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for those asking,
Bristol Investment Fund is the party receiving shares. They are a Hedge Fund out of the Cayman Islands. They have been involved with ACT financing for many years.
Bristol Capital Advisors are the investment manager of Bristol Investment. Paul Kessler is the manager of Bristol Capital Advisors LLC and director of Bristol Investment Fund, Ltd.
They were the 2nd plaintiff in this case but Judge ordered them into arbitration with ACT. They argue they entered into a consulting agreement and obtained a warrant to purchase 500K shares. They delivered Two Notices of Exercise in Jan of 2009 and feel they are entitled to approx. 7.5MM shares. I have no clue how this arbitration went or if it is still ongoing. It is spelled out here.
https://iapps.courts.state.ny.us/fbem/DocumentDisplayServlet?documentId=Wi6ATK7yODUVX0UbFWK3rQ==&system=prod
Example of 144 filed by Bristol Investment in 2008 with ACT
http://msnmoney.brand.edgar-online.com/EFX_dll/EDGARpro.dll?FetchFilingHTML1?ID=5692664&SessionID=3WeKWZDeTZly779
elk,
I understand the orders to indicate the shares ACT delivered were the same as the Judges Order...49.9MM shares I would be surprised if it is any less. I actually hope more wasn't added for compensatory damages or something. What I mean can be seen in Alpha settlement below. They not only gave them all the 2 cent shares the judge ordered but gave them another $110K Debenture under same terms...
(from todays filing with Bristol)
"Ordered, that the portion of ORDER requiring delivery of shares be,
and the same hereby is, vacated"
ALPHA
On June 30, 2009, Alpha Capital submitted a conversion notice in the principle amount of $150,000 into 7,500,000 shares of common stock at $0.02 per share. The Company did not have sufficient authorized shares to satisfy this conversion notice. On July 6, 2009, by means of a settlement between the 2 parties, the Company agreed to deliver the 7,500,000 shares of its common stock no later than September 25, 2009. Further, the Company agreed to provide Alpha Capital with an additional $110,000 Debenture, which is to be upon the same terms and conditions as the April 2008 Debenture.
Bristol vs ACT update:
Settlement agreement reached September 30,2010
Defendenants have delivered certain shares to plaintiff
Order requiring delivery of shares is vacated
plaintiffs bond discharged
STIPULATION OF DISCONTINUANCE
https://iapps.courts.state.ny.us/fbem/DocumentDisplayServlet?documentId=4NpRAMSzDUCnIV9EUjMpaw==&system=prod
PROPOSED ORDER
https://iapps.courts.state.ny.us/fbem/DocumentDisplayServlet?documentId=4NpRAMSzDUCKalRpJ5Zm9w==&system=prod
Lanza's selling is pre-arranged. Scheduled to terminate on the earlier to occur of October 19,2010.
http://www.sec.gov/Archives/edgar/data/1140098/000101376210000926/form8k.htm
Chae,
Absolutely there is hope for success.
so many forces against us?
What "forces" are you speaking of?
Aronson would not be one of them in the context of that time period. I guesss one could choose any of the following.
Outboard/CEOCAST part of massive payoff below
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=46152818
"Between September 29, 2008 and January 20, 2009, the Company settled certain past due accounts payable by the issuance of shares of its common stock. In aggregate, the Company settled $1,108,673 in accounts payable through the issuance of 260,116,283 shares of its common stock".
ALPHA CAPITAL
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=42931396&txt2find=alpha
(page 90)
On September 19, 2008, the Company was delivered judgment with respect to the landlord of its Charlestown, Massachusetts site over unpaid lease amounts. The Company failed to make its monthly lease payments after December 2007, which constituted an event of default under the lease agreement. Accordingly, the Company settled with the landlord in total of $1,751,543 for unpaid rent expenses, attorney fees, interest and damages for unpaid rent incurred through September 9, 2008. The Company abandoned its fixed assets at this site upon vacating the space, and recorded a loss on disposal of fixed assets amounting to $227,543 in its accompanying consolidated statement of operations during the year ended December 31, 2008. The Company accrued the remaining balance for the portion of damages incurred from January 1, 2008 through September 30, 2008 in accrued expenses its accompanying balance sheet at December 31, 2008, net of one payment of approximately $147,000. As of December 31, 2009, the Company had paid the entire amount under the judgment, plus approximately $104,000 in interest, and no longer has any obligations with respect to this judgment.
http://www.sec.gov/Archives/edgar/data/1140098/000114420410013897/v177442_10k.htm
harlem,
A settlement is in the works and should be done shortly if it isn't already. Will the 49.9MM shares the Judge ordered ACT to issue be it, or will there be more added like Alpha? Will it disrupt the restructuring and refinancing agreed to by the "supermajority"(96.8% of note holders)? This is the 3rd lawsuit on this subject, maybe ACT needs to tighten up their contracts so this isn't a problem. Alpha won, Bristol won and Aronson dropped their suit one day before trial but cost ACT around $600K which they are appealing after being denied court costs...
