Archive for March, 2012
Open University offers spinal cord injury solution
The Open University has come up with a 3D cell culture model that could provide insight into how cells in the spinal cord repair after damage.
The research, published in Tissue Engineering, shows how an interface develops between the injured and surrounding tissue after spinal cord injury. The interface inhibits neuronal regeneration, and this research will aid development of treatment to encourage repair.
Dr James Phillips, Lecturer in Health Sciences, explained: Astrocytes are central nervous system (CNS) cells that normally support neuronal activity, but they change behaviour following damage and can inhibit regeneration. With our model, we can simulate the interaction between astrocytes and regenerating neurons after CNS injury.
We found at first the astrocytes in our model were in a resting state, and then became reactive over 15 days, just like they do following CNS damage. As the astrocytes became reactive we were able to monitor the way in which the neurons interacted with them the neurons grew well in their part of the model but when they reached the boundary with the reactive astrocytes they could not penetrate it, mimicking the kind of regeneration failure associated with spinal cord damage.
By using the culture system, the research team can monitor both cell types continuously and control variables to test specific scientific questions. The 3D model provides a powerful new tool for neuroscience research and provides a new way to test the development of new therapies.
The authors Emma East PhD, Jon P. Golding PhD and James B. Phillips PhD from The Open University Faculty of Science, received support from The Wellcome Trust.
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Open University offers spinal cord injury solution
Advanced Cell Technology To Announce 2011 Fourth Quarter and Year-End Results on March 1st
MARLBOROUGH, Mass.--(BUSINESS WIRE)--
Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that it will release 2011 fourth quarter and year-end results on Thursday, March 1st after the market closes. The Company will hold a conference call on Friday, March 2nd at 9:00 am eastern time to discuss the results and provide an update on clinical activities.
Interested parties should dial (888)264-3177 followed by the reference conference ID number 57426004. The call will be available live and for replay by webcast at:
http://us.meeting-stream.com/advancedcelltechnology030212
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 companys periodic reports, including the report on Form 10-K for the year ended December 31, 2010. Forward-looking statements are based on the beliefs, opinions, and expectations of the companys 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 companys 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 Companys clinical trials will be successful.
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Advanced Cell Technology To Announce 2011 Fourth Quarter and Year-End Results on March 1st
International Cellular Medicine Society Grants First Worldwide Accreditation to Tijuana Clinical Trial
Regenerative Medicine Institute, Mexico has been granted full accreditation for its clinical stem cell trials
Portland, Oregon (PRWEB) February 29, 2012
We are pleased that RMI undertook this process, says David Audley, executive director of the ICMS. The clinic understood that patient safety can only be assured through strict evaluation and rigorous oversight. From day one they have embraced the transparency that this program requires.
RMI is the first clinic to achieve this status under the ICMS Accreditation Program. The clinic has undergone two separate site audits as well as an institutional review board review evaluation. Most importantly, the clinic has placed in excess of 50 patients into the Treatment Registry for long-term outcome tracking. The safety profile has been excellent, continued Audley. We have tracked patients over at least two follow-ups and a minimum of six months and not seen a single cell-related adverse event.
The ICMS is currently evaluating nearly a dozen clinics worldwide. Accreditation is based upon the Guidelines for the Practice of Cell-Based Medicine developed and published by the ICMS. Key components of these guidelines are the ethical recruitment of patients, proper consent of patients and compliance with local laws and regulations in the treatment of patients.
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Mr. David Audley International Cellular Medicine Society 503-884-6590 Email Information
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International Cellular Medicine Society Grants First Worldwide Accreditation to Tijuana Clinical Trial
Lafayette's 'R.U.R' deals with robots, role of technology
Lafayette College theater director Michael O'Neill has never seen the classic Czech play "R.U.R," but after teaching it in his theater classes for years, he became intrigued by the relevance of its premise.
So after reading many translations of the play about robots and a mechanized world where people show no emotions, O'Neill decided to write his own translation and produce it at the college. The play opened Wednesday and continues through Saturday at the Williams arts center.
"I made a lot of cuts," O'Neill says. "In those days, they tended to be awfully talky."
"R.U.R." or "Rossum's Universal Robots" was written in 1920 by Karel Capek. It was a response to the death and destruction he had witnessed during World War I and the emotional dislocation and upheavals of the 1917 Communist revolution in Russia.
The play was written as an expressionistic journey into genetic engineering on a mass scale, O'Neill says. It predicted a mechanized world where people have no emotional connections and where workers have lost their human rights. The play takes place in a factory that makes Robots that can think for themselves and can be mistaken for humans.
