duderaja
8 년 전
Does anyone here know anything about this:
Cognate agreed to provide a *redacted* number of manufacturing suites.
In an agreement filed with the SEC in August of last year they agreed:
With [***] Asterias Suites in full operation, the maximum production capacity of AST-VAC1 will be [***]. Our current understanding of the AST-VAC1 process leads us to believe that [***] is the maximum Batch capacity per each manufacturing suite without the incorporation of process improvements and/or additional understanding of the manufacturing process. This understanding may change [***] during the normal course of manufacturing AST-VAC1, or at any point during the term of performance under this SOW 2. Additionally, Cognate understands that Asterias will be performing additional diligence to determine projected rates of enrollment in the AST-VAC1 clinical trial in parallel with the performance of the activities under SOW 1, and that these activities may result in increases to Asterias’ projected maximum production capacity requirements; provided, however, that in no event will [***] be reduced including if Asterias enrolls less patients than projected. Subject to the foregoing proviso, this Section 2.3 of this SOW 2 may change, or need to be changed, if Cognate or Asterias determines such modifications are appropriate, subject to mutual written approval of any such changes, not to be unreasonably withheld or delayed.
KaOsiris
8 년 전
Asterias Announces Additional Motor Function Improvement at 6-months and 9-months Following Treatment with AST-OPC1 in Patients with Complete Cervical Spinal Cord Injuries
-Management to discuss results on conference call today at 5:00 p.m. Eastern / 2:00 p.m. Pacific-
-SCiStar lead investigator Richard Fessler, MD, and John Steeves, Ph.D., Co-Chair of the Spinal Cord Outcomes Partnership Endeavor (SCOPE), will join Asterias management on the call-
News provided by
Asterias Biotherapeutics, Inc.
Jan 24, 2017, 07:00 ET
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FREMONT, Calif., Jan. 24, 2017 /PRNewswire/ -- Asterias Biotherapeutics, Inc. (NYSE MKT: AST), a biotechnology company pioneering the field of regenerative medicine, today announced positive efficacy results from the company's ongoing SCiStar Phase 1/2a clinical trial that showed additional motor function improvement at 6-months and 9-months following administration of 10 million AST-OPC1 cells in AIS-A patients with complete cervical spinal cord injuries (SCI).
"Recovery of upper extremity motor function is critically important to patients with complete cervical spinal cord injuries, since this can dramatically improve quality of life and their ability to live independently," said Richard Fessler, M.D., Professor, Department of Neurosurgery at Rush University Medical Center and lead investigator in the SCiStar study. "Patients in this cohort are seeing what we believe are meaningful improvements in their ability to use their arms, hands and fingers at 6-months and 9-months following AST-OPC1 administration."
"The results to date in the 10 million cell cohort treated with AST-OPC1 cells show that the improvements in arm, hand and finger function observed very early in the study have been maintained and in most patients have even been further enhanced over time," said Steve Cartt, Chief Executive Officer of Asterias. "These results to date are quite encouraging, and we look forward to initiating discussions with the FDA in mid-2017 to begin to determine the most appropriate clinical and regulatory path forward for this innovative therapy. In addition, we anticipate reporting 12-month efficacy and safety data for this cohort, as well as 6-month efficacy and safety data for the currently-enrolling AIS-A 20 million cell and AIS-B 10 million cell cohorts, during the third quarter of 2017."
A total of six patients were enrolled and dosed in the AIS-A 10 million-cell cohort, with five of six patients having now completed their 6-month follow-up and three of six patients having completed their 9-month follow-up.
Improvements in upper extremity motor function are being measured using the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) scale, widely used to quantify functional status of patients with spinal cord injuries. The latest results include the following highlights:
Improvements in Motor Function
Upper Extremity Motor Score - For the five patients who have completed at least 6 months of follow-up, five of five patients saw their early improvements in motor score (UEMS) at 3 months maintained or further increased through their most recent data point (6 months or 9 months, depending on the most recent data available for each patient).
Motor Level Improvement - For patients completing at least 6 months of follow up, as of the date of each patient's last follow-up visit, 100% (five of five) had achieved at least a one motor level improvement (using the ISNCSCI scale) over baseline on at least one side, and 40% (two of five) had achieved two motor levels over baseline on at least one side, with one of these patients achieving a two motor level improvement on both sides.
Matched Historical Control Data - Asterias and key experts in the spinal cord injury field have developed a set of matched historical control data for both Upper Extremity Motor Score and Motor Level Improvement to clearly document expected spontaneous recovery in untreated patients for comparison to results seen in patients treated with AST-OPC1. The key results from this analysis, which show a meaningful difference in the motor function recovery seen to date in patients treated with the 10 million cell dose of AST-OPC1, will be presented during today's conference call.
