Saturday, January 2, 2010

Stem Cells: Hello ACTC


Folks Biotime BTIM was recommended when BTIM was an Over the Counter stock at a stock price of 2.05USD on May 11,2009. BTIM had hit a high of 6.94 USD and at present quoting at USD 4.28 USD. Dec 15,2009 we have made more than 100% profit even after a stock dilution.

ACTC is the choice for now for ACTC has strong technical background to stand on and is a better stock to invest in.
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Ticker Symbol: ACTC.ob (ACTC)
Company Name: Advanced Cell Technology.
Current Market Price: 0.092 USD (thats 9.2 cents per share)
Current Market Capitalization: 56.48 million USD.

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Here are some points worth considering:

- ACTC  owns or has exclusive licenses to 380 patents and patent applications world wide in the field of regenerative medicine and stem cell therapy.
- Companies have licensed patents from ACTC (including BTIM) and have started further research in the specific areas.
- ACTC has filed IND (Investigative New Drug) with FDA for RPE ( Retinal Pigment Epithelium) approval expected in Q1 2010

Here is the cronological list of development for ACTC:
- ACTC in 1997 announced agreement with Genzyme Transgenics to produce human theraputic proteins in the milk of cloned transgenic cattle.

- ACTC in 1999 receives broad US patent covering an improved method of cloning non-human mammals using nuclear transfer technology this has broad utility for numerous applications in human therapeutics and agriculture

- ACTC in 2000 achieved the reversal of cell aging. The company’s breakthrough may be the path to successful use of therapeutic cloning techniques to cure some of humankind’s most intransigent age-related and degenerative diseases such as Parkinson’s, Alzheimer’s and diabetes, as well as heart, liver and kidney disease.

- ACTC in Oct 2000 achieved first successive cloning of an endangered animal to "late stage" fetal development. On Jan 2001 the baby bull gaur was born. Baby Noah died within 48 hours of being born of common dysentery.

- ACTC in Oct 2001 received a grant of 1.8 million from the National Institute of Standards and Technology by Advanced Technology Program (ATP) for research on Transdifferentiation of Adult Somatic Cells for regenerative medicine and cell therapy.

- ACTC in Nov 2001 reported its proprietary cloning technology has been used to produce healthy and normal adult animals.

- ACTC in April 2002 announced the license of animal cloning technology to Immerge BioTherapeutics, Inc. of Charlestown, MA. The worldwide nonexclusive license will cover Immerge’s work in the development of genetically modified pigs for potential use in xenotransplantation (the use of animal organs to address human health issues).

- ACTC in April 2002 announced license of animal cloning technology with PPL theraputics.

- ACTC in march 2003 reported that the cloning patent dispute with Infigen has been awarded in ACTC's favour. ACTC has licensed its cloning patents to Cyagra, PPL Theraputics, Roslin, Immerge biotheraputics, GTC Biotheraputics,

- ACTC in March 2005 reported the first derivation of human embryonic stem cells in completely feeder-layer-free and serum-free conditions. To-date, all human embryonic stem cell lines have been isolated in contact with either mouse or human cells that may have contaminated the stem cells with viruses or other pathogens. “The ability to generate embryonic stem cells without exposure to living cells or serum solves a major problem associated with the use of these cells in future medical therapies,” said Robert Lanza,

- ACTC in MAy 2005 reported that it has entered into two separate agreements to expand its portfolio of intellectual property in regard to somatic cell nuclear transfer (SCNT) and cellular reprogramming.

- ACTC in July 2005 reported that Robert Lanza testified today before the Senate Subcommittee on Labor, Health and Human Services, Education, and Related Agencies, of the Committee on Appropriations. Dr. Lanza’s testimony focused on two approaches to creating pluripotent stem cell lines – that of single cell biopsy of embryos and the dedifferentiation of somatic cells back to pluripotency – and strongly encouraged support for the Stem Cell Research Enhancement Act of 2005.

- ACTC in July 2005 Announced it has entered into a research collaboration agreement with the The Burnham Institute, a California based non-profit medical research institution, to conduct research that aims to isolate stem cell specific differentiation markers.

- ACTC in Sept 2005 raises 17.75 million through private placement of warrants and convertible notes.

