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Zohar
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Aastrom Biosciences, Inc. (NASDAQ: ASTM) Still Awaiting FDA Response to SPA for Phase 3 CLI Trial, Advancement of DCM Trials
In late October of 2010 Aastrom Biosciences (NASDAQ: ASTM) submitted an SPA to the Food and Drug Administration in regards to their Phase 3 trial for the treatment of Critical Limb Ischemia (CLI) and while it was the FDA that granted the company a fast track designation due to its potential to fill an unmet medical need three months have passed and there has been no word on when that critical trial will begin but some are saying a response from the FDA is expected within a month.
Unquestionably ASTM has shown positive steps with their efforts in the area of treatment for CLI, considered the most severe form of peripheral artery disease. As it stands therapeutic options for CLI are limited and often ineffective, leading to more than 160,000 major limb amputations per year in the U.S. Approximately 25% of CLI patients die within 6-12 months of diagnosis and fewer than 25% survive four years. What ASTM is offering, an ability to repair and regenerate tissue damaged by CLI, would certainly be welcomed among those suffering from CLI but it could be some time before it ever gets approved.
The most optimistic estimates have ASTM enrolling between 500-600 patients beginning in March and that enrollment process could take up to 18 months to complete. Once the trial, dubbed RESTORE-CLI Trial, has been completed it would be another year of follow-up to see if the treatments have reduced the rate of amputations and deaths. Realistically it might not be until the second half of 2012 before the company decides if they will move forward with their FDA approval process.
If the initial information from the Phase 2b trial holds true, which showed Aastrom’s Tissue Repair Cell (TRC) technology demonstrated statistical significance in the primary endpoint, time-to-treatment failure, which includes death, amputation, de novo gangrene and doubling in wound size, then that decision to move forward will likely be positive. The 12-month results of that trail are expected sometime in the second quarter.
As pointed out in an earlier OTCEquity article concerning ASTM if the company can make it past that FDA approval process there is plenty to look forward to if you’re a shareholder. Among the most significant is ASTM’s proprietary technology which means that if approved they will not have to worry about generic competition. Not to be forgotten, ASTM will also be standing alone in the CLI treatment arena due to the fact Sanofi-Aventis’ recent Phase 3 trial for CLI failed, giving them an almost complete monopoly on the market. Add to this the fact that ASTM already has their own scalable, automated, cell manufacturing facility and recently announced the formation of a strategic partnership with ATEK Medical in which that company will supply key components and technology for use in Aastrom’s proprietary cell manufacturing process.
Of course for those who have been following ASTM they know that the RESTORE-CLI Trial isn’t the only game in town for the company. They have also been advancing their IMPACT-DCM program and recently released interim data from the first 40 patients at 6-months in the Phase 2 trial. That data was concentrating on the safety and efficacy of direct injection of TRCs into damaged areas of the myocardium; lending evidence that would support their belief that ASTM can safely and effectively treat patients with Dilated Cardiomyopathy (DCM) compared to standard-of-care treatment. The information presented supports the move into a larger-scale Phase 2b program that would start later in 2011 and while none of the results from the small trial were statistically significant there were signs that supported a quality of life benefit with the TRCs.
On top of this trial ASTM is also proceeding with their Catheter-DCM program that is currently enrolling patients to determine the safety and tolerability of administering expanded autologous cell therapy via a catheter (Johnson & Johnson’s NOGA) to patients with heart failure due to dilated cardiomyopathy. They are currently in the process of outlining a Phase 2b program that will use the NOGA device and will likely enroll about 100-150 patients with clearly objective endpoints such as heart function, 6-minute walk test, VO2 max, exercise capacity, or MACE. This will be large enough to clearly provide a roadmap for the phase III program, which we expect management will secure an SPA.
Both the IMPACT-DCM and the Catheter-DCM program have been granted Orphan Drug designation by the FDA.
As positive as the RESTORE-CLI program has been for ASTM it could be their efforts toward DCM that really bring the company success. About 200,000-250,000 people in the U.S. are living with DCM, a condition in which the heart becomes weakened and enlarged, and cannot pump blood efficiently, and 20,000 new cases are diagnosed each year. While the one-year survival rate for a patient diagnosed with DCM is around 75% the five-year survival rate falls to around 30%, once again putting ASTM in a strong position to fill an unmet medical need.
