3SOF

ACTC  Advanced Cell Technology and The Roslin Institute Announce...  by Business Wire  Dec 27 2010 9:02AM 

MARLBOROUGH, Mass., Dec 27, 2010 (BUSINESS WIRE) -- Advanced Cell Technology, Inc. ("ACT"; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that it has entered into a Memorandum of Understanding with Roslin Cells LTD ("Roslin Cells") of Scotland, in which the two companies contemplate a definitive collaboration agreement in the near future. They will work together to establish a bank of Good Manufacturing Practice (GMP)-grade human embryonic stem cell (hESC) lines using ACT's proprietary "single-ceblastomere" technique for deriving embryonic stem cells without damage to the embryo.

The collaboration contemplates that the hESC lines will be created and stored using protocols that meet the regulatory standards of the European Medicines Agency (EMA) and United States Food and Drug Administration (FDA). Roslin Cells will be responsible for maintaining the banked hESC lines, which will be made available for both research and commercial purposes. By utilizing GMP and careful characterization and documentation of the resulting hESC lines, it is intended that the banked hESC lines will be suitable to move readily from laboratory settings into clinic programs, thereby speeding translation research into human treatments. Predictability in price and commercialization terms is a key feature of the goals of the collaboration. Roslin Cells will promote access to the hESC lines from the bank as research reagents to both academic and commercial entities. In addition, 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.

"The relationship with Roslin Cells has grown out of our initiatives in Europe over the past year, and comes as part of our close efforts with the Scottish Development agency. Along with the recent announcement of our European Orphan drug designation filing in our Stargardt's disease treatment program, the relationship with Roslin Cells signals the expansion of our commercial initiatives in Europe, and, more broadly, markets around the world," said ACT's Interim Chairman and CEO, Gary Rabin. "Roslin Cells is already one of the leading organizations in GMP manufacturing of stem cells. Through the creation of hESC lines derived using our proprietary 'embryo-safe' technique, we fully expect Roslin Cells to quickly become a leading hESC bank for Europe, North America and Asia. We foresee major demand for these embryonic stem cells from both researchers and commercial interests across the globe."

"Until we developed our single blastomere technology, embryonic stem cell research had been synonymous with the destruction of human embryos," stated Robert Lanza, MD, Chief Scientific Officer at ACT. "In stark contrast to embryonic stem cells lines currently available for research, such as those on the NIH registry, our single blastomere technique does not destroy the embryo. One of the benefits to an ability to create new hESC lines without destroying embryos is that it addresses ethical concerns of certain researchers."

The Company's single blastomere technique relies on isolating a single cell from a 4 to 8 cell embryo utilizing a one-cell biopsy approach similar to that used in pre-implantation genetic diagnostics (PGD). According to recent literature, one-cell biopsy as part of PGD is carried out routinely around the world, and one to two thousand children are born every year in the United States and Europe after being conceived by in vitro fertilization using one-cell biopsy and PGD.

"The availability of our 'embryo safe' hESC lines has sparked interest in many quarters, including at institutions that have been opposed to conducting embryonic stem cell research in the past," continued Dr. Lanza. "We are exploring opportunities to provide our cells to those institutions.

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 Roslin Cells

Roslin Cells Ltd was established in 2006 by the Roslin Institute with the support of the University of Edinburgh, the Scottish National Blood Transfusion Service and Scottish Enterprise. The company's core mission is to provide ethically sourced, pluripotent human cells manufactured to the highest quality available according to Good Manufacturing Practice (GMP standards). Roslin Cells has been independently verified according to rigorous standards and successfully attained ISO 9001:2008 certification in February 2009 (certificate number:FS 544151). Since then, the company has continued to demonstrate their meticulous standards, with successful annual renewals of their Human Tissue Authority (HTA) and Human Fertilization and Embryology Authority (HFEA) licenses Roslin Cells is headquartered in Roslin, Midlothian, and is a not for profit organization. Further information can be found at www.roslincells.com .

