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I would lean towards "differentiated" based on our current master cell bank,
"We develop a stem cell line. In the current example of the derived RPE cell line, the embryonic cell line utilized our single blastomere technology. It was one of the first lines we developed. We utilize Good Manufacturing Practices to develop what is called a “Master Bank” of human embryonic stem cells. These cells are characterized and tested to insure they are truly hESCs. You should know that one of the scientific tests to determine that the cells are hESCs, is whether they can produce a teratoma or benign tumor. ALL hESCs must be able to do this. We then develop a “working bank” of these cells. They in turn are differentiated into a particular cell type. In this case, RPE cells. We develop a “master bank” of RPE cells, again utilizing Good Manufacturing Practices in our lab in Worcester. That Master Bank of RPE cells is characterized, tested for purity and is worked to the point where it is “terminally differentiated”. Meaning that they can NO LONGER revert back to an embryonic state. The best example I can think of it that: It is now a butterfly and NOT a caterpillar. We test the RPE cells for purity and to insure that NO residual embryonic stem cells still exist. They must be 99+% pure with no lingering hESC’s, period!"
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=53531326
License Agreements with CHA(for transfer to I-CELL board),
RPE Technology and more:
http://sec.gov/Archives/edgar/data/1140098/000114420409040583/v156251_ex10-128.htm
Single Cell Biopsy Technique
http://sec.gov/Archives/edgar/data/1140098/000114420409040583/v156251_ex10-129.htm
Thanks interstate,
Estimated Enrollment: 12
Study Start Date: April 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
http://clinicaltrials.gov/ct2/show/NCT01345006?term=stargardt&rank=2
bsm, yes, Roslin would have a "bank" of cells that can be purchased for research or commercialization. If commercialized then "Commercialization licenses will also provide access to the cell lines biologics master file in order to establish regulatory compliance. If set up the way the PR describes these cell lines would be ready to go straight from the lab into clinical trials. Remember also that currently no FED funding would be available using these cell lines although it does remove the ethical issue for some institutions.
bsm,
selling there Blastomere Technology?
Not 100% sure what your question is. The Blastomere technology may be licensed out as it was with CHA in Korea but definitely not sold. I am guessing you mean other researchers or companies wanting to use cell lines derived from the Blastomere technology? If so, the Roslin deal, yet to be finalized, was set up to do just that. Let me know if that answered your question..thanks
"ACT and Roslin Cells will publish a commercialization license so that third parties will have a reasonable and predictable path to commercialization of products using the same hESC lines that they may use in animal model studies for preclinical data. Commercialization licenses will also provide access to the cell lines biologics master file in order to establish regulatory compliance. Proceeds from commercialization licenses, including milestone and royalty payments, will be shared between ACT and Roslin Cells."
http://www.advancedcell.com/news-and-media/press-releases/advanced-cell-technology-and-the-roslin-institute-announce-agreement-for-storage-and-distribution-of-/
The continuing mail suggests many are confused with our relationships with CHA. I will try again to separate and clarify. Break it down in 2 sections, (1)JV and (2)Exclusive license agreements strictly for S.Korea
Joint Venture: SCRMI Stem Cell and Regenerative Medicine International
CHA holds a 60% interest, ACT 40%
Hemangioblast and Induced Pluripotent Stem Cells
Transfusable Blood Components:
Vascular Repair Cells:
http://www.steminternational.com/
License Agreement #1
RPE Technology for trials and commercialization in S.Korea
Total amount possible was $1.9MM...$1.4MM already paid
Numbers broken down here, http://investorshub.advfn.com/boards/read_msg.aspx?message_id=54720295
License Agreement #2
Blastomere Technology
Exclusive License to use and commercialize the Single Blastomere Technology in South Korea.
Total amount of $300K already paid.
mail ?'s..odds and ends,
"how long for before info hits clinicaltrials.gov?"
After a protocol record has been entered (or modified) and marked as ‘Complete’, it must be approved and released by a PRS administrator. From the time the record is released, it normally takes between 2 and 5 working days for internal quality assurance review and processing for publication on the ClinicalTrials.gov website. Records that contain Results may take up to 30 days.
http://healthcare.partners.org/phsirb/ct.gov_faqdetails.htm
"When is next financial due?"
