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:

Biotech and related conferences in June 2012

June 2012 is a busy month for biotech and related conferences. Below are a few of the conferences taking place:

International Society for Cellular Therapy Annual Meeting 

Date: June 5-8, 2012

Venue: Sheraton Seattle, Seattle, WA

http://www.celltherapysociety.org/index.php/meetings-events/isct-2012-annual-meeting

SeeThruEquity.com SmailCap Equity Conference - sponsored by ProActive Capital

Date: June 5, 2012

Venue: The Cornell Club

http://www.seethruequity.com/content/2012-06-05-conference.aspx

 

National Investment Banking Association Conference

 

Date: June 7-8, 2012

Venue: Le Parker Meridien Hotel, New York, NY

http://nibanet.org/conferences/niba-june-7-8-2012-new-york-ny-conference

International Society for Stem Cell Research 10th Annual Meeting

 

Date: June 13-16, 2012

Venue: Pacifico Yokohama, Yokohama, Japan

http://www.isscr.org/Annual_Meeting_Home.htm

 

The Biotechnology Industry Organization (BIO) International Conference

 

Date: June 18-21, 2012,

Venue: Boston Convention & Exhibition Center, Boston, MA

http://convention.bio.org/

 

Alliance for Regenerative Medicine - Clinical Outlooks for Regenerative Medicine 2012

 

Date: June 19, 2012

Venue: The Starr Center, Schepens Eye Research Institute, Boston, MA

http://www.hsci.harvard.edu/node/4162

Marcum's Inaugural MicroCap Conference

Date: June 20, 2012

Venue: The Roosevelt Hotel, New York, NY

http://www.marcumllp.com/events/microcap-conference

The Alliance for Regenerative Medicine Announces Agenda for Regenerative Medicine Insight Track at Biotech Showcase on January 10 and 11 in San Francisco

Speakers include Advanced Cell Technology, Athersys, Cytori, Dendreon,

Genzyme-Sanofi, Johnson & Johnson, Mesoblast and Shire

The Alliance for Regenerative Medicine (ARM), the international organization representing the interests of the regenerative medicine (RM) community, today released the agenda for its second annual State of the Industry Briefing and RM Insight Track. The meeting will take place on January 10 - 11, 2012 at the Park 55 Wyndham in San Francisco.

The Regenerative Medicine State of the Industry Briefing will focus on recent developments and the future outlook for regenerative medicine, cell therapy and other advanced therapeutics. A full day of panels focused on several disease areas will follow the briefing as part of the Regenerative Medicine Insight track at the Biotech Showcase 2012. The panels will be moderated by key analysts in the sector. Please see agenda below:

Tuesday, January 10, 2012

8:00 – 9:30 AM Regenerative Medicine State of the Industry Briefing

• Gil Van Bokkelen, CEO, Athersys (Moderator)
• Silviu Itescu, CEO, Mesoblast
• Tim Mayleben, CEO of Aaastrom
• Gary Rabin, CEO, Advanced Cell Technology
• Robin Smith, CEO, NeoStem
• Leanna Caron, VP & GM of Cell Therapy & Regenerative Medicine, Genzyme-Sanofi
• Ed Field, COO, Aldagen
• Jay Seigal, CBO, Johnson & Johnson
• Dean Tozer, Senior VP of Corporate Development, ABH-Shire
• Susan Solomon, CEO, New York Stem Cell Foundation
  

Therapeutic Focus Panels

9:30 - 10:45 AM Cardiovascular, AMI and PAD—Part 1

Analyst: Jason Butler, JMP Securities

• Amorcyte, Andrew Pecora, CSO
• Cytori, Marc Hendrick, President
• Athersys, Gil Van Bokkelen, CEO                               
• Mesoblast, Silviu Itescu, CEO                              

10:50AM - 12:15 PM Cardiovascular, CLI and Stroke—Part 2

Analyst: Ren Benjamin, Rodman and Renshaw

• Aastrom, Brian Gibson, VP Finance
• ReNeuron, Michael Hunt, CEO                             
• Aldagen, Ed Field, COO                            
• Tissue Genesis, Anton Krucky, CEO                                      
• SanBio, Keita Mori, CEO

1:45 – 3:00 PM Neurodegenerative Disease, Ophthalmology and Spinal Injury  

Analyst: Steve Brozak, WBB Securities

• StemCells, Inc., Martin McGlynn, CEO 
• NeuralStem, Richard Garr, CEO                           
• InVivo, Frank Reynolds, Chairman of the Board, CEO, CFO,
• Advanced Cell Technology, Gary Rabin, CEO

3:00 – 4:15 PM Renal and AutoImmune Disease

Analyst: Kai Makay, Roth Capital

• Tengion, Mark Stejbach, VP, CCO
• Allocure, John Wirthlin, COO
• Tigenix, Eduardo Bravo, CEO
• Q Therapeutics, Deborah Eppstein, CEO 

4:20 – 5:45 PM Tissue Engineering, Orthobiologics and Artificial Conduits to Wound Care and BioPrinting

Analyst: Jeffery Cohen, Ladenburg Thalmann & Co.