While just about all the news that has come out on Aastrom has been positive the bottom line is that it remains a biotechnology company that is subjected to the painful process of going through the FDA to gain approval. What makes this process particularly painful is the incredible cost that comes with it and in December ASTM managed to raise $22.5 million ($20.5 million after fees) after selling 10 million shares at $2.25 per share. Of course that offering diluted shares and led to a significant drop in share price as it went from a high of 3.09 on Dec. 9 to 2.23 the following day when the offering was announced.
The company has said they intend “to use the net proceeds from the offering for general corporate purposes, including research and development expenses such as expenses related to its Phase 3 CLI program, capital expenditures, working capital and general administrative expenses.”
At the end of the day investors have a company that at one time was trading around the $45.00 mark but is now down around the 2.60 – 2.66 range and has yet to bring in any earnings or produce a product; rather they have accumulate regular losses. As it stands they are trading below their 50-day moving average of 2.75 but above the 200-day moving average of 1.91.
The reality behind ASTM is that while the share price may go up on positive news it could still be years before the company is able to show revenue generated from products. The technology that ASTM has developed has produced solid results and very well may be the ticket to significant profits but you’ll have to be prepared to hold on to your shares for some time if you want to see that payday.
In late October of 2010 Aastrom Biosciences (NASDAQ: ASTM) submitted an SPA to the Food and Drug Administration in regards to their Phase 3 trial for the treatment of Critical Limb Ischemia (CLI) and while it was the FDA that granted the company a fast track designation due to its potential to fill an unmet medical need three months have passed and there has been no word on when that critical trial will begin but some are saying a response from the FDA is expected within a month.
Unquestionably ASTM has shown positive steps with their efforts in the area of treatment for CLI, considered the most severe form of peripheral artery disease. As it stands therapeutic options for CLI are limited and often ineffective, leading to more than 160,000 major limb amputations per year in the U.S. Approximately 25% of CLI patients die within 6-12 months of diagnosis and fewer than 25% survive four years. What ASTM is offering, an ability to repair and regenerate tissue damaged by CLI, would certainly be welcomed among those suffering from CLI but it could be some time before it ever gets approved.
The most optimistic estimates have ASTM enrolling between 500-600 patients beginning in March and that enrollment process could take up to 18 months to complete. Once the trial, dubbed RESTORE-CLI Trial, has been completed it would be another year of follow-up to see if the treatments have reduced the rate of amputations and deaths. Realistically it might not be until the second half of 2012 before the company decides if they will move forward with their FDA approval process.
If the initial information from the Phase 2b trial holds true, which showed Aastrom’s Tissue Repair Cell (TRC) technology demonstrated statistical significance in the primary endpoint, time-to-treatment failure, which includes death, amputation, de novo gangrene and doubling in wound size, then that decision to move forward will likely be positive. The 12-month results of that trail are expected sometime in the second quarter.
As pointed out in an earlier OTCEquity article concerning ASTM if the company can make it past that FDA approval process there is plenty to look forward to if you’re a shareholder. Among the most significant is ASTM’s proprietary technology which means that if approved they will not have to worry about generic competition. Not to be forgotten, ASTM will also be standing alone in the CLI treatment arena due to the fact Sanofi-Aventis’ recent Phase 3 trial for CLI failed, giving them an almost complete monopoly on the market. Add to this the fact that ASTM already has their own scalable, automated, cell manufacturing facility and recently announced the formation of a strategic partnership with ATEK Medical in which that company will supply key components and technology for use in Aastrom’s proprietary cell manufacturing process.
Of course for those who have been following ASTM they know that the RESTORE-CLI Trial isn’t the only game in town for the company. They have also been advancing their IMPACT-DCM program and recently released interim data from the first 40 patients at 6-months in the Phase 2 trial. That data was concentrating on the safety and efficacy of direct injection of TRCs into damaged areas of the myocardium; lending evidence that would support their belief that ASTM can safely and effectively treat patients with Dilated Cardiomyopathy (DCM) compared to standard-of-care treatment. The information presented supports the move into a larger-scale Phase 2b program that would start later in 2011 and while none of the results from the small trial were statistically significant there were signs that supported a quality of life benefit with the TRCs.
On top of this trial ASTM is also proceeding with their Catheter-DCM program that is currently enrolling patients to determine the safety and tolerability of administering expanded autologous cell therapy via a catheter (Johnson & Johnson’s NOGA) to patients with heart failure due to dilated cardiomyopathy. They are currently in the process of outlining a Phase 2b program that will use the NOGA device and will likely enroll about 100-150 patients with clearly objective endpoints such as heart function, 6-minute walk test, VO2 max, exercise capacity, or MACE. This will be large enough to clearly provide a roadmap for the phase III program, which we expect management will secure an SPA.