Accelerated Filers:
10-Q: for Quarterly Period Ended 03/31/11 due Tuesday, May 10, 2011
"rock, are you sure ACTC doesn't share profits from Korean RPE trial?"
Under current agreement nothing whatsoever suggests a split of any kind. ACT was paid $1.4MM($500K more possible).
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=54720295
Dianne,
Any reason why RPE's would be ineffective with "wet" AMD?
Do we know why ACTC is working with "dry" versus "wet"?
Wet AMD is neovascular where unwanted blood vessels form causing damage. Stargardts and dry AMD are non-neovascular and do have similarities. Simply put, the years performing animal studies and preparing for the IND were geared to produce results towards Stargardts and dry AMD. As noted from a link 3 years ago ACT knew what they were shooting for. Dry AMD represents 90% of AMD market and Stargardts was chosen for Orphan benefits and early results. Both will be subretinal injections and appear to be complimentary in some forms to the end result. These are just a FEW points as to the why.
February 01 2008
" ACT is working with the agency to fulfill the FDA's requirements to bring its RPE cell therapy into human clinical trials for the treatment of retinal degenerative diseases such as Retinitis Pigmentosa, Stargardt's disease, and dry age-related macular degeneration (AMD)."
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=26460090
dharmbum,
Until we hear different I would think they are on track to meet the timeframe Rabin stated below in conference call.
"Based on our extensive calendar review, I therefore expect that we will begin both trials relatively contemporaneously, in late May or early to mid June."
nmbr1,
The NIH redefiniotion to allow our cell lines for FED funding is still in limbo. Just yesterday RABIN addressed the issue
Gary Rabin:
Well first of all right now our cell lines are not eligible for NIH funding, the definition of what would be an expectable cell line is still an open question in the US, and so obviously getting NIH funding would be helpful as we take the next set of therapies into the clinic, but we believe that the regulatory overhang of the embryonic stem cell companies has been eased a lot because of Geron success in getting their human trials to begin and ours to begin as well. It took Geron two-years to get through the agency to get approval to begin their human therapies, it took us one-year for our first but only 30 days for our second, so we think that the FDA is now coming to understand that if you have the proper assays, if you take the proper care that you are not going to inject undifferentiated embryonic stem cells or some short follower to that into a person's body we are focusing on developing therapies that can be used, that are safe from the perspective of teratomas and tumors and all those sorts of things that you might be worried about in undifferentiated cells, so we think the regulatory environment has got in a lot friendlier for us obviously the success of Geron safety trial and the success of our safety trial will raise the profile of this industry, it's an industry that for 10, 15-years there has been so much hope pinned on. In the United States there is this fellow Christopher Reeve who is superman and he had this spinal accident and ultimately died and it was around the time of his spinal accident that people became aware of the opportunities around stem cell science and now just this year 2011 we are actually going to see the reality of these things so it's very excited.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=62474597
Steve, you can go to this link and view a list of Market makers from March, it should help you..HDSN is Hudson Securities..
http://www.otcbb.com/asp/tradeact_mv.asp?Issue=actc&searchby=issue&sortby=volume&Month=3-1-2011&downloadname=mv201103.exe&view.x=35&view.y=8
Principal Investigator: Steven Schwartz, MD Jules Stein Eye Institute is involved recently with this trial also involving a Biological intervention. Not Yet Recruiting.
http://clinicaltrials.gov/ct2/show/NCT01327911?term=Neurotech&rank=6
About NT-501
NT-501 is one of Neurotech's lead product candidates under development and consists of encapsulated human cells genetically modified to secrete ciliary neurotrophic factor (CNTF). CNTF is a nerve growth factor capable of rescuing dying photoreceptors and protecting them from degeneration. NT-501 is designed to continually deliver a therapeutic dose of CNTF into the back of the eye in a controlled, continuous basis by means of the Company's proprietary Encapsulated Cell Therapy (ECT) platform. Delivery via ECT bypasses the blood-retinal barrier and overcomes a major obstacle in the long-term treatment of retinal disease.