• ISTO, Scott Gill, CFO
• Organovo, Keith Murphy, CEO                   
• ABH - Shire, Dean Tozer, Senior VP of Corporate Development
• Healthpoint, Rob Bancroft, VP, Strategic and Corporate Development
• Axogen, Karen Zaderej, CEO
• ·      Harvard Biosciences, David Green, CEO

Wednesday, January 11, 2012

9:00 - 10:30 AM Hematology &  Immunology

Analyst: Stephen Dunn, LifeTech Capital

• Dendreon, David L. Urdal, Executive VP, CSO                                         
• Prima BioMed, Martin Rogers, CEO                               
• ImmunoCellular, Manish Singh, CEO
• Coronado, Bobby Sandage, CEO
• bluebird bio, Jeffrey Walsh, COO
• NexImmune, Ken Carter, CEO                                           
• Maxcyte, Doug Doerfler, CEO

To learn more and to register for the conference, please contact Rob Margolin at (646) 201-4192.  Registration is complimentary for credentialed members of the media and the investment community. The State of the Industry briefing is open to the public, but attendance at the disease panels will require registration for individuals without press or investor credentials. 

About Biotech Showcase™ (Innovation – Opportunity – Collaboration):

Now in its fourth year, Biotech Showcase™ will feature corporate presentations by 200+ innovative life science companies to an audience of public and private investors, business development executives and professional advisors who are interested in investment opportunities and collaboration.  The showcase takes place during the week of the annual JP Morgan Healthcare Conference, one of the most important healthcare industry events of the year which attracts thousands of healthcare and life science business executives to San Francisco. Biotech Showcase was co-founded by Demy-Colton Life Science Advisors and EBD Group.  Please visit their website for more information:  www.biotechshowcase.com.

About The Alliance for Regenerative Medicine (ARM)

ARM is a Washington, DC-based non-profit organization that promotes legislative, regulatory, reimbursement, and financing initiatives necessary to facilitate access to life-giving advances in regenerative medicine. ARM also works to increase public understanding of the field and its potential to transform human healthcare, and provides services to support the growth of its member companies and organizations. Prior to the formation of ARM in September 2009, there was no advocacy organization operating in Washington, DC to specifically represent the interests of regenerative medicine companies, research institutions, investors, and patient groups supporting more rapid adoption of technologies in our field. To learn more about ARM or to become a member, visit www.alliancerm.org.

Stem Cells Inc. (STEM): Prices $10M secondary at $1.25

In a surprise offering Stem Cells Inc. (NASDAQ: STEM) announced the pricing of 8 million share offering with matching warrants for gross proceeds of $10M, at the bottom of what has been a declining valuation. Earlier in the week we discussed the perfect storm, the macro-economic outlook coupled with declining balance sheets has hurt biotechnology companies that have "miles to go" before they can reach commercialization. Dendreon's implosion and Geron's departure did not help. As a result valuations have declined for everyone in the cell therapy space. Raising capital at the bottom hurts, but it is the nature of biotechnology and the rule here is dilution versus extinction.

It is surprising to us that the company announced earlier in the week news that the first cohort of the Phase I/II trial in chronic spinal cord injury has been treated (successfully transplanted with the STEM's proprietary HuCNS-SC® neural stem cells).

This trial has a unique design, in which patients with progressively decreasing severity of injury will be treated in three sequential cohorts. The first cohort of patients all have spinal cord injury classified as AIS A, the most severe level identified by the American Spinal Injury Association Impairment Scale (AIS).

We have seen Dr. Stephen Huhn MD, FACS, FAAP, (Vice President and Head of the CNS Program at StemCells) present in the past. He is considered a KOL (Key Opinion Leader) in the field and is highly respected. He is quoted:

"Having completed dosing of the AIS A cohort, screening for AIS B patients, who have a less severe, incomplete type of spinal cord injury, can now begin. Of course, our first priority is to assess safety in each patient, but we will also be evaluating trial patients for changes in sensation, motor and bowel/bladder function."

It’s still early days for STEM and impossible to know if these cells will translate into any efficacy but the good news is that this raise does give the company some runway to see a signal from this trial. It’s a longshot for sure and there are other companies in the space with more mature trials, defined mechanisms of action, dose responses defined, large target markets, and great efficacy signals established in P1 and 2 trials. Look at the developments in cardiology (AMI / CHF) - Mesoblast, Cytori, NeoStem, where we believe proof of concept is coming, but the holy grail of stem cell therapy is to be able to show a signal, anything, in paralysis. STEM now will carry that banner.

Bio Smart Brief : Survey Picks Stem Cells

Bio SmartBrief circulated an Expert Views and Insights piece yesterday. We highlight one of the posted survey sections:

Poll: What field is most likely to yield the biggest breakthrough in the coming year?

