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TiGenix Reports Full Year 2011 Financial Results

Posted: March 15, 2012 at 12:46 pm

LEUVEN, BELGIUM--(Marketwire -03/15/12)- TiGenix NV (EURONEXT: TIG) today gave a business update and announced financial results for the full year 2011.

Business highlights

Financial highlights

"TiGenix has created a new and strong basis in 2011 on which we can build going forward and we have strengthened our position as the European leader in cell therapy," says Eduardo Bravo, CEO of TiGenix. "We have delivered on our promises: we have obtained national reimbursement for ChondroCelect in Belgium and made progress in other European markets. We advanced all clinical stem cell programs on plan, and raised substantial funds from specialized healthcare investors and through non-dilutive financing. Today, TiGenix is well-positioned to reach the next value-enhancing inflection points."

Business Update

Successful integration of Cellerix reinforces leadership position in cell therapyIn May 2011, TiGenix closed the business combination with the stem cell therapy company Cellerix, creating the European leader in cell therapy. During 2011 the Company succeeded in rapidly integrating both entities. The Company now combines top line revenues with an advanced pipeline of clinical stage regenerative and immuno-modulatory products. TiGenix's operations are supported by a strong commercial and manufacturing infrastructure for advanced cell therapies, an experienced international management team and a solid cash position.

As a result of the merger, the Company's development focus has shifted from early stage preclinical programs towards a number of highly promising clinical stage products for inflammatory and autoimmune disorders of high unmet medical need, each addressing markets in excess of EUR 1 billion. TiGenix product pipeline is based on a proprietary stem cell platform that exploits expanded allogeneic (donor-derived) adult stem cells derived from human adipose (fat) tissue ('eASCs'). The platform has been extensively characterized in line with requirements of the European Medicines Agency (EMA) and is supported by exhaustive preclinical and CMC packages.

Given its focus on cell therapy, TiGenix is in the process of divesting its ChondroMimetic franchise, which is based on a biomaterial platform. To be able to concentrate on its core business and move forward with a clean slate, TiGenix has decided to write-off the intellectual property related to the OrthoMimetics acquisition.

ChondroCelect commercial roll-out progressing with first national reimbursementChondroCelect obtained reimbursement in Belgium in May 2011, and is today available in 22 specialized treatment centers.

TiGenix is selling ChondroCelect in the UK, the Netherlands, Germany, and Spain under managed access and private insurance schemes, while pursuing national reimbursement in these countries and France.

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TiGenix Reports Full Year 2011 Financial Results

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Cosmetic Regenerative Medicine – Video

Posted: March 15, 2012 at 9:29 am

13-03-2012 16:42 Hear Dr. Bowen talk about the exciting field of Regenerative Medicine. The type of regenerative medicine Dr. Bowen practices uses our own adult stem cells to achieve desired results.

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Cosmetic Regenerative Medicine - Video

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TiGenix Reports Full Year 2011 Financial Results

Posted: March 15, 2012 at 9:28 am

LEUVEN, BELGIUM--(Marketwire -03/15/12)- TiGenix NV (EURONEXT: TIG) today gave a business update and announced financial results for the full year 2011.

Business highlights

Financial highlights

"TiGenix has created a new and strong basis in 2011 on which we can build going forward and we have strengthened our position as the European leader in cell therapy," says Eduardo Bravo, CEO of TiGenix. "We have delivered on our promises: we have obtained national reimbursement for ChondroCelect in Belgium and made progress in other European markets. We advanced all clinical stem cell programs on plan, and raised substantial funds from specialized healthcare investors and through non-dilutive financing. Today, TiGenix is well-positioned to reach the next value-enhancing inflection points."

Business Update

Successful integration of Cellerix reinforces leadership position in cell therapyIn May 2011, TiGenix closed the business combination with the stem cell therapy company Cellerix, creating the European leader in cell therapy. During 2011 the Company succeeded in rapidly integrating both entities. The Company now combines top line revenues with an advanced pipeline of clinical stage regenerative and immuno-modulatory products. TiGenix's operations are supported by a strong commercial and manufacturing infrastructure for advanced cell therapies, an experienced international management team and a solid cash position.