- ACTC in Oct 2005 reported alternative approach to the generation of embryonic stem cell lines that does not interfere with the developmental potential of embryos.

- ACTC in April 2006 announced exclusive license of key Intellectual property portfolio on Somatic Cell Reporgramming with TranXenoGen Inc.

- ACTC in April 2006 announced collaboration with Xgene Corporation. The goal of the collaboration is to test the functionality of embryonic skin cells in regenerating skin for numerous applications in medicine.

- ACTC in May 2006 announced cross license of Key Intellectual Property with Kirin Brewery Company.

- ACTC in May 2006 announces key theraputic programs: Retinal Pigment Epithelium, Hemangioplast Program and Dermal Program.

- ACTC in August 2006 announces proposed financing for 11.29 million through convertible debentures and warrants.

- ACTC in August 2006 had successfully generated human embryonic stem cells using an approach that does not destroy the developmental potential of embryos.

- ACTC in Sept 2006 announced it has settled its patent dispute involving certain nuclear transfer cloning patents with Roslin Institute, Geron Corporation & Start Licensing. ACT retained its rights under the UMass patents in the human field.

- ACTC in Sept 2006 announced an agreement to collaborate with WiCell Research Institute to jointly distribute to US scientists a range of new cell lines for medical research.

- ACTC in Sept 2006 announced that company scientists and their collaborators rescued visual function in rats through implantation of retinal pigment epithelial cells (RPE) derived from human embryonic stem (hES) cells.

- ACTC in Sept 2006 announced that Dr Robert Lanza will address the National Academy of sciences to explore the latest development in embryonic stem cell science and policy.

- ACTC in Jan 2008 announced receipt of research grant from the National Institute of Health in the amount of 204,439 in conjunction with a research project currently underway with one of its academic partners, The Burnham Institute of Medical Research (Burnham Institue)

- ACTC in Feb 2007 announces collaboration with the Casey Eye Institute at Oregon Health and Science University to conduct pre-clinical studies for its Retinal Pigment Epithelium (RPE) program.

- ACTC in Feb 2007 announced the acquisition of Intellectual Property Assets of Infigen Inc(former competitor) 26 issued patents and numerous pending patent applications. IP related to Somatic cell nuclear transplant , parthenogenesis, and other related technologies for a combination of cash and shares of common stock. The acquisition provides ACTC with exclusive ownership rights to critical technologies in regenerative medicine and the merger of assets is expected to strengthen ACTC’s intellectual property position in the drive towards commercialization of embryonic stem cell and SCNT technology

- ACTC in March 2007 announced preclinical studies using hESC (human Embryonic Stem Cells) derived from ACTC proprietary ACTCellerate technology to determine if hESC are safe and effective in animal models for heart attacks and heart failure.

- ACTC in May 2007 announced an expanded non-exclusive commercial agreement with Wisconsin Alumni Research Foundation (WARF) The expanded agreement grants ACTC rights to commercial use of human embryonic stem cells (hESCs) to develop human therapies, with the exception of neuronal, pancreatic beta cells, and cardiac applications, and enables the marketing of a broad array of research products. This agreement bolsters Advanced Cell’s existing patent estate which currently consists of over 380 owned or licensed patents and patent applications worldwide by granting commercial access to an additional 150 important stem cell technology patents and patent applications.

- ACTC in May 2007 announced that hemangioblast precursor cells derived from human embryonic stem (hES) cells can be used to achieve vascular repair.ACTC describes an efficient method for generating large numbers of bipotential progenitors—known as hemangioblasts—from hES cells that are capable of differentiating into blood vessels, as well as into all blood and immune cell lineages.

- ACTC in May 2007 announced letter of intent to acquire Mytogen Inc and proceed with human clinical trials utilizing myoblast for treatment of heart failure The letter of intent provides for an aggregate purchase price of $5 million payable in ACTC common stock plus the assumption of certain Mytogen liabilities of approximately $1 million.

- ACTC in June 2007 announced major advancements in the process of bringing its Retinal Pigment Epithelial (RPE) program into the clinic to treat various retinal degenerative diseases, including Age-Related Macular Degeneration (AMD). After preliminary discussions earlier this year with staff from the Office of Cellular, Tissue, and Gene Therapies within the Center for Biologics Evaluation and Research at the Food and Drug Administration (FDA), the company has contracted with a leading contract research organization in order to commence work on an extensive preclinical program

- ACTC in June 2007 announced development of first hESC line without destroying an embryo.

