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ASTM up after hours trading on NEWS!
FDA Approves Aastrom Phase III IND for Treatment of Osteonecrosis of the Femoral Head
Monday May 7, 5:58 pm ET
Patient-Specific Stem Cell Trial to Address Unmet Medical Need
ANN ARBOR, Mich., May 7, 2007 (PRIME NEWSWIRE) -- Aastrom Biosciences, Inc. (NasdaqCM:ASTM - News), a regenerative medicine company, today announced that the U.S. Food & Drug Administration (FDA) approved the Company's Investigational New Drug (IND) application to initiate a 120 patient Phase III clinical trial for the treatment of osteonecrosis (also known as avascular necrosis) of the femoral head. Aastrom intends this to be a pivotal trial with the goal of demonstrating clinical safety and efficacy for the submission of a Biologics License Application (BLA). In addition, the Company may have to generate further patient data in this indication, such as data from the ongoing pivotal trial in Spain, to support a U.S. BLA submission. Osteonecrosis is a progressive disease, with no established effective treatments, that often leads to a total hip replacement. Aastrom will use its Bone Repair Cell (BRC) product, based on Tissue Repair Cell (TRC) Technology, to evaluate this approach for treating patients suffering from osteonecrosis.
``This is our first Phase III clinical trial focused on tissue regeneration, and it represents a significant step forward for both the Company and the field of regenerative medicine. We are thrilled to report the achievement of this clinical milestone,'' said George Dunbar, President and Chief Executive Officer of Aastrom. ``Should the clinical trial results meet our expectations, we intend to seek licensure and take the BRC product to market under our existing Orphan Drug Designation.''
Initiation of this clinical trial complements the receipt of an Orphan Drug Designation from the FDA. Orphan drug status is granted to development-stage products that offer potential therapeutic value in the treatment of rare diseases and conditions. The Company may be entitled to several benefits prior to approval, including an expedited FDA review, the reduction or even elimination of filing fees, and the availability of possible tax credits, and will be entitled to seven years of marketing exclusivity once the product receives FDA approval.
This trial will seek to enroll 120 patients, randomized into two patient groups, at up to 20 clinical sites. The planned treatment approach for all patients will include a core decompression surgery where a core track (hole) is drilled into the head of the femur to relieve internal pressure. Patients randomized into the treatment group will have BRCs mixed with a bone matrix carrier placed into the core track, while control patients will receive bone matrix carrier without cells. If healthy bone can be successfully regenerated in the femoral head, we expect the need for a hip replacement could be delayed or eliminated in osteonecrosis patients. The primary efficacy endpoint of this trial is to prevent or delay the progression of osteonecrosis to fracture, and potentially collapse of the femur head, which will be measured by a blinded third-party reviewer through MRI and CT imaging. Patients will be followed for a total of 24 months, post-treatment.
``Osteonecrosis is a pressing medical problem in orthopedic medicine. This disease generally afflicts younger people, and often has a poor prognosis. More than half of the patients progress to debilitating fractures of the femoral head which require a total hip replacement without appropriate treatment, within two years of initial diagnosis,'' said Marc W. Hungerford, M.D., Assistant Professor of Orthopedics at the Johns Hopkins University School of Medicine. ``This trial represents a novel and promising approach aimed at preserving the functional integrity of the hip joint. It could potentially eliminate the need to subject the patient to major surgery.''
The tissues involved in osteonecrosis of the femoral head include bone, bone marrow and blood vessels (vascular), complicating the development of effective treatments in the past. Aastrom's TRC-based products, which include a proprietary mixture of stem and progenitor cells derived from a small sample of the patient's own bone marrow, have been used in other clinical trials involving different indications to evaluate regeneration in all three of these tissues. With this capability, the application of TRC Technology may offer a novel means to regenerate the tissues lost due to osteonecrosis.
This study initiation is Aastrom's second clinical trial evaluating the Company's TRC Technology in patients with osteonecrosis of the femoral head. In January, the Company announced it had treated the first two patients in a pivotal clinical trial for osteonecrosis in Spain.
Up in A/H nicely... thanks
thanks, I'll watch, PM me if your on to something early
Exactly! Now all I need is a sweet pick for tomorrow so i can make some bank and go celebrate!
Any suggestions, maybe an in and out on UWNK news?
Since ur on the topic....I got some great snail mail today...
it reads...
This Court Orders That
mboomer17 (edit) and Angela aboomer17 (edit)
who were married at Clark County, Henderson, Nevada
on November 28, 1998
be divorced and that the divorce take effect May 31, 2007
31 days after the date of this order.
WOOOOOO HOOOOOOOO!!!
This looks ready to go...
mboomer17: DMTN, GPTC, ETLC
Penny picks
cool, thanks will keep an eye on that one
yeah me too..
So of course I got my SKCI and looking for a big week, what else is on the platter for some quick flippage?
I'm looking at DMTN and may try to pick off some bottom bouncers like PGMI, EPCG, IVME and/or ETLC.
Whats on your watch list?
yes, great for a laugh...
