
There can never be any guarantees with a company pushing at the frontiers of science like MMI, but the sceptics have completely misjudged the risk/reward balance here. If MMI gets just one of the present portfolio working, the potential is massive. Given the likely news flow as trials come along over the next 12 months, the downside is modest.
There might, too, be a pleasant and highly significant surprise on the upside if some of the possibilities relating to avian flu and DNA vaccines come good.
I may comment in more detail in the next few days. But David Best's presenetation - read the final sections especially carefully - says most of it. I have not reproduced the slides. But if you are interested in MMI - and the fight against cancer - you will want to read this long report in full. I hold shares in MMG.
Chairmans Report
Let me briefly explain the MMI business model: We do no raw
research ourselves, instead, we identify and acquire, from leading academic
organisations, world class technologies that have the potential to satisfy unmet needs in major therapeutic markets. We then manage the preclinical and early clinical developments and patent prosecution before licensing on to major pharmaceutical marketing partners. Our main focus is cancer and infection where there is massive unmet need. More details are in our annual report. Copies are available electronically from our website (www.mmigroup.co.uk) and from the free annual report services accessed from the London Stock Exchange web site on the Financial Times.
Cancer is now the most common form of death in the developed world. One in three
will get cancer and one in four will die of it. In the UK, over 270,000 people get cancer each year, and 155,000 die of it.
Its not all gloom and doom though as these charts show: Although breast cancer is
the single most common form of cancer, medical advances in recent years have
improved survival rates to around 80%. Prostate cancer is also very common,
affecting around 85% of men by the age of 85, most men will die with prostate cancer not of it.
Sadly this is not the case for some other cancers, especially lung cancer which
remains the single biggest killer and where survival rates have not improved. Colon cancer is also very common and there is still a need for better medicines. About two thirds of all cancer deaths are caused by lung; colon; prostate; oesophageal; pancreas;stomach; lymphoma; ovarian; myeloma; and melanoma; along with those cancers often caused by viral infection, that is, liver and cervical. These are the cancers that MMIs pipeline addresses.
Viral infection is also a major problem. HIV now infects around 40 million people. Over half of these are in Sub-Saharan Africa, with around 10 million in the developed world. Some estimate that the number will double
in the next ten years. AIDS is a medical and humanitarian disaster but the hepatitis problem is many times bigger. There are over two billion people infected with hepatitis worldwide.
Pandemics such as influenza, SARS and bird flu are in the headlines too.
As well as viral infections such as AIDS and hepatitis, bacterial infections have not gone away. The emergence of antibiotic-resistant strains such as MRSA, and TB is well documented.
These are the viruses and bacteria that MMIs pipeline is focused on. So lets look at that pipeline and see how we have added to it during the last year:
In Genvax, we licensed in, on a worldwide exclusive basis, what Cancer Research UK and the Leukaemia Research Fund described as their Flagship technology.
Cancer charities are continuing to fund several clinical trials with the Genvax DNA vaccine technologies and we are working in collaboration with scientists at
Southampton University to develop these.
Our Oncosense subsidiary exercised an option over further promising ruthenium
compounds which emerged from our collaboration with Edinburgh University, we
further extended that collaboration and in addition, Dr James Hoeschele, the inventor of Carboplatin, the market leading cancer drug, joined our team in Edinburgh to carry out highly specialised radio- labelling work.
Viratis, our anti- viral subsidiary, extended its agreement with Kings and Queen Mary colleges in London to add a hepatitis ribozyme to the existing HIV/AIDS one. Viratis also licensed an immune sponge technology from the same colleges. This has applications in rheumatoid arthritis, asthma and other immune disorders. A further collaboration with Kings College, to develop delivery mechanisms, is underway. The supply side of MMIs business model is working well.
During the past year, Genvax achieved nothing less than a global first. Immunology is a highly complex subject, but in the simplest of terms, Genvax DNA vaccines used in sick patients were able to stimulate a powerful response in both parts of the immune system, the antibody response and the cellular response. There are several cancer therapies in development that stimulate an antibody response, however, creating a significant and sustained stimulation of the heavy guns of the immune system, the cytotoxic T lymphocytes or CTLs, had proved elusive, until now!
