SanBio Announces Enrollment of First Cohort of Patients in Its Clinical Trial of Stem Cell Therapy for Chronic Stroke

MOUNTAIN VIEW, Calif., March 20, 2012 /PRNewswire/ -- SanBio Inc. today announced the successful enrollment of the first dose cohort of patients in its Phase 1/2a clinical trial testing the safety and efficacy of a novel allogeneic stem cell therapy product, SB623, in patients suffering from chronic deficits resulting from previous stroke injuries. The first 6 patients, of a total of 18, have been successfully administered SB623. The trial is being conducted at Stanford University and the University of Pittsburgh. No safety concerns have been reported. For details regarding this clinical trial, please refer to http://www.strokeclinicaltrial.org.

SB623 is derived from adult bone marrow and has shown safety and efficacy in rodent models of chronic stroke. "This represents a major milestone in the human clinical testing of this important new approach for regenerative medicine", said Keita Mori, SanBio CEO. "We are pleased to learn that the initial dose level was well tolerated."

SB623 is being delivered to the damaged region of the brains of patients who have suffered an ischemic stroke. Product safety is the primary focus of the study but various measurements of efficacy are also being tested.

"The successful completion of the initial dose cohort is a major step in any first-in-human study", said Dr. Ernest Yankee, SanBio's Vice President of Development. "We are looking forward to initiating the next two dose cohorts and wrapping up the study. The safety findings thus far are very encouraging"

About SB623: SB623 is a proprietary cell therapy product consisting of cells derived from genetically engineered bone marrow stromal cells obtained from healthy adult donors. SB623 is administered adjacent to the area damaged by stroke and functions by producing proteins that aid the regenerative process.

About SanBio: SanBio is a privately held San Francisco Bay Area biotechnology company focused on the discovery and development of new regenerative cell therapy products.

For more information: http://www.san-bio.com

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SanBio Announces Enrollment of First Cohort of Patients in Its Clinical Trial of Stem Cell Therapy for Chronic Stroke

9/11 search and rescue dog receives stem cell therapy

A special dog used to help people is getting some much-needed help of her own at a Virginia clinic, myFOXdc.com reported.

Red, a 12-year-old black Labrador, is one of the last surviving search and rescue dogs deployed during the 9/11 attacks.

Her handler, Heather Roche, told WTTG-TV that Red was recently certified when Sept. 11, 2001, occurred, and the devastating terror attacks were her first big mission.

Red's job was to find DNA evidence at The Pentagon's north parking lot with 26 other dogs, and according to Roche, she did a "fantastic job."

"I got her as a puppy ... You have to convince [her] everything that she does, whether it's climbing ladders or any kind of search, that it's her idea," Roche told WTTG-TV. "No matter what I've asked her to do, she's done it and she's done it flawlessly."

But in her old age Red developed crippling arthritis, and underwent stem cell regenerative therapy Monday to help ease her pain so she can get back out on the job.

Dr. John Herrity of Burke Animal Clinic in Burke, Va., told WTTG-TV, "Red has a back issue that, after a fall from a ladder has not really been right, and has been living in pain, so we're going to give those stem cells IV [intravenously] and then also inject them along the back to try to help Red's comfort."

"She's had a great career and has made a difference to a lot of families by bringing their loved ones home," Roche said.

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9/11 search and rescue dog receives stem cell therapy

Vitro Biopharma Receives Approval for Presentation to the International Society for Cellular Therapy

GOLDEN, Colo., March 20, 2012 (GLOBE NEWSWIRE) -- Vitro Diagnostics, Inc. (OTCQB:VODG.PK - News), dba Vitro Biopharma, has recently received approval for its presentation entitled "GMP Cell Culture Media for Expansion of MSCS Prior to Allogeneic or Autologous Transplantation." The Company recently expanded its stem cell media products to include clinical grade MSC-Gro(TM) media for use in clinical trials of stem cells. The Company will present its current findings at the annual meeting of the International Society of Cellular Therapy (ISCT) in Seattle, Washington this coming June. To get more information regarding the International Society of Cellular Therapy visit http://www.celltherapysociety.org/

Vitro Biopharma has developed a series of products to support clinical application of adult stem cells known as mesenchymal stem cells (MSCs) that are completely divorced and different from ethically contentious embryonic stem cells. MSCs are derived from numerous adult tissue sources including bone marrow, blood, adipose tissue, teeth, etc and show considerable promise in clinical applications especially for treatment of injury and diseases affecting joints, bone, ligaments and tendons. There are over 200 ongoing clinical trials of MSCs to study potential treatment of diabetes, Parkinson's disease, organ transplant rejection, osteoarthritis, MS, spinal cord injury, stroke, myocardial infarction, cardiovascular disease, liver degeneration, COPD and other medical conditions.