Alpha Capital
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=42931396&txt2find=alpha
Bristol vs ACT update,
ACT withdrew their Appeal from ORDER issued Aug. 31, 2010
October 5, 2010
NOTICE OF WITHDRAWAL OF NOTICE OF APPEAL
https://iapps.courts.state.ny.us/fbem/DocumentDisplayServlet?documentId=4NpRAMSzDUAA/pgXSfabmw==&system=prod
JUDGES ORDER is on page 18 here
https://iapps.courts.state.ny.us/fbem/DocumentDisplayServlet?documentId=4NpRAMSzDUDHsTBmogGisg==&system=prod
Prior post on Bristol VS ACT
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=54999956
You have been saying the same thing for 2 years now, how have all those predictions fared so far? Evil MM's, nothing else matters..lol
Mail,
Folks, I do not have any definitive answers as to why the pps is doing what it is except to say the selling pressure is there as it has been for years. Once again, the monthly redemptions went out last Friday. According to info below you can probably figure 9-10MM shares. Even though the principal amount is lower the pps is also much lower so the above number is probably close. We have plenty of pressure now so I really hope the Bristol case doesn't allow another 50MM shares to go off at .02 per share..
from 10Q..redemptions for first 6 months
Issuance of 57,505,561 and 0 shares of common stock in redemption of debt
morning elysse,
As with any stock I own I would fall into the cautiously optimistic category. It would be difficult for me to fall into the "optimistic" category considering we are working with the FDA, NIH issues and the constant battle to obtain respectable funding or project partners.
As most have noticed it doesn't matter what ACT PR's of late we get no traction. As mentioned many times prior I believe this is a result of the past 10 years and crdedibility remains a huge issue here. As Caldwell has stated many times it is important for them to validate their technology via clinical trials. I agree 100% with that statement but would add the Company itself needs to be validated, not just their technology. Moving to trials and producing positive results would begin to take care of both issues, imo. Validation as a serious player in the biotech field would also open up different avenues for funding/partnerships which will be sorely needed if the AMD "dovetails" off the SMD. There is no way we could continue with more of the current CD financing and billions of shares and still be considered in the marketplace.
Good things have happened with ACT since they became SEC compliant again but one would be hard pressed to believe it if you only looked at the pps...moving into trials won't solve everything but it would help in a big way..cautiously optimistic is where I stand.
yep, "live and learn": http://investorshub.advfn.com/boards/read_msg.aspx?message_id=54933965
rumit,
question 1) for now I have no comment as I have not looked into the subject at all.
2) Regarding the Myoblast program that we are dusting the cobwebs from. In 3 years (Oct 07 to now) we have yet to be able to attract any funding for this program, despite seemingly fantastic results. While the optimistic among us may think that we may be close to getting funding, the pessimistic among us are more doubtful. Now that we have 400MM shares available, do you think we will resort to selling shares to fund a P2?
Nope, not near enough shares available to fund the $18MM from prior post + another $15MM or so for Myoblast restart considering the current PPS under the present financing terms.
Jon,
ACT has 1.75 Billion shares authorized. How quickly the shares will be used depends on how soon they cash in the available financing they have and more importantly at what price. It would also be a mistake to use the 1.75B as the starting number. Using a figure of 1.4B-1.5B would be much closer to reality. The warrants alone represent 230+MM shares and all these type items must be kept in reserve(not used) for contractual obligations.
With the above in mind we currently have about 400-500MM shares available for issue. Below, from last 10Q, you will see approx. $18MM in funding was available as of June 30. Example, if funding was all converted at 10 cents that would represent about 180MM shares. If converted at 5 cents it would be 360MM shares. As you can see it makes a huge difference. Plus you need to subtract the monthly redemptions(about 10MM shares/month) as well as other conversions. So, once again it depends on how quickly funding is needed and converted and at what price. Bottomline, at current pps they disappear very very quickly.
(from 10Q)
During 2010, we received cash proceeds of $2,650,000 in convertible promissory note financings with JMJ Financial. As of June 30, 2010, $3,520,000 remains available to us.