About Encapsulated Cell Therapy
Neurotech's core technology platform is Encapsulated Cell Therapy (ECT), a unique technology that allows for the long-term, sustained delivery of therapeutic factors to the back of the eye. ECT implants consist of human cells that have been genetically modified to produce a specific therapeutic protein and encapsulated in a semi-permeable hollow fiber membrane. The diffusive characteristics of the hollow fiber membrane are designed to promote long-term cell survival by allowing the influx of oxygen and nutrients while simultaneously preventing direct contact of the encapsulated cells with the cellular and molecular elements of the immune system. The cells continuously produce the therapeutic protein which diffuses out of the implant at the target site. ECT enables the controlled, continuous delivery of therapeutic factors directly to the retina, thereby bypassing the blood-retina barrier.
http://www.drugs.com/clinical_trials/neurotech-s-nt-501-implant-slows-vision-loss-patients-geographic-atrophy-associated-dry-amd-11477.html
This is the all important step needed to begin recruitment and prepare the first human subjects for injection. Other sites gaining IRB approval can filter in anytime but this was the crucial one. The clinical trial process has begun..
"I am honored to be leading the clinical collaboration," said Steven Schwartz, MD, Ahmanson Professor and Retina Division Chief, at UCLA's Jules Stein Eye Institute and Principal Investigator of the trials.
(Steven Schwartz)
http://www.uclahealth.org/body.cfm?id=479&action=detail&ref=11817
ACT Announces UCLA Institutional Review Board (IRB) Approval of its Phase 1/2 Clinical Trials using hESC-Derived RPE Cells for t
Date : 04/28/2011 @ 8:00AM
ACT Announces UCLA Institutional Review Board (IRB) Approval of its Phase 1/2 Clinical Trials using hESC-Derived RPE Cells for t
Advanced Cell Tech (OTCBB:ACTC)
Intraday Stock Chart
Today : Thursday 28 April 2011
Advanced Cell Technology, Inc. ("ACT"; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that the Jules Stein Eye Institute at the University of California, Los Angeles (UCLA) has received institutional review board (IRB) approval to be a site for its Phase 1/2 human clinical trials for Stargardt's Macular Dystrophy (SMD) and Dry Age-Related Macular Degeneration (Dry AMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs).
"It is only appropriate that an institution with the global stature of UCLA's Jules Stein Eye Institute would be a site for the first-ever clinical trials using embryonic-derived stem cells to treat diseases of the eye, and we could not be more pleased," said Gary Rabin, interim chairman and CEO of ACT. "One of the world's foremost institutions for ophthalmology-related clinical trials, the institute represents an ideal partner for both trials, and we are eagerly anticipating starting them as soon as possible."
The Phase 1/2 trials will be prospective, open-label studies designed to determine the safety and tolerability of the RPE cells following sub-retinal transplantation into patients with SMD and Dry AMD.
"The outstanding scientific and leadership teams at ACT are extremely impressive. Together, our collaboration has led to both FDA and IRB permission to commence these trials. This signals the long-awaited societal and institutional 'green light' to take what will hopefully be a huge step forward into the realm of human stem cell science. I am honored to be leading the clinical collaboration," said Steven Schwartz, MD, Ahmanson Professor and Retina Division Chief, at UCLA's Jules Stein Eye Institute and Principal Investigator of the trials.
Enrollment criteria for patient selection will be posted at www.ClinicalTrials.gov in coming days.
About Dry AMD and SMD
Degenerative diseases of the retina are among the most common causes of untreatable blindness in the world. As many as thirty million people in the United States and Europe suffer from macular degeneration, which represents a $25-30 billion worldwide market that has yet to be effectively addressed.
Approximately 10% of people ages 66 to 74 will have symptoms of macular degeneration, the vast majority the "dry" form of AMD – which is currently untreatable. The prevalence increases to 30% in patients 75 to 85 years of age.