Vitro Biopharma will present the current status of its clinical grade MSC-Gro(TM) Brand of culture medium for growth and differentiation of MSCs at the ISCT meeting. Through its extensive research and experience with cell culture media, Vitro Biopharma has developed highly competitive media that is suitable for clinical applications. Critical characteristics are that they are serum-free, chemically-defined and free from animal-derived components. Furthermore, it is essential that serum-free media perform the same as formulations containing contain blood serum, a complex mixture of biologically active components with intrinsic variability from batch to batch and safety issues regarding potential infectious agents. Vitro will present its results regarding each of these points and the status of FDA approval of its clinical products.

Dr. Jim Musick, Vitro's President & CEO, said, "We are very pleased to be approved for presentation at the ISCT Annual Meeting. It is apparent from the reported widespread efficacy of MSCs in clinical trials and the low incidence of adverse effects that there is potential to achieve regulatory approval for advanced treatment of many diseases, injuries and cellular degenerative conditions. Our new clinical products expand our offering of tools to support stem cell research by providing highly competitive new products for clinical studies including our serum-free, animal-free and chemically defined MSC-Gro(TM) Brand of media formulations optimized for human MSC self-renewal & lineage-specific differentiation, together with LUMENESC(TM) high performance assays of stem cell quality, potency and response to toxic agents. We intend to leverage our current advances in human medical MSC-based treatments to offer products for treatment of horses, dogs and cats. The results of MSC therapy in animals may also provide safety and efficacy data to support human clinical studies."

About Vitro Diagnostics, Inc.

Vitro Diagnostics, Inc. dba Vitro Biopharma (OTCQB:VODG.PK - News) (http://www.vitrobiopharma.com), owns US patents for production of FSH, immortalization of pituitary cells, and a cell line that produces beta islets for use in treatment of diabetes. Vitro also owns a pending international patent for generation of pluripotent stem cells. Vitro's mission is "Harnessing the Power of Cells(TM)" for the advancement of regenerative medicine to its full potential. Vitro operates within a modern biotechnology manufacturing, R&D and corporate facility in Golden, Colorado. Vitro manufactures and sells "Tools for Stem Cell and Drug Development(TM)", including human mesenchymal stem cells and derivatives, MSC-Gro(TM) optimized media for stem cell self-renewal and lineage-specific differentiation. Vitro recently formed a strategic alliance with HemoGenix(R), Inc. (http://www.hemogenix.com/) to jointly manufacture and distribute LUMENESC(TM) and LumiSTEM(TM) quantitative assays for determination of stem cell quality, potency and response to toxic agents.

The Vitro Biopharma logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=12086

Safe Harbor Statement

Certain statements contained herein and subsequent statements made by and on behalf of the Company, whether oral or written may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward looking statements are identified by words such as "intends," "anticipates," "believes," "expects" and "hopes" and include, without limitation, statements regarding the Company's plan of business operations, product research and development activities, potential contractual arrangements, receipt of working capital, anticipated revenues and related expenditures. Factors that could cause actual results to differ materially include, among others, acceptability of the Company's products in the market place, general economic conditions, receipt of additional working capital, the overall state of the biotechnology industry and other factors set forth in the Company's filings with the Securities and Exchange Commission. Most of these factors are outside the control of the Company. Investors are cautioned not to put undue reliance on forward-looking statements. Except as otherwise required by applicable securities statutes or regulations, the Company disclaims any intent or obligation to update publicly these forward looking statements, whether as a result of new information, future events or otherwise.