Similarly, other DNA vaccines in development often cause an initial boost to the
immune system, but the effects of repeated vaccination have been disappointing. Not with the Genvax vaccines. This is a highly complex subject. If shareholders want to discuss this after todays meeting, please telephone or e-mail your queries. We would be delighted to explain.
Preliminary results for a trial in patients with lymphoma were reported to the Second International Conference on DNA Vaccines in March this year. A two-pronged trial in bone marrow cancer, or myeloma, continued to be promising and the first nonbespoke vaccine trial, this time for prostate cancer began in February.
Three major patents for the Genvax technology also granted during the year. Patents in DNA vaccines are almost as confusing as immunology itself. Not surprisingly, some commentators did get confused.
To avoid any more confusion, this is what one of the US granted patents for DNA
vaccines looks like. Here is the original document, potentially worth more than its weight in gold.
Now the science bit. On the left, we see the Genvax DNA vaccine cassette for cancer. This is the appropriate cancer antigen fused to a fragment of tetanus toxin. When the patient receives the vaccine, the immune system thinks it is dealing with tetanus, one of the most powerful immunostimulants. This causes the patients immune system to mount a massive immune response, both antibody and CTLs, and these deal with the cancer. Bespoke Genvax DNA vaccines are appropriate for cancers such as lymphoma and myeloma. Universal Genvax DNA vaccines are suitable for epithelial cancers such as prostate, colon, lung, and stomach.
The Genvax vaccines can, and have been, constructed to deal with viral and bacterial infections too. The market potential for this Genvax platform technology therefore covers not only cancer but viral and bacterial infection too. Now with clinical proof-of-concept, the Genvax vaccines have very significant potential.
It is not ethically acceptable to report on an ongoing clinical trial as that might bias the results. What we can say to-date is as follows:
In a multi-centre, UK, open label, dose escalating trial of 25 patients with lymphoma, which began in 2001 and ended in 2004, there were no toxic effects reported. There were only mild side effects with no patient having to be withdrawn from the trial. The majority of the patients gave an immunological response to the vaccine.
We can confirm this by using a sophisticated technique that measures the levels of various immune factors and blood cells in blood samples taken before and after each course of vaccinations. This work is very time consuming and so far, only some of the samples taken from the Southampton patients have had this detailed analysis, and it was these results that were reported earlier this year. The results clearly show that the Genvax DNA vaccines were indeed causing a powerful and sustained immune response in both parts of the immune system. The remaining blood samples should be analysed by the end of the year and the overall results will then be released.
As the myeloma and prostate cancer trials are ongoing, we cannot comment other than to say that they are progressing and patients continue to be recruited at escalating dose levels. It is reasonable to assume from this that there have been no serious negative events and that the trials are progressing well. It is also important to note that the prostate cancer vaccine is a universal vaccine not a bespoke one like the lymphoma and myeloma ones. Regulatory approval for the colon cancer vaccine trial has now been given and recruitment has begun.
The criteria for this trial mean that patients may not only be given the vaccine following both surgery and chemotherapy, they may also be given it immediately after surgery alone. Other trials are due to begin soon.
There are three groups of potential therapies in our Oncosense subsidiary, ones based on the precious metal ruthenium, on pineapple proteases and the enzyme
endosialidase, which may be helpful in preventing secondary tumours. There is only time to talk about ruthenium today.
Ruthenium is a precious metal similar to platinum. We attach various side chains
known as arene rings, along with other side chains or ligands. The various
combinations of all these give us around 8,000 compounds protected by granted
patents. Here are a few early compounds, but these are not the ones heading for the clinic.
We have shown in laboratory tests that our ruthenium compounds are much more
effective than the market leading drugs based on platinum. Independent tests have also shown that they are not only less toxic than the platinum drugs but remarkably, even safer than tamoxifen, a well known drug for breast cancer, which is so safe, it can even be given to prevent breast cancer.
We have also shown that different ruthenium compounds have different activities
against different tumours, raising the prospect that we have not one, but a whole new class of cancer drugs.
Patents have now granted in the biggest markets and we have now selected three lead candidates that will go forward to clinical trials. If the clinical trials results are in line with the laboratory ones, then we have a blockbuster or series of blockbuster drugs.
The ruthenium inventor, Professor Peter Sadler from Edinburgh, has been elected to the Royal Society in recognition of his work.
