Stem Cell Therapies Focus on Causes of Chronic Disease at Neostem

In a recent video, “RedChip Money Report,” President and CEO of RedChip Dave Gentry interviews Dr. Robin Smith, chairman and CEO of NeoStem.

NeoStem is a biopharmaceutical company that is developing and manufacturing stem cell therapies in order to capitalize on the current paradigm shift. It is a New York Stock Exchange company that was ranked No. 7 nationally in Deloitte’s 2012 Technology Fast 500. Smith has been the CEO of NeoStem for at least six years.

In the video, she says that the company creates “novel cell therapy products to treat chronic diseases.” It also has a contract manufacturing business that helps other countries to develop their cell therapy products. Smith says that stem cell treatments started with bone marrow transplants, and that many blood disorders and cancer treatments incorporate cell therapy. Cell therapy focuses more on the causes of disease in order to prolong the quality of life.

She explains:

“We realized these cells of our body are a way to naturally repair itself. And we realized that we can take these cells from the different parts of our body and create therapies or vaccines to help treat differnet patients with chronic diseases.”

NeoStem received grants from the National Institute of Health and the Department of Defense. Smith says that in addition to cardiovascular therapy, the company is developing therapies in autoimmune disorders and regenerative medicine.

She says:

“Our Vsels, these very small embryonic-like stem cells, we believe have regenerative properties. Using the Department of Defense funding and through different grants, we’re looking to developing therapies for things like wounds—closing wounds more quickly; bones—through osteoporosis or through damage; vision—through retinal disease or macro degeneration. It’s a way to restore damaged tissue.”

Smith states that the Department of Defense is very focused on helping companies with exciting technologies, to develop them and get them into the clinic. This is so cell therapies that are safe, cost effective, and can treat damaged tissue and underlying disease to get into clinics as soon as possible.

RedChip is an international small-cap research firm and an Inc. 5000 company. "The RedChip Money Report" airs on Saturdays at 2:30 p.m. on Fox Business News and discusses small-cap investing, interviews with Wall Street analysts and executives of public companies, and provides financial book reviews. Dave Gentry is a leading authority on small-cap stocks, has been a consultant to hundreds of public companies, and has made multiple guest appearances on both CNBC and Fox Business News.

Watch the full video here.

Robin L. Smith, M.D., of Neostem on the Vatican, regenerative medicine, and women's empowerment

NeoStem, Inc. (NYSE: NBS; Stock Twits: $NBS) is engaged in the development and manufacturing of cell-based therapies in the U.S.   

NeoStem, continues to develop and build on its core capabilities in cell therapy, capitalizing on the paradigm shift occurring in medicine. We anticipate that cell therapy will have a significant role in the fight against chronic disease and in lessening the economic burden that these diseases pose to modern society. We are emerging as a technology and market leading company in this fast developing cell therapy industry.

In this interview, Dr. Robin Smith, CEO of NeoStem and Chairman and President of the Stem for Life Foundation discusses a range of topics including regenerative medicine, stem cell research, the Vatican's involvement with Neostem, and Neostem's potential in developing countries:

Fibrocell CEO David Pernock on Fibroblasts and LAVIV; Other Projects in the Works

Fibrocell Science, Inc. (OTC Bulletin Board: FCSC) is a biotechnology company focused on developing autologous cell therapies for aesthetic, medical and scientific applications. Fibrocell Science is committed to advancing the scientific, medical and commercial potential of autologous skin and tissue, as well its innovative cellular processing technology and manufacturing excellence.

The company makes LAVIV (azficel-T), a groundbreaking new way to rejuvenate skin. LAVIV is the first and only FDA-approved treatment that uses a patient’s own collagen-producing cells (fibroblasts) to improve the look of smile lines. LAVIV is available exclusively through Fibrocell-trained, board-certified dermatologists and plastic surgeons. An ever growing list of practicing dermatologists and surgeons is available at MyLaviv.com. 

