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.

NeoStem Study indicates Bone Marrow Stem Cells May Preserve Heart Tissue After Heart Attack ($NBS)

NeoStem (NYSE Amex: NBS) is a leader in the development and manufacture of cellular therapies. NeoStem has a  strategic combination of revenues, including that which is derived from the contract manufacturing services performed by Progenitor Cell Therapy, LLC, a NeoStem company. NeoStem endeavors to be an integrative force in the cell therapy industry. By vertically integrating the collection, storage and processing of cell units and the development, manufacturing, distribution, and delivery of cell therapy products, they are positioned to take advantage of growth in the cell therapy industry as a whole.

Results from the The PreSERVE-AMI Study, sponsored by Amorcyte, LLC, a NeoStem, Inc. company, indicate that stem cells retrieved pelvic bone marrow restore tissue and improve heart function in heart attack patients.  The study evaluated the safety and efficacy of stem cell treatments and focused on patients who had received a stent to open the blocked artery and heart attack injuries caused by a prolonged period of blocked blood supply.  The NeoStem company Progenitor Cell Therapy also assisted this study by processing stem cells in preparation for infusion.  

Vijaykumar S. Kasi, MD, PhD, principal investigator for the clinical trial at Orlando Regional Medical Center, commented,

"Severe heart failure, often the end result of large or multiple heart attacks, is a major health care challenge, impacting more than five million people in the United States and costing more than $35 billion annually. Stem cell therapy is part of the movement from treatment to cure and has the potential to overcome limitations and expenses of heart transplants and offers hope for patients who are desperately praying for another chance at life."

Read the full article here.  

ImmunoCellular Therapeutics ($IMUC) licenses mesothelin cancer antigen from Johns Hopkins

ImmunoCellular Therapeutics (OTCBB:IMUC) announced that they have entered into an agreement with Johns Hopkins University which sees the college grant an exclusive, worldwide license to intellectual property surrounding the tumor-associated antigen mesothelin.(The terms of the agreement were not disclosed).

Antigens are substances that cause the immune system to produce antibodies against it. Mesothelin is highly expressed in pancreatic cancer, ovarian cancer and mesothelioma.

The company will employ this intellectual property in the development and commercialization of ICT-140, a multivalent, dendritic cell-based vaccine for the treatment of ovarian cancer, one of multiple tumor types in which mesothelin is over-expressed.

ICT-140 is designed to target cancer stem cells as well as daughter cells in ovarian cancer by targeting multiple different antigens including mesothelin, Her-2/neu, IL-13Rα2 and several other undisclosed antigens.

ImmunoCellular president and CEO Manish Singh said: "As we continue the development of a novel, dendritic cell-based vaccine for the treatment of ovarian cancer, this licensing agreement for mesothelin technology will allow us to ensure that we have the critical components for a successful vaccine.

"We look forward to the ongoing support of Dr. Jaffee and her colleagues at Johns Hopkins as we develop the vaccine. We expect to file an Investigative New Drug application for the vaccine in the fourth quarter of this year."

IMUC recently started a phase II trial of its lead product candidate, ICT-107, a dendritic cell-based vaccine targeting multiple tumor associated antigens for glioblastoma. We do know that NeoStem's PCT is working with IMUC as the "contract maanufacturer".

Earlier this month the company received a "notice of allowance" from the U.S. Patent and Trademark office for its patent relating to the targeting of cancer stem cells in the treatment of patients with glioblastoma, an aggressive form of brain cancer.

The patent, called “Cancer Stem Cell Antigen Vaccines and Methods”, covers various methods of using dendritic cells combined with antigens derived from glioblastoma cancer stem cells.

Daily Dose Conclusion: The IMUC P1 Glioblastoma data is promising. The data set is smalla nd single center but if replicated in Phase II this could be the makings of the next Dendreon at a deep value. Also keep an eye on Prima BioMed working in ovarian cancer, also a dendritic cell approach.

