OK so you thought the title of the other thread was out of date BUT unfortunately there is no way to edit thread titles.

So here is a new title

This one has got the charts at the top again & has a link to the old one.
http://www.moneyam.com/InvestorsRoom/posts.php?tid=5021

ProSavin Phase I/II Update
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TIDMOXB

RNS Number : 3956Y

Oxford Biomedica PLC

22 December 2010

OXFORD BIOMEDICA ANNOUNCES UPDATE ON PROSAVIN(R) PHASE I/II STUDY IN PARKINSON'S DISEASE

-- Encouraging third cohort results using enhanced administration technique --

-- Data Monitoring Committee supports progression to 5x dose in Q1 2011 --

Oxford, UK - 22 December 2010: Oxford BioMedica plc ("Oxford BioMedica" or "the Company") (LSE: OXB), a leading gene therapy company, announces new data from the on-going Phase I/II trial of ProSavin(R) for the treatment of Parkinson's disease (PD). Three-month data from the third patient cohort show that ProSavin(R) continues to be safe and well-tolerated following treatment with a 2x dose using an enhanced administration technique developed by the Company. The enhanced technique has been shown to reduce the surgical delivery time, will facilitate higher dosing and has the potential to provide better reproducibility of administration as study centres expand.

By way of background, the current Phase I/II study is designed to assess the safety, efficacy and dose evaluation of ProSavin(R) in patients with mid-stage PD who are experiencing reduced benefit on L-DOPA "equivalent" therapy. To date, nine patients have been treated in cohorts of three. In June 2010, Oxford BioMedica reported 24-month results from the first cohort which received a 1x dose of ProSavin(R), in addition to 12-month results from the second cohort which received a 2x dose of ProSavin(R). Motor function is assessed according to the Unified Parkinson's Disease Rating Score (UPDRS) in patients' "OFF" state (i.e. after withdrawal of PD medication). Quality of life is assessed based on a standard measure of clinical benefit using a patient questionnaire known as PDQ-39. Patients from the third cohort who received a 2x dose of ProSavin(R) using the Company's enhanced administration technique have now reached their three-month assessment:

Highlights of third cohort at three months (2x dose, enhanced administration)

-- Favourable safety profile with no serious adverse events related to ProSavin(R) or the enhanced administration technique;

-- Average motor function improvement of 26%, consistent with 28% improvement using the old administration technique at the 2x dose, with a maximum of 52% improvement in one patient;

-- All three patients show improvements in at least one indicator of clinical benefit; and

-- Surgery delivery time for the 2x dose reduced by approximately 50%.

Highlights across all treatment cohorts (total of nine patients)

-- Patient diary data show an increase in "ON" time (when PD symptoms are not present) in all three cohorts;

-- L-DOPA "equivalent" therapy has either reduced or remained stable in all three cohorts, in what is usually a progressively degenerative disease requiring an increase in dose;

-- Quality of life has either improved or remained stable in all three cohorts, again where it would usually be expected to worsen; and

-- ProSavin(R) continues to have a favourable safety profile 30 months post-treatment (1x dose) and 18 months post-treatment (2x dose);

- As previously reported, 1x dose data showed average motor function improvement of 20% at 24-months (with a maximum of 30% in one patient) and 2x dose data showed average motor function improvement of 29% at 12-months (with a maximum of 56% in one patient).

The study's independent Data Monitoring Committee (DMC) has reviewed the data and supports the Company's proposal to proceed to a 5x dose, facilitated by the enhanced administration technique, in a six-patient cohort. Importantly, the 5x human dose is the allometrically-scaled equivalent (i.e. a dose that is scaled for the difference in brain size between humans and the pre-clinical model) to the highly efficacious pre-clinical dose published in Jarraya et al. Sci Transl Med. 2009 Oct 14;1(2). The DMC also gave its approval to open the second site in the UK at Addenbrookes Hospital, Cambridge, with Dr Roger Barker as Principal Investigator, which will recruit some of the six patients into the 5x dose cohort.