· During 2010, we received $1,685,000 from the 2009 convertible debenture. The convertible debenture contains an Additional Investment Right that allows the Company to receive an additional $3,483,000 in funding.
· During 2010, we received $830,165 from the issuance of our Series A-1 convertible preferred stock credit facility. The facility allows for a maximum placement of $5,000,000.
· During 2010, we received $1,985,000 from the issuance of Series B preferred stock. The agreement allows for a maximum placement of $10,000,000.
north4000,
thanks, that is interesting. I live 20 minutes from where Infigen headquarters was/is and use to know some of the players there. I made several visits to the ABS facility to see the tremendous breeding cattle they had at the time. Below is a link that gives a pretty detailed summary of what took place in the lawsuit. Thanks ...
http://www.lexisone.com/lx1/caselaw/freecaselaw?action=OCLGetCaseDetail&format=FULL&sourceID=bdihja&searchTerm=ehfK.aija.aadj.eeOj&searchFlag=y&l1loc=FCLOW
Lawsuit: Bristol Investment Fund VS ACT Update,
(August 31, 2010)
Judge ordered preliminary injunction granted in part.
ACT ordered to deliver 2.5MM shares at .02 per share(convertible debenture) and 47.4MM shares at .02 per share for (warrants)
https://iapps.courts.state.ny.us/fbem/DocumentDisplayServlet?documentId=4NpRAMSzDUDHsTBmogGisg==&system=prod
(Sept.9, 2010)
ACT files Appeal
https://iapps.courts.state.ny.us/fbem/DocumentDisplayServlet?documentId=4NpRAMSzDUC+iZAzv3o9zA==&system=prod
(Sept 9, 2010)
Plaintiff posts $100K Bond
If decided plaintiff was NOT entitled to injunction plaintiff will pay defendant all damages and costs.
https://iapps.courts.state.ny.us/fbem/DocumentDisplayServlet?documentId=4NpRAMSzDUDKozhAGIhypA==&system=prod
(September 28, 2010)
Status conference held, another scheduled for Oct.
http://iapps.courts.state.ny.us/iscroll/Appearances.jsp?IndexNo=600730-2009
Lawsuit described from last 10Q..page 30
Bristol Investment Fund, Ltd. and Bristol Capital, LLC v. Advanced Cell Technology, Inc. and Mytogen, Inc. (Supreme Court of the State of New York, County of New York): On March 9, 2009, plaintiffs filed a complaint and summons in the Supreme Court of the State of New York, County of New York against the Company and its subsidiary Mytogen, Inc. Plaintiffs’ complaint alleges, among other things, that the Company has breached the terms of certain contracts with plaintiffs; namely, convertible debentures and a consulting agreement. Plaintiffs seek preliminary and permanent injunctive relief directing the Company to deliver to plaintiff Bristol Investment Fund, Ltd. (“Bristol”) 2.5 million shares of its common stock, declaring a conversion price of $0.02 for the convertible debentures held by plaintiffs, and directing the Company to honor plaintiff’s future conversion requests. Plaintiffs also seek compensatory damages in an amount to be determined at trial, but alleged in the complaint to exceed $1.5 million. On May 1, 2009, the Company filed an answer to plaintiffs’ complaint. On May 13, 2009, the Company filed a motion to stay the action and to compel arbitration of all claims by Bristol. The court has not yet ruled on the Company’s motion to stay the action and to compel arbitration. On or about September 16, 2009, plaintiffs filed an order to show cause, seeking the issuance of a preliminary injunction directing the Company to deliver to Bristol 2.5 million shares of its common stock pursuant to a convertible debenture and 47.4 million shares of its common stock pursuant to common stock purchase warrants, declaring a conversion price of $0.02 for the convertible debenture held by plaintiffs, and enjoining or restraining the Company from issuing shares of its common stock to any entity other than plaintiffs or the other holders of convertible debentures. On September 25, 2009, the Company submitted its response in opposition to plaintiffs’ motion and moved by cross-motion for dismissal of the complaint, based on the terms of the consent, waiver, amendment and exchange agreement entered into between the Company and the holders of over 95% of the outstanding principal amount of the Amended and Restated Debentures. The court has not yet ruled on the respective motions. The Company intends to continue to contest the case vigorously.
rumit,
Delaware Corp. Law on Annual Meetings
http://delcode.delaware.gov/title8/c001/sc07/index.shtml
ACT has their bylaws set up in such a fashion that "special meetings" and "annual meetings" are basically the same in meaning. So, when a special meeting is called it counts as an annual meeting.