This slide shows how ruthenium compares to the market- leading platinum based
drugs: Ruthenium appears to be active against a broader range of cancers than is seen with platinum ones. There are 3 platinum drugs available and we have some 8,000 ruthenium compounds covered by the patents, we have synthesised over 100, and selected around 15 compounds of particular interest.
Several cancers are resistant to platinum, but those same tumours are not resistant to ruthenium. Platinum drugs, especially cisplatin, are highly toxic. In independent laboratory tests we have been unable to show liver toxicities at likely therapeutic dosages. (MW note - this suggests a high degree of safety - tests have not revealed any damage at likely dosage levels).
Patents on the platinum drugs have mostly expired so these are now generic drugs
whereas patents on ruthenium have only just granted.Although the platinum drugs are widely used because they are effective, in most cases, the ruthenium equivalents are more, or much more effective.
Platinum once injected rapidly binds to blood; therefore less free drug is available to do its job. The ruthenium compounds tested so far are only slightly bound to blood so more free drug is available.
Around 10-15% of patients are allergic to platinum and have to be taken off it. Those manufacturing platinum can also become sensitised to it. Although ruthenium is used in industry, there are no reports of sensitisation.
Even though the platinum drugs have been available for many years, their mode of
action is still not fully understood. Professor Sadler and our team have learned a lot about how ruthenium works and therefore we can design ruthenium compounds more effectively.
Obviously the platinum drugs gained regulatory approval many years ago. The
regulatory pathway for ruthenium is equally clear so we know exactly what we have to do to get approval. The potential for rapid approval means that we have a long product lifecycle of a patented drug.
So far, ruthenium appears to be potentially better than platinum on every count. If we get the same results in the clinical trials then it is likely that ruthenium will become a major new class of cancer drugs with multi billion $ potential.
This slide shows the results of the industry-standard efficacy test for cancer drugs know as the IC50. This simply means how much drug is needed to kill half the human cancer cells growing in a laboratory dish under carefully controlled conditions.
We buy in human cancer cell lines from the European Reference Library. These are
grown up in our Cambridge tissue culture laboratory and then treated with either one of the three platinum drugs or one of our ruthenium ones. The amount needed to kill half the cells is recorded, the lower the number, the more effective the drug.
A figure of 100 means that the drug does not effectively kill that cancer cell- line. So, in column one, Carboplatin is not effective against colon cancer. The most effective platinum drug against colon cancer is cisplatin, but our ruthenium one is nearly 5 times more effective. Ruthenium gives better results in all the major cancer types. In lung cancer, ruthenium is nearly 14 times more effective than cisplatin. It must be noted hear that cisplatin is highly toxic so carboplatin may be used. If that is the case, ruthenium is nearly 100 times more effective in lung cancer. You will recall that lung cancer is the biggest killer of all, and all the cancers shown in this chart are difficult to treat, and yet ruthenium is more effective on every one.
Viruses like AIDS enter a human cell by attaching themselves to two receptors that are formed as a result of various chemical messages known as RNA. The Viratis ribozyme is an enzyme that destroys the RNA message that is responsible for creating the receptors. No receptors, no virus gets in the cell.
How does the Viratis ribozyme compare with the standard treatment for AIDS known
as HAART or Triple Therapy, and how does it compare to the newer drugs that also
try to block the entry of the AIDS virus into the human cell?
Laboratory data shows that our ribozyme is effective and the design of it suggests that toxicity is unlikely. As the ribozyme prevents the virus from entering the cell, the virus is unable to replicate and therefore resistance too is unlikely.
HAART patents are coming toward their end of their life, whereas the Viratis ones have only granted recently. We know that HAART and the newer drugs are unpleasant, so patients often give up. Obviously we have no clinical data yet.
HAART targets many sites on the virus and this may be why the side effects are
unpleasant. The Viratis ribozyme is specific to the two receptors that are necessary for cellular entry.
Most biological drugs need a delivery mechanism and we are working on several
developments here. Although Viratis is at an earlier stage than either the Genvax vaccines or ruthenium, the market potential is clearly significant.
We now know the ribozyme technology will also apply to hepatitis B.
During the year we added the immune sponge technologies, which, although at an
early stage, appear to have potential in treating diseases like rheumatoid arthritis and asthma. Further Viratis patents were also granted during the year.