Oxford BioMedica plans to initiate treatment of the 5x dose cohort in Q1 2011. To date, nine patients have been treated at the Henri Mondor Hospital, Paris, with Professor Stephane Palfi as Principal Investigator. The first patient in the 5x dose cohort will be treated in Paris, one month after which subsequent patients can be treated in parallel at both sites which is expected to increase the rate of recruitment and treatment. Results from the first three patients in the 5x dose cohort are expected in mid-2011. Depending on the efficacy seen with the 5x dose, a Phase II trial of ProSavin(R) could be initiated in the EU/US in 2012 and planning is underway for this stage of the development programme.

Commenting on the nine patients treated, Professor Stephane Palfi said: "The safety of the new administration method and the continued safety profile of ProSavin(R) are both very favourable and the data from the earlier cohorts provide encouraging signs of long-term benefit. We can now be confident to administer ProSavin(R) at a dose which showed the best benefit in a severe pre-clinical model of Parkinson's disease."

John Dawson, Chief Executive Officer of Oxford BioMedica, said: "This first-in-man Phase I/II study is an appropriately cautious approach to a potentially revolutionary treatment for Parkinson's disease. With the excellent safety profile and sustained, positive signs of clinical benefit we have seen at the lower doses, we are confident that progressing ProSavin(R) to the 5x dose could further enhance efficacy and therefore significantly increase the product's value. We are making the necessary preparations to advance ProSavin(R) into Phase II development as rapidly as possible including site expansion, regulatory guidance and manufacturing and we look forward to continuing our discussions with potential partners as we generate more data from this increasingly valuable asset."

Im know medical expertbut these points seem to be crucial and exciting

-- Encouraging third cohort results using enhanced administration technique --

-- Data Monitoring Committee supports progression to 5x dose in Q1 2011 --


-- Quality of life has either improved or remained stable in all three cohorts, again where it would usually be expected to worsen; and

-- ProSavin(R) continues to have a favourable safety profile 30 months post-treatment (1x dose) and 18 months post-treatment (2x dose);



First bit of good news

This announcement seems to be a good way of insuring complete take up of Open Offer well prior to deadline. I remain optimistic for this small innovative British Company - 2011 will it seems see them hit the headlines for good reasons.

Posted by a guy on another BBI have copy and paste this up as it echos my view exactlyalthough OXB is still a risky puntthe current price could make it a very nice earner:-


"Well, we are where we are!

I havent posted anything since the placing 13-12-10, I didnt want to post anything until I knew what today RNS had in it.

I thought the Placing was going to happen from talking to the company (just inference not a direct statement).
But I didnt think it was going to happen until the New Year and I would have expected them to at least tried to raise the share price by any means available eg concerted PR campaign etc.
Some I know (on this board) got out just before the dirty deed was done, and to them I say well done, I would have myself if Id read it correctly, but sadly I was fully loaded.

Although I have a portfolio of shares and other investments I have over the years developed a far too heavy weighting towards Biomedica shares, but for the following reasons (God help me) Im going to take up all my options AND a big chuck of the additional offering (subject to share price immediately before committing):-

Ive had lengthy discussion with some of the directors and Lara (who deserves a medal she seems to be contacting everyone).
I do believe them when they say that they had gone over and over the timing of the placing in the end it got taken a little out of their hands but I dont think it was far away from happening anyway. They firmly believe that the market would not have taken them seriously next Aug/Sept/Oct when they would have to have done it anyway. They also firmly believe that negotiating the Prosavin deal next summer would have been made extremely difficult with only 5 to 6 months money left.
I personally was never told that there was a Prosavin deal on table.
So the poultry amount raised was really out of their hands (apart from perhaps the above mentioned PR campaign).

I mentioned above todays RNS, well my biggest fear was delay (however, fear of slippage will always be with us), I was concerned that the placing timing might have been because the 2X infusion result nowhere near as good as the injected method. I also feared that go ahead for 5X infusion would get delayed. This, if it was 4 to 5 months (which is not unheard of for OXB), would seriously have depleted most of the gains of the placement.
So todays RNS has settled those immediate fears, I have also discussed these results and they havent given any signs that there are any worries for us once the detail is revealed.