(below is only partial info)
BY-LAWS OF
ADVANCED CELL TECHNOLOGY, INC.
ARTICLE I
STOCKHOLDERS
1.1 Place of Meetings. All meetings of stockholders shall be held at such place as may be designated from time to time by the Board of Directors, the Chairman of the Board or the President or, if not so designated, at the principal office of the corporation.
1.2 Annual Meeting. The annual meeting of stockholders for the election of directors and for the transaction of such other business as may properly be brought before the meeting shall be held on a date and at a time designated by the Board of Directors, the Chairman of the Board or the President (which date shall not be a legal holiday in the place where the meeting is to be held). If no annual meeting is held in accordance with the foregoing provisions, a special meeting may be held in lieu of the annual meeting, and any action taken at that special meeting shall have the same effect as if it had been taken at the annual meeting, and in such case all references in these By-laws to the annual meeting of the stockholders shall be deemed to refer to such special meeting.
1.3 Special Meetings. Special meetings of stockholders for any purpose or purposes may be called at any time by the Board of Directors, the Chairman of the Board or the President, and shall be called by the President or, in his absence or disability, by a vice president or by the Secretary upon the written request of the holders of not less than one-tenth of all the shares entitled to vote at the meeting, such written request to state the purpose or purposes of the meeting and to be delivered to the president, each vice president, or secretary. In case of failure to call such meeting within 60 days after such request, such shareholder or shareholders may call the same. Business transacted at any special meeting of stockholders shall be limited to matters relating to the purpose or purposes stated in the notice of meeting.
http://www.sec.gov/Archives/edgar/data/1140098/000110465905049818/a05-17557_1def14a.htm
This is ACT's description of the Myoblast program from shareholder letter in 2007..
Myoblast Program
Milestones:
* Acquired Mytogen, Inc., and its Myoblast therapy for the treatment of heart failure. Therapy successfully completed Phase I human clinical trials.
* Presented 6-month data at TCT 2007 demonstrating safety and improvement in heart failure measures.
* Presented 12-month data at the AHA’s 2007 conference in Orlando demonstrating safety and persistence of therapeutic effect over an extended period of time.
* Entered into a letter of intent with Catholic Healthcare West for a proposed exclusive business arrangement to establish a clinical trial research site and a North American regenerative medicine interventional cardiology training center for our Phase II Myoblast clinical trial.
* Pursuing international partnerships for Phase II human clinical trials.
* On schedule to begin Phase II human clinical trials at eight sites shortly.
We acquired our Myoblast Program in connection with our acquisition of privately-held Mytogen, Inc., which closed in September 2007. The myoblast therapy involves transplantation of expanded autologous myoblasts derived from a small biopsy of skeletal muscle from a patient’s leg. The myoblasts are expanded into hundreds of millions of cells over a period of three weeks and then transplanted back into the patient’s scarred heart tissue via a catheter-based procedure. The Myoblast Program to date has successfully completed four Phase I human clinical trials utilizing the therapy safely in over 40 patients. While the successful Phase I human clinical trials were focused on the safety of the therapy, the clinical data from those trials suggested that the myoblasts can improve heart function that leads to an improved quality of life for the patient.
In October and November of this year, Dr. Nabil Dib, one of the principal investigators for our Myoblast Program, presented 6-month and 12-month data for the program at TCT 2007, a leading interventional cardiology conference, and at the American Heart Association’s annual meeting in Orlando, Florida, respectively. The two sets of data: 1) demonstrated myoblast safety with no evidence for increased risk of arrhythmia; 2) distinguished the ACT Myoblast Program as the leader in the industry as it is the only program not required to use anti-arrhythmia medications and/or an implanted defibrillator device; 3) showed that the effects of ACT’s myoblast therapy persisted for an extended period of time, an effect that has not been demonstrated by any other cellular therapy for heart disease; 4) provided evidence that the hearts of the patients that received the therapy showed less cardiac remodeling in comparison to controls, remodeling being a progressive enlargement of the heart that signifies worsening of function; and 5) that by using the ACT technology doctors have for the first time the opportunity to successfully replace scarred heart tissue with healthy muscle via intracardiac injections of autologous skeletal myoblasts.
We are on schedule to begin the Phase II human clinical trial for the treatment of heart failure in approximately 160 patients. In that light, we entered into a letter of intent with Catholic Healthcare West, America’s eighth largest hospital system, for a proposed exclusive business arrangement to establish a clinical trial research site and a North American regenerative medicine interventional cardiology training center for our Phase II Myoblast clinical trial. In addition, we are actively pursuing international partnerships to investigate our Myoblast Program and to commence international Phase II human clinical trials for the novel therapy. If the Phase II trials prove successful, we will proceed with a pivotal Phase III trial.