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NeoStem's ($NBS) First Patient is Enrolled in Amorcyte Trial

Wow, what a long way NeoStem (NYSE AMEX: NBS) has come. In the past year this company has been transformed from one focused on pre-clinical VSEL's which hold promise of being a naturally pluripotent adult stem cell to a Phase II clinical company with a well-designed, well vetted therapy (CD34+/CXCR4+ Cell derived from a patient’s own bone marrow) for the preservation of Heart function. The name of the trial is PreServe!

From the press release:

"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 with ejection fraction less than or equal to 48%, as determined by cardiac magnetic resonance imaging."

This is a critical element of the NeoStem story. Unlike most of the other companies who are also working in the heart attack space, NeoStem is based on their understanding of the underlying biology of heart attacks. It typically takes 5-6 days for the ischemic signal from the healthy but overworked myocytes (heart cells) that surround the infarct tissue to build up to a point where the CD34 cells can migrate locally via their cell receptor (CXCR4). They then modulate the process of angiogenesis where it’s needed.

In other words, if you give cells too soon, it becomes cellular Advil (calming down inflammation) but not really modulating the localized needs around the peri-infarct zone, and if you give cells too late, the myocytes are not rescued. This is the only cell therapy company we are aware of that has been so explicit with their understanding of the active cell type (it’s not a gamish of stem cells, its CD 34+ cells), delivered at a specific dose, at a specific time.

Conclusion: Look for news from NeoStem on this trial which has the potential to transform the way heart attacks are treated. This will take 12 months to complete enrollment with data 6 months after last patient is treated. Also keep an eye out for the company to divest their 51% ownership in the China Generics company. This should be a welcome event by The Street that could unlock significant shareholder value.

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Today, January 25, 2011, NeoStem Senior Management, Subsidiaries Invited to Speak at Seventh International Conference on Cell Therapy for Cardiovascular Disease; $NBS

NeoStem, Inc. (AMEX: NBS; Stock Twits: $NBS) is an emerging biotechnology company engaged in the development and manufacturing of cell-based therapies in the U.S. Its January 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 acquisition of PCT gives NeoStem not only access to a world class contract manufacturing cell therapy company but provides a platform and expertise around the evaluation, development and regulatory requirements to develop autologous, allogeneic, immunomodulatory and vaccine-based therapeutics. 

NeoStem announced that several of its representatives have been invited to present at the Seventh International Conference on Cell Therapy for Cardiovascular Disease held from January 25-27, 2012 in New York City. The invited include NeoStem’s Chief Medical Officer, the lead investigator for its PreSERVE Phase 2 clinical trial for AMR-001 for preservation of heart function in post acute myocardial infarction patients, and the President of Progenitor Cell Therapy, LLC, a NeoStem subsidiary. 

The Cardiovascular Research Foundation is organizing the conference, which will be held at the Myrna L. Daniels Auditorium in the Vivien and Seymour Milstein Family Heart Center at NYPH/Columbia University Medical Center.

The program “will be dedicated to the evolving field of cell-based therapies being developed for the repair and regeneration of cardiac and vascular disease, as well as related diseases such as diabetes and stroke.” The conference this year “will focus on preclinical and clinical studies on the path to commercialization, highlighting the status of molecular, cell, and tissue products in addition to delivery systems. Leaders from the international community will convene to present their work, experiences, observations, and opinions on the benefits and unmet challenges of cell-based therapies.”

NeoStem will present as follows:

• At 4:30 PM on Wednesday, January 25, Andrew L. Pecora, MD, FACP, Chief Medical Officer of NeoStem, will speak on an industry session entitled "Focus on Acute Injury Technologies."
• At 9:20 AM on Thursday, January 26, Arshed A. Quyyumi, MD, FRCP, FACC, principal investigator of the PreSERVE AMI Phase 2 trial and Professor of Medicine and Cardiology at Emory University, will speak on a panel entitled "Early and Next Phase Studies" within a session entitled "Acute Injury: STEMI and NSTEMI".
• From 7:30 to 8:30 AM on Friday, January 27, Robert A. Preti, PhD, President of Progenitor Cell Therapy will speak as part of Industry Session III entitled "Focus on Procedure, Systems Management, and Advanced Technologies."