Stargardt's Macular Dystrophy (SMD) is one of the most common forms of macular degeneration in the world. SMD causes progressive vision loss, usually starting in children between 10 to 20 years of age. Eventually, blindness results from photoreceptor loss associated with degeneration in the pigmented layer of the retina, called the retinal pigment epithelium or RPE cell layer.
About Advanced Cell Technology, Inc.
Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.
About the Jules Stein Eye Institute
Established in 1966, the Jules Stein Eye Institute represents the culmination of a dream shared by ophthalmologist, businessman and philanthropist Dr. Jules Stein and his wife Doris, of creating a world-renowned center dedicated to the preservation of vision and the prevention of blindness. The Institute's comprehensive programs for the care of patients with eye disorders, research in the vision sciences, education in the field of ophthalmology and outreach to the community, coupled with its state-of-the art facilities, have brought national and international recognition to the Institute and UCLA. Many have contributed to this tradition of excellence and many more will carry it forward as the Institute continues its mission to advance ophthalmology worldwide.
It is nothing new if you put weight in FINRA numbers, I don't. Below are a few examples from last year.. Below examples are some questions you need to ask yourself before understanding those numbers.
50% aggregate shorting today.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=47412337
33%
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=47660585
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=58109113
FINRA: Accurate reporting?
One of the primary functions of broker-dealers is to act as intermediaries for investors that are buying or selling stock. Often, to carry out that function, broker-dealers will handle such investor orders on a riskless principal basis. A riskless sale is one in which a broker-dealer, after having received an order to sell a security, sells the security as principal, at the same price, to satisfy that order. Regulations require broker-dealers to mark their proprietary riskless sell order as short if they don't own the security, even if the customer order to sell the security is long. Since broker-dealers generally don’t maintain a position, a significant number of such riskless sales are reported as short, even though the customer is selling long, and the broker-dealer intends to and will buy the shares from the long selling customer immediately after the proprietary riskless short sale takes place. Typically, the broker-dealer's position is short for considerably less than one second.
Accordingly, the marking of sell orders as short by market makers, block positioners, and broker-dealers effecting riskless principal transactions may not always accurately reflect what has transpired, and publishing data derived from these transactions may not increase market transparency and bolster investor confidence. FINRA appears to acknowledge these constraints by noting in the filing that
"information relating to market maker [or supplemental liquidity provider] status is not currently included in the trade report submission; thus, FINRA currently is unable to separately identify the trades of equity market makers [and supplemental liquidity providers] in the monthly short sale transaction file
the number represents "The mid-month short interest report is based on short positions held by members on the settlement date of the 15th of each month."
"raise an eyebrow"? Not a bit, it would akin to saying our institutional ownership is HUGE..:)
Twaro,
This is alarming information, that is an inordinate amount of shares being shorted:
Actually, it is peanuts and amounts to nothing. It represents about 2/10ths of 1% of our float. Look and see what percentage of the float is short interest for our competitors..
mail ?,
"because of ACT's "no harm to embryo" process the Europe potential ban does not apply to us, correct?"
Not true according to this statement,
"In Europe, regulations regarding embryonic stem-cell research differ from country to country. However, a ruling on Mar. 10, 2011, by the European Court of Justice of the European Communities denied patents on ES cells to Oliver Brüstle of the University of
Bonn on ethical grounds. The court found that even if cell lines could be established without the destruction of embryos, the commercialization of human embryos was unacceptable, and contrary to public policy. This ruling may push European countries to adopt restrictive policies regarding embryonic stem cells and inhibit the development of ES-based therapies."
http://stemcellresearchformichigan.com/media/news/PharmaTech.NewChallengesUseofEmbryonicStemCells.3.31.2011.pdf
That would be the case. This is directly from the confernce call as stated by Rabin.