- ACTC in June 2007 announced recent approval by US Senate of 152 billion Labour HHS Education appropriations bill  has an ammendment to the bill which expands federal funding for embryonic stem cell research by changing a critical date relating to the eligibility of stem cell lines. The amendment would fundamentally change current federal embryonic stem cell policy by permitting federally-funded research on stem cell lines that were derived before June 15 of this year, as opposed to the current marker of August 9, 2001. The committee noted that this moving of the date forward by almost six years will advance progress toward treatments and cures by significantly expanding the number of stem cell lines eligible for federally funded research.

- ACTC in Sept 2007 announced 12.55 million private placement which will result in 10 million in gross proceeds.

- ACTC in Sept 2007 announced that ACTC Single Cell Biopsy Technique to be considered for federal funding. ACT’s groundbreaking Single Cell Biopsy technique was cited by the National Institute of Health (NIH) as an alternative method in its implementation plan.The NIH plan calls for “aggressively pursuing an assessment of the potential of alternative sources of pluripotent stem cell lines, including altered nuclear transfer; single cell embryo biopsy, and reprogramming, or dedifferentiation of somatic cells, such as skin cells.”

-  ACTC in Oct 2007 announced selection of ACTC Myoblast Phase 1 trial by American Heart Association (AHA) as a featured late breaking trial for its annual scientific sessions conference in Orlando Florida.

- ACTC in Jan 2008 announced that the National Institute of General Medical Sciences at the National Institutes of Health (NIH) has awarded the company an SBIR Phase 1 Small Business Grant. The company will use the grant proceeds to conduct research that will allow for rapid labeling and purification of specific lineage restricted cells (LRCs) in cultures of differentiating human embryonic stem cells. If successful, the research will help the company more rapidly develop new regenerative therapies for a variety of indications including cardiovascular disease as well for commercialization of the LRCs and their peptide-targeting agents as research reagents. The research aims to create a process by which specific markers can be identified that will act like nametags allowing LRCs to be identified and then purified.

- ACTC in Feb 2008 announced completion of pre-IND meeting with the FDA for RPE Therapy for the Treatment of Retinal Degenerative Disease.

- ACTC in Feb 2008 announced for the first time a robust and highly efficient process for the generation of high-purity hepatocytes (liver cells). This is a significant step towards the efficient generation of hepatocytes for use in regenerative medicine and drug discovery.

- ACTC in Feb 2008 announced agreement with Pharming Group N.V. giving Pharming an exclusive, global license to non-human use of certain patents associated with but not limited to oocyte activation patents held by Advanced Cell Technology. According to the terms of the license agreement, Pharming will pay Advanced Cell Technology a one-time license fee. Prior, Pharming had a nonexclusive license to these patents. Based in the Netherlands, Pharming Group N.V. is focused on developing treatments for genetic and aging diseases, specialty products for surgical indications, and intermediates for various applications and nutritional products.

- ACTC in March 2008 announced a supply agreement with Biologics Delivery Systems Group, Cordis Corporation (a Johnson & Johnson company), in which Biologics Delivery Systems will supply catheters for the Phase II human clinical trial of ACT’s myoblast therapy for the treatment of heart failure.

- ACTC in March 2008 announced a clinical trial agreement with Chandler Regional Medical Center and Mercy Gilbert Medical Center, members of Catholic Healthcare West (CHW), the nation’s eighth largest healthcare system, to become ACT’s first clinical trial sites for the Phase II myoblast study.

- ACTC in April 2008 announced ACTCellerate platform has yielded 140 cell types from Human Embryonic Stem Cells.One of the hurdles with hESC has been a commercially viable means for the expansion of sufficient numbers of the cell types needed for tissue regeneration. With the publication of work entitled “The ACTCellerate Initiative: large-scale combinatorial cloning of novel human embryonic stem cell derivatives,” ACT scientists have solved some of these problems.

- ACTC in August 2008 announced the generation of functional Red blood cells from hESC. ACTC and its collaborators at the Mayo Clinic and the University of Illinois, shows for the first time that the oxygen-carrying capacity of hESC-derived blood cells is comparable to normal transfusable RBCs, and that the cells respond to biochemical changes in a physiologically effective manner.