"I thought that the play had a lot to say about today and our interest in human cloning and our dependence on technology," O'Neill says. "I was concerned about our growing dependence on our cell phones and our computers and the increasing mechanization of everyday life. I also thought that that this play was particularly relevant to Lafayette, which has such a big engineering program."
The play was the first to introduce the word robot to the English language.
"Actually the word robot means 'worker' in Czech, and the Robots in our production look less like Hollywood robots than Soviet workers from the 1920s," O'Neill says. Costume designer Locklyn Brooks has created gray and monochrome outfits that make the Robots look less like machines and more like people, he says.
O'Neill says the play is not so much science fiction as a social satire with a utopian vision.
"This is actually a very traditional play, and despite the presence of the Robots, its main theme is that the human race needs love to be able to survive," he says.
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Lafayette's 'R.U.R' deals with robots, role of technology
Genetics study focused in North Carolina
The Collaborative Cross, a project that aims to duplicate the diversity of human genetics in a lab mouse population, is currently focused in North Carolina.
Genetics play an important role in the most common diseases. As humans cannot be tested genetically in a lab environment, the Collaborative Cross is developing a strain of human genetics in mice. The goal is to ultimately fast-track important discoveries about genetics and disease into tests and treatments that will impact human health.
After a series of 15 essays were published in the Genetics Society of America, the Collaborative Cross set up at UNC Chapel Hill.
The project is led by Fernando Pardo-Manuel de Villenaof the UNCdepartment of genetics, David Threadgill, a geneticist at North Carolina State University, and Gary Churchill of the Jackson Laboratory. The mice are being housed at UNC Chapel Hill.
Villena wrote one of the papers featured in Genetics. His paper provides the first comprehensive description of the mouse genome library.
The Collaborative Cross is a free resource for all scientists.
In a press release from UNC Health Care, Terry Magnuson, chair of genetics at UNC Chapel Hill and vice dean for research at the UNC School of Medicine, said, "Just as a museum curator is responsible for the heritage of art in their facility, our colleagues at UNC and NC State University are responsible for the heritage of the mice in the Collaborative Cross. As scientists use this resource to find ways to prevent and address the genetic changes that cause disease, findings in laboratory experiments should be much easier to translate to humans."
The Collaborative Cross project is also being used for studies on breast cancer.
Dr. Norman E. Sharpless, UNC Lineberger's associate director for translation research, said in a press release from UNC Health Care, "I expect that the results of this work will help human breast cancer patients. Huge consortia are successfully identifying regions of the genome associated with important human diseases like cancer and diabetes, but there are limitations in working with the human genome. The Collaborative Cross provides the best means to understand why certain genes are linked to certain diseases."
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Genetics study focused in North Carolina
Meet Cord Blood Registry’s Leader of Laboratory Operations – Video
28-02-2012 16:31 Learn more about cord blood stem cells here http://www.cordblood.com Cord Blood Registry takes pride in leading the cord blood banking industry with its state-of-the-art lab. Meet Kristen, who leads the effort to make sure we're providing our clients with the best once their babies' stem cells arrive in Tucson. Kristen is one of the many people who make sure that, from that first phone call to the day your baby's stem cells are collected and stored, you receive the industry's best service and support. For more information on CBR's processes, visit: http://www.cordblood.com
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Meet Cord Blood Registry's Leader of Laboratory Operations - Video
Women Can Make New Eggs After All, Stem-Cell Study Hints
Women may make new eggs throughout their reproductive yearschallenging a longstanding tenet that females are born with finite supplies, a new study says. The discovery may also lead to new avenues for improving women's health and fertility.
A woman has two ovaries, which release eggs during her monthly ovulation.(Learn more about the human body.)
Previous research had suggested that a woman is born with all the egg cells she will ever have in her lifetime.
But in recent experiments, scientists discovered a new type of stem cell in the ovaries thatwhen grown in the labgenerates immature egg cells.The same immature cells isolated from adult mouse ovaries canturn into fertile eggs.
Stem cells,found in embryos and certain adult body tissues, have the potential to grow into many different types of cells.
(See"Liposuction Fat Turned Into Stem Cells, Study Says.")
The finding reinforces the team's previous experiments in mice, which had identified a new type of ovarian stem cell that renews a female mouse's source of eggs throughout its fertile years.
That study, published in the journal Nature in 2004, was the "first to reach the conclusion that this long-held belief in our fieldthat young girls are given a bank account at birth that you can no longer deposit eggs to, just withdraw fromwas no longer true," said study leaderJonathan Tilly.