Next is the biggest shock the manufacturing facility, which I really couldnt work out. As weve all thought and read on here this seems like a massive mistake when youre strapped for cash. Having spoken to Biomedica the biggest clinchers for me are (least import first) 1) We get more of the Prosavin action 2) Sanofi want OXB to mange the optical manufacturing 3) it will guarantee manufacturing and stop delays AND most importantly 4) It makes economic sense !! I hadnt realised the manufacturing costs for the Lentivector products are so high, it will pay for itself very quickly.

Sanofi Optical products. They talk about this as if it a now a given and just a formality. I think this is foolish but you cant get more positive than that.

Trovax. I still believe this could be massive, and Im glad that they think so also. Apparently Provenge has increased dramatically the interest in Trovax."

Have only skimmed through some of the posts, but any would be investor should remember that only a small percentage of development drugs reach commercial sale, less than 10% springs to mind. Sanofi hasn't even reached Stage 3 yet so an awful long way to go. I doubt OXB have sufficient funds to see it through and will have to come back to the Market for more cash.

The returns on Bios can be remarkable but so few actually reach commerciality, most crash and burn, AZM a most recent example.

Peteronly a small percentage of development drugs reach commercial sale, less than 10% springs to mind

I cannot find that statistic at any of these levelsPhase 1 trials Phase 2 trials Phase 3 trials Phase 3 Randomisationalso you say:-


Sanofi hasn't even reached Stage 3 yet so an awful long way to go

Please expand on that statement...it doesnt make sense...

FWIW if they were being "Taken Out" then the same leaking mechanism would have started to ramp up the sp. That they are committed to selling shares (subject s-app), means there is no news for the "forseeable future".

Furthermore I don't see a BigBio taking them out too soon - they will have plenty of opp. in the past....as soon as Sanofi waved goodbye, leaving a fat cheque (for example).
The truth is OXB isn't going anywhere fast; but that's not the reason I'm investing - I think it is the best prospect at 5p I can find.

I'll agree they are taking their time about it, but they report RNS as and when - - - I get the impressioopn this is an honest Research Bio.
PS If tabasco sold out weeks ago, what's the problem? - although I'll admit I thought it was within hours of the Ann. but maybe that's "not reading" his words, rather scanning for the sense and wrongly concluding I thought he was lucky (shall we say?).. Look at the sp fall and it seems V.many had advance warning - something that the City fails to fix . . . . could it be there are too many at it? I missed the Newspaper comment entirely.
I'm posting the cheque today . . . . deadline is 1st wk in Jan11.
Good luck, I hope to show a sm profit soon- reads: I'm av. dn..

PS Yes that figure 90% fail...read are not funded through to commercialisation. The costs ramp-up going thro' Phase Trials, so weeding out early is Good....in the case of OXB they have some newer products, but somehow have failed to get something to sell. I liked PTI(Protherics) for that reason...a regular income. "Research" can become a purpose in its own right, whereas investors want Products flying off the shelves, even if it's nail-cure.
The biggest worry is that someone else finds an equally-good cure, then the Q is "Is it worth the risk" = to topple the early-bird?

Apologies - a mistype, should have read:

Prosavin does not appear to have reached Phase 2:

"Depending on the efficacy seen with the 5x dose, a Phase II trial of ProSavin(R) could be initiated in the EU/US in 2012 and planning is underway for this stage of the development programme"

Full Explanation of Clinical Trials

The 90% failure of drugs not reaching commercial proportions was something I stumbled upon whilst invested in a company called CeNeS (which turned out to be an unmitigated disaster). CeNeS did actually reach Phase 3 successfully, but having retunred to the market so many times for additional funds, they ran out of options and were eventually absorbed by a major. It costs somewhere in the region of $1Billion from original concept to appearance on the shelves in your local chemist, which explains why so many of these R&D minnows disappear or are taken over. In the meantime, your original investment is diluted so many times it becomes pratically worthless.

(And if you're wondering why I have responded Tabby, as it is the season of goodwill, you've become unsquleched - Happy Xmas).