As a result of the merger, the Company's development focus has shifted from early stage preclinical programs towards a number of highly promising clinical stage products for inflammatory and autoimmune disorders of high unmet medical need, each addressing markets in excess of EUR 1 billion. TiGenix product pipeline is based on a proprietary stem cell platform that exploits expanded allogeneic (donor-derived) adult stem cells derived from human adipose (fat) tissue ('eASCs'). The platform has been extensively characterized in line with requirements of the European Medicines Agency (EMA) and is supported by exhaustive preclinical and CMC packages.

Given its focus on cell therapy, TiGenix is in the process of divesting its ChondroMimetic franchise, which is based on a biomaterial platform. To be able to concentrate on its core business and move forward with a clean slate, TiGenix has decided to write-off the intellectual property related to the OrthoMimetics acquisition.

ChondroCelect commercial roll-out progressing with first national reimbursementChondroCelect obtained reimbursement in Belgium in May 2011, and is today available in 22 specialized treatment centers.

TiGenix is selling ChondroCelect in the UK, the Netherlands, Germany, and Spain under managed access and private insurance schemes, while pursuing national reimbursement in these countries and France.

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TiGenix Reports Full Year 2011 Financial Results

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FDA Blocks Stem Cell Therapy: Is the Government Playing a Cell Game? – Video

Posted: March 15, 2012 at 8:59 am

09-03-2012 18:23 A company is locked in a battle with the FDA over the use one's own stem cells. The company argues that one has the right to over one's own body? If that's true, why is the FDA blocking this treatment? Find out. Plus, doctors are refusing to treat children that do not get vaccinated. Is this ethical? See more at http://www.pjtv.com

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FDA receives complaint about Houston company that stored Gov. Perry's stem cells

Posted: March 15, 2012 at 8:59 am

The U.S. Food and Drug Administration has received a complaint alleging the Houston company involved in Gov. Rick Perry's unregulated adult stem-cell operation is a potential danger to patients and not in compliance with federal law.

In an eight-page letter sent last month, University of Minnesota bioethicist Leigh Turner called on the FDA to investigate Celltex Therapeutics Corp., which banks people's stem cells for future reinjection in the event of disease or injury. Perry was the company's first customer last year.

"It appears their business plan involves injecting or infusing on a for-profit, commercial basis non-FDA-approved adult stem cells into paying customers," Turner wrote in the Feb. 21 letter. "This plan conflicts with FDA regulations governing human stem cells."

An FDA spokeswoman declined comment, but Turner said an agency official told him the matter has been assigned to an investigator and is being taken seriously.

Celltex co-founder David Eller said Tuesday night he is confident the company will "meet all FDA specifications." He emphasized that Celltex doesn't administer stem cells, but stores and processes them at the behest of doctors who later reinject them into patients.

Dr. Stanley Jones, a Houston orthopedic surgeon, injected Perry's stem cells during his back surgery in July.

The plan by Celltex and Perry to make Texas a leader in the therapy have been controversial since details about the governor's procedure became known last summer. The therapy, drawing on the ability of adult stem cells to replenish dying cells, is promising but thought by most medical researchers to need much more clinical study before it is commercialized.

Stem cells are a kind of medicine known as biologics, therapy involving living cells rather than chemicals. Most medical experts say that adult stem-cell therapy involves more than the "minimal manipulation" the agency allows without its oversight because the cells are isolated, cultured in a laboratory and stored for some period of time before being reinjected.

The FDA has recently stepped up enforcement of unregulated adult stem cell activity, though legal experts interviewed last fall by the Chronicle said it was unclear whether the agency would look into Perry's procedure because he seemed fully informed and unharmed by it.

The Texas Medical Board is currently considering a policy that would require providers of stem cells and other experimental drugs to use them only with the permission of independent review committees that assess trials for patient safety. The policy comes up for final approval in April.

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Grekos' attorney: Another physician treated patient who died

Posted: March 15, 2012 at 8:59 am

Interview with Dr. Zannos Grekos Grekos contests that his office has done ...

LEE COUNTY A week after Dr. Zannos Grekos was accused of performing a stem cell treatment on a patient who died, his attorney said another physician was treating the patient at the Bonita Springs practice.

