FREIENBACH, Switzerland, March 14, 2012 /PRNewswire/ — EffRx Pharmaceuticals SAtoday announced that the U.S. Food and Drug Administration (FDA) has approved BINOSTO(alendronate sodium) Effervescent Tablets, previously known as EX101, for the treatment of osteoporosis in postmenopausal women, and as a treatment to increase bone mass in men with osteoporosis. EffRx anticipates that BINOSTO will be commercially available in the United States in the third quarter of 2012.

Christer Rosen, Chairman & CEO of EffRx states: “We are very pleased to receive this approval from the FDA. BINOSTO is a breakthrough innovation for the treatment of osteoporosis, offering those patients who have difficulty with tablets the proven fracture risk reduction of alendronate in a pleasant tasting and easy-to-swallow buffered solution.”

Osteoporosis affects more than 200 million people in the 7 major markets and the global market is estimated to be USD10 billion and growing, especially in the emerging markets. BINOSTO is an innovative treatment option that can assure physicians that they are providing a proven efficacious therapy for those patients who have difficulty with tablets. A Harris Interactive Poll concluded that up to 40% of American adults have difficulties with swallowing tablets.

About BINOSTO:

BINOSTO is a once weekly, strawberry flavored effervescent tablet containing alendronate 70mg that rapidly dissolves in half a glass (4oz) of plain room temperature water to make a buffered solution. BINOSTO is available in packs of 4 and 12 tablets.

BINOSTO was developed by EffRx based on an agreement with Merck & Co, Inc. granting EffRx the worldwide rights to all effervescent and related patents of FOSAMAX (alendronate). Patents have been granted to EffRx providing exclusivity for BINOSTO through February 2023. Additional patents are pending.

About EffRx:

EffRx Pharmaceuticals SA is a drug delivery company based in Freienbach, Switzerland. EffRx specializes in improving existing high volume pharmaceutical products by utilizing its novel techniques in different effervescent executions. The primary focus of EffRx is in metabolic bone disease, oncology supportive care, pediatric medications and support to larger companies in Life Cycle Management.

EffRx has a licensing agreement with Nycomed, a Takeda Company, for development, manufacturing and commercialization of EffRx patented effervescent alendronate for the treatment of osteoporosis in all territories in the world except USA, Canada and Japan.

Link:
FDA Approves BINOSTO™, First and Only Effervescent Osteoporosis Treatment in a Buffered Solution

FREIENBACH, Switzerland–(BUSINESS WIRE)–

EffRx Pharmaceuticals SA today announced that the United States Food and Drug Administration (FDA) has approved BINOSTO (alendronate sodium) Effervescent Tablets, previously known as EX101, for the treatment of osteoporosis in postmenopausal women, and as a treatment to increase bone mass in men with osteoporosis. EffRx anticipates that BINOSTO will be commercially available in the United States in the third quarter of 2012.

Christer Rosn, Chairman & CEO of EffRx states: We are very pleased to receive this approval from the FDA. BINOSTO is a breakthrough innovation for the treatment of osteoporosis, offering those patients that have difficulty with tablets the proven fracture risk reduction of alendronate in a pleasant tasting and easy to swallow buffered solution.

Osteoporosis affects more than 200 million people in the 7 major markets and the global market is estimated to be USD10 billion and growing, especially in the emerging markets. BINOSTO is an innovative treatment option that can assure physicians that they are providing a proven efficacious therapy for those patients who have difficulty with tablets. A Harris Interactive Poll concluded that up to 40% of American adults have difficulties with swallowing tablets.

About BINOSTO:

BINOSTO is a once weekly, strawberry flavored effervescent tablet containing alendronate 70mg that rapidly dissolves in half a glass (4oz) of plain room temperature water to make a buffered solution. BINOSTO is available in packs of 4 and 12 tablets.

BINOSTO was developed by EffRx based on an agreement with Merck & Co, Inc. granting EffRx the worldwide rights to all effervescent and related patents of FOSAMAX (alendronate). Patents have been granted to EffRx providing exclusivity for BINOSTO through February 2023. Additional patents are pending.

About EffRx:

EffRx Pharmaceuticals SA is a drug delivery company based in Freienbach, Switzerland. EffRx specializes in improving existing high volume pharmaceutical products by utilizing its novel techniques in different effervescent executions. The primary focus of EffRx is in metabolic bone disease, oncology supportive care, pediatric medications and support to larger companies in Life Cycle Management.

