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Friday, June 12, 2009

Cell Therapy Industry HiLites 2009-06-12

Autologous manufacturing is not the deal breaker it used to be. If these [cell-based] vaccines work for really difficult-to-treat diseases, the manufacturing issues will be worked out.” Howard Liang, MBA, Ph.D., Analyst and Biotechnology Managing Direct at Leerink Swan. "Special Report: Customized Cancer Vaccines Finally (Maybe) Arrive". GEN News Highlights. 12 June 2009.

Amen. Glad to hear someone else saying it.


Ok, well, if no one else wants to advertise here...

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Neuralstem, Inc (NYSE AMEX: CUR) received notice from the NYSE Amex Exchange that its shareholder’s equity has dropped below the $2,000,000 threshold required by the NYSE Amex for continued listing. The Company intends to submit a plan to the Exchange. CEO and President Richard Garr said, “We are confident that the company will be in compliance.”

National Institutes of Health has awarded a $5 million grant to Q Therapeutics (co-founded by former NIH researcher Mahendra Rao), the University of Utah's Cell Therapy Facility and Johns Hopkins University School of Medicine to start human clinical trials of Q-Cells for myotrophic lateral sclerosis, or ALS -- better known as Lou Gehrig's disease.

Opexa Therapeutics, Inc. (NASDAQ: OPXA) received a favorable ruling from NASDAQ allowing an extension to regain compliance and continue the listing of the Company’s securities on The NASDAQ Capital Market.


StemCells, Inc. (NASDAQ: STEM) announced positive data from its Phase I clinical trial of its proprietary HuCNS-SC® product candidate (fetal-derived purified human neural stem cells). The six-patient Phase I trial was designed primarily to assess the safety associated with transplanting HuCNS-SC cells as a treatment for infantile and late infantile NCL, often referred to as Batten disease

Celsense, Inc. is one of the recipients in a 4-year $1.95M grant from the National Institutes of Health to test its in vivo cell trafficking MRI reagent in human clinical studies. The funded studies will be the first effort to evaluate Cell Sense, the Company’s fluorocarbon-based magnetic resonance imaging (MRI) cell tracking reagent, for clinical use. Additionally, the studies will garner preliminary data critically important for improving immunotherapeutic delivery strategies in metastatic colorectal (CRC) and other forms of cancer.

The Cell Sense technology makes transplanted cells visible by MRI. Therapeutic cells are labeled ex vivo with the Cell Sense reagent prior to administration to the patient. Cell migration and biodistribution are subsequently monitored using fluorine-19 (19F) MRI or magnetic resonance spectroscopy (MRS).

The key advantage of Cell Sense is purported to be that the 19F images are extremely selective for the labeled cells, with no background signal from the host’s tissues. Furthermore, accurate cell quantification in regions of interest is possible. Existing data from pre-clinical studies using human cells is said to show that the Cell Sense reagent is highly biocompatible inside cells and does not affect their innate function.

A clinical-grade version of the Cell Sense reagent has been formulated by Celsense, Inc. and is currently being subjected to mandatory in vitro and animal safety studies in preparation for human trials.

Never a company to shy away from making bold and early claims, Advanced Cell Technology, Inc. (OTC:ACTC.PK) Chairman and CEO William M. Caldwell IV said earlier this week that they are completing the "finishing touches" on a submission to seek FDA approval to conduct human clinical trials with a cell therapy that may be able to address many of the 200 plus known retinal diseases.


It's hard to put this story under any one category but since the financial terms weren't released and it's not yet clinical, I'll call it "commercial". J&J's
Ortho Biotech Oncology Research & Development, a unit of Centocor Research & Development, Inc., has announced that it has entered into a five-year Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), with Steven A. Rosenberg, M.D., Ph.D., chief, Surgery Branch, serving as the NCI principal investigator, to research and develop novel cell therapy technologies as potential treatments for a variety of cancers.

The deal bring together Ortho's and Rosenberg's adoptive immunotherapy technologies designed to work by helping the immune system fight cancer.

Rosenberg has been a pioneer in the field of adoptive immunotherapy of cancer developing Tumor Infiltrating Lymphocytes (TILs) - T cells obtained from a patient's tumor, expanded and then re-administered to actively seek and destroy cancer cells. In recent years, Dr. Rosenberg's team developed a new technology in which T cells obtained from a patient's blood are genetically engineered to express receptors that give them specific immunity against cancer cells and then re-administered.