Safety
The trial results to date continue to reveal a positive safety profile for AST-OPC1. There have been no serious adverse events related to AST-OPC1 and data from the study indicate that AST-OPC1 can be safely administered to patients in the subacute period after severe cervical spinal cord injury.
In September 2016, Asterias reported positive early efficacy data for AST-OPC1 from the AIS-A patients that had been dosed with 10 million AST-OPC1 cells in the SCiStar study. Today's data show that the improvements in motor function seen at 3 months post-implantation of AST-OPC1 for these patients appear to be maintained, and in some cases improved even further, on continued follow up. Furthermore, these results suggest that the observed gains exceed the expected rates of spontaneous recovery in a closely matched population of historical controls.
Each year in the U.S. more than 17,000 people suffer a severe, debilitating spinal cord injury. These injuries can be devastating to quality of life and ability to function independently. Lifetime healthcare costs for these patients can often approach $5 million. Improvements in arm, hand and finger functional capabilities in these patients can result in lower healthcare costs, significant improvements in quality of life, increased ability to engage in activities of daily living, and increased independence.
Conference Call and Webcast Today at 5:00 p.m. ET (2:00 p.m. PT) to Discuss the Results
Asterias will host a conference call and webcast today, January 24, 2017 at 5:00 p.m. Eastern / 2:00 p.m. Pacific to discuss the results. Company management will be joined by Richard G. Fessler, MD, PhD, Professor, Department of Neurosurgery at Rush University Medical Center and SCiStar lead investigator, and John Steeves, Ph.D., Co-Chair of the Spinal Cord Outcomes Partnership Endeavor (SCOPE) and Professor of International Collaboration on Repair Discoveries (ICORD).
mokew
8 년 전
Jan 04, 2017 (Marketwired via COMTEX) -- SAN FRANCISCO, CA--(Marketwired - January 04, 2017) - Now in its fifth year, the 2017 Life Sciences Report Biotech Watchlist includes nineteen small-cap biotech companies selected by top analysts in the field, and will be presented at the Biotech Showcase in San Francisco on January 11.
Included in this article are: Actinium Pharmaceuticals Inc. (nyse mkt:ATNM) Asterias Biotherapeutics Inc. (nyse mkt:AST)
The collection of small-cap biotechs on the 2017 Watchlist are developing therapies to address diverse indications including rare diseases, asthma, inflammatory bowel disease, spinal cord injury, hemophilia, and a number of cancers. The platforms are equally diverse, representing traditional biologics, cell therapies and vaccines. Watchlist companies include:
Asterias Biotherapeutics Inc. : ~$226M market cap. This stem cell company is addressing two key markets: spinal cord injury and cancer, with a dendritic cell (DC) therapy using genetically engineered autologous and allogeneic stem cells.
http://www.marketwatch.com/story/the-life-sciences-report-announces-19-companies-selected-for-the-2017-small-cap-biotech-watchlist-2017-01-04?siteid=bigcharts&dist=bigcharts
Tim501
8 년 전
Now that we know their tech works -- at least for this first tested indication -- even with slightly less robust numbers in longer read outs, they still will go to market (easily and perhaps quickly) as THE new standard of care -- since current treatment is to send them home for total home care. Early 2a trail results see these patients becoming able to take care of themselves. It's night and day.
Sure it is early -- but we have so much more than we expected --- perhaps even at much later points in the current 2a trial. Based on the conference call, I would think they should see as good if not better results with the new cohort (partial spinal fractures, not total). And they can work long term toward giving everyone 20m cells - the newly approved number that they have yet to use. That seems to be the most impressive thing here - better, earlier results and not even using the max dosage yet. Hard not to get excited.
It is early in this trial. But this is a platform drug opportunity where it looks like their first go (trial paid for partially by partner) is going to be a winner. Great management as well so I was buying with them and hoping, and frankly it didn't take long, but some summer days kinda sucked!
Everybody is smiling big today. if you doubt, just look at the recent volume. The move from $3 to $4 came after the video of one of the patients came out where he is now lifting weights -- in 90 days. Talking, eating, writing. This guy signed his trial consent form by holding the pen in his mouth and others moved the paper.
Today's move up and strong close was because of the data. More to come.
Tim
DeepDive
8 년 전
Unbelievable news!!!
Dear BioTime Investor,
We have some encouraging news to share with you.
News that was released this morning by the University of Southern California offers hope to patients suffering from severe spinal cord injury. A team of doctors at USC are evaluating the safety and efficacy of AST-OPC1 as a therapy for spinal cord injuries. As reported, a paralyzed patient in the study regained the use of his arms and hands after treatment with AST-OPC1 in April. Asterias announced that it expects to report its interim efficacy data on September 14, during the 55th Annual Scientific Meeting of the International Spinal Cord Society (ISCoS), which is being held in Vienna, Austria.