"This lead clinical partner has nearly completed approval work on it's university's institutional review board, which has not raised any significant issues, and we expect their final approval within about two weeks.. Once the approval is received, the trial will be listed on the clinicaltrials.gov database, a service of the NIH. At that time, we will begin officially recruiting patients, though we and our clinical partners have been inundated with requests from patients to participate in the trials.
from today
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=62474325
application was known since last fall
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=56371927
In addition to this article posted a while back, ESC's in EU,
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=62148955
another one out today
http://www.reuters.com/article/2011/04/27/europe-stemcells-scientists-idUSLDE73Q1AR20110427
bsm,
Gary Rabin on Pharma Television 27 April 2011
In this episode of PharmaTelevision News Review, Fintan Walton talks to Gary Rabin, Interim Chariman and CEO of Advanced Cell Technology
http://www.pharmatelevision.com/PTVGUide.aspx
http://investorstemcell.com/forum/advanced-cell-technology/803.htm
Jon, with regard to my comments today on IRB, this is the chain of events leading to what I stated.
March 21 conference call
"This lead clinical partner has nearly completed approval work on it's university's institutional review board, which has not raised any significant issues, and we expect their final approval within about two weeks."
When that time period more than went by, poster Interstate received the following mail from Rabin.
April 8
"The lead clinic has an IRB board meeting to approve the trial end of next week. They had some kind of scheduling issue. We can't announce the agreement and post on clinicaltrials.gov until they get formal board approval. Soon!"
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=61863211
That meeting would have been April 14-15. If approved, trial data would have appeared on clinicaltrials.gov in approx. 2-5 days. Nothing to date on the site. All of the above were what my comments were based on.
interstate and all,
I e-mailed the PRS administrators who review all clinical trial info submitted to clinicaltrials.gov to see if I could roust anything out of them but they replied saying only ACT could verify that. It would seem after the e-mail you received from Rabin,
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=61863211,
one of two things happened.
a)lead clinic did not grant IRB approval at meeting that Rabin suggested.
b)approval received and sent to clinicaltrials.gov and PRS reviewed and did not accept.
I would tend to go with "a"...jmo
Yes, but it is strictly in regards to SCRMI, not the separate exclusive deals for South Korea.
mail ?,
"rock, lots of talk on other boards in regards to a JV in South Korea with CHA and possibly filing an IND? Your thoughts on this?"
To be blunt, it makes no sense. Given the following, why would CHA need to JV with ACT when CHA has the exclusive to develop and commercialize in South Korea? CHA has paid $1.7MM for these licenses and has the muscle to pursue themselves. So what would be the reason for a JV with ACT when they have license to it all? It certainly isn't for ACT's clinical trial experience..:)
CHA could file an IND for RPE anytime but maybe they would like to see things move forward here prior to spending the coin for trials there?. They have everything they need to pursue on their own, imo..
Exclusive License Agreement for ACTC's Single Cell Biopsy Technique..
Cha paid ACT $300K
Exclusive License Agreement for ACTC's RPE Technology, SCNT technology and other technical info...
CHA paid ACT $1.4 Million to date. Another $500K due ACT if CHA receives Korean grant for no less than $7.5 Billion WON.
you are waiting on info from a trial in application process while most wait the start of 2 trials already FDA cleared months ago..got it..:)
"info from the ongoing 2nd trial."
That is in reference to what?
stock options have to be exercised(purchased) before you are considered an owner. Once purchased they are voting shares.
The following upcoming events(S.Korea and Boston) with ACT/SCRMI reps involved was mailed to me for posting..thanks Jon
April 26 - 28, 2011
Boston, MA
World Stem Cells for Drug Developers Summit
Overcoming the Practical and Scientific Challenges of ESC and iPS Cell Models
Speaker: Shi Jiang Lu Senior Director
Advanced Cell Technology
http://stemcells-drugdevelopment.com/speakers
April 29-30, 2011
JW Marriott, Seoul, Korea
The 3rd International Collaborative Symposium on Stem Cell Research
Robert Lanza
Kwang-Soo Kim
http://www.chastemcell.com/2011/
sports,
Not sure how to frame my response but will give it a shot. Going back a couple years ACT repeatedly made the case that starting with the SMD trials "was the only practical choice" and "Highest likelihood of seeing signal in phase I" made a ton of sense to me. I saw it as the road map to the AMD trials and was hopeful the SMD patient treatment would be well underway with some positive indications in place prior to EU trials and even the AMD trial in the States. I perceived this as important, logical and agreed with ACT this was the prudent pathway. As it stands now, we could have 3 or possibly even 4 trials underway simultaneously. Wonderful if everything goes as planned, not so if it doesn't. Some might say it's because they "know" it will work. I would respond by saying 85% of all clinical trials do NOT get past Phase 3 and receive NDA approval and I am sure most of the 85% did not spend 10's of millions of dollars without being just as confident. With that said, I await info on clinicaltrials.gov to get the ball rolling here in the US to treat a patient...jmo
1)Orphan Drug Designation
• Stargardt’s Disease is the only practical indication with which to begin clinical trial
• Highest likelihood of seeing signal in phase I.