23%		Stem-cell therapies
14%		Specific disease therapies -- HIV, cancer
14%		Vaccines
12%		Someplace unexpected
10%		Genomic discoveries
8%		Advanced biofuels
8%		Agricultural biotech
7%		Gene therapy
4%		Synthetic biology

Cell Therapy - Is there value for stock market investors?

The cell therapy space has been hit hard over the past year triggered by a perfect storm of events from the macro-economic environment:

• Biotechnology has come under pressure, where investors fear not only dilution but extinction; and
• Companies in the Small-Cap Biotech space often operate with a years worth of cash, and this has made investors nervious.

We have been down this road in the past, can anybody say Y2K?

Dendreon's (NASDAQ: DNDN) rise became the rallying cry for investors so its subsequent plunge became the proof for the bears that cell therapy just doesn't work. Both examples are in our opinion false. Provenge, like so many biotech products before it, is the first in a new therapeutic category. We lived through the monoclonal antibodies in the 90's, and then the HIV market in Y2K. Most recently the success of the nucleosides (Pharmasset) is now destined to be acquired by Gilead (GILD). We hope our followers saw the run up in Inhibitex (INHX) that resulted.

What's the connection? A pattern has emerged, and Provenge is not just a cell therapy but the first of a cell based approach to immunology/cancer. The follow-on products will be better. Take a look at the work that PrimaBioMed (ASX: PRR) is doing or even better, Coronado (OTCBB: CNDO) (which we have been following for some time).

What we want to begin discussing today is cell therapy on the regenerative medicine side of the equation. Oncology has always had tough hurdles but on the regenerative side the unmet medical need is often just as great, in fact, greater in some places. 

No one yet has been able to explain Mesoblast (MSB-Australia) to us but Cephalon and now Teva are in partnership and the stock has a market cap approaching $2 billion. This is an allogenic (other peoples cells) model, which pharma likes. It is the so called pills in a bottle model. Peer companies include Pluristem (PSTI) and Athersys (ATHX), at much lower valuations ($100 million or lower). On the autlogous side no one seems to be paying any attention to NeoStem (AMEX: NBS). This company acquired Progenitor Cell Therapy the contract manufacturing company that worked on Provenge and today is working with many of the cell therapy companies we are following.

Can an autlogous model work?  Baxter thinks so, and has been highlighting their autlogous cells for cardiac ischemia. Interesting because the Baxter product is very similar to the NeoStem product - both are CD34+ cells with some differences. NeoStem is begining their Phase 2 trial for a cell therapy that promises to stabilze failing hearts after a heart attack.

We recently attended the Stem Cell Therapy on the Mesa conference, and we were "blown away" with the number of products in clinical trials. We saw companies from all over the world - some had revenues with approved products, and others had great data and proof of concept with thereapies that can work for everything from cardiovascular disease to healing damaged muscles and tendons.

Going Forward: We will be actively following the "Cell Therapy Space" now. That means we will be watching the developments on two fronts:

• Oncology/Immunology side, and
• Regenerative Medicine side.

We will be commenting on the trials, the news developments in the space, the competitive landscape, talking with managment, and posting our articles on where we believe the ground breaking science, product profiles, and catalysts lie that can trigger the next paradigm shift in the space.

Remember, Lipitor is going to leave a big hole in Pfizer's pipleine as it goes generic. Pharma and Biotech have to act. Early signs abound that cell therapies are no longer a case of if, but when, and the answer to that is tied to clinical trials, which represent a highly defined process.

Reuters reports on Stem cell research: "It will only take a few successes to really change the field"

Very interesting VBlog today at Reuters on Stem Cell Research, it states:

"Dozens of adult stem cell treatments are moving through clinical trials and showing early success, raising hopes that some could reach the market within five years.

"It will only take a few successes to really change the field," said Gil Van Bokkelen, chief executive of Athersys Inc and chairman of the Alliance for Regenerative Medicine. "As you see things getting closer and closer to that tipping point, you're going to see a frenzy of activity take place."

Many of the trials focus on heart disease and inflammatory conditions, some of the biggest markets in medicine. The cells used are derived from adult tissue such as fat, or bone marrow, thereby circumventing the ethical concerns raised by the use of cells derived from embryos.

Data for the most part remains early, but as more results emerge, pharmaceutical companies are beginning to take note.

"A lot of big companies are looking to place bets on some Phase II products once that data has been confirmed," said Paul Schmitt, managing partner at venture capital firm Novitas Capital. "Even now they're attending all the medical meetings and talking to all the stem cell companies."

Venture funds like Novitas are taking different approaches to playing the emerging field. Novitas invested $4 million in Amorcyte Inc, a company recently acquired by NeoStem ($NBS) that is developing a treatment for heart disease. It is sticking to that investment for now."

 See the full story and slideshow at Reuters.