This news is a big step forward and shows the power behind the “pluripotent” platform that BioTime and Asterias utilize for novel cell-based therapies. Restoring the level of function that could improve the neurological function and quality of life of patients with spinal cord injuries, is, we believe, just the start of what may be many important new therapies to come from this platform.
As we have said for some time, the power of pluripotent technology has the ability to provide a number of potential cell-based therapies. With this in mind, we remain strong believers in the Asterias team and its clinical pipeline.
Currently, BioTime holds approximately 48% or $61M of the outstanding common shares of Asterias Biotherapeutics (NYSE MKT: AST). Several news and media opportunities are expected on this news. Also, we expect future updates will be found on the USC media content center located at www.keckmedicine.org.
Here’s a link to all of the USC media, including the news release and b-roll:
http://www.keckmedicine.org/stem-cell-patient-media-assets/
stocktrademan
9 년 전
$AST recent news/filings
bullish
## source: finance.yahoo.com
Wed, 09 Sep 2015 11:00:00 GMT ~ Asterias Biotherapeutics Announces Publication of Preclinical Data that Supports the Safety and Use of AST-OPC1 as a Treatment for Spinal Cord Injury (SCI)
[PR Newswire] - MENLO PARK, Calif., Sept. 9, 2015 /PRNewswire/ -- Asterias Biotherapeutics, Inc. (NYSE MKT: AST), a leading biotechnology company in the emerging field of regenerative medicine, today announced the publication ...
read full: http://finance.yahoo.com/news/asterias-biotherapeutics-announces-publication-preclinical-110000096.html
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Tue, 08 Sep 2015 15:18:05 GMT ~ ASTARTA carries on programs of social and economic partnership
[at noodls] - As a responsible employer and lessee, agro-industrial holding ASTARTA is involved in improvement of living conditions in the regions where it operates. Within ASTARTA's Strategy of Corporate Social Responsibility ...
read full: http://www.noodls.com/view/D5CCB058BB45F1F56C17E7B773F27F83C2BE11C4
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Mon, 31 Aug 2015 11:09:44 GMT ~ Asterias's stem cell therapy shows promise in study
[Reuters] - Asterias Biotherapeutics Inc said initial data from a small study showed that its lead stem cell therapy could improve mobility in patients paralyzed by a spinal cord injury. Its success is a key step toward proving that embryonic stem cell research could cure diseases such as cancer, Parkinson's and serious health conditions such immune deficiencies, stroke and spinal injuries. Data showed that the severity of the spinal injury was reduced in the first patient and two other patients were able to resume their rehabilitation programs soon after being injected with the stem cells.
read full: http://finance.yahoo.com/news/asteriass-stem-cell-therapy-shows-110944358.html
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Mon, 31 Aug 2015 11:00:00 GMT ~ Asterias Biotherapeutics Concludes Recruitment of Initial Safety Cohort of the SCiStar Phase 1/2a Dose-Escalation Clinical Trial of AST-OPC1 for Complete Cervical Spinal Cord Injury
[PR Newswire] - MENLO PARK, Calif., Aug. 31, 2015 /PRNewswire/ -- Asterias Biotherapeutics, Inc. (NYSE MKT: AST), a biotechnology company focused on the emerging field of regenerative medicine, today announced that the third patient was successfully dosed at Chicago-based Rush University Medical Center in a Phase 1/2a clinical trial evaluating activity of escalating doses of AST-OPC1 (oligodendrocyte progenitor cells) in newly injured patients with sensory and motor complete cervical spinal cord injury (SCI).
read full: http://finance.yahoo.com/news/asterias-biotherapeutics-concludes-recruitment-initial-110000191.html
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Thu, 27 Aug 2015 11:30:00 GMT ~ Asterias Biotherapeutics to Present at Upcoming Investor Conferences
[PR Newswire] - MENLO PARK, Calif., Aug. 27, 2015 /PRNewswire/ -- Asterias Biotherapeutics, Inc. (NYSE MKT: AST), a leading biotechnology company in the emerging field of regenerative medicine, today announced that executives ...
read full: http://finance.yahoo.com/news/asterias-biotherapeutics-present-upcoming-investor-113000219.html
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$AST charts
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$AST company information
## source: otcmarkets.com
Link: http://www.otcmarkets.com/stock/AST/company-info
Ticker: $AST
OTC Market Place: Not Available
CIK code: 0001572552
Company name: Asterias Biotherapeutics, Inc.