EffRx has a licensing agreement with Nycomed, a Takeda Company, for development, manufacturing and commercialization of EffRx patented effervescent alendronate for the treatment of osteoporosis in all territories in the world except USA, Canada and Japan.

More here:
Effrx Announces: FDA approves BINOSTO®, First and Only Effervescent Osteoporosis Treatment in a Buffered Solution

MARLBOROUGH, Mass.–(BUSINESS WIRE)–

Advanced Cell Technology, Inc. (ACT, OTCBB: ACTC), a leader in the field of regenerative medicine, today announced year-end results for the year ended December 31, 2011. The Company utilized $13.6 million in cash for operations during the year, compared to $8.8 million in the year-earlier period. The increase in cash utilization resulted primarily from ACTs ongoing clinical activities in the US and Europe. ACT ended the year with cash and cash equivalents of $13.1 million, compared to $15.9 million in cash and cash equivalents in the year-earlier period.

Some of the 2011 highlights included:

2011 was a very important and successful year for ACT as we began our Phase 1/2 trials for the treatment of macular degeneration, said Gary Rabin, chairman and CEO of ACT. We are very excited about the preliminary Phase 1/2 clinical data from our dry-AMD and Stargardts disease trials, which were published in The Lancet earlier this year. The data demonstrated the safety of ACTs human embryonic stem cell (hESC)-derived retinal pigment epithelium (RPE) cells for the treatment of both diseases. The vision of both patients appears to have improved after transplantation, and no adverse safety issues have been observed. We look forward to validating these early findings as we expand these clinical activities throughout this year. Additionally, we made significant progress in advancing our scientific platform, expanding our board of directors and management team and strengthening our balance sheet.

The Company also announced today that it expects to shortly file a preliminary proxy statement with the Securities and Exchange Commission in which it will seek shareholder approval for a reverse split of between 1-for 20 and 1-for 80 shares. The Company is pursuing the reverse split for the sole purpose of meeting the requirements necessary for a listing on the Nasdaq Global Market. The Company believes that a listing on a national change will allow it to expand its shareholder base and improve the marketability of its common stock by attracting a broader range of investors.

Conference Call

The Company will hold a conference call at 9:00 a.m. EST tomorrow, during which it will discuss 2011 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, visitwww.advancedcell.com.

Forward-Looking Statements

Read the original:
Advanced Cell Technology Announces 2011 Financial Results

ALAMEDA, Calif.–(BUSINESS WIRE)–

BioTime, Inc. (NYSE Amex: BTX), a biotechnology company that develops and markets products in the field of regenerative medicine, today announced that Chief Executive Officer Michael D. West, Ph.D. will present at the 7th Annual New York Stem Cell Summit at Bridgewaters New York City on Tuesday, February 21, 2012 at 8:48 a.m. ET. Dr. West will provide an update and new information on the Company's manufacturing technologies and cell-based therapeutics in development. The presentation will be available online at www.biotimeinc.com.

The annual New York Stem Cell Summit provides investors, industry, practitioners, and analysts with the latest developments and investment opportunities in the stem cell marketplace.

About BioTime, Inc.

