Category Archives: Companies

Stem Cell Therapy For Treating Pattern Baldness

RepliCel Life Sciences is developing an autologous cell-based procedure for the treatment of androgenetic alopecia (pattern baldness) and general hair loss in men and women. The procedure has the potential to become the first minimally invasive solution for hair loss. Please see website for more info.

Survey: Americans Favor Expanded Cord Blood Stem Cell Research

SAN BRUNO, Calif., July 10, 2014 /PRNewswire/ — Far from being sharply divided, the American people are in broad support of more stem cell research, according to the results of an online survey released today by Cord Blood Registry® (CBR®) to coincide with National Cord Blood Awareness Month.

The poll included responses from 1,130 individuals to reveal: their belief in the need for continued research to rapidly bring stem cell therapies to the clinic; their level of awareness and understanding of umbilical cord blood as a source of stem cells; and their familiarity with the use of cord blood stem cells in established and experimental therapies.

The survey found that nearly 9 of 10 Americans either agree or strongly agree that further research should be conducted to investigate the potential of stem cells to stimulate the body’s own repair mechanisms to heal tissues or organs. In addition, the survey results indicate that more than 75% of Americans are aware of stem cell research to develop more effective treatments for conditions and diseases such as Alzheimer’s, brain injury, and cancer. The survey also shows that 8 in 10 Americans believe in the medical benefits of stem cell research and would like to learn more about therapeutic strategies which augment, repair, replace or regenerate organs and tissues.

BioCision Launches New Program to Support Stem Cell Training and Research

Program Provides Academic Centers in the U.S. and EU Cutting Edge Cryopreservation Tools

LARKSPUR, Calif. – Dec. 10, 2012 – As part of its ongoing effort to support the scientific community, BioCision LLC, a leader in the advanced temperature management of biomedical samples, announced the availability of free “Cool Stem Kits” to academic stem cell research programs in the U.S. and Europe. Stem cells are a promising area of research for an array of treatments and cures, but cultures require frequent handling and many labs lack the equipment needed to ensure the reproducibility required for clinical research.

“Nearly everyone inside and outside of the scientific community agrees that stem cell research represents one of the most exciting and promising frontiers for treating a myriad of diseases and conditions,” said Rolf Ehrhardt, CEO, BioCision. “As an innovator of sample handing, cooling and freezing products, we felt a program like this would be of great service to the stem cell community.”

Each “Cool Stem Kit” includes recently launch, second generation cooling products:

~ CoolBox XT™ Cell Freezing Workstation for ice-free, power-free sample cooling while preparing stem cells for cryopreservation or assays
~ CoolCell® LX Freezing Containers for alcohol-free cell cryopreservation to provide highly reproducible controlled-rate freezing
~ CoolSink™ XT module to eliminate temperature variability in the incubator or at 4° C
~ TruCool™ leak proof and barcoded cryovials
~ TruCool™ ergonomic microcentrifuge tubes
~ CryoCeps™ cryovials grippers

“The area of stem cell research is full of unknowns, which is part of what motivates scientists,” said Rick I. Cohen, Ph.D., Director of the Stem Cell Training Course at Rutgers University. “When we discovered BioCision’s cryopreservation products, we were eager to incorporate them into our research protocol to further standardize our research methods. The new system has not only increased overall efficiency, it has improved cell viability post thaw.”

To request a kit, please contact CoolStem@biocision.com. For more information about BioCision and the company’s full line of sample standardization products, please visit www.biocision.com.

About BioCision
BioCision’s mission is to standardize pre-analytical sample handling. BioCision develops novel products that eliminate variability in common, often-overlooked, laboratory procedures. The products are marketed globally and are widely used by the leading institutions in the biotech, pharmaceutical, clinical, diagnostic, academic and government scientific community. BioCision’s products include CoolRack®, CoolSink™ and ThermalTray™ laboratory tube and plate temperature standardizing modules, CoolBox™ ice-free benchtop coolers, CoolCell® alcohol-free cell freezing containers and TruCool™ accessories and consumables.

NeoStem’s CEO, Dr. Robin L. Smith, Letter to Shareholders

NEW YORK , Jan. 3, 2012 /PRNewswire/ —

Dear NeoStem Shareholders,

We would like to take a moment to both look back at 2011 – a transformative year for NeoStem (NYSE Amex: NBS) – and to look ahead to near term catalysts that we expect to move the company forward in 2012 and beyond.

We have closed two acquisitions – Progenitor Cell Therapy, LLC (“PCT”) and Amorcyte, LLC (“Amorcyte”).

We believe our therapeutic product development team is very close to accomplishing its aggressive goal of getting a first patient enrolled in our AMR-001 Phase 2 clinical trial for the treatment of AMI with the clinical sites beginning to open.  This brings us closer to achieving our goal of enrollment of the targeted 160 patients in the study over the next year or so with first data follow-up six months after the last patient is enrolled (roughly mid-2013).

Our cell therapy manufacturing business is growing and client satisfaction confirms our belief and excitement that we have unique skills and people (expertise, quality and work ethic) to serve as a platform to be a global leader in the cell therapy space.

We raised $16.5 million in gross proceeds in 2011 for working capital, including research and development of our cell therapeutic candidates.

We received awards of over $1.7 million in Department of Defense funding for development of our VSELTM Technology to treat osteoporosis and $245,176 from the National Institutes of Health (NIH) with Excell Therapeutics to progress our T regulatory program in Lupus.