By reinforcing these earlier results in people, the new study is a "big step forward" from the mouse work, emphasized Tilly, director of the Vincent Center for Reproductive Biology at Massachusetts General Hospital in Boston.
From a purely biological perspective, the concept that a woman would continually generate new eggs during her reproductive years makes sensesince men constantly replenish their sperm, Tilly added. (Read how men produce 1,500 sperm a second.)
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Women Can Make New Eggs After All, Stem-Cell Study Hints
International Cellular Medicine Society Grants First Worldwide Accreditation to Tijuana Clinical Trial
Regenerative Medicine Institute, Mexico has been granted full accreditation for its clinical stem cell trials
Portland, Oregon (PRWEB) February 29, 2012
We are pleased that RMI undertook this process, says David Audley, executive director of the ICMS. The clinic understood that patient safety can only be assured through strict evaluation and rigorous oversight. From day one they have embraced the transparency that this program requires.
RMI is the first clinic to achieve this status under the ICMS Accreditation Program. The clinic has undergone two separate site audits as well as an institutional review board review evaluation. Most importantly, the clinic has placed in excess of 50 patients into the Treatment Registry for long-term outcome tracking. The safety profile has been excellent, continued Audley. We have tracked patients over at least two follow-ups and a minimum of six months and not seen a single cell-related adverse event.
The ICMS is currently evaluating nearly a dozen clinics worldwide. Accreditation is based upon the Guidelines for the Practice of Cell-Based Medicine developed and published by the ICMS. Key components of these guidelines are the ethical recruitment of patients, proper consent of patients and compliance with local laws and regulations in the treatment of patients.
###
Mr. David Audley International Cellular Medicine Society 503-884-6590 Email Information
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International Cellular Medicine Society Grants First Worldwide Accreditation to Tijuana Clinical Trial
Stem-Cell Therapy Takes Off in Texas
By David Cyranoski of Nature magazine
With Texas pouring millions of dollars into developing adult stem-cell treatments, doctors there are already injecting paying customers with unproven preparations, supplied by an ambitious new company.
The US Food and Drug Administration (FDA) has not approved any such stem-cell treatment for routine clinical use, although it does sanction them for patients enrolled in registered clinical trials. Some advocates of the treatments argue, however, that preparations based on a patient's own cells should not be classed as drugs, and should not therefore fall under the FDA's jurisdiction.
There are certainly plenty of people eager to have the treatments. Texas governor Rick Perry, for instance, has had stem-cell injections to treat a back complaint, and has supported legislation to help create banks to store patients' harvested stem cells.
One company that has benefited from this buoyant climate is Celltex Therapeutics, which "multiplies and banks" stem cells derived from people's abdominal fat, according to chairman and chief executive David Eller. Its facility in Sugar Land, just outside Houston, opened in December 2011 and houses the largest stem-cell bank in the United States.
Celltex was founded by Eller and Stanley Jones, the orthopaedic surgeon who performed Perry's procedure, and it uses technology licensed from RNL Bio in Seoul. Because clinical use of adult-stem-cell treatments are illegal in South Korea, RNL has since 2006 sent more than 10,000 patients to clinics in Japan and China to receive injections.
Celltex says that although it processes and banks cells, it does not carry out stem-cell injections. It declined to answer Nature's questions about whether its cells have been used in patients. But there is evidence that the company is involved in the clinical use of the cells on US soil, which the FDA has viewed as illegal in other cases.
Public hype
In addition to the publicity surrounding Perry's treatment, a woman named Debbie Bertrand has been blogging about her experiences during a five-injection treatment with cells prepared at Celltex. Her blog (http://debbiebertrand.blogspot.com) hosts photographs of herself alongside Jones; Jennifer Novak, a Celltex nurse; Jeong Chan Ra, chief executive of RNL Bio; and her doctor, Jamshid Lotfi, a neurologist who works for the United Neurology clinic in Houston. Another photo is captioned: "My cells are being processed in here for my next infusion!!!" A third shows Bertrand, Lotfi and a physician called Matthew Daneshmand, who is, according to the caption, injecting Bertrand's stem cells into an intravenous drip, ready for the infusion. Nature has been unable to contact Bertrand.
