ASTM - Sector: Healthcare---Industry: Biotechnology & Drugs

[thai626]

OMG, I can't believe I'm up at 5:10 am in the west coast just to check the boards and check to see if ASTM jaw bone reconstruction results are out lol.  Anyways, I really can't wait for the open.

To think that this rise is not even on company relevant news...........I can only imagine what will happen when ASTM releases clincial trial results.  NOTE:  Jaw bone reconstruction results are due by the end of December!! (according to CEO Douglas Armstrong). 

http://biz.yahoo.com/prnews/051221/new005.html?.v=36

http://finance.yahoo.com/mp#astm

http://biz.yahoo.com/e/051221/astm8-k.html


Here's the line that I really loved.
"Results showed that all 5 patients treated locally with Aastrom's TRCs, exhibited a statistically significant increase in bone height at the 3-month evaluation point, and the cell graft had started to integrate with the surrounding preexisting bone of the upper jaw by 4 months, with no cell-related adverse events"

"Results such as these provide increasing evidence that TRCs can be safely used to regenerate bone in humans whose ability to maintain and repair their skeleton is impaired by disease or trauma," stated Janet M. Hock, B.D.S., Ph.D., Vice President Global Research and Chief Scientific Officer of Aastrom.

FOUSC, good luck to you in the contest.  Hopefully we'll both be top 3.   

Thai

[setravis]

Starting to kick a little in the pre-market...
+5.26%.......Volume @......99,664

[wrangler]

Aastrom Biosciences Reports Positive Human Jaw Bone Reconstruction Results from Feasibility Clinical Trial
Related Stocks   
ASTM


-- Results Indicate Company's Tissue Repair Cell Product Safely Builds New Bone for Dental Implants --

ANN ARBOR, Mich., Dec. 21 /PRNewswire-FirstCall/ -- Aastrom Biosciences, Inc. (ASTM - news) announced today the interim results from its feasibility clinical trial conducted with the Teknon Hospital Maxillofacial Clinic in Barcelona, Spain, to evaluate the use of Aastrom's Tissue Repair Cells (TRCs) for maxillary (upper jaw) bone reconstruction in 5 patients, completed to support placement of dental implants. The study results showed clinical safety, and that the TRC treatment sites all exhibited bone growth that was statistically significant and had the desired initial integration with preexisting bone. An internal report of the clinical study, which provides more detailed information, is being filed today on Form 8-K with the SEC. This report may also be accessed on Aastrom's website using the link: http://www.aastrom.com/pdf/Jaw_Barcelona-051220.pdf.

The goal of this proof of concept, internally controlled clinical trial was to evaluate the safety and ability of TRCs -- a proprietary autologous bone marrow-derived stem cell product -- to increase bone height in the posterior maxilla (upper jaw) of 5 patients, who had severe bone loss in the region and minimal residual bone remaining. The patients were judged to have a poor prognosis with previously lost teeth due to periodontal disease and tooth decay, and additional risk factors that are known to compromise bone regeneration and preservation. These risk factors included many years of smoking, osteoporosis and advanced age. The intent of the TRC therapy was to help rebuild healthy bone so that there was enough bone to accommodate the length of the dental implants. A standard bone graft technique was used as an internal concurrent control on the other side of the maxilla.

All of the primary outcomes described by the trial protocol were successfully achieved. Results showed that all 5 patients treated locally with Aastrom's TRCs, exhibited a statistically significant increase in bone height at the 3-month evaluation point, and the cell graft had started to integrate with the surrounding preexisting bone of the upper jaw by 4 months, with no cell-related adverse events. The results were obtained from radiographs, and from biopsies taken at the interface of the original bone and the new tissue. All patients went on to receive 3-4 dental implants on each side of their maxilla.

The study employed an internal concurrent control, in which the patients were treated on one side of the maxilla with the TRC test treatment added to a standard of care procedure, and on the other side with the control standard of care procedure, a mixture of platelet-poor plasma and commercial bone mineral matrix. There was a statistically significant difference in bone formation and quality between test and control sides. Bone height in the grafted area and integration of graft into surrounding bone were increased in the TRC test maxilla, when compared with control sites receiving standard of care treatment. Post-operative bruising and swelling observed at some (3/5) of the control sites, were not observed in the TRC treated maxillae (0/5). This is the second clinical bone graft trial to report that surgical sites treated with TRCs appear to exhibit less inflammation or swelling than sites treated without TRCs.

"Edentulous patients who have lost this much jaw bone can be very difficult to treat," commented Dr. Federico Hernandez-Alfaro, Principal Investigator for the trial. "TRCs may offer an improved treatment over existing therapies because they appear to naturally accelerate integration of new bone with the existing bone in the patient, and increase bone mass for implant placement."

"Results such as these provide increasing evidence that TRCs can be safely used to regenerate bone in humans whose ability to maintain and repair their skeleton is impaired by disease or trauma," stated Janet M. Hock, B.D.S., Ph.D., Vice President Global Research and Chief Scientific Officer of Aastrom. "These early clinical studies explore tissue healing and regeneration in patients with compromised conditions, and teach us what to expect from stem cell therapy, and how to optimize the use of TRCs in clinical situations."