BioTime, headquartered in Alameda, California, is a biotechnology company focused on regenerative medicine and blood plasma volume expanders. Its broad platform of stem cell technologies is developed through subsidiaries focused on specific fields of applications. BioTime develops and markets research products in the field of stem cells and regenerative medicine, including a wide array of proprietary ACTCellerate™ cell lines, culture media, and differentiation kits. BioTime's wholly owned subsidiary ES Cell International Pte. Ltd. has produced clinical-grade human embryonic stem cell lines that were derived following principles of Good Manufacturing Practice and currently offers them for use in research. BioTime's therapeutic product development strategy is pursued through subsidiaries that focus on specific organ systems and related diseases for which there is a high unmet medical need. BioTime's majority owned subsidiary Cell Cure Neurosciences, Ltd. is developing therapeutic products derived from stem cells for the treatment of retinal and neural degenerative diseases. Cell Cure's minority shareholder Teva Pharmaceutical Industries has an option to clinically develop and commercialize Cell Cure's OpRegen™ retinal cell product for use in the treatment of age-related macular degeneration. BioTime's subsidiary OrthoCyte Corporation is developing therapeutic applications of stem cells to treat orthopedic diseases and injuries. Another subsidiary, OncoCyte Corporation, focuses on the diagnostic and therapeutic applications of stem cell technology in cancer, including the diagnostic product PanC-DxTM currently being developed for the detection of cancer in blood samples, therapeutic strategies using vascular progenitor cells engineered to destroy malignant tumors. ReCyte Therapeutics, Inc. is developing applications of BioTime's proprietary induced pluripotent stem cell technology to reverse the developmental aging of human cells to treat cardiovascular and blood cell diseases. BioTime's newest subsidiary, LifeMap Sciences, Inc., is developing an online database of the complex cell lineages arising from stem cells to guide basic research and to market BioTime's research products. In addition to its stem cell products, BioTime develops blood plasma volume expanders, blood replacement solutions for hypothermic (low-temperature) surgery, and technology for use in surgery, emergency trauma treatment and other applications. BioTime's lead product, Hextend®, is a blood plasma volume expander manufactured and distributed in the U.S. by Hospira, Inc. and in South Korea by CJ CheilJedang Corp. under exclusive licensing agreements. Additional information about BioTime, ReCyte Therapeutics, Cell Cure, OrthoCyte, OncoCyte, BioTime Asia, LifeMap Sciences, and ESI can be found on the web at www.biotimeinc.com.

Forward-Looking Statements

Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for BioTime and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of BioTime and its subsidiaries, particularly those mentioned in the cautionary statements found in BioTime's Securities and Exchange Commission filings. BioTime disclaims any intent or obligation to update these forward-looking statements.

To receive ongoing BioTime corporate communications, please click on the following link to join our email alert list:
http://phx.corporate-ir.net/phoenix.zhtml?c=83805&p=irol-alerts

View post:
BioTime CEO Michael D. West to Present at New York Stem Cell Summit

A new study at Johns Hopkins University has shown that stem cells from patients' own cardiac tissue can be used to heal scarred tissue after a heart attack. This is certainly exciting news considering heart failure is still the No. 1 cause of death in men and women.

The study included 25 heart attack victims, 17 of whom got the stem cell treatment. Those patients saw a 50% reduction in cardiac scar tissue after one year, while the eight control patients saw no improvement.

The procedure involves removing a tiny portion of heart tissue through a needle, cultivating the stem cells from that tissue, and reinserting them in a second minimally invasive procedure, according to Bloomberg.

“If we can regenerate the whole heart, then the patient would be completely normal,” said Eduardo Marban, director of Cedars-Sinai Heart Institute who was the study's lead author. “We haven't fulfilled that yet, but we've gotten rid of half of the injury, and that's a good start.”

Business section: Investing ideas
Interested in investing in the promise that stem cell therapy holds? For a look at the investing landscape, we compiled a list of the 10 largest companies involved in stem cell therapy.

Do you think this industry will see growth from stem cell research? (Click here to access free, interactive tools to analyze these ideas.)

1. BioTime (NYSE: BTX  ) : Focuses on regenerative medicine and blood plasma volume expanders. Market cap at $291.95M. The company develops and markets research products in the field of stem cells and regenerative medicine. It develops therapeutic products derived from stem cells for the treatment of retinal and neural degenerative diseases; cardiovascular and blood diseases; therapeutic applications of stem cells to treat orthopedic diseases, injuries, and cancer; and retinal cell product for use in the treatment of age-related macular degeneration.

2. Cleveland BioLabs (Nasdaq: CBLI  ) : Market cap at $111.50M. Its products include Protectan CBLB502, a radioprotectant molecule with multiple medical and defense applications for reducing injury from acute stresses, such as radiation and chemotherapy by mobilizing various natural cell protecting mechanisms, including inhibition of apoptosis, reduction of oxidative damage, and induction of factors that induce protection and regeneration of stem cells in bone marrow and the intestines, and Protectan CBLB612, a modified lipopeptide mycoplasma that acts as a stimulator and mobilizer of hematopoietic stem cells to peripheral blood, providing hematopoietic recovery during chemotherapy and during donor preparation for bone marrow transplantation.