And there was no stem cell treatment performed, only liposuction, said Richard Ozelie, the Boca Raton attorney representing Grekos.

Ozelie does not identify the other doctor but said in a statement Wednesday that the Lee County Sheriffs Office and the Lee County Medical Examiners Office both have that information.

The patient, identified by state authorities through the initials R.P., did have liposuction at the Regenocyte medical facility in Bonita Springs, Ozelie said in the statement. The Sheriffs Office later identified the man who died as Richard Poling , 77, of Newburgh, Ind.

The attorney issued the one-page statement because of concerns with the accuracy of media coverage after the state Department of Health suspended Grekos license March 7. The case has received some national media attention.

The next day, the Sheriffs Office launched a criminal investigation into Grekos practice, Regenocyte, 9500 Bonita Beach Road, Suite 310.

Sheriffs Office spokesman Lt. Larry King had no comment Wednesday and said the agencys investigation is continuing.

In the suspension order, the state health department said Grekos infused or directed that the patient have concentrated stem cells infused into his blood stream. The state order said the patient suffered cardiac arrest and died.

The emergency suspension was issued because Grekos violated a license restriction from February, 2011, not to do anything with autologous stem cell treatment or bone marrow aspirate, according to the state order.

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Grekos' attorney: Another physician treated patient who died

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QF signs research deal with HMC

Posted: March 15, 2012 at 8:59 am

Qatar Foundation for Education, Science and Community Development (QF) has signed a research collaboration agreement with Hamad Medical Corporation (HMC), driven by a shared desire for further advancement in stem cell research, with the ultimate goal of preventing cancer from evolving to a life- threatening stage. The world loses millions of people to cancer, which is why Qatar Foundation strives to combat this disease, Faisal Mohammed al-Suwaidi, president, research and development, QF, said, adding: The use of stem cells in researching new treatments has begun to prove its effectiveness, so we are undertaking more studies in this field. This will undoubtedly contribute to building a better future for mankind. The agreement was signed by al-Suwaidi and Edward Hillhouse, HMCs senior policy adviser for academic health systems and acting medical director. Abdelali Haoudi, QF vice-president of research and deputy director of Qatar Biomedical Research Institute (QBRI), commented: QF, through the QBRI, has established a new research collaboration agreement with HMC, which has the potential to deliver major advances in the field of stem cell therapy applied to cancer. Our joint efforts will not only work to discover treatments designed to destroy cancer cells, but revolutionise the scientific approach to fighting disease in the future. Research will be conducted at Al Amal Hospital in Doha, with efforts concentrated on enhancing its reputation across the globe, particularly for its studies on leukemia. Stem cell research is a growing innovative field and one of the priority research areas for both QF and HMC, said Dr Hanadi Raffi Elayoubi, head of the Bone Marrow Transplant Unit and chief of staff at Al Amal Hospital. This research programme does not only target leukemia, the top third cancer diagnosis in Qatar, but represents one of the first translational cancer research programmes in HMC. We have the setting and the clinical programme at Al Amal Hospital that will allow the translation to bed site to the patient. This is certainly a very important partnership initiated by QF to develop translational research that might impact patients care, he added. Scientists from both HMC and QBRI will work under the guidance of Dr Salem Chouaib, research director at the French National Institute for Health and Biomedical Research, and head of the cancer immunology division at Paris-based Institute Gustave Roussy. Labelled the European leader in cancer research and treatment, the institute will also share its expertise as part of this agreement. Through his work, Dr Chouaib seeks to transform theoretical concepts of cancer research into clinical application. As part of this agreement, he will work to foster a strong relationship between QF and other French scientists specialising in this area of study. QFs newly signed agreement with HMC will support QF on its mission to build human capacity in Qatar by ensuring that scientists have the necessary resources and means to explore alternative treatments for curing cancer. A proven cure for cancer continues to elude medical science. While chemotherapy and radiation treatment can kill malignant tumors, they do not cure every patient and, despite the billions of dollars invested globally on research, cancer remains one of the worlds major causes of death.