According to the National Heart, Lung, and Blood Institute (NHLBI), a division of the National Institutes of Health (NIH), approximately 5 million people in the United States have congestive heart failure (CHF) and an estimated 400,000 new cases are diagnosed each year. Roughly 50% of CHF patients die within 5 years. The annual number of deaths directly from CHF increased from 10,000 in 1968 to 42,000 in 1993, with another 219,000 related to the condition. CHF is the first-listed diagnosis in 875,000 hospitalizations, and the most common diagnosis in hospital patients 65 years and older. Consequently, we are excited by both the market opportunity for our Myoblast Program as well as the potential to help the growing number of patients suffering from heart failure in the United States and abroad.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=25574968
rumit,
Advanced Cell Technology, Inc. (the "Company") held its Annual Meeting of Stockholders on December 28, 2007 at 10:00 a.m., at the offices of Pierce Atwood LLP, One Monument Square, Portland, ME 04101
last post on subject,
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=52946073
prior to that,
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=46288263
someone mailed this link to me,
http://www.thechairmansblog.com/william-caldwell/2008-09-advanced-cell-ceo-blog.html#respond
rumit,
I really don't view the recent events as a change in strategy. The hESC IND has been presented to the FDA and ACT responded. Until the FDA is satisfied we remain on clinical hold. How long is anyones guess.
The Mytogen adult stem cell trial has been in our fold since 2007. They have been looking to fund this Phase 2 trial for years and todays PR indicates they still haven't. I see it as something to be worked on and of course ACT put out another time line for next year but not a top priority in the near term, imo.
iPSC's, I find this one the most interesting from a news standpoint.
1)About a year ago Caldwell said "It is still in the early stages of what I classify as a “science project”.
2) In February ACT files research report " News reported that a range of therapeutic cell types obtained from induced pluripotent stem (iPS) cells exhibit abnormal expansion and early cellular aging." ESC's are the way to go.
3)In order for SCRMI to receive the $1.9MM they needed to apply about March..About one moth after the above.
As the 60/40 JV suggests, CHA is likely to be calling the shots to move forward and not totally all Lanza/ACT. They own the majority and including the iPSC's along with the hemangioblast program is a good thing, imo.
Back to the strategy topic. Take out the CHA JV news and we only have the adult stem cell Mytogen news which has been here a long time. The "laser focus", imo, is still on the RPE trials but in the meantime we talk/promote something else.
Info from last 10K,
Mytogen acquired IP assets from GenVec and Diacrin.
GenVec Agreement - On December 28, 2005, Mytogen and GenVec, Inc. entered into a patent assignment and security agreement (indefinite period). Under the agreement, as amended on July 31, 2007, GenVec assigned certain agreements and intellectual property to Mytogen, and retained a royalty-free non-exclusive license, with the right to grant sublicenses, to practice the intellectual property in connection with products, processes or services developed or provided by GenVec other than autologous and allogenic skeletal myoblasts for cardiac therapy. Under the original agreement, Mytogen granted a security interest in the assigned intellectual property, but the security interest was released in the amendment to the agreement. Under the agreement, as amended, Mytogen must use commercially reasonable efforts to commercialize the assigned intellectual property, including by spending specified amounts in support of research and development in support of such commercialization; Mytogen must pay GenVec one-half of the first milestone payment (anticipated to be two million U.S. dollars) received by Mytogen under the Terumo Agreement; and Mytogen must also pay GenVec four percent (4%) of the net sales revenue from sales or other provision of products, processes or services covered by the agreement.