Forward-Looking Statements

Statements in this news release regarding future financial and operating results, future growth in research and development programs, potential applications of our technology, opportunities for the company and any other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words "will," "believes," "plans," "anticipates," "expects," "estimates," and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: limited operating history, need for future capital, risks inherent in the development and commercialization of potential products, protection of our intellectual property, and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in the company's periodic reports, including the report on Form 10-K for the year ended December 31, 2009. Forward-looking statements are based on the beliefs, opinions, and expectations of the company's management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. Forward-looking statements are based on the beliefs, opinions, and expectations of the company's management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change.

SOURCE: Advanced Cell Technology, Inc.


Investors:
CEOcast, Inc.
Dan Schustack, 212-732-4300
or
Press:
Gotham Communications, LLC
Bill Douglass, 646-450-3615

ACTC  Advanced Cell Technology Receives FDA Clearance For...  by Business Wire  Jan 3 2011 8:00AM 

MARLBOROUGH, Mass., Jan 03, 2011 (BUSINESS WIRE) -- Advanced Cell Technology, Inc. ("ACT"; OTCBB:ACTC), a leader in the field of regenerative medicine, announced today that the US Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application to treat Dry Age-Related Macular Degeneration (AMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). ACT is now permitted to initiate a Phase I/II multicenter clinical trial to treat patients with Dry AMD, the most common form of macular degeneration in the world. There are currently no treatments available for this prevalent disease of an aging global population. Dry AMD, representing a substantial global market opportunity and afflicts between 10-15 million Americans.

Age-Related Macular Degeneration has two predominant forms, wet and dry. Dry AMD is the most common form, accounting for almost 90% of all cases. The progress of Dry AMD includes a breakdown or thinning of the layer of RPE cells in the patient's macula, the region at the center of the retina responsible for high acuity vision. Over time, the progressive loss of RPE cells and accompanying loss of photoreceptors can cause severe vision loss and even blindness.

"ACT is now the first company to receive FDA clearance for two hESC trials, and is now a true translational leader in the field of regenerative medicine," said Gary Rabin, Interim Chairman and CEO of ACT. "It marks a major step forward, not just within the stem cell sector, but, potentially for modern healthcare techniques. We plan to proceed into the clinic with both of our hESC-based programs as quickly as possible. ."

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.

"Dry AMD is the leading cause of blindness in individuals over the age of 55," stated Robert Lanza, MD, ACT's Chief Scientific Officer. "As the population ages, the incidence of AMD is expected to double over the next 20 years, further exacerbating this unmet medical need. Using our clinical-grade hESC lines, we are able to generate a virtually unlimited and reproducible supply of healthy RPE cells. Because only a small number of cells (50-200K) are needed to treat each patient, manufacturing and distribution of the therapeutic product is scalable with many similarities to the drug businesses that pharmaceutical companies understand well. Based on our animal model studies, we are very excited about the opportunity to treat patients. In a rat model of macular degeneration, we have seen a remarkable improvement in visual performance over untreated animals, without any adverse effects. We have also maintained near-normal function in a mouse model of Stargardt's Disease, a form of juvenile macular degeneration. In addition to this trial, we plan to concurrently use our RPE cells in our Phase I/II Clinical Trial for Stargardt's Disease, which received the green light from the FDA in November. We hope to see a similar benefit in both Stargardt's Disease and Dry AMD patients."

ACT's Dry AMD therapeutic program uses RPE cells derived from hESCs to replace the lost RPE cells in the patient's eyes. ACT's proprietary RPE cell manufacturing process is protected by a number of broad patents, as is the use of hESC-derived RPE cells for treating macular degeneration. While the initial portion of the clinical trial will focus on safety, in subsequent clinical trials the Company hopes to demonstrate that the RPE cells injected into the retinal space will be capable of slowing or halting progression of the disease, and potentially even restoring some visual acuity to patients.