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Vitro Biopharma Receives Approval for Presentation to the International Society for Cellular Therapy

NeoStem Provides Updates and Reports Year End Results

NEW YORK, March 20, 2012 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE Amex:NBS) ("NeoStem" or "the Company") is a leader in the cell therapy industry, developing cell based therapeutics supported by the Company's expertise in contract manufacturing. This strategic combination and depth of experience in cell therapy development and manufacturing provide NeoStem with unique capabilities to develop its own cell therapies and that sets the Company apart from others in the cell therapy landscape. 2011 represented a major year of strategic transition for NeoStem, and the Company plans to build upon that in 2012 and in the years ahead.

NeoStem reported its audited results for 2011. Consolidated revenues for the year ended December 31, 2011 were $73.7 million compared to $69.8 million for 2010. The Company's consolidated net loss for 2011 was $56.6 million, which included $10.3 million of non-cash equity-based compensation expense, $19.4 million of goodwill impairment charges and $9.0 million of depreciation and amortization. Overall, the Company's consolidated cash loss for 2011 was $15.5 million (see reconciliation below). Net loss attributable to NeoStem common shareholder interests for 2011 was $47.8 million, or $0.54 per share.

As of December 31, 2011, the Company had consolidated cash and cash equivalents of $12.7 million, and an additional $2.5 million in cash held in escrow (classified in Other Assets).

NeoStem believes that the opportunities that exist today in cell therapy are robust and growing despite a persistently difficult financial environment, making this an opportunistic time to pursue the monetization of the Company's 51% ownership of Suzhou Erye Pharmaceutical Co., Ltd. and bolster its cell therapy business. In June 2011, the Company engaged a financial advisor to lead the effort to pursue the possible divestiture of the Company's interest in Erye. Marketing efforts are underway and have generated interest from both financial and strategic buyers.

On the therapeutics side of the business NeoStem now has a pipeline of assets that includes Amorcyte (Phase 2 trial for preservation of heart function after a heart attack), Athelos (physician sponsored Phase 1 trials for a range of auto-immune conditions) and pre-clinical development work on its VSEL(TM) technology. The Company's most advanced asset is AMR-001 for the treatment of acute myocardial infarction for which enrollment for a Phase 2 study in the United States commenced in January. The study is a multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of infarct-related artery infusion of AMR-001, an autologous bone marrow derived cell therapy enriched for CD34+ cells. AMR-001 is administered 5 to 11 days post-stent placement in patients diagnosed with an ST segment elevation myocardial infarction ("STEMI") with ejection fraction less than or equal to 48%. The study will include 160 subjects, age 18 and older, randomized 1:1 between treatment and control. The manufacturing, product supply, and logistics for the trial will be supported by Progenitor Cell Therapy, LLC, NeoStem's contract manufacturing company.

Amorcyte currently has ten activated clinical trial sites for its Phase 2 AMI clinical trial with the initial patients enrolled. Trial enrollment is expected to be completed in approximately one year with data read out six months following the last treated patient. The Amorcyte franchise is supported by a strong patent portfolio which includes both composition of matter and methods of treatment around use of these hematopoietic stem cells for treatment of cardiac ischemia and other ischemic tissue that result from vascular insufficiency. The Company sees Amorcyte as a pipeline of therapeutics with potential in multiple indications from STEMI to congestive heart failure and other related vascular insufficiencies. The Amorcyte product addresses both an unmet medical need and a large potential market.

"One of the most important attributes of AMR-001 is that it's 'natural.' We are enhancing the body's normal and natural response to ischemic injury," said Dr. Robin Smith, CEO of NeoStem. "Ample historical evidence, published literature and our own compelling Phase 1 data give us confidence that this product will ultimately make it to the marketplace. Our next most advanced asset is held by Athelos Corporation, (a NeoStem company, partnered with Becton, Dickinson and Company) which is developing a novel T-cell platform for immunological disorders. The Athelos T-cell technology represents an innovative approach to restoring immune balance with potential applications in graft vs. host disease (GvHD), solid organ transplant (SOT) and autoimmune diseases, such as asthma and diabetes. Multiple physician sponsored phase 1 studies are expected to report results that will be used to determine the direction of clinical development.

"NeoStem is also developing pre-clinical assets, including its VSEL(TM) Technology platform for regenerative medicine, which NeoStem believes is an endogenous pluripotent non-embryonic cell that has the potential to change the paradigm of cell therapy as we know it today. These activities have received awards in excess of $2.5 million which funds support the work of prestigious researchers who are pioneering this science with NeoStem.