2)ACT has obtained Orphan Drug Designation in United States
Significance of Market Exclusivity: Barrier to Entry
The only practical choice for first clinical trial involving
RPE cells for macular degeneration.
Clinical trial sites:
Any of the 6 sites PR'd by ACT are respectable institutions that could do the job. In response to mail on "why I feel it might be Casey Eye"...Because there is no clinical site that has been more involved over the past 4 years preparing all of the preclinical studies needed for IND approval. Dr. Raymond Lund has been involved from the start and has even been involved with ACT writing research reports on Long Term Safety of RPE hESC's. Below are just a few links supporting MY notion that Casey would be the logical first choice. No matter who it might me, it is time. In January we were close or had a deal done, otherwise the following would NOT have been inserted in Rabins PR...
"Specific inclusion and exclusion requirements and Investigator contact information will be posted shortly at clinicaltrials.gov. Patients and their caregivers should refer to this source rather than contacting ACT or its representatives."
Casey Eye Institute
(2007)
Advanced Cell Technology, Inc. (OTCBB:ACTC) today announced that it has entered into a sponsored research agreement with Oregon Health and Science University. The Company is collaborating with Dr. Raymond Lund, Dr. Richard Weleber and Dr. Peter Francis at the Casey Eye Institute to conduct preclinical studies for its Retinal Pigment Epithelium ("RPE") Program. Specifically, the research team is conducting a dosage study utilizing the Company's RPE cells in the Royal College of Surgeons ("RCS") rat model and plans to conduct similar studies in other rodent models of retinal degenerative disease. The Company is also in discussions with the Oregon Health and Science University team in regard to future plans for a Phase I human clinical trial.
(2007)
RESEARCH SERVICES AGREEMENT BETWEEN OHSU AND ADVANCED CELL TECHNOLOGY, INC.
http://www.sec.gov/Archives/edgar/data/1140098/000104746907002240/a2176695zex-10_100.htm
TO PRINCIPAL INVESTIGATOR: Raymond Lund
Raymond Lund, Ph.D., a scientific collaborator with ACT, and considered one of the world’s foremost experts in retinal cell physiology and vision restoration, commented, “The study results of ACT’s RPE cells implanted in the various animal models of macular degeneration was phenomenal. If ACT observes even a fraction of that benefit in humans, it will be nothing short of a home run."
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=56967329
(DEC, 2010)
Our research team forged a relationship with Raymond Lund, PhD, considered to be one of the world’s foremost experts in vision restoration and retinal cell physiology, when he was at the Moran Eye Institute and subsequently followed him to the Casey Eye Institute at Oregon Health & Sciences University (OHSU). At OHSU, preclinical “Proof of Concept” and efficacy work was conducted utilizing Dr. Lund’s proprietary Royal College of Surgeons (RCS) rat model for retinal disease.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=57445243
Long-Term Safety and Function of RPE from Human Embryonic
Stem Cells in Preclinical Models of Macular Degeneration
BIN LU,a CHRISTOPHER MALCUIT,b SHAOMEI WANG,a SERGEJ GIRMAN,a PETER FRANCIS,a LINDA LEMIEUX,b
ROBERT LANZA,b RAYMOND LUNDCasey Eye Institute, Oregon Health and Science University, Portland, Oregon; Advanced Cell Technology,
Worcester, Massachusetts, USA
http://onlinelibrary.wiley.com/doi/10.1002/stem.149/pdf
It is no secret that Jules Stein was under consideration from January PR. If Jules was the lead clinic that was suppose to have an approval meeting last week, and did approve IRB, then we will know well before May. Once IRB approval is in and info is sent to clinicaltrials.gov, it still takes 2-5 days for PRS to review/process and publish. I am not saying Jules is the "lead clinic", we will know WHO when published. If I had to guess, I would say author posted premature info. In order for a trial TO BE conducted at Jules, IRB approval is needed. All clinical sites involved with trials will need IRB approval.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=61561497
(January PR for dry AMD)
The Phase I/II trial will be a prospective, open-label study that is designed to determine the safety and tolerability of the RPE cells following sub-retinal transplantation into patients with Dry AMD. Twelve patients will be enrolled in the study at multiple clinical sites. Sites currently under consideration are the Jules Stein Eye Institute at UCLA, and the Ophthalmology Department at Stanford University School of Medicine. Additional sites may be considered.