- ACTC in Dec 2008 announced creation of JV with leading Korean biotech company CHA Biotech. The new company Allied Cell Technology will develop human blood cells and other clinical therapies based on ACTC’s proprietary hemangioblast cell technology.

- ACTC in Dec 2008 announced that ACTC has entered into a license with Ireland-based Transition Holdings, Inc, for certain of its non-core technology. Under the agreement, Transition agreed to acquire a license to the technology for $2.5 million, which includes the extinguishment of $1.5 million of debt and an additional funding commitment of $1 million. The intellectual property does not relate to any of the Company’s advanced clinical programs.

- ACTC in May 2009 announced that CHA Biotech and ACTC have entered into a licensing agreement under which Advanced Cell will license its 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 Bio for development and commercialization exclusively in Korea. ACT received an undisclosed up-front license fee. The Company believes there are some 200 different retinal diseases that may be impacted by this stem cell derived therapy including macular degeneration, which represents a $28 billion dollar market. 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.

- ACTC in Nov 2009 announced that it filed an Investigational New Drug (IND) Application with the US Food and Drug Administration (FDA) to initiate a Phase I/II multicenter study using embryonic stem cell derived retinal cells to treat patients with Stargardt’s Macular Dystrophy (SMD).
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The other important data is the Short Squeeze data for ACTC its down 82% which means there is going to be some positive news flowing out real soon. (Short Squeeze Data for ACTC : Link)

Conclusion: ACTC is the stock to be in if you are looking for stem cell as an investment destination. It is well established and even the US govt looks up to ACTC for advise and recent developments in stem cell arena.
- Labour HHS Education appropriations bill passed on July 2007 had an ammendment to stem cell research bill.  The bill would expand federal funding for embryonic stem cell research by changing a critical date relating to the eligibility of stem cell lines. The amendment would fundamentally change current federal embryonic stem cell policy by permitting federally-funded research on stem cell lines that were derived before June 15 of this year, as opposed to the current marker of August 9, 2001. The committee noted that this moving of the date forward by almost six years will advance progress toward treatments and cures by significantly expanding the number of stem cell lines eligible for federally funded research.


Key among those lines would be upwards of twenty cell lines from Advanced Cell Technology (ACTC). These would include the Company’s single cell blastomere lines, created without the destruction of embryos



The RPE IND approval is going to be an easy breeze for ACTC considering the amount of pre-clinical test and ACTC standing in stem cell field..you can expect some real great upside as the stock is discovered by mainstream investors (the last to get in on the bandwagon!!)












8 comments:

Anonymous said...

I am aware of all that was posted. The question is what future does ACTC hold for the investor.
I hold only because I am willing to wait and play the big boards,i.e., F, GERn, etc,etc.

Patience w/any stk if one believes in it. We shall see.

Tyler said...

Thanks for the link to StemCellTracker.com and the great coverage you offer!

I'll be sure to reciprocate.

Anonymous said...

Anonymous:

ACTC has been collecting patents with potential. It has shown the ability to build important additions like the "Single Cell Biopsy" technique

Yes there has been a lot of dilution of equity, yes the stock has not been performing as well as some other stocks in stemm cell arena.

One must understand that it has all the right capabilities so its just a question of time.

- Company also has quite a few patents that have been licensed.
- Company has formed joint ventures with other firms.
- The RPE IND also looks to be a low hanging fruit as:
1. Stargardt’s Macular Dystrophy (SMD) not a disease which is widely prevelant.
2. So the sample size of the clinical trial will be small (easy to manage)
3. Orphan drug status will allow approval in quicktime.
4. RPE once approved for SMD has potential additional market for Age related Macular Degeneration which will be a kicker.

- ACTC has the ears of the federal govt, by the fact that company has been called on number of occasions to present their case infront of Federal govt staff.

Right now with a market cap of 60-70 million and a lot of dilution already completed further dilution would be some time down the line.

I think we are favourably placed to expect an upside on this stock.

=happy investing

Theo said...

What percentage of your portfolio would you allocate to ACTC vs. SRZ? Are we talking 50/50?

Thx.

Anonymous said...