"Behind the development of these therapeutic assets is the NeoStem cell therapy contract manufacturing business (PCT) which itself continues to grow. New clients have engaged PCT to assist them in the development of their products, including a global, diversified healthcare company who recently selected PCT to provide stem cell processing in our two GMP manufacturing facilities in the United States (California and New Jersey). PCT's prominence in the marketplace continues to grow and that is reflected by both client satisfaction and the revenues the company generates.

"As we look to the year ahead, we are excited on multiple fronts. Our capital preservation efforts are now bearing fruit as our cash burn rate is in-line with our peers. We expect to continue to carefully invest our capital in projects that meet our internal rate of return hurdle and risk parameters. We believe the PCT and Amorcyte acquisitions have created true value for our shareholders and we look forward to demonstrating that as these assets reach their respective value inflection points. We see the unmet medical need in cardiology and the treatment burden associated with chronic diseases as representing a significant challenge to modern society. We believe that cell therapy holds many of the solutions to the health crisis that societies face and have the potential to create real pharmacoeconomic benefit as well as shareholder value for our company.

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NeoStem Provides Updates and Reports Year End Results

Cell-in-a-Box® Encapsulation Technology Creates Extensive Applications within the Stem Cell Arena

SILVER SPRING, Md.--(BUSINESS WIRE)--

Nuvilex, Inc. (OTCQB:NVLX), an emerging biotechnology provider of cell and gene therapy solutions through its acquisition of the SG Austria assets, today discussed the value of encapsulation, freezing, storage, survivability and localization of human stem cells once implanted using the proprietary Cell-in-a-Box technology.

The encapsulation of human stem cells is enabled by the Cell-in-a-Box technology, which can then be frozen, stored and later implanted into target tissues. The benefits of encapsulation are several: first, the process allows for freezing of stem cells for long-term storage without appreciably affecting viability. Second, encapsulation protects the stem cells from stress factors caused by direct aeration and sheer forces associated with bioreactors. Third, Cell-in-a-Box encapsulated stem cells are held in place at the site of implantation, maximizing their potential efficacy as they have the potential to stimulate growth of surrounding new, healthy tissue. Finally, encapsulated cells may prevent any potential side effects associated with direct injection since they remain localized to the area of treatment when encapsulated.

Dr. Robert Ryan, Chief Executive Officer of Nuvilex, commented, For many years it was assumed stem cells existed only to replace cells that had died or were damaged. Recent studies suggest factors stem cells secrete provide signals to surrounding tissue that can stimulate regeneration. The potential therefore, is that if stem cells can be maintained at a particular site where damaged, removed or non-functional tissue was through some sort of holding mechanism, this may aid in a positive growth response in that tissue. In addition, the stem cells themselves have the potential to undergo development into the appropriate cell type at that location, potentially creating miniature organs. The Cell-in-a-Box technology is designed specifically for those purposes. Thus, encapsulated stem cells would be implanted and remain in place, ultimately being able to serve a broad number of medical applications entirely dependent on where in the body they are placed.

About Nuvilex

Nuvilex, Inc. (OTCQB:NVLX) is an emerging international biotechnology provider of live clinically useful, therapeutically valuable, encapsulated cells, as well as services for encapsulating live cells for the research and medical communities. Through substantial effort, the aspects of our corporate activities alone and in concert with SG Austria continue to move toward agreement completion and ultimately a strong future together. Our companys ultimate clinical offerings will include cancer, diabetes and other treatments using the companys industry-leading cell and gene therapy expertise and cutting edge, live-cell encapsulation technology.

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 involving risks and uncertainties, including product demand, market competition, and Nuvilexs ability to meet current or future plans which may cause actual results, events, and performances, expressed or implied, to vary and/or differ from those contemplated or predicted. Investors should study and understand all risks before making an investment decision. Readers are recommended not to place undue reliance on forward-looking statements or information. Nuvilex is not obliged to publicly release revisions to any forward-looking statement, to reflect events or circumstances afterward, or to disclose unanticipated occurrences, except as required under applicable laws.

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Cell-in-a-Box® Encapsulation Technology Creates Extensive Applications within the Stem Cell Arena