rumit and all,
If you click the link now, this does NOT appear"and conducted at U.C.L.A.’s Jules Stein Eye Institute"
http://www.scientificamerican.com/article.cfm?id=a-cure-within-sight
euro and all,
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=62151829
I made the following statement this weekend in a reply to poster euro,
as of approx. one month ago, we had about 117MM .10 warrants that had not yet been exercised.
After refiguring, the number of 10 cent warrants not yet exercised would be approx. 70-90MM. The 117MM would include warrants NOT in the money. Next filing should zero in on it..
ACT also has granted CHA Exclusive license for RPE Technology(SCNT and Blastomere) which is spelled out in this post.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=54720295
sports,
the $300K represented the entire payment due under agreement. The agreement took place May 8, 2009.
ACT granted CHA Biotech an Exclusive License to use and commercialize the Single Blastomere Technology in South Korea. Total payment to ACT for Exclusive License was $300,000.
Twaro and farvie,
Twaro,
"We have had a lot of interest in the company by institutional biotech/healthcare investors, many of which cannot buy stocks on the OTCBB or sub $1, $2, and $5 equities."
Yes, that e-mail was posted here prior.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=61190236
The quote above is akin to saying if I had $100K in a bank savings account the bank will give me a much better interest rate than the $1000 I now have. Also note that quote was tied into the context of a RS. I am well aware of the "reasons" institutions are not loading up and have suggested in many posts here I did NOT expect it to happen contrary to what others here were saying. This is one of many posts that detail just that.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=58314841
Yesterdays post only indicated I thought it would be more than the paltry 700K shares that it is. With the OS# where it is it would take 15MM shares to equal 1%. I have been a strong advocate of an uplist with institutional ownership being one of the many advantages.
farvie,
As I recall, almost three years ago, such was not the case for Geron, prior to their phase I?
Geron was a big board stock, not a penny stock trading at less than .20 with a boat load of shares....huge difference
I also understand the "timing" of an uplist. Had we made the move in January it would have been a rough road as trials have not even begun. The idea that ACT cleansed the books to be a good looking OTC:BB stock wasn't the plan or goal. I respect the opinions of some here who believe we can make it to a big board on our own with a $3-$4 share price and deep down I hope they are right, I for one do not believe we can. A $4.5-$6 Billion market cap is unrealistic,imo, on the OTC.
At some point in time when trials are underway and efficacy progression reports trickle in I would suggest the uplist will take place "not to alienate the bigger players" whom all stocks need and can make a huge difference. If we truly are "a leader in the field of regenerative medicine" as all PR's indicate, then a move is warranted where true recognition can be realized. I hope sooner than later we can trade in one cent increments and not 4 digits...:)
"We have had a lot of interest in the company by institutional biotech/ healthcare investors, many of which cannot buy stocks on the OTCBB or sub $1, $2, and $5 equities. Obviously, at some point in the future, if it is advantageous for us to do RS (and only if!), we would consider it, but in the meantime, we do not want to alienate our many shareholders. I think you can see that we are running this company for a big future, not for short term movements in the stock."