Both the IMPACT-DCM and the Catheter-DCM program have been granted Orphan Drug designation by the FDA.
As positive as the RESTORE-CLI program has been for ASTM it could be their efforts toward DCM that really bring the company success. About 200,000-250,000 people in the U.S. are living with DCM, a condition in which the heart becomes weakened and enlarged, and cannot pump blood efficiently, and 20,000 new cases are diagnosed each year. While the one-year survival rate for a patient diagnosed with DCM is around 75% the five-year survival rate falls to around 30%, once again putting ASTM in a strong position to fill an unmet medical need.
While just about all the news that has come out on Aastrom has been positive the bottom line is that it remains a biotechnology company that is subjected to the painful process of going through the FDA to gain approval. What makes this process particularly painful is the incredible cost that comes with it and in December ASTM managed to raise $22.5 million ($20.5 million after fees) after selling 10 million shares at $2.25 per share. Of course that offering diluted shares and led to a significant drop in share price as it went from a high of 3.09 on Dec. 9 to 2.23 the following day when the offering was announced.
The company has said they intend “to use the net proceeds from the offering for general corporate purposes, including research and development expenses such as expenses related to its Phase 3 CLI program, capital expenditures, working capital and general administrative expenses.”
At the end of the day investors have a company that at one time was trading around the $45.00 mark but is now down around the 2.60 – 2.66 range and has yet to bring in any earnings or produce a product; rather they have accumulate regular losses. As it stands they are trading below their 50-day moving average of 2.75 but above the 200-day moving average of 1.91.
The reality behind ASTM is that while the share price may go up on positive news it could still be years before the company is able to show revenue generated from products. The technology that ASTM has developed has produced solid results and very well may be the ticket to significant profits but you’ll have to be prepared to hold on to your shares for some time if you want to see that payday.
viralic
Forumer storico
BUY PER KERYX..........t.p. 8/10 euro.........
Keryx Biopharmaceuticals (NASDAQ: KERX | PowerRating ) è focalizzata sullo sviluppo, acquisizione e commercializzazione di prodotti farmaceutici importante medico per il trattamento di malattie pericolose per la vita, tra cui il cancro e la malattia renale.
Keryx ha attualmente 2 in ritardo-fase di Fase III droga, Zerenex e Perifosine, con la FDA sotto una Special Protocol Assessment (SPA) dichiarazione. Un "SPA" è una dichiarazione da parte della FDA che disegnano una proposta di studio di Fase III, gli endpoint clinici, e le analisi statistiche sono accettabili per l'approvazione della FDA.
L'approvazione di fase III di entrambi i farmaci devono spingere Keryx oltre gli obiettivi di prezzo analista che sono attualmente tra gli $ 8 e $ 10 per azione. Attualmente, Keryx è considerato un "BUY" da 5 principali società di Wall Street.
Keryx Biopharmaceuticals (NASDAQ: KERX | PowerRating ) è focalizzata sullo sviluppo, acquisizione e commercializzazione di prodotti farmaceutici importante medico per il trattamento di malattie pericolose per la vita, tra cui il cancro e la malattia renale.
Keryx ha attualmente 2 in ritardo-fase di Fase III droga, Zerenex e Perifosine, con la FDA sotto una Special Protocol Assessment (SPA) dichiarazione. Un "SPA" è una dichiarazione da parte della FDA che disegnano una proposta di studio di Fase III, gli endpoint clinici, e le analisi statistiche sono accettabili per l'approvazione della FDA.
L'approvazione di fase III di entrambi i farmaci devono spingere Keryx oltre gli obiettivi di prezzo analista che sono attualmente tra gli $ 8 e $ 10 per azione. Attualmente, Keryx è considerato un "BUY" da 5 principali società di Wall Street.
tradermen
Forumer storico
viralic
Forumer storico
Li hanno bocciati tutti e 3 .......per l'obesità.....ma si ..che gli americani crepino tutti a causa del loro peso.....!!!
DickSIM
Prima o poi....ci becco!
Li hanno bocciati tutti e 3 .......per l'obesità.....ma si ..che gli americani crepino tutti a causa del loro peso.....!!!
e questo dopo il Panel favorevole........
se nn ricordo male!passaggio della news pubblicata su Bloomberg......
But Arena shares rose a penny to $1.59. WBB Securities analyst Steve Brozak said analysts were surprised by the FDA decision on Orexigen, but investors had already discounted Arena shares over its diet pill setback.
"This is FDA 101," he said. "It just makes life very, very problematic for biotech investors."