3. Gentium: Focuses on the development and manufacture of its primary product candidate, defibrotide, an investigational drug based on a mixture of single-stranded and double-stranded DNA extracted from pig intestines. Market cap at $128.29M. The company develops defibrotide for the treatment and prevention of hepatic veno-occlusive disease (VOD), a condition that occurs when veins in the liver are blocked as a result of cancer treatments, such as chemotherapy or radiation, that are administered prior to stem cell transplantation.

4. Geron (Nasdaq: GERN  ) : Develops biopharmaceuticals for the treatment of cancer and chronic degenerative diseases, including spinal cord injury, heart failure, and diabetes. Market cap at $265.57M. The company has licensing agreement with the University Campus Suffolk to develop human embryonic stem cell-derived chondrocytes for the treatment of cartilage damage and joint disease.

5. Harvard Bioscience: Develops, manufactures, and markets apparatus and scientific instruments used in life science research in pharmaceutical and biotechnology companies, universities, and government laboratories in the United States and internationally. Market cap at $118.28M. Develops devices used by clinicians and researchers in the field of regenerative medicine, including bioreactors for growing tissue and organs outside the body, and injectors for stem cell therapy.

6. Lydall (NYSE: LDL  ) : Designs and manufactures specialty engineered products for thermal/acoustical, filtration/separation, and bio/medical applications in the United States. Market cap at $163.44M. In addition, it offers Cell-Freeze, a medical device used for cryogenic storage of peripheral blood stem cells.

8. Osiris Therapeutics (Nasdaq: OSIR  ) : Focuses on the development and marketing of therapeutic products to treat various medical conditions in the inflammatory, autoimmune, orthopedic, and cardiovascular areas. Market cap at $157.26M. A stem cell company, focuses on the development and marketing of therapeutic products to treat various medical conditions in the inflammatory, autoimmune, orthopedic, and cardiovascular areas.

7. Verastem: Market cap at $229.00M. Focuses on discovering and developing proprietary small molecule drugs targeting cancer stem cells (CSCs) in breast and other cancers.

Interactive Chart: Press Play to compare changes in analyst ratings over the last two years for the stocks mentioned above. Analyst ratings sourced from Zacks Investment Research.

Kapitall's Alexander Crawford does not own any of the shares mentioned above.

See original here:
Stem Cell Stocks: Mending Scarred Hearts

KIMS Qatar Medical Centre introduced its newly started Osteoporosis Management Clinic at a recent briefing.
The new clinic is set up under Dr Ashish Nathmadhav Bhangle, a specialist in orthopaedic surgery.
While making a presentation Dr Bhangle said he is focusing on conditions like osteomalacia (Vitamin D deficiency), osteoporosis, chronic degenerative diseases like osteoarthritis of knees and cervical and lumbar spondylosis which are very common in Qatar.
The most common symptoms of osteoporosis are overall muscle weakness, non-specific bone pain, easy fatigability, lethargy etc. “People suffering from osteoporosis may not even recall a trivial fall or trauma that might cause a fracture in the foot or spine. Spinal compression fractures may result in loss of height with a stooped posture (called dowager’s hump). Fractures at other sites, commonly the hip or bones of the wrist, usually result from a trivial fall,” pointed out Dr Bhangle.
Lebanese national Suzanne Adib Jurbi, the first patient treated at the Osteoporosis Management Clinic was also present. She hailed the treatment extended to her by the team led by Dr Bhangle.
At the briefing, besides KIMS Qatar executive director Nishad Azeem chief medical officer Dr K M R Mathew, and manager (marketing & business development) Abhik Roy also spoke.

Original post:
Presentation on osteoporosis

MONDAY, Feb. 13 (HealthDay News) — Stem cell therapy's promise for healing damaged tissues may have gotten a bit closer to reality. In a small, early study, heart damage was reversed in heart-attack patients treated with their own cardiac stem cells, researchers report.

The cells, called cardiosphere-derived stem cells, regrew damaged heart muscle and reversed scarring one year later, the authors say.

Up until now, heart specialists' best tool to help minimize damage following a heart attack has been to surgically clear blocked arteries.

“In our treatment, we dissolved scar and replaced it with living heart muscle. Such 'therapeutic regeneration' has long been the holy grail of cell therapy, but had never been accomplished before; we now seem to have done it,” said study author Dr. Eduardo Marban, director of the Cedars-Sinai Heart Institute in Los Angeles.