Lotfi says that he has administered cells processed by Celltex to more than 20 people. "Five or six" -- including Bertrand -- have multiple sclerosis and "four or five" have Parkinson's disease, he says. Lotfi explains that patients sign up for treatment by contacting Novak, and that cells are prepared by removing about five grams of fat -- containing roughly 100,000 mesenchymal stem cells -- from the patient's abdomen. Over a three-week period, the cells are cultured until they reach about 800 million cells. Lotfi says that patients get at least three injections of 200 million cells each, and that the cells do not take effect for a few months. According to Lotfi, Celltex charges US$7,000 per 200 million cells, and pays Lotfi $500 per injection.
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Stem-Cell Therapy Takes Off in Texas
Cryo-Cell Reports Financial Results for Fiscal 2011
OLDSMAR, Fla., Feb. 29, 2012 /PRNewswire/ --Cryo-Cell International, Inc. (OTC:QB Markets Group Symbol: CCEL) (the "Company"), the world's first private cord blood bank to separate and store stem cells in 1992, today announced results for its fiscal year 2011.
"Cryo-Cell fiscal 2011 results are indicative of a company that is in the process of making many organizational and operational improvements," stated David Portnoy, Cryo-Cell's Chairman and Co-CEO. "Although the implementation of these steps is still in the early stages, we are encouraged in our belief that our goals will be achieved."
Mark Portnoy, Cryo-Cell's Co-CEO, added, "With the transition of the new Board of Directors last year, the Company made significant changes over the last six months. We are continuing to improve the IT systems and website, and have embarked on a major rebranding/marketing effort. Although these efforts have increased our expenses, we have balanced that somewhat with cost reductions. We feel these are appropriate and necessary investments for the Company's future. In addition, the Company has implemented its previously announced stock repurchase plan, and to date, has repurchased 415,117 shares on the open market and in private transactions."
Financial Results
Consolidated revenues for fiscal year ended 2011 were approximately $17.9 million compared to approximately $17.7 million for fiscal 2010. The revenues for fiscal 2011 consisted of approximately $16.5 million in processing and storage fee revenue and approximately $1.4 million in licensee income compared to approximately $16.2 million in processing and storage fee revenue and approximately $1.5 million in licensee income for fiscal 2010. Licensee income for the fiscal year ended November 30, 2011 primarily consisted of approximately $1.3 million in royalty income earned on the processing and storage of cord blood stem cell specimens in geographic areas where the Company has license agreements. The remaining licensee income of approximately $41,000 related to installment payments of non-refundable up-front license fees from the licensees of the Company's umbilical cord blood program in Costa Rica, Nicaragua and Germany. Licensee income for the fiscal year ended November 30, 2010 primarily consisted of approximately $1.3 million in royalty income earned on the processing and storage of cord blood stem cell specimens in geographic areas where the Company has license agreements. The remaining licensee income of $175,000 related to installment payments of non-refundable up-front license fees from the licensees of the Company's umbilical cord blood program in Chile, Colombia, Peru, Nicaragua, Pakistan, Curacao, Bonaire, St. Maarten, Aruba and Suriname.
The Company reported a net loss in fiscal 2011 of approximately ($2.1 million), or ($0.18) per basic and diluted share, compared to net income of approximately $3.5 million, or $0.29 per basic and diluted share in fiscal 2010. The decrease in net income for fiscal 2011 principally resulted from a 31% increase in marketing, general and administrative expenses. The increase was due in part to an increase in fees associated with the annual meeting. The total fees expended for the 2011 Annual Meeting were approximately $957,000. The increase was also due to a write-off of approximately $211,000 for abandoned patents and trademarks due to the decision of management to discontinue pursuing certain patents and trademarks and an approximate $627,000 impairment of previously capitalized costs associated with the development of internal use computer software. Also, included in marketing, general and administrative expenses is approximately $950,000 related to an accrual of severance in accordance with the employment agreement of Mercedes Walton, the Company's former Chairman and CEO dated August 15, 2005, as amended July 16, 2007 because the circumstances relating to her termination are in dispute. Per the employment agreement, Ms. Walton would be entitled to severance in the amount up to $950,000 related to lost salary, bonuses and benefits if she had not been terminated for Cause, as defined in the agreement. The Company believes that Ms. Walton has not earned the right to this severance and intends to defend this position. Excluding all one-time charges noted above, the Company had net income before one-time charges in fiscal 2011 of approximately $645,000, or $0.05 per basic and diluted share before one-time charges. Included in the net income of $3.5 million for fiscal 2010 was the reversal of approximately $1.7 million of the Company's valuation allowance for income taxes. The decision to reverse a portion of the allowance was based on the Company's historical operating performance and future projections of taxable income.