Here's the quote of the day from that board
"You can dispute your sentence here, but it won't do you any good cause I'm the King and it's good to be the King. Hence, you're wrong and I'm right"
lol, nothing wrong with my swing! Thanks...
What do you think of CBAK off the bottom, Q due May 8th
you said:
"no moron is short millions of shares on a penny stock."
This tells me you really have no idea what your talking about.
Your agenda on this board is pretty clear.
Tsafi, the golf game is getting much better, went out again yesterday morning. Great fun, drink too much...
So, is it only OLMP or should we assume dilution everytime we see the MM only on the ask and not on the bid too??
mmmmmmm Wisers! hic
I think this does have very significant potential, the only reason people are not lining up to get in here, is that we still dont know when the product will be finished and released. Next month or next year?
That PR will blow the roof off this one.
Until then its a waiting game.
The fact that this is still on the grays also doesnt bode well for most investors although there was some solid buying all week at .50
I definitely want to be holding a nice position of this when it explodes, but I will flip in the interim and try to build a position of freebies for when things really heat up.
Thanks, I appreciate both of your thoughts on this.
Great stuff.
Big Board
mboomer17: GG, FNET, NRMX
looks like IFT led you wrong on this one.
I had marked your post because I thought it was an interesting indicator. But doesnt look like it was reliable in this particular case.
I would say right now the chart looks better than back when u first pegged this. RSI over 50, testing 50 MA and macd turning.
thoughts?
Think this is the bottom for OPBL?
did you get some PGMI?
this does look good but there is almost no volume...
can still make money on grays...
EXBX in at .40 out at .50 for a nice 25%
If we can get any kind of significant buying pressure here, this thing is ready for breakout.
lmao
Are we buying here or lower?
i got a keg full o powder and these byatches wont fill me at .06
.05? wtf Im sitting here at .06
whats B/A now?
lol, no offense taken, being 6'4" i dont get called that often
Thats my pathetic effort to get cheapies, I know I gotta come up
Do we have any recent confirmation on share structure?
well, you could always average down after an ugly day like today...
heres a link to my cost averaging calculator.
Only enter numbers in the Green highlighted Fields.
(your cost, number of shares and selling target price)
Everything else will auto calculate.
http://putstuff.putfile.com/75371/7938030
Let me know what you think or if you have any questions.
Hey FSun, so I watched most of that painfully boring council session and they finally got around to it at about 3:15 (EST). Thanks for the link.
There was no mention or discussion surrounding the number of terminals allowed in the restaurant. There was some discussion about landscaping requirements and increasing the height of a wall next to a residential area. Also some talk about ensuring there was no outside food service or music and if there would be seating outside at all.
The guy presenting for the company was a Mr. Lucas?
He stated that they did intend to have seating outside but no food service or music. The board approved the petition.
This all just seemed like some more red tape BS to me.
They have a bunch of morons on that council.
When the hours of op were mentioned, the one moron on council said "so your only gonna be open for two hours? You said from 10am to 12am, thats only two hours". Needless to say, they had to spell it out to him. No wonder its taking so long to get chit done in FLA.
Some other notes:
Address is 8901 4th Street North.
The building has commercial properties to the north and west and residential to the east.
Hours will be 10am to Midnight Monday to Saturday and reduced hours on Sunday.
The one real positive I took from watching this snoozefest was that the one girl on the council said "I expect this to be a very popular restaurant, I know my son cant wait to go".
So appears that there is lots of interest from the community and thats a good thing, we want that place to be packed when it opens so H3 can start signing on new franchises.
When they ever get the store open, with some celebs on site, this should give us a nice pop in the share price.
We all know, this store is the key to success of H3. Once the store launches, if all goes well, the franchise opps are endless.
On a more immediate front, add to the fact that Ben Gordon and the Bulls swept the defending champs in 4 straight.
If they can get BG7 on the shelves while Gordon and the Bulls are kicking some NBA ass, then this should kick things up a notch short term.
Lets get this party started.
Still accumulating and keeping the dream alive.
this is some sick chit, are they just trying to scare the weak out of their shares or is there dumping going on?
Anyone confirm float recently with TA?
Nice Board, I dont think most traders really understand the benefit of this.
I too have a Cost Averaging Calculator. Very Similar to yours but a little easier and more informative.
Only Enter in Values in the GREEN cells.
Your cost and number of shares each time you buy and what your sell target is.
The rest will autocalculate.
http://putstuff.putfile.com/75371/7938030
Let me know if anyone has any questions.
In the example, lets say you purchased 10000 shares of XYZ company at .07 and you pay $29 trading fee.
So you enter in 729 and 10000 shares.
You can see that if you sell at .06 then you will be down 129 bucks or 17.7%
If you were able to buy today at .05 you could purchase 20000 more shares for $1029.
(enter 1029 and 20000 in the second buy row)
Now, if you sell at .06 you end up out with $42 profit
You can play around with your sell target number and get a good idea for how Averaging down (or up) can work to your advantage.
then again, might not be enough volume to get back out today
NXNO on this dip?
news and volume on SKCI looks good
did you confirm share structure this am?