Making It A Better World:

Portfolio allocation is 60:40 SRZ:ACTC respectively since SRZ is an established player with 1.5 billion dollar sales to back the current market capitalization.

=happy investing

Anonymous said...

Below is from the 520Mmeber strong Private Google Group from one of the posters "Ceasar". He has a great take on ACT being that he is an actual medical researcher and has a deeper grasp from a laymans view.

Btw feeed loves Lanza incase anyone had a question about it.



http://www.ustream.tv/recorded/3933270

http://groups.google.com/group/advanced-cell-technology

I realized after watching the One Med Video that I missed a key aspect of
the Production Model that ACTC will use on all related
"Retina Related" products that they will address. My error is so large
because I was thinking of your typical production costs and model
for a typical biotech company. But in fact, the model and the production
costs that ACTC will employ is so edgy that your typical analysts
would have missed it. Fortunately, Caldwell referred to it yesterday. In
layman's terms, it is "stem cells in a bottle or vial". Additionally, after
you have secured your "creator/stem cells" (as opposed to a progenitor
cells), these creator/stem cells can replicate indefinitely. Thus you
have manufacturing raw materials that replicate themselves indefinitely.
Now, has anyone seen a manufacturing process where you raw materials
appear to manufacture on their own and do not exhaust on an indefinite
basis? This implies a manufacturing cost structure that will translate
into enormous profits because its operational, shipping, and maintenance
cost is unbelievably cost effective in comparison to your typical pharma
model. Thus I believe that the valuation for the "Retina Related" products
for ACTC will be in the billions, specially after it is designated as an
Orphan Drug. I will speculate that this valuation will be above 5 billion at
least... and Caldwell and Lanza and Mickunas knew this from the very
beginning.
Those guys are something else.


Take this above analysis and apply it in the "cardio vascular market". I
have personally been involve in some details to discussion of JVs between
Major Pharmas and some small biotech firms. I am also familiar with the NOGA
System that J&J is using on this trial. I have also double checked on Dr.
Dibbs background. He is the Authority on this area. He also owns a couple of
clinics involve in the use of this systems. This market is huge but it also
requires very substantial investments. To give you a sense of what Caldwell
will need ... a 50-75 million dollars is just about what he will need to
bring this product into the market. He will probably ask the JV partner to
put up 75 to 100 millio into the table. If he succeeds and when he succeeds,
the valuation for this product revenue stream will easily be 25 billion in
the low end of the estimate. The big pharmas will see this
vision and Caldwell will get his JV announcement in the next few months.


Then you move to the "artificial blood market", and again, I have spent at
least 3 years of my professional life on this market, and this is as big
if not bigger that the Cardiovascular Market. Note that "Artificial Blood"
have been the Holy Grail for many biotech companies for as long as I can
remember. Many biotech companies tried doing this and failed. ACTC has a
good chance of making it via their stem cell approach. If ACTC succeeds
the whole "Blood Banking Industry" including the testing, storage, and
delivery of blood and other blood products will be turned upside down. ACTC
approach has the ability to do this. I can not even begin to guess on how
huge this valuation would be. TURNING THE BLOODBANKING INDUSTRY ON ITS HEAD
will obsolete hundreds of companies and the whole blood banking
infrastructure.


All of the above paradigm change is WORLDWIDE.


Thus this stock is fucking cheap if you have the vision to see this.


Cuenca

Anonymous said...

Cuenca:

yes ACTC is definitely one of the great companies to watch for the next decade..

Creator/Stem cells I assume are stem cells that replicate indefinitely(It seems cancer cells also replicate indefinitely as the telomerase length does not decrease with each a division/replication)

Well the question is if you sell one vial and it can be used indefinitely who will ever come back..

I think the plan is to make "Master Batch" and then sell the progenitors with restricted lifespan (replication ability..)

Also one must remember that microsoft just bought the MSDOS operating system .. and then made the right moves..

A lot of companies that have licensed specific patents from ACTC have a higher market cap than ACTC..

So there is lot that can happen between having the technology and making money out of it..

still I would place my bets with ACTC...hopefully SRZ will provide me better short term return

=happy investing

Alex said...

I wish you were still active on this blog. Your ideas have definitely paid off! Any plans on sharing more insights?
Thank you.