Peterthanks for the replyand a merry xmas to you and your family

As I have said on several occasionmy re-investment in oxb is a complete punt whilst riskyI believe the upside from this point is favourite what clinched it for me.. was Sanofi and the manufacturing facilitythis seems madness when buying time and fighting for your lifebut

What if Sanofi had already had a quite word and gave reassurances?what if a deal is already done?We know Sanofi want OXB to manage the optical manufacturingthis ties in with Oxb confidence in only setting a few mil aside to fund the business
Dont forget this additional cash will fund the purchase of the manufacturing facility beyond Sanofi Aventiss option to license one or more of the ocular programmesthis is a done dealand would trigger double-digit $million payments
That is what we know.how about what we dont know?

Sorry Hangonjust read your postcould the first leaking mechanism have been to deter pis from taking up the offer?Would that leave Sanofi doing oxb a big favour and buying a shed load?if Sanofi has already offered oxb and the bods a healthy futuredo you think the bod would worry if the SP was low when an offer for the company came in?no more worries for the bodpis ecstatic with 25p or moreand Sanofi having it off on the cheapeveryones a winner Rodney!

I hope the bod would think their collective efforts are worth more than 25p
In general, but not set in stone:
I will only buy Plus below 25p, AIM below 50p and FTSE below 1 (other than FTSE100, which have a dividend history, etc.)
Indeed Plus is now off my list, their business model is "self,self" with little regard IMHO to we investors - just look at the rag-bag (can I say that?) of co's that are attracted there. I find making a profit very unlikely.(rant over!).
Now, OXB is fully-listed, ISA-able and presumably fully compliant with FTSE Rules, etc. This is not a toy pharma ( if their "Future" is to believed). Even 50p would not reflect their future value, but probably close "now" with much to prove.
An example of a Toy-Pharma is PY- (you can guess), with their SP graph, Boo-Hoo = lost a lot I did.BTW I read in the FT, the "reason" for OXB fundraising was to exert more "clout" when negotiating a Partner-Deal in 2011 - This makes sense, esp. as the UK"ecomomy" doesn't appear to be turning round too quickly. i.e. do it "now" - it's just a pity PI's have been shafted as usual, in the short-term, anyway.

+What really amazes me is the FTSE100-level is nearly 6000. Wow and BP isn't paying a Divi and many Retailer may have (Snow) sob-stories to tell- and industry also, I suspect (Blame it on the Weather!)....

t
re your post1329 "posted my sale" where?you are so good at providing evidence and building up proof this shouldnt be too dificult a question for you to answer.
thanks
regards
jkd

JKDI would normally tell someone with your unrefined manner to whistle into the mistralbut having answers seems to piss you off moremerry xmas!


Dil- 19 Oct 2010 12:16 - 36 of 222
Can I take it you've joined me then tabby ?
tabasco - 19 Oct 2010 13:57 - 37 of 222
Might have?
Dil- 19 Oct 2010 15:13 - 38 of 222
Nice and cosy here ... just you and me.
tabasco - 12 Dec 2010 23:07 - 1305 of 1341
Sold of my holding to finance avn.

Reference **********

Date 18/10/10

Time 16:17

Settlement Date 21/10/10

User *******


Type Stock Quantity Price GBP Consideration

SELL Oxford Biomedica Ordinary 1p 400,000 0.09134 GBP 36,536.00


Status Executed

Oxford BioMedica gains on positive ProSavin data
UK News | December 23, 2010
Selina McKee

Shares in Oxford BioMedica were on the rise yesterday after it announced encouraging data from a Phase I/II trials of ProSavin, backing earlier findings indicating that the drug is safe and effective in patients with Parkinson's disease.

One of the companys flagship candidates, ProSavin is administered directly into the brain to deliver the genes for three enzymes - AADC (aromatic amino acid decarboxylase), TH (tyrosine hydroxylase) and CH1 (GTP-cyclohydrolase 1) - that transform certain cells into ones able to produce the neurotransmitter dopamine. Parkinsons disease is characterised by the degeneration of cells that produce dopamine, and so the drug is designed to replenish stock in patients with the illness and thereby reverse some of the associated symptoms.