However, outside experts cautioned that the findings are preliminary and the treatment is far from ready for widespread use among heart-attack survivors.

The study, published online Feb. 14 in The Lancet, involved 25 middle-aged patients (average age 53) who had suffered a heart attack. Seventeen underwent stem cell infusions while eight received standard post-heart attack care, including medication and exercise therapy.

The stem cells were obtained using a minimally invasive procedure, according to the researchers from Cedars-Sinai and the Johns Hopkins Hospital in Baltimore.

Patients received a local anesthetic and then a catheter was threaded through a neck vein down to the heart, where a tiny portion of muscle was taken. The sample provided all the researchers needed to generate a supply of new stem cells — 12 million to 25 million — that were then transplanted back into the heart-attack patient during a second minimally invasive procedure.

One year after the procedure, the infusion patients' cardiac scar sizes had shrunk by about half. Scar size was reduced from 24 percent to 12 percent of the heart, the team said. In contrast, the patients receiving standard care experienced no scar shrinkage.

Initial muscle damage and healed tissue were measured using MRI scans.

After six months, four patients in the stem-cell group experienced serious adverse events compared with only one patient in the control group. At one year, two more stem-cell patients had a serious complication. However, only one such event — a heart attack — might have been related to the treatment, according to the study.

In a news release, Marban said that “the effects are substantial and surprisingly larger in humans than they were in animal tests.”

Other experts were cautiously optimistic. Cardiac expert Dr. Bernard Gersh, a professor of medicine at Mayo Clinic, is not affiliated with the research but is familiar with the findings.

“This study demonstrates that it is safe and feasible to administer these cardiac-derived stem cells and the results are interesting and encouraging,” he said.

Another specialist said that while provocative and promising, the findings remain early, phase-one research. “It's a proof-of-concept study,” said interventional cardiologist Dr. Thomas Povsic, an assistant professor of medicine at the Duke Clinical Research Institute, in Durham, N.C.

And Dr. Chip Lavie, medical director of Cardiac Rehabilitation and Prevention at the John Ochsner Heart and Vascular Institute, in New Orleans, also discussed the results. He said that while the study showed that the cardiac stem cells reduced scar tissue and increased the area of live heart tissue in heart attack patients with moderately damaged overall heart tissue, it did not demonstrate a reduction in heart size or any improvement in the heart's pumping ability.

“It did not improve the ejection fraction, which is a very important measurement used to define the overall heart's pumping ability,” Lavie noted. “Certainly, much larger studies of various types of heart attack patients will be needed before this even comes close to being a viable potential therapy for the large number of heart attack initial survivors.”

Povsic concurred that much larger studies are needed. “The next step is showing it really helps patients in some kind of meaningful way, by either preventing death, healing them or making them feel better.”

It's unclear what the cost will be, Povsic added. “What society is going to be willing to pay for this is going to be based on how much good it ends up doing. If they truly regenerate a heart and prevent a heart transplant, that would save a lot money.”

Marban, who invented the stem cell treatment, said the while it would not replace bypass surgery or angioplasty, “it might be useful in treating 'irreversible' injury that may persist after those procedures.”

As a rough estimate, he said that if larger, phase 2 trials were successful, the treatment might be available to the general public by about 2016.

More information

The U.S. National Heart, Lung, and Blood Institute describes current heart attack treatment.

Read more from the original source:
Stem Cell Treatment Might Reverse Heart Attack Damage

GAITHERSBURG, MD–(Marketwire -02/08/12)- Cytomedix, Inc. (OTC.BB: CMXI.OB – News) (the “Company”), a leading developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis, announces the completion of the acquisition of Aldagen, Inc., a privately-held biopharmaceutical company developing regenerative cell therapies based on its proprietary ALDH bright cell (“ALDHbr”) technology. Under the terms of the transaction as described below, Cytomedix issued preferred shares valued at $16 million based on a 10-day volume-weighted average price (“VWAP”) calculated through February 2, 2012. Cytomedix will issue additional consideration to be paid in common stock upon the successful attainment of several clinical milestones. As part of the transaction, certain Aldagen investors purchased $5.0 million of Cytomedix common stock in a private placement concurrent with the closing of this acquisition.