Terumo Agreement - Diacrin, Inc. and Terumo Corporation entered into a development and license agreement on September 4, 2002 (indefinite license period); the agreement was transferred to Mytogen on December 28, 2005. Under the agreement, the parties agreed to collaborate to develop and commercialize products in the field described as autologous skeletal myoblasts for cardiac therapy (and conditionally allogenic skeletal myoblasts for cardiac therapy) in Japan and such other Asian countries as the parties may agree. Pursuant to the agreement, Terumo has an exclusive, royalty-bearing license, with a limited right to grant sublicenses, under certain technology and patent rights controlled by Mytogen; and a non-exclusive, non-royalty bearing right and license to use certain data resulting from clinical trials for products based on the licensed technology and patent rights for purposes of seeking regulatory approvals. The agreement specifies the rights and obligations of the parties with respect to collaboration and development of products covered by the agreement. The agreement also requires Terumo to make certain milestone payments, including the following: two million dollars upon initiation of any clinical trials of any covered product in Japan; two million dollars upon the first filing for regulatory approval of a covered product in Japan; one million dollars upon the first filing for regulatory approval of a covered product in any country other than Japan if the territory is expanded to include countries other than Japan; two million dollars upon the first commercial sale of a covered product in Japan; and one million dollars upon the first commercial sale of a covered product in any country other than Japan if the territory is expanded to include countries other than Japan. Terumo is also required under the agreement to pay royalties in an amount equal to ten percent (10%) of the net sales on covered products. In May 2008, Terumo exercised an option to extend a milestone for one year for $300,000. The milestone consisted of a Phase I clinical trial for the Myoblast Program in Japan and was extended for two years.
"Is todays PR indicating the FDA just approved PHASE 2?"
Absolutely not. Phase 2 was already cleared when we acquired Mytogen in 2007.
Transaction Significantly Accelerates Stem Cell Clinical Development Activities; Phase II Clinical Trials to Begin Shortly
"The FDA has reviewed the “end-of-Phase I” data and will allow Advanced Cell Technology to proceed with a Phase II human clinical trial."
http://www.advancedcell.com/news-and-media/press-releases/advanced-cell-technology-completes-acquisition-of-mytogen-inc/
fuller/rumit,
I had many mail questions last nite after yesterdays pps tumble. I relayed to most of them I expected Caldwell to issue news on something to try and stabilize things. Well, we got it and it seems to me it was just something to write about. We have known 99% of the info for a long time. Financing still is not a done deal. Whatever, here is some info for some that may not have seen it. Fuller, when the Mytogen trial was an inch from beginning, NO PR was issued saying they had no funds and were not going forward. We had to wait and dig through a SEC filing much later. So will they PR if the FDA has more questions?
(about a year ago)
What is the status of the Myoblast and Blood programs?
I just discussed the status of the Red Blood Cell program (it resides in the Joint Venture with CHA). We have not been able to secure the necessary funding to pursue our Phase II Clinical Trial for the autogolous adult stem cell myoblast heart disease therapy. This program is currently on hold until we raise sufficient capital for that Trial. We believe we may have the ability to fund these programs if the authorized shares are increased. It is our belief that the program will require $15 million to gear up the processing lab and complete the Phase II FDA approved clinical Trial.
Link to Clinical trials info..
http://clinicaltrials.gov/ct2/show/NCT00626314?term=NCT00626314&rank=1
Advanced Cell Technology Provides Update on Its Myoblast Program
Advanced Cell Tech (BB) (OTCBB:ACTC)
Intraday Stock Chart
Today : Wednesday 29 September 2010
Advanced Cell Technology (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, provided an update today on the status of its myoblast program. The program has successfully and safely completed Phase I human clinical trials in more than forty patients in over four independent studies. The Company is in the process of evaluating the data and is working with its scientists to evaluate the size and score of a potential Phase II trial. ACT began its myoblast program for the treatment of heart failure, advanced heart disease, myocardial infarction, and ischemia with the acquisition of Mytogen Inc in 2007.
The Phase I trials were conducted on a myoblast stem cell therapy involving transplantation of expanded autogolous myoblast (adult progenitor stem cells) derived from a small biopsy of skeletal muscle in the leg. The technology allows for expansion of the myoblast into hundreds of millions of cells over the course of two to three weeks. The surplus is then transplanted back into the patient's scarred heart tissue. The transplanted cells are incorporated into the muscle tissue, are entrained in the beat of the heart, and from preliminary data, appear to also enhance revascularization of the infarcted area.
Data collected from the trials suggests that the transplanted myoblast often improve heart function, and can lead to a significant improvement in quality of life for the patient. In the Phase 1b study, the company was able to score patients using the New York Heart Association Quality of life test, and the average observed improvement was significantly better than typical standard of care therapies in use today. According to the National Institute of Health, approximately five million people suffer from congestive heart failure, with an estimated 400,000 new cases diagnosed each year. Of the total number afflicted with the disease, 50% will die due to related complications within five years.
“We believe our phase II study would represent one of the most advanced stem cell studies conducted to date,” said William M. Caldwell IV, ACT’s Chairman and CEO. “In addition to evaluating our clinical options, the Company is also considering the most effective way to finance the cost of the study, which could include grants, partnerships or capital provided by foundations. We are also in negotiations with several countries in Europe to conduct a similar trial. The market potential in the EU is even greater than in the U.S. by up to 50% in patient population size by some estimates.”