The drug has performed well in clinical trials to date, and these latest three-month data - from a third patient cohort of the ongoing Phase I/II study - show ProSavin to be safe and well-tolerated following treatment with a 2x dose of the drug, delivered using a new enhanced administration technique developed by the firm to cut the surgical delivery time and facilitate higher dosing.

Aside from adding weight to ProSavin's safety profile, the results also show an average motor function improvement of 26%, which is consistent with 28% improvement using the old administration technique at the 2x dose, the group said, and noted that all three patients showed improvements in at least one indicator of clinical benefit.

Going forward, an independent Data Monitoring Committee is supporting the firm's plans to test a 5x dose of the drug via its enhanced administration technique in a six-patient cohort, which it intends to kick off sometime during the first quarter of 2011, and has also given the green light for a second site in the UK at Addenbrookes Hospital, Cambridge.

"With the excellent safety profile and sustained, positive signs of clinical benefit we have seen at the lower doses, we are confident that progressing ProSavin to the 5x dose could further enhance efficacy and therefore significantly increase the products value," commented Oxford BioMedica's chief executive John Dawson.

http://www.pharmatimes.com/Article/10-12-23/Oxford_BioMedica_gains_on_positive_ProSavin_data.aspx

Jkd.I will except your apology any timenight daymakes no difference to me? Have a look at the SP 1st Feb. see if the luck is still holding
I dont do rampingbut a fun guess is 7phappy new year all
Regards
Tabasco

t
all that your other recent posts have done, is to confirm the points i made in my posts 1319 & 1341.the holes are still there for all who are interested but i aint telling where. anyway they are sooo obviuos i shouldnt need to, so do yourself a favour and stop digging.
happy new year
regards
jkd

Jkd.I asked you to put up or shut upas per usual you are incapable of eitherfrom the way you writeI guess you must be 70 something.thats a good age for a guy yet to reach pubertythe guys that read this thread are not interested about you views or riddles on the saucy one they want to make money
If you care to start a I dislike Tabasco threadI would be more than happy to contribute in my own satirical waynow run alongdouble up on your Complanand try and find something constructive to doas opposed to something disruptivemake your wife a cup of teaby christ she deserves one
Regards
T

OXFORD BIOMEDICA PLC

RESULTS OF FIRM PLACING AND PLACING AND OPEN OFFER

On 13 December 2010, the Board of Oxford BioMedica plc (the "Company" or "Oxford BioMedica") announced details of a proposed share issue to raise gross proceeds of GBP20 million (GBP18.4 million net of expenses) by way of a firm placing of 278,916,543 new ordinary shares of 1 pence each (the "New Ordinary Shares") (the "Firm Placing") and a placing and open offer of up to 121,083,457 New Ordinary Shares (the "Placing and Open Offer)" at a price of 5 pence per New Ordinary Share.

Defined terms used in this announcement shall have the same meaning as those terms defined and used in the prospectus of the Company dated 13 December 2010.

The Open Offer closed for acceptances at 11.00 a.m. on 6 January 2011. At that time the Company had received valid acceptances in respect of 115,756,980 Open Offer Shares from Qualifying Shareholders. This represents approximately 95.6 per cent. of the Open Offer Shares offered. All eligible applications received from Qualifying Shareholders will be allocated their pre-emption entitlements and all eligible applications under the Excess Application Facility will be allocated their Open Offer Shares as applied for.

The Firm Placing and Placing and Open Offer remain conditional, amongst other things, upon the passing of the Resolutions at the General Meeting to be held at 10.00 a.m. on 7 January 2011 and Admission occurring no later than 8.00 a.m. on 10 January 2011 or such later time or date as the parties to the Placing Agreement may determine.

Application has been made to the UK Listing Authority for the New Ordinary Shares to be admitted to the premium segment of the Official List and to the London Stock Exchange for the New Ordinary Shares to be admitted to trading on the London Stock Exchange's main market for listed securities. It is expected that Admission will become effective on 10 January 2011 and that dealings in the New Ordinary Shares will commence at 8.00 a.m. on 10 January 2011. Thereafter, Oxford BioMedica will have a total of 944,875,557 Ordinary Shares in issue.