Dr. Pecora, CMO of NeoStem, commented,

"As a presenter at the first industry session, I look forward to informing industry leaders about the PreSERVE Phase 2 clinical trial for AMI which is now open for enrollment and may provide data readout 18 months from the first patient enrollment, as well as discussing the recent patent issued to use the Amorcyte technology beyond cardiovascular disease." 

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

"This conference represents validation that the development of cell therapies for diseases outside of bone marrow transplantation is progressing as represented by their current clinical data. Our acquisition of Amorcyte last year has positioned NeoStem to be a leader in the cell therapy cardiovascular space. We are excited to be a part of the developing science represented by this important conference and share our expertise represented by the progress with Amorcyte and our capabilities to assist the field with the manufacturing services of PCT."

Read the full news release at PR Newswire. 

WBB Upgrades NeoStem ($NBS), Target = $2.00

WBB Securities upgraded NeoStem (NASDAQ: NBS) to a Buy with a 12 months price target of $2.00 per share. The report cited a few reasons which include:

1. Expansion of the intellectual property associated with Amorcyte beyond STEMI (Heart attacks) to all Vascular Insufficiency.
2. New PCT clients on-board such as Immunocellular (IMUC) - (working on a dendritic cell based approach to brain cancer), and Islet BioSciences (microencapsulated insulin-producing, pathogen free swine (pigs) for type 1 diabetes’s. NeoStem actually gets a royalty on commercial sales (utilizing PCT's manufacturing currency to participate in clients downstream revenues).
   
3. Divestiture of China Generic company (WBB estimates $25 million).
4. The start of the Amorcyte Phase II trial.

Alliance for Regenerative Medicine, January 10, 2012, San Francisco

The Alliance for Regenerative Medicine Announces Presenting Companies and Second Annual State of the Industry Briefing and Regenerative Medicine Insight Track at Biotech Showcase

Event Takes Place on January 10, 2012 in San Francisco; Expanded Agenda Includes Panel Sessions on Major Regenerative Medicine Target Indications

PRESENTING COMPANIES: Aastrom Biosciences, Advanced BioHealing, Advanced Cell Technology, Aldagen, Allocure, Amorcyte, Athersys, Axogen, Coronado Biosciences, Cytori Therapeutics, Dendreon, Harvard Biosciences, Healthpoint, ImmunoCellular Therapeutics, InVivo Therapeutics, ISTO Technologies, Maxcyte, Mesoblast, MolMed, Neostem, Neuralstem, NexImmune, Organovo, Prima Biomed, Q Therapeutics, ReNeuron, SanBio, StemCells, Inc., Tengion, TiGenix, Tissue Genesis

The Alliance for Regenerative Medicine (ARM), the international organization representing the interests of the regenerative medicine community, today announced that the second annual State of the Industry Briefing will take place on January 10, 2012 in San Francisco. 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.

The Regenerative Medicine State of the Industry Briefing will focus on recent developments and the future outlook for the cell therapy and regenerative medicine industries. Speakers will include Gil Van Bokkelen, CEO of Athersys; Silviu Itescu, CEO of Mesoblast; Tim Mayleben, CEO of Aaastrom; Gary Rabin, CEO of Advanced Cell Therapy; Dr. Robin Smith, CEO of NeoStem and senior executives from large pharmaceutical companies. The panels will cover the outlook for the industry, a review of pipelines and clinical trials, and a general discussion of critical success factors including technology advancements, regulatory issues and the financial outlook for the sector.

A series of analyst-led, therapeutic area focused panels will follow the briefing. The panels will discuss therapeutic categories where regenerative medicine holds great promise including cardiology and ischemic related disease, spinal injury, ophthalmology, metabolic disease, and central nervous system disorders as well as an exploration in cell based solutions in immunology and oncology. The panels will be moderated by analysts from Rodman & Renshaw, Piper Jaffray, JMP Securities, ROTH Capital Partners, and WBB Securities and feature participation from more than 25 companies including:

Aastrom, Advanced BioHealing/Shire, Advanced Cell Technology, Aldagen, Athersys, Cytori, Healthpoint, ISTO Technologies, Maxcyte, Mesoblast, Neostem, Organovo, ReNeuron, SanBio, StemCells, Inc., Tengion and Tigenix.