The FDA has given ACT clearance to proceed with a Phase II trial, which is expected to begin in the first half of 2011. The open-enrollment trial will target patients who are not eligible for angioplasty or coronary artery bypass surgery and have a poor quality of life despite the help of a pacemaker or defibrillator device.
thanks mercurialmike,
looks like the $8MM dollar man missed that call?..:)
11
Action Plan: NIH
Current Challenge to hESC Federal Funding
•Current situation: Lawyers controlling actions / trying to maintain status quo
•Mindful of this as a lightning rod for mid-term elections
•The Reality: NIH is facing a permanent injunction on federal funding, perhaps as early as end of month
•ACT?s Blastomere technique may be a fallback until the issue is resolved in Congress.
•ACT is offering to make its hESC lines available to academic laboratories
http://www.advancedcell.com/documents/0000/0264/Presentation-at-the-12th-Annual-Rodman-Renshaw-Healthcare-Conference-in-New-York-City.pdf
Ernie,
It is not the job of the FDA to hold back an approval based on its prior approval of a different approval for a different issue using a type of therapy "because they were approved first".
I agree 100%.
I think the problem for ACTC is they don't seem to have the drive and desire that Geron had in pushing its treatment.
I would disagree. Phase 1 clearance is all about "safety" and it seems apparent that the FDA has some issues with data ACT is presenting.
fuller,
Getting into the clinic to validate the technology is critical for ACT so I find myself concerned also. I probably would have been less concerned if the "Complete Response" PR was never written. I didn't understand the strategy of issuing the PR when it came out and still don't understand why it was necessary. As shareholders we hear everything ACT does is great and ready to go. What we don't hear is what is coming from the FDA and when they made the decision. Hearing only one side of the story makes it easy to blame the FDA. What we do know is this IND is still on a clinical hold. I am from the camp that doesn't believe after almost 60 days they are still jaw jacking back and forth on the phone.
elk,
No doubt the resources of both hESC and iPS will be used in blood research and other projects. The link rumit recently posted for SCRMI website has a lot of info. Make sure to hit all the links..
http://www.steminternational.com/
"This benzidine-Giemsa stained peripheral blood smear shows a granulocyte in a sea of red blood cells. Inspired by the life saving properties of red blood cells, we focus on using human embryonic stem cells and induced pluripotent stem cells as resources for the generation of donorless transfusable blood."
fwiw, your theories are as good as anyones except the "caldwell theory"..imo
That is my point rumit, this is in the early stages and will take considerable dollars to complete or resume the ongoing study. Results are unknown so why not use and apply for grants/funding now available?
If they were close to "universal blood" with hESC's what would yestedays announcement be for? The bolded below indicates a change of direction,imo. This won't happen anytime soon,imo. Don't get me started on Caldwells $8.5MM bonus..lol
"In this proposal, based on our recent "proof-of-concept" results, we hypothesize that hiPS cells suitable for clinical translation can be generated by direct delivery of reprogramming proteins attached to a cell penetrating peptide. In particular, we will generate fully reprogrammed hiPS cell lines from both healthy and O(-) subjects by direct protein delivery and test whether these cells can be propagated and expanded in vitro indefinitely, thus providing a potentially inexhaustible and donor-less source of blood lineage cells. This proposal will fully optimize the protein reprogramming methods to establish a highly efficient and safe way of reprogramming human tissues without genetic manipulation, and will address whether these hiPS cells can be used as a personalized platelet source and/or universal RBC source."
okoil,
Could they be trying to keep it down with all the confusion so that when they have something really great to PR, ACTC will jump significantly?
IMO, absolutely not.
rumit,
we may be making this out to be more diffcult than it really is. It may be strictly a funding issue. Yesterdays news may have indicated that. The hESC funding has been a total zero and nightmare for ACT to date.
rumit,
I am with you, it seems very confusing. Not long ago Caldwell stated iPS was a science project. Then the report from ACT that iPS cells showed early aging and the hesc's were the route to go. It has been a mixed message from my standpoint. The o-negative "start" seems to be the key. Here are some links that may help or just confuse.