In a recent video interview, Fibrocell CEO David Pernock explains more about what a fibroblast is and how the company's process works: 

“The fibroblasts that we have reside directly under the dermis of the skin and what they're responsible for is the production of collagen and other growth factors, which help to support the skin." He explains that when we age, our number of fibroblasts diminishes. As a result, the skin looks thinner and wrinkles appear.

He continues,

"What we do, through a revolutionary process - actually the first and only of its kind in the world - is to take a small sample of skin from a patient, separate the fibroblast cell, [and] reproduce hundreds of millions of fibroblast cells directly from the patient for reintroduction underneath the skin." 

View the full video below.

See Wikipedia.com for more information on fibroblasts. 

Fibrocell is currently working on other applications for LAVIV, including acne scarring, restrictive burn scars, and vocal cord scarring. The company also has several additional projects in the works, including a personalized skin care cream as a complimentary sale to LAVIV as well as a stem cell program with UCLA and Mit. The company has announced an exclusive license with UCLA on Dermal Cell Research, and a research collaboration with MIT. 

For more information on Fibrocell, see the company's August 2012 Investor Presentation below. 

Fibrocell science investor-presentation-august_2012 from UpGraded Strategies

Fibrocell Science Inc. Initiates Private Stock Sale, Partners with Intrexon Corp. - $FCSC

Fibrocell Science Inc. (OTC: FCSC) has initiated a private stock sale in order to raise $45 million. The sale is restricted to institutional investors and high-net-worth individuals. The company has also formed a partnership with Intrexon Corp., a Blacksburg, Virginia-based synthetic biology company, to further develop its laViv cell therapy technology.

The Exton, Pa., company said the private stock sale involves a select group of institutional investors and high-net-worth individuals, including NRM VII Holdings, a Third Security affiliated fund.

Fibrocell’s laViv launched in 2011 to remove wrinkles. It extracts and multiplies a patient’s collagen-producing cells, then re-injects those cells into the patient. To date, laViv is the only FDA-approved cell therapy technology in aesthetic dermatology. Read more here. 

In a video about laViv’s FDA approval, CEO of Fibrocell Science Inc. David Pernock says,

“Our FDA approval meant the world to our company. What we’re able to do with this support … is offer people a very natural way to correct their nasolabial folds - smile line wrinkles - and not use any synthetic products or mass-produced products—ours is 100 percent made for the patient, specifically for you. It’s a big deal for the company and a big deal for the patients.”

See the full video below.

Coronado Biosciences Added to Russell 3000(R) Index

Coronado Biosciences, Inc., (CNDO), a biopharmaceutical company focused on the development of novel immunotherapy agents for the treatment of autoimmune diseases and cancer, announced today the Company has been added to the Russell Global, Russell 3000(R) and Russell Microcap(R) Indexes following the reconstitution of the Russell's U.S. and global equity indexes.

"We are excited to be included in the Russell 3000(R) Index," said Dr. Bobby W. Sandage, Jr., Coronado's President and CEO. "We believe that our addition to the Index will increase the visibility of our Company to a broader range of potential investors."

Annual reconstitution of Russell's U.S. indexes captures the 4,000 largest U.S. stocks as of the end of May, ranking them by total market capitalization to create the Russell 3000(R) Index and Russell Microcap Index. Membership in the Russell 3000, which remains in place for one year, means automatic inclusion in the large-cap Russell 1000(R) Index or small-cap Russell 2000(R) Index as well as the appropriate growth and value style indexes. The Russell 3000 also serves as the U.S. component to the Russell Global Index, which Russell launched in 2007. Russell determines membership for its equity indexes primarily by objective, market-capitalization rankings and style attributes.

Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for both passive and active investment strategies. In the institutional marketplace, an industry-leading $3.9 trillion in assets currently are benchmarked to them. Russell calculates more than 80,000 benchmarks daily covering approximately 98 percent of the investable market globally, 83 countries and more than 10,000 securities. These investment tools originated from Russell's multi-manager investment business in the early 1980s when the company saw the need for a more objective, market-driven set of benchmarks in order to evaluate outside investment managers.