The New Ordinary Shares, when issued and fully paid will rank equally in all respects with the Existing Ordinary Shares.

This announcement should be read in conjunction with the full text of the Prospectus. A copy of the Prospectus is available at the UKLA's National Storage Mechanism and will be available for inspection at www.hemscott.com. In addition, the Prospectus is available to view on the Company's website (www.oxfordbiomedica.co.uk). Copies of the Prospectus are also available from the offices of Oxford BioMedica plc, Medawar Centre, Robert Robinson Avenue, The Oxford Science Park, Oxford, OX4 4GA.

A good report back from a ADV.. poster.. that was at the meeting today..


7 Jan'11 - 16:58 - 8755 of 8763

"I arrived 45 minutes early quite deliberately and was, as I suspected, immediately recognised by Alan Kingsman. Having previously exchanged emails he knew what my concerns were and so we spent just over 20 minutes before the meeting going over them. This was followed by John Dawson approaching me (as a result of my tete a tete with Prof Kingsman) and a further 10 to 15 mins one to one ensued.

As a result, I made no comments DURING the meeting and stuck my hand up to approve each proposal (which was going to pass anyway).

What did I learn?

1. Whether WE like it or not JD and the whole board are convinced that current and ongoing negotiations are influenced strongly by the lack of a cash pipeline. They have been planning the cash raising for many months and believe that the market have been selling down the SP from 12p to 10p to 8p SOLELY because of the cash runway. They were afraid that to wait longer would mean a drop to 6p and a cash raising would then have to be at 4p or thereabouts.
JD claims his experience tells him that serious big players track their target for a period of 2 years quite typically and will rather pay a multiple of a figure discussed at earlier stages for the satisfaction of de-risking.

2. JD claims this fund raising hurt him too as he chose shares over a cash payment when he joined and has had to pay out for his share of the fund raiser. (I said Sure, but youll vote yourself enough share options in due course and a modest debate ensued between us)

3. To the question wont there be another cash call in 2012 he said we will not do another cash call.



Note: interesting statements from the Prof, JD and Andrew Wood DURING the meeting with regard to the issue of the underwriting fees, leaks, etc.
They clearly dont have much regard for the City. They called around a lot of institutions with regard to the fund raiser and they all quoted similar (high) charges. The Prof in particular hates the leaking but has become inured to it. He says whenever you decide to GO with a fund raising, institutions are offered participation (and they become insiders), It shouldnt, but it always leaks, and there is nothing you can do about it. It is part of the justification the City use for the heavy discount (that the SP will sink prior to the actual announcement). You cant do anything because the only recourse is to pull the fund raiser and the effect of that on the SP is even worse.

4. Factory. The capital cost of the factory is only 1.9m (it IS the one in Oxford as predicted by Martin C-J). Therefore the cash runway is extended much further than some of us feared as they have put in the running costs (including staff) in the figures used for the disposition of the funds. Why this matters is as follows:-
When they do a P2 trial it can cost them 1m for a manufacturer to make the product, they will save the bulk of that sum with each of the P2 trial on the ocular product in 2011/2012.
There are very few contractors in the world that can make, for example, Lentivector product. This creates real problems in scheduling and therefore timing.
They believe that Sanofi will PREFER OXB to be the manufacturer for the ocular products not only through trial but also through marketing.