Aastrom is implementing a "proof of concept" clinical plan to evaluate the ability of TRCs to generate three different types of bone: long bone, jaw bone and spine. Trials involving multiple centers in both the U.S. and Europe are actively evaluating TRCs in the repair of severe non-union fractures, where preliminary results have demonstrated both safety and bone growth success. A trial for the regeneration of spine bone (vertebral fusion) has been initiated in the U.S. under a newly approved IND. In addition, the Company is now engaged in a human clinical trial in Germany evaluating the use of its TRCs to treat limb ischemia in diabetic patients through the regeneration of vascular tissue in extremities.

About Tissue Repair Cells

Tissue Repair Cells (TRCs) are Aastrom's proprietary mixture of bone marrow-derived adult stem and progenitor cells produced using patented single- pass perfusion technology in the AastromReplicell(R) System. The clinical procedure begins with the collection of a small sample of bone marrow from the patient's hip in an outpatient setting. TRCs are then produced in the automated AastromReplicell System over a 12-day period. It has been demonstrated in the laboratory that TRCs are able to develop into different types of tissue lineages in response to inductive signals, including blood, bone, cartilage, adipose and vascular tubules. In previous clinical trials, TRCs have been shown to be safe and reliable in regenerating certain normal healthy bone marrow tissues.

[thai626]

Hello everyone,

Recently the CEO Doug Armstrong of Aastrom Biosciences (ASTM) put in a request for them to start looking for a new CEO.  However, in the press release, he also states that he would like to still remain chairman of the board of directors.  Does anyone see the fact that he is stepping down as a positive/negative/neutral?  I'm just curious cause I'm just torn among all three choices.  To me, it could also mean to me that ASTM is on its next stage in the company which is manufacturing and business relations.  What do you all think???   

I would really hate to hear it's negative news because there hasn't been anything negative in the press lately regarding clinical trials, FDA, etc.............In fact, it's the total opposite.  All clinical trial results have been extremely good.  NO debts, burn rate = 1.2 million with close to 30 million in their account right now.



Here's the news release of Armstrong's request.
Aastrom Biosciences Announces Management Succession Process
Wednesday December 28, 9:00 am ET 
-- Long-Term CEO and Chairman to Continue at Board Level --


ANN ARBOR, Mich., Dec. 28 /PRNewswire-FirstCall/ -- Aastrom Biosciences, Inc. (Nasdaq: ASTM - News) today announced that at the request of Chairman and Chief Executive Officer, R. Douglas Armstrong, Ph.D., Aastrom's Board of Directors' Corporate Governance and Nominating Committee will initiate a process to identify potential candidates to succeed Dr. Armstrong as Chief Executive Officer, allowing him to transition out of day-to-day management. The transition process is expected to occur during 2006. Upon the naming of a successor to the position of Chief Executive Officer, Dr. Armstrong, subject to his reelection by shareholders, intends to remain deeply involved in the Company's business and strategic direction as a member of the Board of Directors, with overall responsibilities determined by the Board at that time.

Speaking on behalf of the Board, R. Douglas Armstrong, Ph.D., Chief Executive Officer and Chairman of Aastrom said, "Today's announcement is consistent with our goal of providing a long-term leadership succession process for the Company, but more importantly, it marks the beginning of an exciting new chapter in Aastrom's ongoing business evolution. Aastromeffective transition for the new Chief Executive Officer, and then intend to continue to provide strategic direction and to be an available resource for both the management team and the Board."  has reached a new stage with our expanded senior management team, our new directors, our ongoing and significant progress in the clinic, and our enhanced operational capabilities. In the near term, I will continue my responsibilities as CEO and Chairman of the Board, with particular focus on ensuring an  Dr. Armstrong has been the Chief Executive Officer of Aastrom Biosciences, Inc. for more than 14 years, and the Chairman of the Board for the past 6 years. During Dr. Armstrong's tenure, he led the Company from the early stages of research and development into product and clinical development. In addition, he led its transition from a private company to a Nasdaq-listed company and its recent emergence as a leading stem cell company in active clinical trials. The Company has successfully shown that its Tissue Repair Cell bone marrow stem cell products can be used safely in patients and have demonstrated their ability to regenerate certain human tissues.

Dr. Armstrong further stated, "Aastrom is entering a new era as we move into and through the clinical, regulatory and market development activities, and establish our manufacturing operations to bring our first-of-its-kind Tissue Repair Cell products into the medical marketplace. I am excited about Aastrom's position and opportunities, and look forward to continuing my role with the Company and the management succession process."


I'm holding on to this stock regardless unless they report some real awful news!!

Thai

[calven]

Time to start watching this one again folks. If it crosses above that BLUE resistance line we could get some fireworks...

[thai626]

Time to start watching this one again folks. If it crosses above that BLUE resistance line we could get some fireworks...