Meanwhile, researchers at Ortho Biotech Oncology Research & Development independently developed a different and proprietary adoptive immunotherapeutic approach that uses tumor antigens and other materials to stimulate T cells from a patient's blood to become Cytotoxic T Lymphocytes (CTLs), which recognize and attack tumor cells.

Both technologies show postive early clinical results in melanoma,
a type of skin cancer that ranks sixth among U.S. men and seventh in U.S. women for the most commonly diagnosed cancer, according to the NCI.

Under the CRADA, Dr. Rosenberg's lab will conduct a clinical trial in melanoma patients using Ortho Biotech Oncology Research & Development's proprietary technology. It is hoped that the technology will be effective in other types of cancer, as well.

They expect to begin clinical testing of the immunotherapy technology in melanoma patients by the end of 2009, with the possibility of additional studies for other types of cancer and other technologies in years to come.

Cellular Dynamics International, Inc. has secured an exclusive license on a patent portfolio surrounding cardiovascular progenitor cells. The license covers differentiation of stem cells into all cell types of the human heart. The patent portfolio was generated by and obtained from Gordon Keller, Ph.D. and Mount Sinai School of Medicine.

Cardiovascular progenitor cells are capable of further differentiation into the multiple cell types of the heart, including cardiomyocytes, endothelial cells, and vascular smooth muscle cells, both in vitro and in vivo. CDI intends to commercialize the technology to the pharma and biotech industry for predictive toxicology and screening purposes. Iit's not clear whether the license also includes clinical applications but if so they may be looking for licensing partners
given their current lack of interest in developing these cells into therapeutics.

In a not-so-surprising move, StemCells Inc (NASDAQ: STEM) has decided to close StemCell Sciences in Melbourne, Australia after its acquisition of the company in March. British staff will now be holding their breath to see if the same will happen to them. STEM says it has offered relocation packages to employees should they wish to move to sunny California. This leaves one "stem cell" firm in Australia where previously there were four (SCS, Bresagen, Embryonic Stemcells Inc and Mesoblast). If there is good news it is that, if I recall correctly, the three others were acquired and not just shuttered.

After many months of actively looking to offload its contract manufacturing subsidiary, Fresenius Biotech, has finally sold EUFETS AG to BioNTech AG. BioNTech is looking ot leverage the acquisition to further its quest to develop innovative molecular immunotherapies and biomarker based diagnostic approaches for individualized treatment of cancer and other severe human diseases.

Having used a contract manufacturer for what and when they needed, BioLife Solutions has now reverted back to internal manfucturing with the completion of construction and validation of their internal GMP manufacturing facility. Recently they gleefully released the first production lot for sale of their biopreservation media products made in the new Bothell, WA plant.

StemCyte Therapeutics is collaborating with Chennai-based Apollo Hospitals in joint venture with Ahmedabad-based Cadila Pharmaceuticals to set up what reports to be a first-of-its-kind umbilical cord blood (UCB) public bank for India.

Ok this news is a little soft but its a product that continues to be reinvented and a company we don't hear from much so I'll give them the space. HepaLife Technologies, Inc. (OTCBB: HPLF) (FWB: HL1) (WKN: 500625) has expanded their Advisory Board to support planning (e.g., refine the clinical strategy and patient treatment protocols) for their expected bioartificial liver clinical trial. HepaLife is developing a cell-based bioartificial liver system, HepaMate, as a potentially lifesaving treatment for liver failure patients. HepaMate is comprised of a blood plasma separation cartridge, a hollow-fiber bioreactor filled with proprietary porcine liver cells, a charcoal column, an oxygenator, circuit tubing and a plasma reservoir. These components are assembled into a patented blood/plasma circulation system, which is placed on the HepaDrive perfusion platform. The HepaMate technology has previously been tested in clinical studies involving more than 200 patients and has been the subject of over 50 scientific papers. It is anticipated that the upcoming trial would be a pivotal trial of the technology.

ThermoGenesis Corp. (Nasdaq: KOOL) mentioned in a recent press release that their Res-Q system - a point-of-care system designed to collect, process, and reinfuse bone marrow stem cells for therapeutic use, is anticipated to be launched on the market this month. Presumably in markets outside the US? They also discussed that they had received $500,000 in an SBIR grant from the NIH to study and develop biomaterials that can be used to deploy placental stem cells in bone repair and regenerative medicine applications. Now free money is free money but this seems a bit of a stretch to me for a company not without its struggles in its penetrating the market with its current cord blood storage and cord blood/bone marrow process systems. Apparently the the Res-Q platform is also being studied for potential use in the preparation of platelet rich plasma (PRP) from peripheral blood. Give them credit for continuing to think long-term and cross-platform despite struggles with their existing products.