"We are excited to once again bring together many of the leading experts in the regenerative medicine field to report on the progress made during 2011 and provide an outlook for 2012 and beyond," said Gil Van Bokkelen, PhD, Chairman of ARM and CEO of Athersys. "Based on the significant response to the meeting last year, it's clear that recognition of the near-term therapeutic promise of regenerative medicine is growing, and this event represents a great opportunity for investors and others to hear from industry leaders and gain insight into the tremendous potential of the field."

This event was developed by the Alliance for Regenerative Medicine, and will be held as part of the Biotech Showcase 2012 conference taking place at the Park 55 Wyndham in San Francisco beginning at 8:00 a.m. 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.

The Alliance for Regenerative Medicine (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, 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 .

Media Contact:
      Michelle Linn
      Linnden Communications
      Phone: 508-362-3087

Insider Buying at NeoStem ($NBS) supports a Solid Therapeutics Story build on a Manufacturing Platform- PCT

There is nothing we like to see more than insiders putting their money with shareholders. We took note of several insiders from Neostem (NYSE AMEX: NBS) including CEO Dr Robin Smith, CMO Dr Andrew Pecora, and VP Business Development, Jason Kolbert, all making inside purchases.

NeoStem has been popping up on a radar screen a lot these days. First with the acquisition of Progenitor Cell Therapy earlier this year, and now the acquisition of Amorcyte (P2 asset for AMI). This trial is expected to enroll its first patient in Q1-2012 and according to management is ready to go. We expect the trial to enroll the target 160 patients within 12 months with data read-out 6 months afterwards.

We do know that the Amrocyte product is differentiated. It is an enriched cell population, bone marrow derived of CD 34+ cells, and that the company established a biologically effective threshold dose that must be met (>10 mln cells) to show efficacy. NeoStem talks in great definition about the mechanism of action, the dose, the biological (angiogenesis) and clinical effect they intend to measure, perfusion. There is ample historical evidence to suggest that CD34+ cells are potent ones for neoangiogenesis. A recent paper published by Baxter principal investigator and thought leader, Dr. Douglas Losordo suggests that among all the cells types, CD34+ are the most potent. (Baxter is moving forward in a P3 trial with a CD 34+ cell) for cardiac ischemia. The Baxter trial harvests the cells from peripheral blood after delivering a mobilizing agent (GCSF). Our understanding is that these cells are not as effective at homing, but that fine as Baxter delivers them locally using direct injection to the heart itself (where NeoStem injects into the infarct related artery) and allows the cells to home along the ischemic (oxygen starved) gradient travelling to where they are needed. We believe that the historical literature does not lie and that Baxter offers proof of concept for NeoStem.

Some question if the autologous model is viable in the wake of Dendrion. We would remind folks that NeoStem acquired both Progenitor Cell therapy (PCT) and Amorcyte for a 1-2 punch. PCT did the majority of clinical autologous manufacturing for Dendrion's Provenge. So PCT knows how to manufacture. We also know that autologous has lots of advantages over allogeneic.

While Bears are quick to point out the advantages of pills in a bottle model (allogeneic) the data suggests that only autologous cells (your own cells) will truly integrate into the target (your own heart) and continue to modulate neoangiogenesis. NeoStem has publically declared that they plan to divest their majority ownership in the China generic company they own. That should be a catalyst for the stock too. So by comparison to the rest of the field we see NeoStem with a solid manufacturing base of operations in PCT (several contract manufacturing clients in Phase 3, Phase 2 and Phase 1 generating revenues and creating options for commercial manufacturing down the road as one of the better positioned companies in the space. Apparently the insiders agree.