"It is estimated that over ten million Europeans suffer from Age-Related Macular Degeneration, representing a vast unmet need and a significant market opportunity," commented Edmund Mickunas, ACT's Vice President of Regulatory Affairs. "We are moving ahead aggressively to seek regulatory clearance from the European Medicines Agency to conduct clinical trials in Europe."

Specific inclusion and exclusion requirements and Investigator contact information will be posted shortly at http://clinicaltrials.gov . Patients and their caregivers should refer to this source rather than contacting ACT or its representatives.

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 .

Forward-Looking Statements

Statements in this news release regarding future financial and operating results, future growth in research and development programs, potential applications of our technology, opportunities for the company and any other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words "will," "believes," "plans," "anticipates," "expects," "estimates," and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: limited operating history, need for future capital, risks inherent in the development and commercialization of potential products, protection of our intellectual property, and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in the company's periodic reports, including the report on Form 10-K for the year ended December 31, 2009. Forward-looking statements are based on the beliefs, opinions, and expectations of the company's management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. Forward-looking statements are based on the beliefs, opinions, and expectations of the company's management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. There can be no assurance that the Company's clinical trials will be successful.

SOURCE: Advanced Cell Technology, Inc.


Investors:
CEOcast, Inc.
Dan Schustack, 212-732-4300
or
Press:
Gotham Communications, LLC
Bill Douglass, 646-450-3615

•FDA OKs second Advanced Cell stem cell trialat Reuters(Mon 11:23AM EST)
http://www.reuters.com/article/idUSN0313817620110103?feedType=RSS&feedName=marketsNews&rpc=43


Day's Range: 0.23 - 0.2680
52wk Range: 0.04 - 0.27
Volume: 44,707,682
Avg Vol (3m): 24,987,900
Market Cap: 263.89M
P/E (ttm): N/A
EPS (ttm): 0.00
Div & Yield: N/A (N/A


Technicals
Last Price Quote is:
40.10%above 13-day EMA
98.07%above 50-day EMA
RS Rating: N/A 

At 2:22PM  ACTC.OB is abt to close the gap. Will watch for an entry here after this fall.
Just triggered my buy. I'll keep fingers crossed. Wish me luck.

Out with a penny and a half profit

Advanced Cell Technology Inc. is Today's Focus Stock on MicroStockProfit.com

Press Release Source: MicroStockProfit.com On Tuesday January 4, 2011, 6:50 am EST

DALLAS, Jan. 4, 2011 (GLOBE NEWSWIRE) -- MicroStockProfit.com announces an investment report featuring Advanced Cell Technology Inc. (OTCBB:ACTC - News). The report includes financial, comparative and investment analyses, and industry information you need to know to make an educated investment decision.



The full report is available at: www.microstockprofit.com/lp/ACTC



Advanced Cell Technology Inc. (ACTC) is a biotechnology company focused on the development of cellular therapies for the treatment of rare and common diseases that impact millions of people worldwide. It applies stem cell-based technologies and other proprietary methods in the area of regenerative medicine to bring patient-specific therapies from the lab to the bedside. The Company is in the final stages of moving toward the initiation of phase I clinical trials for its Retinal Pigment Epithelial (RPE) program, which addresses a number of retinal degenerative disorders.



For only $19 a month, you can sign up for our real-time stock alert service. Click here to join now: http://www.pennystocklive.com/premium-membership/



In the report, the analyst notes:



"ACTC announced that it was cleared by the U.S. Food and Drug Administration (FDA) to test a therapy made from embryonic stem cells in patients with macular degeneration, a leading cause of blindness. The Company is now allowed to initiate a phase I/II multicenter clinical trial to treat patients with the so-called dry form of macular degeneration.



"ACTC Thursday closed above its 13-day moving average. This is generally considered to be an indication of a bullish trend."