Incorporated In: DE, USA
$AST share structure
## source: otcmarkets.com
Market Value: Not Available
Shares Outstanding: Not Available
Float: Not Available
Authorized Shares: Not Available
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$AST extra dd links
Company name: Asterias Biotherapeutics, Inc.
## STOCK DETAILS ##
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## FUNDAMENTALS ##
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Key Statistics (yahoo.com): http://finance.yahoo.com/q/ks?s=AST+Key+Statistics
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Balance Sheet (yahoo.com): http://finance.yahoo.com/q/bs?s=AST
Cash Flow (yahoo.com): http://finance.yahoo.com/q/cf?s=AST+Cash+Flow&annual
## HOLDINGS ##
Major holdings (cnbc.com): http://data.cnbc.com/quotes/AST/tab/8.1
Insider transactions (yahoo.com): http://finance.yahoo.com/q/it?s=AST+Insider+Transactions
Insider transactions (secform4.com): http://www.secform4.com/insider-trading/AST.htm
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Ownership Summary (nasdaq.com): http://www.nasdaq.com/symbol/AST/ownership-summary
Institutional Holdings (nasdaq.com): http://www.nasdaq.com/symbol/AST/institutional-holdings
Insiders (SEC Form 4) (nasdaq.com): http://www.nasdaq.com/symbol/AST/insider-trades
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## SOCIAL MEDIA AND OTHER VARIOUS SOURCES ##
PST (pennystocktweets.com): http://www.pennystocktweets.com/stocks/profile/AST
Market Watch (marketwatch.com): http://www.marketwatch.com/investing/stock/AST
Bloomberg (bloomberg.com): http://www.bloomberg.com/quote/AST:US
Morningstar (morningstar.com): http://quotes.morningstar.com/stock/s?t=AST
Bussinessweek (businessweek.com): http://investing.businessweek.com/research/stocks/snapshot/snapshot_article.asp?ticker=AST
$AST DD Notes ~ http://www.ddnotesmaker.com/AST
tradetrak
9 년 전
I can't even believe that they put this out as PR. Talk about OLD news. WTH... talk about a buzz kill.
Asterias Biotherapeutics Announces Publication of Preclinical Data that Supports the Safety and Use of AST-OPC1 as a Treatment for Spinal Cord Injury (SCI)
7:00 AM ET 9/9/15 | PR Newswire
Asterias Biotherapeutics, Inc. (NYSE MKT: AST), a leading biotechnology company in the emerging field of regenerative medicine, today announced the publication of a manuscript in Regenerative Medicine relating to AST-OPC1 (oligodendrocyte progenitor cells). The publication describes the results from preclinical safety studies that were submitted to the U.S. Food and Drug Administration (FDA) as part of an Investigational New Drug Application. AST-OPC1 is currently in a Phase 1/2a dose-escalation clinical trial for complete cervical spinal cord injury (SCI).
The preclinical results showed that AST-OPC1 cells did not cause any adverse clinical observations, toxicities, allodynia or tumors. AST-OPC1 exhibited robust persistence and limited migration within the thoracic and cervical spinal cord. In addition, AST-OPC1 demonstrated nerve growth stimulating properties and remyelinating properties that supported restoration of function in animal models.
"The positive preclinical results support the general safety of AST-OPC1 and indicate minimal risk of the transplanted cells reaching unintended locations," said Dr. Edward Wirth, Chief Medical Officer. "In addition, the results indicate that AST-OPC1, when administered during the subacute phase of SCI, can act through multiple repair pathways that are relevant to SCI, including trophic factor signaling, cavity reduction, and stimulation of axon outgrowth and myelination. We believe that the results summarized in this manuscript support the continued clinical development of AST-OPC1 as a subacute treatment for SCI."
The publication, titled "Preclinical Safety of hESC-Derived Oligodendrocyte Progenitors Supporting Clinical Trials in Spinal Cord Injury," appeared online ahead of the print edition of Regenerative Medicine. The majority of safety testing was conducted in nude rats subjected to thoracic SCI, providing a well-established model of the target clinical population, and additional tumorigenicity studies were conducted in uninjured SCID/bg mice. Importantly, these rodent models enabled testing of AST-OPC1 in a large number of subjects and in an immunocompromised environment that was permissive to human cell survival. Both of these attributes facilitated assessment of key safety concerns associated with AST-OPC1 administration, including the resultant biodistribution, toxicity, and tumorigenic potential of the transplanted cells.
"The breadth and depth of the preclinical studies now published provided the basis for a successful first-in-man Phase 1 study with AST-OPC1, and set up the foundation for overall safety in support of the use of AST-OPC1 in other neurological diseases, including multiple sclerosis and stroke," said Jane Lebkowski, President Research and Development and Chief Scientific Officer.