About Coronado Biosciences

Coronado Biosciences is engaged in the development of novel immunotherapy biologic agents. The company's two principal pharmaceutical product candidates in clinical development are: TSO (Trichuris suis ova or CNDO-201), a biologic for the treatment of autoimmune diseases, such as Crohn's disease, ulcerative colitis and multiple sclerosis; and CNDO-109, a biologic that activates natural killer (NK) cells, for the treatment of acute myeloid leukemia (AML) and solid tumors.

Forward-Looking Statements

This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to the company's product development programs and any other statements that are not historical facts. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated risks relating to the results of research and development activities, uncertainties relating to preclinical and clinical testing, financing and strategic agreements and relationships, the early stage of products under development, our need for substantial additional funds, government regulation, patent and intellectual property matters; our dependence on third party suppliers and competition, as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

Contact:

Investor Relations
Lucy Lu, MD, Executive Vice President
& Chief Financial Officer
Coronado Biosciences, Inc.
781-238-6619; ir@coronadobio.com
Marcy Nanus, Vice President
The Trout Group, LLC.
646-378-2927; mnanus@troutgroup.com
Media Relations
Dennis S. Dobson Jr., CEO
Dobson Media Group
203-258-0159; dobsonpr@erols.com

NeoStem Signs a Definitive Agreement to Divest its 51% Ownership Interest in Suzhou Erye (NBS)

NeoStem, Inc. (AMEX: NBS; Stock Twits: $NBS) is engaged in the development and manufacturing of cell-based therapies in the U.S.  ItsJanuary 2011 acquisition of Progenitor Cell Therapy, LLC ("PCT") is central to the Company's strategic mission of capturing the paradigm shift to cell therapy.

The Company announced that it has "entered into a definitive agreement to sell its 51% interest in Suzhou Erye Pharmaceutical Co. Ltd. (“Erye”), a China-based generic pharmaceutical company, for  $12,280,000 in cash and the return to the Company of (i) 1,040,000 shares of the Company’s Common Stock and (ii) the cancellation of 1,170,000 options and 640,000 Common Stock warrants, which collectively represent 1.3% of the Company’s fully diluted issued and outstanding shares. The closing of the transaction is subject to the approval of NeoStem shareholders and certain other conditions." The transaction is expected to close by the fourth quarter of 2012.

Chairman and CEO of NeoStem Dr. Robin L. Smith stated,

"We are pleased to have reached this significant milestone in our business. This divestiture will enable NeoStem to bolster its cash position in the United States, reduce its legal and financial reporting expenditures, simplify its financials and become a pure play in the rapidly growing cell therapy industry. Consummation of the transaction will also eliminate significant Erye debt from the Company's balance sheet, which was over $37 million as of March 31, 2012."

NeoStem first gained its interest in Erye in October 2009. At the time, the company was heralded for its innovative business move into the emerging Chinese pharmaceutical industry. In 2011, "the Chinese government imposed new policies affecting price and volume controls of certain pharmaceutical products, including generic antibiotics, which reduced the division’s profitability and positive cash flows. This dampened Erye’s operating results and was the catalyst for NeoStem to begin to evaluate opportunities to monetize its interest in Erye."

The divestiture "will enable NeoStem to focus full time on its goal to emerge as a leader in the cell therapy market. The Company is enrolling patients in its PreSERVE AMR-001 Phase 2 clinical trial for preserving heart function after a heart attack and expanding its cell therapeutic contract manufacturing business, PCT. NeoStem also plans to continue to develop and to build on its core capabilities in cell therapy to capitalize on the paradigm shift that is occurring in medicine."

Read more at NeoStem.com. 

Type 1 Diabetes on Rise Among Youth @ WSJ (ISLT)

Islet Sciences, Inc. (OTCBB: ISLT) is a development-stage biotechnology company with patented technologies focused on transplantation therapy for people with insulin-dependent diabetes. The Company's transplantation technology includes methods for the culturing, isolation, maturation, and immuno-protection (microencapsulation) of islet cells. Islet Sciences’ mission includes the introduction of commercial products with applications to cell-based replacement therapy in the healthcare marketplace.

In the Wall Street Journal, Kate Linebaugh writes about a new study from the CDC showing that there has been a 23% jump in the prevalance of Type 1 diabetes among American youth. 