Martin P. Rosendale, Chief Executive Officer of Cytomedix, commented, “Since joining Cytomedix as chief executive in 2008, our strategy has evolved, but the vision to transform the Company from a wound-care based technology platform into a broader regenerative medicine company has remained constant. In pursuit of this vision, we started with the successful 2010 acquisition and integration of the Angel System, a unique, best-in-class PRP platform technology that has allowed us to grow from nominal sales to $6 million per year in just over 18 months.

“This strategic acquisition of Aldagen provides Cytomedix with a novel, patent-protected cell selection technology that fits well with our existing commercial products and strengthens our long-range growth profile,” he continued. “In combination, we now touch the three pillars of regenerative medicine with autologous stem cells, platelet-derived signal molecules and plasma scaffolds,” he added. “We view the acquisition of Aldagen as an opportunistic transaction at an attractive valuation that will allow us to build and expand our new product development efforts with Aldagen's technology, intellectual property, people and clinical expertise. In terms of maximizing opportunity for our shareholders while managing and mitigating risk, we feel this transaction is very advantageous.”

Commenting on the acquisition, Richard Kent, M.D., Chairman of the Board of Aldagen and a Partner with Intersouth Partners, Aldagen's largest shareholder, said, “We are delighted to join forces with Cytomedix as this alignment unites commercial products with a growing revenue stream with a deep pipeline of clinical opportunities. We believe these autologous technologies are complementary and hold potential to produce more therapeutics than either one could on its own. The commitment of additional capital into Cytomedix by certain Aldagen investors underscores our confidence in the very promising potential for the combination of these regenerative technologies to change how we treat a variety of large disease areas with continued unmet medical need.”

Transaction Terms

At the closing, Cytomedix issued 135,398 newly designated Cytomedix Series E preferred shares to Aldagen shareholders. Pro forma for the conversion of these shares to common stock, as set forth in the designations documents for the Series E preferred stock, Aldagen shareholders will own approximately 17.3% of Cytomedix common shares outstanding after the concurrent conversion and/or redemption of all existing Cytomedix preferred shares.

There are also contingent clinical milestone payments totaling up to 20,309,723 shares, which will be issued to Aldagen shareholders upon the achievement of predetermined clinical milestones associated with an ongoing Aldagen Phase 2 trial in post-acute ischemic stroke. Notably, 80% of this contingent consideration is issuable only upon a favorable clinical efficacy signal in the above-mentioned trial. The costs of the clinical trial will be funded, in part, by the $5.0 million investment made by Aldagen shareholders, $3.0 million in proceeds from completed or committed warrant exercises by existing Cytomedix shareholders, as well as a portion of Cytomedix' cash on hand. All upfront and contingent consideration shares are subject to lockup restrictions ranging from six to 18 months.

As part of the transaction, as of the closing date three Aldagen Board members have joined the Cytomedix Board, which has been expanded to nine seats. They are Richard Kent, M.D., Chairman of the Board of Aldagen; Lyle Hohnke, Ph.D., Aldagen's former CEO; and Joseph Del Guercio, Managing Director of CNF Investments and a current Board Observer for Aldagen. Concurrent with these additions, Craig Mendelsohn has stepped down from the Cytomedix Board.

In addition, Edward L. Field, Aldagen's Chief Operating Officer, has been appointed as Chief Operating Officer of Cytomedix.

Aldagen is now a wholly-owned subsidiary of Cytomedix and will retain manufacturing and product development facilities in Durham, N.C.

For additional information about this transaction, please refer to the Company's Report on Form 8-K, filed with the Securities and Exchange Commission on or about February 8, 2012.

About Aldagen

Aldagen is a clinical-stage biopharmaceutical company developing patent-protected autologous cell-based therapeutics for tissue repair and regeneration. Aldagen's clinical development efforts are led by a team of leading researchers and experienced clinicians. All product candidates target conditions with significant unmet medical needs. Aldagen has a deep product pipeline and data generated in a number of disease states including:

ALD-301 for the treatment of peripheral arterial disease (“PAD”) and critical limb ischemia (“CLI”) ALD-201 for the treatment of ischemic heart failure ALD-401 for the treatment of ischemic stroke

Safety has been demonstrated in more than 70 patient treatments across all clinical trials of ALDHbr cells and positive study results in CLI and cardiac ischemia have been published and presented at major medical meetings. A growing body of scientific data validates Aldagen's proprietary technology, including approximately 250 peer-reviewed publications and presentations. Aldagen has the only stem cell selection technology utilizing an intracellular enzyme marker to fractionate essential regenerative cells from bone marrow.