"No more pads or tampons, period." Lifecell International is set to introduce in India next month menstrual cups as a cost-effective option to control menstrual flow in women and as a preparatory move for the company's menstrual-blood banking project called Femme, which is scheduled to begin in July


Xconomy's Luke Timmerman does a nicewriting up an informative piece on Denderon's recent AGM and the thinking around the company of what will be involved in taking the company "all the way".

Ok its another pre-clinical item (which I rarely cover) but again this one's just too cool to ignore. The New Scientists did a nice job of looking at Doris Taylor's work at University of Minnesota. Her team is looking to expand on their success creating rat hearts using stem cells. The ultimate goal is to some day create a limitless supply of transplant organs for humans. The team took stripped-down scaffolding of one rat heart and coated it with tissue produced from another rat's stem cells. They now want to repeat the procedure using hearts and other organs from human cadavers or larger animals.


The NIH received 49,015 comments in response to its draft guidelines for human stem cell research. One of those was submitted by

President Barack Obama should appoint a commission on stem cell research to help the therapy fulfill its promise to save lives and reduce medical costs, says Geron Corp. Chief Executive Officer Tom Okarma.

The California Institute for Regenerative Medicine (CIRM) received 73 preapplications for the CIRM Disease Team Awards RFA 09-01. The principal investigator for 15 of those applications is based with a for-profit entity. All of the teams proposed a wide variety of collaborators with several of the not-for-profit principal investigators citing collaborators in the for-profit sector. After review by a panel of outside experts and the CIRM in-house science team, a subset of these teams have been asked to prepare a full application, which will be due to CIRM July 16. Word on the street is that to-date just over 20 of the 73 have been given the green light to the next step.

** has posted a handy chart covering the public companies they follow in the stem cell sector showing the types of stem cells and business from which theyy hope to derive income as evidenced by the company's own statements, owned intellectual property, and/or areas of research. The one critically useful but missing column is the phase in which each of these products in.

One of my contacts, Scott Shields, Reimbursement and Health Policy Consultant at Argenta Reimbursement Advisors and owner of Blue Train Consulting Group, LLC has launched "The Reimbursement Wiki".

It promises to be a valuable online resource for reimbursement information particularly for those of us who do not work in that field full time. Below is his announcement of the site's launch:

I am announcing the public availability of my Reimbursement Wiki. I have compiled links to coding, coverage, and payment information, as well as information such as the following: - Medicare (URLs for rules, topics such as surgeries, compounding, CED, MS-DRGs, DME, inpatient list, laboratory and diagnostic testing, etc.) - Managed Care (URLs for medical/coverage policy sites at various payers, technology assessment organizations, literature on coverage decision making, etc.) - Medicaid (URLs for CPT/HCPCS code lookup by state for payment info, state fee schedules, drug product data, etc.) - Payment (URLs for Medicare payment basics, top 200 CPT/HCPCS codes, top 100 lab procedures, literature on drug pricing, etc.) There is plenty more -- basically, reimbursement and health resources I have collected in one place for reference purposes. The URL is The Reimbursement Wiki is ongoing project of mine, and I add material based on topics of current work, so not all topics are represented equally. Nevertheless, I find it an invaluable resource, and I hope you do, too. Access to the Reimbursement Wiki is free. Please register at, and email me your @ID. I will then invite you through the wiki. My email address is, or you can contact me via LinkedIn.


Organogenesis, Inc has established an annual scholarship program with Canton High School to honor a graduating senior pursuing a career in life sciences research or biomedical engineering. Kudos for them. We need more of that! Me?
I sponsored a child this week. No big deal but it reminds me to remind you...

...find a way to make a difference in your world today.

One more thing. You want to make sure you hear cell therapy-related news faster? Get on Twitter and follow me. I'm @celltherapy.

Ok. Hope you found that useful.
I'm trying to get back to my every Friday schedule here. I'll do my best. Happy weekend.

Lee Buckler, BEd, LLB
Cell Therapy Group

toll-free: 1-877-760-1966
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Skype: lee.buckler | Twitter: @celltherapy

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