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Verastem, Inc. Reports Year-End 2011 Financial Results

Posted: March 14, 2012 at 10:04 pm

CAMBRIDGE, Mass.--(BUSINESS WIRE)--

Verastem, Inc., (NASDAQ: VSTM - News) a biopharmaceutical company focused on discovering and developing drugs to treat breast and other cancers by targeting cancer stem cells, today reported financial results for the year ended December 31, 2011 and also commented on certain corporate accomplishments and plans.

"We achieved important milestones in the discovery and development of drugs targeting cancer stem cells last year and anticipate further progress this year," said Christoph Westphal, M.D., Ph.D., Chairman, President and Chief Executive Officer of Verastem, Inc. "In particular, we acquired our focal adhesion kinase (FAK) program and are progressing two lead candidates, VS-4718 and VS-5095 in parallel through preclinical studies. In our Wnt/Beta-catenin program, VS-507 is currently in IND-enabling toxicology studies. We expect to initiate clinical trials with VS-507 and one of either VS-4718 or VS-5095 over the next 12-15 months.

We anticipate that the capital raised through our recently completed initial public offering will provide sufficient funds for operations into 2016, said Robert Forrester, Chief Operating Officer of Verastem, Inc. We believe that the IPO gives us the ability to maintain rights to our compounds through Phase 2 and provides the capital we need to do the right science and the right clinical trials without a financing overhang.

Recent Accomplishments

Our significant recent accomplishments include the following:

Full Year 2011 Financial Results

As of December 31, 2011, Verastem had cash, cash equivalents, short-term investments and long-term investments of $56.8 million compared to $3.6 million on December 31, 2010. In February 2012, we received net proceeds from our IPO of approximately $56.7 million.

Net loss for the year ended December 31, 2011 was $13.7 million, or $10.59 per share applicable to common shareholders, as compared to $784,000, or $0.91 per share, for the period from August 4, 2010 (inception) to December 31, 2010 (2010 Period). Net loss includes stock-based compensation expense of $1.6 million and $52,000 for the year ended December 31, 2011 and the 2010 Period, respectively.

For the year ended December 31, 2011, research and development expense was $9.9 million compared to $400,000 for the 2010 Period. The major components of research and development expense in 2011 were: contract research organizations ($3.7 million), payroll expense ($1.5 million), consulting fees ($1.3 million), laboratory supplies ($1.0 million), non-employee stock-based compensation ($1.0 million) and license fees ($842,000).

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Verastem, Inc. Reports Year-End 2011 Financial Results

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BioTime Announces Fourth Quarter and Fiscal Year End 2011 Financial Results and Recent Corporate Accomplishments

Posted: March 14, 2012 at 10:04 pm

ALAMEDA, Calif.--(BUSINESS WIRE)--

BioTime, Inc. (NYSE Amex: BTX), a biotechnology company that develops and markets products in the field of regenerative medicine, today reported financial results for the fourth quarter and year ended December 31, 2011 and highlighted recent corporate accomplishments.

At the forefront of our corporate strategy is a plan to develop and acquire novel technologies in the stem cell field and to establish one of the broadest sets of capabilities in the industry. We made significant strides towards the accomplishment of that goal through further development of our products and through key strategic acquisitions in 2011. We are now positioned to focus on commercializing these emerging technologies, said Michael D. West, Ph.D., BioTime's President and CEO. We are on track to begin human clinical trials in 2012 for HyStem-Rx as a medical device for the delivery of adipose stem cells for reconstructive surgery and transplantation, and we look forward to providing updates on our progress of this and other important product development programs during 2012, including the PanC-DxTM cancer diagnostic development program.

Financial Results

Revenue

For the quarter ended December 31, 2011, on a consolidated basis, total revenue was $1.6 million, up $0.2 million or 15% from $1.4 million for the same period one year ago. The increase in revenue year-over-year in the fourth quarter 2011 is primarily attributable to an increase in the sale of research products.