Aldagen's proprietary bone marrow fractionation process identifies and isolates metabolically active cells expressing high levels of the enzyme aldehyde dehydrogenase, or ALDH, which is a key enzyme involved in the regulation of gene activities associated with cell proliferation and differentiation. The selected biologically instructive cells, ALDHbr cells, have the potential to promote the repair and regeneration of multiple types of cells and tissues, including the growth of new blood vessels, which is critical to the generation of healthy tissue. Preclinical research suggests that ALDHbr cells specifically migrate to sites of ischemic damage and induce the formation of new blood vessels at those sites. In human clinical trials utilizing ALDHbr cells, evidence of improved perfusion in ischemic tissue has been observed. Other stem cell therapies require expansion of cells that increase manufacturing and regulatory risk, increase processing costs and may delay treatment of the patient up to several weeks. Aldagen produces well-characterized cell populations with a high level of purity without the need for these additional steps, thereby enabling a rapid turnaround time — typically 36 hours once the bone marrow is received.

Opus National Capital Markets served as financial advisor and Cozen O'Connor served as legal counsel to Cytomedix on the acquisition. The Merchant Banking Group of Burrill & Company served as financial advisor and Hutchison Law Group served as legal counsel to Aldagen, Inc. on the transaction.

Conference Call

Cytomedix and Aldagen management will hold a conference call to discuss the acquisition and to answer questions beginning at 10:00 a.m. Eastern time on Thursday, February 9, 2012. Shareholders and other interested parties may participate in the call by dialing 888-713-4214 (domestic) or 617-213-4866 (international) and entering passcode 15132911. The call will also be broadcast live on the Internet at www.streetevents.com, www.fulldisclosure.com and www.cytomedix.com. A slide presentation will accompany the conference call and will be posted at 8:00 a.m. Eastern time on Thursday, February 9, 2012, to the home page of the Company's website at www.cytomedix.com.

A replay of the conference call will be available beginning two hours after its completion through February 16, 2012, by dialing 888-286-8010 (domestic) or 617-801-6888 (international) and entering passcode 48593244. The call will also be archived for 90 days at www.streetevents.com, www.fulldisclosure.com and www.cytomedix.com.

About Cytomedix, Inc.

Cytomedix develops, sells and licenses regenerative biological therapies primarily for wound care, inflammation and angiogenesis. The Company markets the AutoloGel™ System, a device for the production of autologous platelet rich plasma (“PRP”) gel for use on a variety of exuding wounds; the Angel® Whole Blood Separation System, a blood processing device and disposable products used for the separation of whole blood into red cells, platelet poor plasma (“PPP”) and PRP in surgical settings; and the activAT® Autologous Thrombin Processing Kit, which produces autologous thrombin serum from PPP. The activAT® kit is sold exclusively in Europe and Canada, where it provides a completely autologous, safe alternative to bovine-derived products. The Company is pursuing a multi-faceted strategy to penetrate the chronic wound market with its products, as well as opportunities for the application of AutoloGel™ and PRP technology into other markets such as hair transplantation and orthopedics while actively seeking complementary products for the wound care market. Additional information regarding Cytomedix is available at www.cytomedix.com.

Safe Harbor Statement
Statements contained in this communication not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Cytomedix' actual results may differ materially due to a number of factors, many of which are beyond Cytomedix' ability to predict or control, including many among others, risks and uncertainties related to the Company's ability to successfully integrate this acquisition, to successfully manage contemplated clinical trials, to manage and address the capital needs, human resource, management, compliance and other challenges of a larger, more complex and integrated business enterprise, viability and effectiveness of the Company's sales approach and overall marketing strategies, commercial success or acceptance by the medical community, competitive responses, the Company's ability to raise additional capital and to continue as a going concern, and Cytomedix's ability to execute on its strategy to market the AutoloGel™ System as contemplated. To the extent that any statements made here are not historical, these statements are essentially forward-looking. The Company uses words and phrases such as “believes”, “forecasted,” “projects,” “is expected,” “remain confident,” “will” and/or similar expressions to identify forward-looking statements in this press release. Undue reliance should not be placed on forward-looking information. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual events to differ from the forward-looking statements. More information about some of these risks and uncertainties may be found in the reports filed with the Securities and Exchange Commission by Cytomedix, Inc. Cytomedix operates in a highly competitive and rapidly changing business and regulatory environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. Except as is expressly required by the federal securities laws, Cytomedix undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason. Additional risks that could affect our future operating results are more fully described in our U.S. Securities and Exchange Commission filings, including our Annual Report for the year ended December 31, 2010, filed with the SEC and other subsequent filings. These filings are available at http://www.sec.gov.