To read the entire report visit: www.microstockprofit.com/lp/ACTC



See what investors are saying about ACTC at http://www.stockhideout.com



Get breaking news on ACTC at http://thestockmarketwatch.com/



MicroStockProfit.com is a small-cap research and investment commentary provider. MicroStockProfit.com strives to provide a balanced view of many promising small-cap companies that would otherwise fall under the radar of the typical Wall Street investor. We provide investors with an excellent first step in their research and due diligence by providing daily trading ideas, and consolidating the public information available on them. For more information on MicroStockProfit please visit: http://www.microstockprofit.com



MicroStockProfit.com Disclosure



MicroStockProfit.com is not a registered investment advisor and nothing contained in any materials should be construed as a recommendation to buy or sell any securities. MicroStockProfit.com is a Web site wholly owned by BlueWave Advisors, LLC. Neither MicroStockProfit.com nor its affiliates have a beneficial interest in the mentioned company; nor have they received compensation of any kind for any of the companies listed in this communication. Please read our report and visit our Web site, MicroStockProfit.com, for complete risks and disclosures.


Contact:
MicroStockProfit.comBrian [email protected]

Small-Cap Research on Advanced Cell Technology Inc. and Bioheart Inc. - Biotech Companies Success Pinned to Clinical Trials

Press Release Source: Wall Street Equity Research On Wednesday January 5, 2011, 8:19 am EST
JOHANNESBURG, SOUTH AFRICA--(Marketwire - 01/05/11) - www.wallstreetequityresearch.com gives shareholders valuable insight on biotechnology stocks Advanced Cell Technology Inc. (OTC.BB:ACTC - News) and Bioheart Inc. (OTC.BB:BHRT - News). Sign up today at www.wallstreetequityresearch.com to receive free research reports on these equities.

As baby boomers continue their march into old age, many companies in the Biotechnology Industry are focusing their efforts on the treatment of the dysfunctions and diseases afflicting the aged. The treatment of heart attacks and macular degeneration, a cause of vision loss, are two such areas that have been receiving attention as of late. With new research into the applications of stem cells, companies in the industry are racing to be the first to successfully apply them in the treatment of various ailments. Visit us at http://www.wallstreetequityresearch.com/ to understand the catalysts and forces driving or affecting the biotechnology industry in today's economic environment.

www.wallstreetequityresearch.com is a specialized website where investors can have specific access to free reports biotechnology industry; traders looking for analyst opinions on Advanced Cell Technology Inc., Bioheart Inc. and other companies in this industry are welcomed to sign up for a free one year membership at http://www.wallstreetequityresearch.com/.

Advanced Cell Technology Inc., whose business revolves around the use of stem cells to treat vision loss, has been performing well as of late. The company has recently received $25 million in funding, and is hoping to use it to bring a few of their projects through clinical trials. The company has also recently been approved by the FDA to start clinical trials on patients with dry AMD, a form of macular degeneration that can lead to loss of vision and blindness. Traders can get direct and free access to today's full report on Advanced Cell Technology Inc. by signing up at http://wallstreetequityresearch.com/January052011AdvancedCellTechnologyInc.(ACTC.OB)050111.php.

Fellow stem cell biotech company Bioheart Inc. is not faring as well. The company, which is researching the use of stems cells in the treatment of heart attack patients, has recently suspended their clinical trials due to a funding dispute. Of concern to those funding the trial is the question of patient safety. Traders can have complimentary access to today's complete research report on Bioheart Inc. by signing up at http://wallstreetequityresearch.com/January052011BioheartInc.(BHRT.OB)050111.php.

About Wall Street Equity Research:
Wall Street Equity Research looks to bring simplicity and highly sophisticated research to an ever-changing investing environment. Wall Street Equity Research has been partnering with a number of North American and Emerging Economies analysts to bring you the best of both continents in terms of market analysis and analytical opinions.

Contact:
Contact Person: Edward D. Brooks [email protected]

ACTC - Volume Alert...

Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the field of regenerative medicine.


Technicals
Last Price Quote is:
-2.35%below 13-day EMA
19.90%above 50-day EMA
RS Rating: N/A 

nice vid: http://www.ustream.tv/recorded/11974983