For the full year 2011, total revenue, on a consolidated basis, including royalties from product sales and other revenue, revenue recognition of deferred license fees and grant income, was $4.4 million, up $0.7 million or 18% from $3.7 million in 2010. The increase in revenue is primarily attributable to an increase in grant revenue and a increase in the sale of research products, slightly offset by a decrease in royalties from the sale of Hextend, BioTime's proprietary blood plasma volume expander used in surgery and trauma care. The grant revenue increase is attributable to a new grant received in 2011 from the Office of the Chief Scientist of the Ministry of Industry, Trade and Labor of Israel and recognized through BioTimes subsidiary Cell Cure Neurosciences, Ltd. Research products revenue increased as BioTime and its subsidiaries continued to develop a broader line of research products for stem cell research.

Expenses

Total expense for the three months ended December 31, 2011 was $7.1 million, compared to expense of $5.2 million for the fourth quarter of 2010. Operating expenses increased 37% year-over-year in the fourth quarter due to an increase in staffing, stock option compensation, and the expansion of research and development efforts, including additional expenses in the HyStem-Rx clinical development program and PanC-DxTM cancer diagnostic development program. Expenses of certain BioTime subsidiaries are funded in part by equity investments from the minority shareholders of those subsidiaries.

Total expense for the full year ended December 31, 2011 was $23.0 million, compared to $13.5 million for the full year ended December 31, 2010. The increase in expenses is primarily related to an increase in staffing, stock option compensation, the expansion of research and development efforts, and the operating expenses incurred by businesses acquired by BioTime during 2010 and 2011. In this regard, total expense for 2011 reflects a full year of operation of subsidiaries acquired during the course of 2010 and $2.0 million of amortization expenses related to patent technology of the businesses acquired during 2010 and 2011.

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Washington Center for Pain Management Begins Enrollment in United States Stem Cell Therapy Study in Subjects With …

Posted: March 14, 2012 at 10:01 pm

EDMONDS, Wash., March 14, 2012 /PRNewswire/ --Washington Center for Pain Management is participating in a nationwide FDA-cleared adult stem cell study testing novel treatment for chronic low back pain and has enrolled its first patient. The study will test the use of Mesenchymal Precursor Cells (MPCs) adult stem cells derived from bone marrow that will be directly injected into the lumbar disc. The minimally invasive procedure may offer an alternative to back surgery for eligible patients with chronic pain from degenerative discs.

An estimated 30 million people in the United States suffer from back pain. Degenerative disc disease is the most common cause of low-back pain, which develops with the gradual loss of a material called proteoglycan, which cushions the bones of the spine and enables normal motion.

Most patients with low-back pain respond to physical therapy and medications, but in advanced cases, artificial disc replacement or spinal fusion -- removal of the degenerated discs and the fusion of the bones of the spine -- is necessary. However, these surgeries often are not entirely effective.

"Millions of Americans are debilitated by chronic low back pain," says Dr Hyun Joong Hong MD, the lead investigator at The Washington Center for Pain Management. "This promising therapy is at the cutting edge of medical science and has the potential to create a paradigm shift in our approach to minimally invasive solutions to this disease."

Researchers will enroll approximately 100 study participants. About fifteen participants will be enrolled at The Washington Center for Pain Management and the rest at 11 other medical centers throughout the United States. The trial is scheduled to last for three years.

Washington Center for Pain Management is enrolling study participants suffering from moderate low-back pain for a minimum of six months and whose condition has not responded to other, conventional treatments.

Once enrolled, patients are randomly assigned to one of four treatment groups:

Patients will receive a single injection of their assigned test agent directly into the center of the target discs within their spine and will be monitored for safety. Patients will also be monitored using imaging to identify any changes in their disease condition or disease progression. Use of pain medications, self-reports of pain, subsequent surgical interventions and assessments of disability, quality of life, productivity and activity will be evaluated. Repair of the disc and reduction of chronic back pain will be assessed in each patient.

Promising results have been observed in prior research using animal models when stem cells were investigated for the repair of damaged spine discs. The cells were well tolerated in these study animals.

This study is sponsored by Mesoblast Limited, a world leader in the development of biologic products for the broad field of regenerative medicine. Mesoblast has the worldwide exclusive rights to a series of patents and technologies developed over more than 10 years relating to the identification, extraction, culture and uses of adult Mesenchymal Precursor Cells (MPCs). The MPCs are derived from young adult donors' bone marrow and are immune tolerant.

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