Read the original post:
Cytomedix Expands Commitment to Regenerative Medicine With Acquisition of Aldagen

Editor's Choice
Academic Journal
Main Category: Genetics
Also Included In: Bones / Orthopedics
Article Date: 02 Feb 2012 – 10:00 PST

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Healthcare Prof:
According to a study published in the online version of the journal The Oncologist, a genetic variation that increases the risk of individuals who take bisphosphonates, developing serious necrotic jaw bone lesions, has been identified by researchers at the Columbia University College of Dental Medicine.

Bisphosphonates are a common class of osteoclastic inhibitors that work by attaching to calcium in the bone and inhibiting osteoclasts, bone cells that disintegrate the bone's mineral structure. The finding opens the door for a genetic screening test to determine which individuals can take these medications safely.

At present, approximately 3 million women in the U.S. take oral bisphosphonates for the treatment or prevention of osteoporosis. Furthermore, each year, thousands of cancer patients are given intravenous bisphosphonates to prevent excess calcium (hypercalcemia) from gathering in the blood and to control the spread of bone cancer.

Lead researcher of the study, Athanasios I. Zavras, DMD, MS,DMSc, associate professor of Dentistry and Epidemiology and Director of the Division of Oral Epidemiology & Biostatistics at the Columbia University College of Dental Medicine, explained:

“These drugs have been widely used for years and are generally considered safe and effective. But the popular literature and blogs are filled with stories of patients on prolonged bisphosphonate therapy who were trying to control osteoporosis or hypercalcemia only to develop osteonecrosis of the jaw.”

Often, osteonecrosis of the jaw (ONJ) results in painful and difficult-to-treat bone lesions, which can ultimately result in entire jaw loss. Among individuals taking bisphosphonates, ONJ usually occurs in those who go through invasive dental procedures or those with dental disease.

At present, figures on the incidence of ONJ in individuals taking oral bisphosphonates are unreliable. According to the American College of Rheumatology, estimates vary from 1 in 1,000 to 1 in 100,000 patients each year of exposure to the drug. Approximately 5% to 10% of cancer patients taking intravenous bisphosphonates are affected by ONJ.

According to prior investigations, genetic factors play a significant role in predisposing patients to ONJ. Dr. Zavras and his team conducted genome-wide examination of 30 individuals who have developed ONJ while taking bisphosponates and compared them with several disease free individuals who used bisphosphonates.

Results showed that individuals who has a small variation in the RBMS3 gene were 5.8 times more likely to develop ONJ than individuals without the variation. The researchers also identified small variations in two other genes that may contribute to ONJ risk – IGFBP7 and ABCC4.

Dr. Zavras, explained:

“Our ultimate goal is to develop a pharmacogenetic test that personalizes risk assessment for ONJ, a test that you could give to people before they start to use bisphosphonates.

Those who are positive for this genetic variation would select some other treatment, while those who are negative could take these medications with little fear of developing ONJ.”

Dr. Zavras, continued:

“At the moment, many women discontinue or avoid treatment for serious osteoporosis because they are afraid of losing their jaw bones. There even are reports of dentists who have refused to perform certain invasive procedures in patients taking bisphosphonates. So there is a great need for a pharmacogenetic screening test to determine which patients are really at risk for ONJ.”

The researchers explain that additional studies are required in order to determine if the RBMS3 gene variation is seen in other racial groups, as the current investigation only examined Caucasians.

The study was supported by the National Institute of Dental and Craniofacial Research.

Written by Grace Rattue
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

Visit our genetics section for the latest news on this subject. “Genomewide Pharmacogenetics of Bisphosphonate-Induced Osteonecrosis of the Jaw: The Role of RBMS3” Paola Nicoletti et al.
The Oncologist, First Published Online January 20, 2012; doi: 10.1634/theoncologist.2011-0202

Source: Columbia University Medical Center

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