Despite all that activity, we kept tight control on costs and also maintained income from our service activities. Overall, we ended the year with no bank borrowings and a 49% increase in cash.
MMIs objective is to add shareholder value through drug development. We did a lot of drug development during the year and the growth in the value of the Company reflected that.
Last year I said that we had an exciting year ahead, and so it was. Lots more
happened. We believe that the coming year will be even more exciting and we have some very ambitious plans.
With those plans in mind, in early September we discussed the strategic options with our major institutional shareholders. They were, like us, unanimously of the view that it would be in the best interests of shareholders to raise funds to take our products higher up the value curve rather than licensing them to pharmaceutical companies now.
All our existing institutional shareholders at least maintained their percentage
shareholding and several significantly increased their stakes. Major new institutional shareholders supported the placing, which at 10 million, is more than MMI hasraised in its entire history and is sufficient to carry out our ambitious plans.
The 10 million will be used mainly to expedite the current Genvax trials results analysis, and expand the trials programme. Additional staff has already been recruited to work in the Genvax team at Southampton. The funds will also be used to develop the commercial manufacturing process, including the one for the bespoke vaccines.
We have already entered into an agreement with Sigma-Aldrich who are now three
weeks into a 12 week programme to manufacture commercial grade ruthenium for
clinical trials. This is being done in their state-of-the-art, FDA approved facility in Maddison, Wisconsin, USA. Under this agreement, we maintain ownership of everything and this is extremely useful in negotiations with pharmaceutical marketing partners. It also means that shareholders continue to own the full potential of ruthenium.
As soon as we have manufactured products, we will complete the final safety tests and begin clinical trials.
The funds will also be used to develop and test delivery mechanisms for our Viratis anti-viral ribozymes.
Its useful having the strongest balance sheet in our entire history at this stage of our discussions with major pharmaceutical companies, and it is also useful having a little spare just in case one of the several new technologies we are evaluating appears to be another potential blockbuster.
This (MW note. slide not reproduced here) update of the clinical status of our therapeutic pipeline shows a few surprises!
The first Genvax anti- viral DNA vaccine for the CMV virus is already in the clinic. This is part of the myeloma trial where the objective is to prevent the bone marrows from healthy volunteers becoming infected with this virus that can be fatal to the bone marrow recipient whose immune system is at that time, ineffective.
There is already some preclinical data on a DNA vaccine for influenza and some
preclinical data on a DNA vaccine for a serious bacterial infection that we cannot identify for commercial reasons.
The MMI therapeutic pipeline, especially for cancer, is now as good as those of some major pharmaceutical companies.
The final part of the MMI business model is to gain the endorsement of global
pharmaceutical marketing partners. They are only interested in products with
competitive profiles and blockbuster potential. They need to see convincing clinical data and also require granted patents in major territories.
We are currently in discussions with several of the worlds biggest pharmaceutical companies who recognise the potential within our pipeline. Obviously, as Genvax DNA vaccines are the most advanced of our products, with five clinical trials ongoing, then this is the main focus of these discussions. A number of those companies have acknowledged that Professor Stevensons work is of global significance. A number of discussions are on a much broader front than Genvax alone.
In Viratis, we believe it will be possible to extend the ribozyme technology to a number of additional viral infections beyond the current AIDS and hepatitis B ones. This may be another platform technology.
Following the recent appointment of Sigma-Aldrich who are right now manufacturing the first 3 ruthenium compounds for clinical trials, I can also confirm that we have now appointed CXR Biosciences to carry out some of the final preclinical tests on these products enabling them to go forward into clinical trials.
Lastly, given all the recent publicity about pandemics, we are in discussions with a number of parties concerning the possibility of using the clinically-proven Genvax DNA vaccine technology to overcome the manufacturing issues with conventional vaccines for certain infectious diseases.
If the results of the Genvax clinical trials continue to be successful;
If just one of the 8,000 ruthenium compounds is as effective and safe in the clinic as it is in the lab;
If just one of the Viratis ribozyme platform is successful;
Then we will make a real difference to patients with cancer or infectious diseases. If any one of these milestones is achieved, if we reach agreement with just one of the global pharmaceutical companies that we are in discussions with; Then it will transform your company.
Thank you.