FEB 2010 BioWorld
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=46624354
My follow up to article
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=46625633
"The firm had a solicitation at the Department of Defense for $5.6 million to create universal blood, but none of the Bush lines were O negative, and ACT was unable to get the White House to sign off on permitting the use of the company's single blastomere technique."
http://investorshub.advfn.com/boards/read_msg.aspx
message_id=46950661
PATIENT-SPECIFIC AND UNIVERSAL DONOR BLOOD CELL FROM PROTEIN-INDUCED IPS CELLS
Details and description
http://projectreporter.nih.gov/project_info_details.cfm?aid=8045716&icde=5465234
Revenue,
The Company’s revenues are generated from license and research agreements with collaborators.
First 6 months of 2010..approx. $410,000 in revenue(about $125K less than first 6 months of 2009) Deferred revenue $971K(not earned)
Genzyme Transgenics Corporation... less than 10% of revenue
Exeter Life Sciences, Inc...$61,500
START Licensing, Inc. ..$49,000
Terumo Corporation (less than 10% of revenue)
International Stem Cell Corporation ..$56,000
Transition Holdings, Inc.. $102,000
CHA Biotech and SCRMI ..$65,000
Statements on topic,
Contract called for the following:
1)upfront license fee of $750K..
2)additional fee of $250K within 30 days
3)additional fee of $100K in 90 days
4)another $300K due within 10 days upon Filing of IND with FDA
Total: $1.4 Million due ACT...ACT has been paid this amount and accounted for it in 10K(see below)
The other $500K would be due if CHA recives grant funding from Republic of Korea for either the RPE, SCNT or Blastomere technology in the amount of 7.5 Billion Korean Won.(approx. $6.5MM US Dollars)
That accounts for the $1.9MM..
(page 70 of 10K)
On March 30, 2009, the Company entered into a second license agreement with CHA under which the Company will license its RPE technology, for the treatment of diseases of the eye, to CHA for development and commercialization exclusively in Korea. The Company is eligible to receive up to a total of $1.9 million in fees based upon the parties achieving certain milestones, including the Company making an IND submission to the US FDA to commence clinical trials in humans using the technology. The Company received an up-front fee under the license in the amount of $1,100,000 during the second quarter of 2009, and another $300,000 progress payment on December 3, 2009. Under the agreement, CHA will incur all of the costs associated with the RPA clinical trials in Korea. The Company is recognizing revenue from this agreement over its 17-year patent useful life.
http://www.sec.gov/Archives/edgar/data/1140098/000114420410013897/v177442_10k.htm
Upon request,
ACT has had multiple deals/license agreements with CHA. The latter two paragraphs below are license agreements with CHA so they can commercialize in Korea.
SCRMI is the joint venture of which CHA owns 60%, ACT owns 40%. Focus- Hemangioblasts & Induced Pluripotent Stem Cells
Stem Cell & Regenerative Medicine International, Inc. - On December 1, 2008, the Company and CHA Bio & Diostech Co., Ltd. (“CHA”), a leading Korean-based biotechnology company focused on the development of stem cell technologies, formed an international joint venture. The new company, Stem Cell & Regenerative Medicine International, Inc. (“SCRMI”), will develop human blood cells and other clinical therapies based on our Hemangioblast Program, one of our core technologies. SCRMI has agreed to pay the Company fee of $500,000 for an exclusive, worldwide, license to the Hemangioblast Program (indefinite license period).
CHA – On March 31, 2009, we entered into a licensing agreement (indefinite license period) under which we have licensed our retinal pigment epithelium (“RPE”) technology, for the treatment of diseases of the eye, to CHA for development and commercialization exclusively in Korea. We are eligible to receive up to $1.9 million in fees based upon achieving certain milestones, including us making an IND submission to the US FDA to commence clinical trials in humans using the technology, which we currently plan to do during the second half of 2009. We received an up-front fee of $250,000 and additional consideration under the agreement in the amount of $850,000. Under the terms of the agreement, CHA will incur all of the cost associated with RPE clinical trials in Korea.
CHA – On May 21, 2009, we have entered into a licensing agreement (indefinite license period) under which we will license our proprietary single blastomere technology, which has the potential to generate stable cell lines, including retinal pigment epithelium (RPE) cells for the treatment of diseases of the eye, to CHA for development and commercialization exclusively in Korea. We received a $300,000 up-front license fee. We believe there are some 200 different retinal diseases that may be impacted by this stem cell derived therapy including macular degeneration. Age-related macular degeneration (AMD) affects more than 30 million people worldwide and is the leading cause of blindness in people over 60 years of age in the United States (Source: Foundation For Fighting Blindness
Lanza's scheduled 600K share sells on Monday is filed,
http://www.sec.gov/Archives/edgar/data/1140098/000101376210002313/xslF345X03/primary_doc.xml