5. PROSAVIN They showed us the (talked about) video of the star patient from the very first cohort at the 1X dose. The first video was done before dosing (in l-dopa OFF) and the second done 2 years after dosing so no question of placebo effect. Each video shows a man seated at the left hand end of a wall, he gets up, walks along the wall to the end, turns around, then walks back to the chair. In the before we see a delayed lift off from the chair in a very unsteady movement, a slow and shuffling unsteady gait, a halt at the end (wanting to turn around but body not obeying), then almost falling as the slow turn is made, followed by the stooped shuffle back.
In the after his rise from the chair looks completely normal, his gait remains a little stooped but clearly confident and at normal speed, the turn around at the end of the wall would have been worthy of 4 10s on Come Dancing (or whatever it is now called!).
There can be NO QUESTION THAT PROSAVIN WORKS even at low doses, but now for the complexities of the situation:-
- Prof Kingsman explains that dosing using biological products is inherently inaccurate;
- The spread (not the terms the Prof used) or take up of Prosavin and similar into the brain cells is also variable;
- Monkeys sit in a cage, are given fixed amounts of food, do same things every day, are zapped to a nil dopamine state are predictable. Human patients are NOT consistent (except in the fact that they are all failing on l-dopa but some worse than others), they turn up for their treatment, then turn up for their review meetings on FIXED dates. If the patient is ill that day, they still have to use that days measurements. Patients have (anecdotally) had a close relative die within a couple of days of the process; or in another case felt so good they thought they would spend a week or two completely redecorating their house, turning up for their measurement completely knackered! - point is human patients NOT CONSISTENT.
- 1x and 2x doses were similar, therefore not much expected of 2x (also confirms that 1x and so on are just labels not strict ratios.
- Stuart Naylor confirms that the 2x INFUSION candidates were much more severely Parkinsonian than earlier candidate.

(I had a bit of a debate with he and the Prof about putting a little more laymans script around their RNS. Explain a little more about the conditions, what they expected to get, etc. Their professional attitude to this is that they wont do it as it could lead to wrong interpretation, I argued the opposite. I didnt win!

- We need to remind ourselves that the trials so far are only about toleration and dose escalation
- It seemed fairly clear to me that they dont consider themselves expert in the dose administration and my impression was that the infusion method was brought to them by the experts on the administration as it has previously been used by another drug development company.
- They clearly EXPECT the 5x dosing to give all candidates a consistent level of improvement i.e. remove all Parkinsonian symptoms. Results will be available in JUNE 2011 and JD expects to do the sort of deal that is acceptable pretty quickly following that. (It may be counterintuitive to the like of us, but JD claims that big pharma (even if the believe the science) will only do a deal when it is de-risked.
- The deals (and there have apparently been a number) offered have all been much too low for what JD believes is a billion $ drug.
- Cambridge centre is set up now so following the first two individual candidates for 5x infusion being done consecutively they and Paris will process candidates in parallel. Cambridge, Addenbrookes, Roger Barker.

The threshold dose point that I posted earlier is not really right. More accurately, there is a dose level in monkeys (5x equivalent) where ALL candidates improve consistently to a mean.
In the primates, when they then de-escalated the doses, they got exactly the same results as they are getting with low dose humans very variable.

5. TROVAX Trovax works and will pass a suitable P3 in due course (although as Stuart Naylor explained they will need to partner it and at present the stigma of a failed P3 still surrounds the product. There IS a lot of interest and, like Prosavin deal candidates, these are people who want to stick around for a year or two to see the product de-risked before they will negotiate seriously.
They have to earn back respect with the blinded P2s with placebo arm that are already planned. Interesting there IS a study, which has gone for peer review that starts with the findings about blood status that came out of Trist and reviews ALL the previous P2s they did. The study shows that the good blood findings from Trist are consistent in all the P2s. This SHOULD make a good story to tell.
BTW the East European centre had mostly candidates with very poor blood condition (Stuart explains that as a cancer sufferer approaches the end game not his words a common condition is a thickening of platelets and other problems).


SUMMARY: (All IMHO) They won me over but the timescale is a minimum 6 months before big news (5x infusion 3 month results), more likely a year (Big Prosavin deal), really good in 2 years (ocular products into clinic and Trovax P3 deal)"

t
re your post 1346.
now why would i want to construct such a thread?
i just question all posters who proclaim themselves to be invincible, as in,"never wrong".
if they respond and wish to have a nice intellectual conversation about it then that is fine with me.it is unfortunate however if that response is abusive.
fortunately it rarely is, abusive that is, apart from your replies which mostly are, but not always, just mostly. maybe it is t who dislikes jkd.
have a nice weekend.
regards
jkd