She writes,

"The growth in Type 1 stumps researchers who haven't been able to identify what triggers the autoimmune response or explain why an increasing number of people are afflicted. About 80% of Type 1 diabetics don't have a close relative with the disease.

'We don't know yet what is triggering diabetes or why it is increasing,' said Dana Dabelea, professor of epidemiology and pediatrics at the University of Colorado, Denver."

Researchers have several theories about the reasons behind the suddent jump:

"A leading theory known as the accelerator hypothesis suggests that greater weight gain and growth early in life puts stress on insulin-producing cells in the pancreas that sets off the autoimmune attack.

Another explanation is the so-called hygiene hypothesis, which is also linked to the rise of asthma and food allergies. Children in a modern society contend with fewer parasitic, viral and bacterial illnesses than previous generations, so the underchallenged immune system begins reacting to other stimuli in ways that are harmful." Read more at The Wall Street Journal. 

While it is undoubtedly important to try to research the possible causes of this trend, it is also important to develop new, more effective treatments for the growing population of Type 1 diabetes patients in the US. There are over 200 million diabetes sufferers in the US, and 5-10% of these patients are Type I insulin-dependent. Current treatments for Type I diabetes are palliative and require constant glucose monitoring and repeated daily insulin injections. This is a difficult regimen for responsible adults, and can be much worse for less mature patients, such as teenagers.

By contract, Islet Sciences' approach involves the transplantation of glucose-producing pancreatic islet cells, which could allow patients to become independent of injected insulin and eliminate the need for constant monitoring of their blood glucose levels. This would be especially beneficial to adolescents, who are much less likely to take their health and their treatments seriously. Read more at www.isletsciences.com. 

Medgenics Initiates U.S. Biopump Processing Site (MDGN)

Medgenics, Inc. (NYSE AMEX: MDGN; Stock Twits: $MDGN) is developing and commercializing Biopump, a proprietary tissue-based implantable platform technology for the sustained production and delivery of therapeutic proteins using the patient's own skin biopsy, for the treatment of a wide range of chronic diseases starting with anemia, hepatitis C and hemophilia. Medgenics believes this approach has multiple benefits compared with current treatments, which require the patient to endure years of costly injections of therapeutic proteins.

The Company announced that it has initiated its first U.S. Biopump processing facility in Davis, California, a good manufacturing practice (GMP) certified facility. The Company’s contract manufacturing organization (CMO) processes EPODURE Biopumps here for the treatment of anemia. This marks the first Biopump processing site outside of Israel, and provides Medgenics (MDGN) with a significant ability to scale-up its clinical and commercial capabilities to address global therapeutic areas such as anemia and hemophilia.

In a key dry run test of the production system, "tissue micro-organs were obtained and loaded into individual closed processing chambers in Israel, and then shipped to the U.S. CMO Biopump processing center in California. There, the micro-organs were processed in their closed systems into fully functioning EPODURE Biopumps, meeting the release criteria for use in human clinical trials in the U.S. This demonstrates Medgenics capability to support the treatment of patients at remote clinical sites, transporting their Biopumps to and from strategically located processing facilities, thereby allowing for multicenter clinical trials and practical commercial implementation."

Medgenics recently announced that it had received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to conduct a Phase IIb study of EPODURE for the treatment of anemia in dialysis patients in the U.S.

Andrew L. Pearlman, Ph.D., President and Chief Executive Officer of Medgenics, stated,

"The launch of this U.S. processing facility is another important step for advancing our U.S. clinical trials and product commercialization. The initial processing of Biopumps in the GMP facility of our U.S. CMO resulted in product that meets all quality requirements for use in human clinical trials. We plan to continue with processing additional lots of product to ensure consistency and reliability before the U.S. clinical trial commences. Importantly, this U.S. GMP processing center has been launched through an existing facility, which is much less capital intensive and simpler to establish than typical protein production facilities. As Medgenics grows and expands, we believe that similar Biopump processing facilities can be easily set up in other sites around the world."

Reading more at Seeking Alpha.