You know how much I love this stock Calven.  I can't wait for the day where ASTM breaks the down slopping resistance line.  It's the biggest holding in my portfolio so hopefully this will take off again soon.  Plus, it's my pick the stock picking contest 

[Melf Elf]

calven and thai,

Applause for reminding me of the bigger picture on ASTM.   

After getting to and beyond its 4-year Inverse H&S target last January, it sold off sharply into May.  From there, it has several very nice bullish patterns, but it formed a H&S top over the summer, and broke to the downside in September.

The 1.88-1.90 on calven's chart "could be" a double-bottom, but the chart action on the daily looks pretty uninspiring, and the H&S Top target of 1.68 still is IN PLAY.



Bigger picture, though, still looks good.  Weekly chart coming up next.

[Melf Elf]

Broke out of a 4-year Inverse H&S and went well beyond the target.  2005 was a year of consolidating that gain in a Symmetrical Triangle formation.

If we get the 1.68 target that is IN PLAY from the H&S top of the daily chart (last post), the Symmetrical Triangle on this weekly chart would morph into a Bullish Falling Wedge, or a Bull Flag/Bull Channel (dotted blue line), back toward the H&S neckline breakout.

That still would look long-term bullish.

[thai626]

calven and thai,

The 1.88-1.90 on calven's chart "could be" a double-bottom, but the chart action on the daily looks pretty uninspiring, and the H&S Top target of 1.68 still is IN PLAY.



Bigger picture, though, still looks good.  Weekly chart coming up next.

I knew we couldn't sneek the head and shoulders pattern past you Melf Elf.  I saw that too but I didn't want to face the truth.  However, I like the double bottom pattern better so I hope the H&S pattern never plays out.  I would really hate to see ASTM break the 1.90 support.  Good analysis....Keep up the good work!!

Thai

[boatguy]

OK, In at 2.15. 

3 million traded the last 2 hours of trading 2.20 AH, I see STEM made a big move too.

Lets see a big run so Thai can win the contest!

[Melf Elf]

The 1.88-1.90 on calven's chart "could be" a double-bottom, but the chart action on the daily looks pretty uninspiring, and the H&S Top target of 1.68 still is IN PLAY.

They tried to hold that 1.88-1.90 support on Wednesday when ASTM reported that Q2 losses widened on lower revenues.  It closed at 1.89, but that support broke on a closing basis on Thursday.

I knew we couldn't sneek the head and shoulders pattern past you Melf Elf.

Thai,

Unfortunately, they couldn't sneak it past the market, either.   

Friday, they tanked it, and the H&S Top target of 1.68 finally MADE.

[thai626]

Just updating one of my favorite stocks.   

Although there was a recent selloff in ASTM, I think it was an over reaction to ASTM's financial report.   The selloff had no impact on my decision to sell or hold as ASTM is one of my long term plays. 

Clinical trials are still progressing as expected and analysts still have kept their target price of over $4.  I'm looking forward to their next clinical trial results press release as I believe it will be another positive stride for Aastrom. 


IMO, Aastrom has been going through accumulation.  For instance, yesterday's premarket, there was an order for 223,500 shares   .  No private investor purchases that many shares at one time........unless they know something that the average investor doesn't.

Here's a short term chart..........I hope it can break out of the resistance this week. 

Thai

P.S.  I would love to hear others perspective on this stock.  Good luck trading all!!

[thai626]

HOLY MACARONI   


What the heck happened to ASTM?  Looking at the level II quotes, I saw that huge orders were placed for 1.3 million, 1 million, a few orders over 500k etc.  THIS IS HUGE!!!

Fous.......THE TIME HAS COME MY FRIEND!!!!!!!!!! 


WUHAHAHAH

[brandyjoco]

Check the news on YAHOO. They were granted orphan status for their bone marrow procedure. 13 million shares traded in 15 minutes.

[thai626]

Aastrom gets orphan status for bone marrow drug
Thu Mar 23, 2006 3:32 PM ET
NEW YORK, March 23 (Reuters) - Aastrom Biosciences Inc. (ASTM: Quote, Profile, Research) said on Thursday U.S. regulators have granted orphan drug status to its Tissue Repair Cells bone marrow cell treatment for osteonecrosis, a painful condition in which tissue inside a bone is dying and unable to regenerate itself.

The condition, which usually attacks young male adults, often leads to a need for total hip joint replacement, the company said.

Orphan status is granted by the U.S. Food and Drug Administration for drugs that treat conditions or diseases that affect fewer than 200,000 people in the United States. The designation comes with a seven-year marketing exclusivity period if the drug is approved for sale.


OK...  Here is my technical chart for ASTM (long term chart).
The first of three hurdles have been successful (medium term resistance)........The second hurdle which is the 200dma is next to come but I would expect that to be tested tomorrow morning.  The third hurdle is the long term resistance line that we could never break in the past.  However, if we break that I think we can be on our way to seeing the $3 - $3.50 range again.  Hopefully, since the news came out so late in the day, that ASTM continues its run in the morning.