As of November 30, 2011, the Company had approximately $7.3 million in cash, cash equivalents, marketable securities and other investments compared to $9.5 million as of November 30, 2010, representing a 23% decrease. The decrease is primarily attributable to the funding of a Grantor trust in the amount of $2,500,000 to escrow amounts that may become payable to the Company's former Chief Executive Officer and other executive officers of the Company under their respective Employment Agreements as a result of a change in control. The Company had no long-term debt at the end of fiscal 2011.
About Cryo-Cell International, Inc.
Cryo-Cell International, Inc. was founded in 1989 and was the world's first private cord blood bank to separate and store stem cells in 1992. Today, Cryo-Cell has over 240,000 clients worldwide from 87 countries. Cryo-Cell's mission is to provide our clients with the premier stem cell cryopreservation service and to support the advancement of regenerative medicine.
Cryo-Cell operates in a state-of-the-art Good Manufacturing Practice and Good Tissue Practice (cGMP/cGTP)-compliant facility, is ISO 9001:2008 certified and accredited by the AABB. Cryo-Cell is a publicly traded company. OTC:QB Markets Group Symbol: CCEL. Expectant parents or healthcare professionals may call 1-800-STOR-CELL (1-800-786-7235) or visit http://www.cryo-cell.com.
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Cryo-Cell Reports Financial Results for Fiscal 2011
Nuvilex Reveals Goldman Small Cap Research Cites Groundbreaking Cancer Therapy in Updating Buy Recommendation
SILVER SPRING, Md.--(BUSINESS WIRE)--
Nuvilex, Inc. (OTCQB:NVLX), an emerging biotechnology provider of cell and gene therapy solutions, announced today Goldman Small Cap Research has reissued its buy recommendation on Nuvilex with a short term price target of $0.50 per share.
According to the research report prepared by Goldman, The current share price represents but a fraction of its true value, in our view. With recently increased interest and valuation in the pancreatic cancer treatment arena, we believe that Nuvilex is worth $0.20 just on the oncology therapies alone and that the shares will reach $0.50 in the next six months. Looking ahead, as milestone events occur, $1.00 per share is within reach over the next 12-18 months.
Goldman bases this value projection, in part, on the pending acquisition of SG Austria assets, and with it complete control over the cell encapsulation technology that forms the backbone of Nuvilexs planned biotechnology development. The report states in part the following:
Following execution of the SG Austria asset acquisition, we expect to see a flurry of events and progress on the development side which will serve as catalysts, including when management submits its protocol for the next stage pancreatic cancer trial. We would not be surprised to see the stock break through the $0.50 price on such news as well as progress on the next stage of trials for other therapies.
One reason we are so convinced of the great buying opportunity is the fact that pancreatic cancer treatments are currently at the forefront of the biotech space and are enjoying very high valuations. Although Nuvilex is a not a drug producer, but an existing therapy enhancer through the use of its live cell encapsulation enhancement platform, the timing of these milestone events could not be better for Nuvilex and a re-valuation of its offering.
The Goldman report also compares alternative oncology therapies, including Gemzar from Threshold Pharmaceuticals and Merrimack Pharmaceuticals drug encapsulation technology, noting that, contrary to these treatments, the Nuvilex live-cell encapsulation technology is not limited to one specific use, but can be adapted to use for a host of cell types. The report states, Its difficult to compare apples-to-apples in this space as Nuvilex is the only firm utilizing live-cell encapsulation therapy for cancer, while all the other treatments are based upon a particular drug usage. Contrasting the results of different Phase II clinical trials, the Goldman report comments that the pancreatic cancer therapy, based on completed Phase 1/2 data, appears to have yielded statistically greater results than competing technologies.
Commenting on The Goldman Report, Nuvilex Chief Executive Officer, Dr. Robert Ryan, stated, The report did an excellent job highlighting the value and capabilities of our cell encapsulation technology, not just for cancer therapy, but also for the vast array of treatments where live-cell encapsulation can aid multiple diseases. In the case of the completed cancer trials, it generated superior results with lower drug dosages, and reduced chemotherapeutic side effects. As we move forward with diabetes and stem cell therapy treatments, we are confident our success will, as Goldman predicts prompt leaders in multiple treatment segments to partner with Nuvilex in order to maintain their respective market shares.
Investors are recommended to study the Goldman Research Report for a detailed review and valuation methodology regarding Nuvilex.
About Nuvilex
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Nuvilex Reveals Goldman Small Cap Research Cites Groundbreaking Cancer Therapy in Updating Buy Recommendation