We co-hosted a spectacular international conference in partnership with the Vatican’s Pontifical Council for Culture on Adult Stem Cells: Science and the Future of Man and Culture, moving forward the public discussion of adult stem cells and adult stem cell research.

Our cord blood banking enrollment more than doubled over the previous year.

We have been marketing our ownership in Suzhou Erye Pharmaceutical Co. Ltd. subsidiary for possible sale.

We have positioned our intellectual property portfolio to expand beyond the current indications and give us a strong position in the cell therapy arena.

We continue to make great headway in integrating IT systems, legal, finance, and marketing for our multiple entities to achieve cost savings and maximize efficiencies.

NeoStem gained a significant pharmaceutical partnership with Becton Dickinson through our co-ownership of Athelos, Inc. (80% NeoStem, 20% BD). We are actively pursuing additional strategic relationships with major pharmaceutical and biotechnology companies in 2012.

We look forward to keeping you updated and encourage your questions via the contact information below. I also encourage you to learn more by visiting our company websites, www.neostem.com, www.amorcyte.com, and www.progenitorcelltherapy.com, our social media outlets, and our company blog at thechairmansblog.com/robin-l-smith. Thank you for your continued support of NeoStem and our ongoing transformation.

Sincerely,

Dr. Robin L. Smith
Chairman and CEO

About NeoStem, Inc.
NeoStem, Inc. (“NeoStem”) is a leader in the development and manufacture of cell 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. That manufacturing base is one of the few cGMP facilities available for contracting in the burgeoning cell therapy industry, and it is the combination of PCT’s core expertise in manufacturing and NeoStem’s extensive research capabilities that positions the company as a leader in cell therapy development. Amorcyte, Inc., also a NeoStem company, is developing a cell therapy for the treatment of cardiovascular disease. Amorcyte’s lead compound, AMR-001, represents NeoStem’s most clinically advanced therapeutic, poised to commence enrollment of patients in a Phase 2 trial for the preservation of heart function after a heart attack.  Athelos Corporation, also a NeoStem company, is developing a T-cell therapy for a range of autoimmune conditions with our partner Becton-Dickinson.  NeoStem’s pre-clinical assets include its VSEL™ 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.

Open Letter to Shareholders from Pluristem Therapeutics CEO Zami Aberman

Dear Shareholders,

As we close in on the end of the calendar year, it is important to look back upon all that we at Pluristem have accomplished over the last 12 months, but it is even more crucial to focus the majority of our energies on the challenges and opportunities awaiting Pluristem Therapeutics in 2012 and beyond.

Here is a recap of our recent achievements, which have put the company on course for a very successful future.

Phase I CLI Study Data

In early November we announced positive 12-month data from our Phase I open-label, dose-escalation clinical trials, conducted under protocols approved by the Food & Drug Administration (FDA) in the U.S. and the Paul-Ehrlich-Institute (PEI) in Germany. PLX-PAD cells met all the clinical studies’ protocol endpoints, demonstrating a safe immunologic profile at all dosage levels and suggesting that PLX-PAD is potentially effective in treating patients suffering from Critical Limb Ischemia (CLI). The results demonstrated no significant safety issues and proved that PLX-PAD cells can be safely given IM to patients without matching, even when the patients are dosed twice from the same placental source. These results, together with the great effort we invest in our manufacturing and operating capabilities, will provide us significant advantages when marketing PLX in the future.

United Therapeutics Update

As you know, during the recently-closed first quarter of our fiscal year we recognized our first revenues from our exclusive out-license agreement with United Therapeutics Corporation (NasdaqGS: UTHR) for the use of Pluristem’s PLacental eXpanded (PLX) cells to develop and commercialize a cell-based product for the treatment of Pulmonary Hypertension (PH). We are pleased with the collaboration to-date and are working closely with United Therapeutics on ensuring that we hit the upcoming key milestones in our quest to develop and receive regulatory approval for a product treating PH.

Manufacturing Facility Construction

One of the cornerstones of Pluristem’s strategy is to manufacture our PLacental eXpanded (PLX) based products and then enter into strategic partnerships with large pharmaceutical companies around the world for marketing and distribution, as we had done with United Therapeutics.

To that end, we reported in October that we had signed a deal with Biopharmax Group Ltd., a company specializing in the design and construction of biotechnological and pharmaceutical facilities, to handle the build-out of a new cGMP manufacturing facility in Israel that will meet regulatory authorities’ requirements. We expect the facility to be completed by the end of the 2012 calendar year. This facility will allow us to significantly scale up our manufacturing capacity and will enable us to produce PLX cells for the treatment of over 150,000 patients annually, meeting the expected near-term demand for our products.

Financial Status

In our recently released 10-Q quarterly report, we were pleased to record our first revenues. These revenues are the result of the licensing deal with United Therapeutics and they are a meaningful validation of our platform technology. We have a strong balance sheet with over $45 million in cash and cash equivalent and short term bank deposits. We have successfully maintained a controlled and modest burn rate, despite making significant progress. Although we expect our burn rate to increase in the coming year, resulting from initiation of advanced clinical trials, no significant increase in manufacturing expenses is foreseen, due to our efficient production process. This advantage will become more and more noticeable as we progress with our clinical trials.

Our Potential Impact

Before I close, I wanted to outline for you why our work at Pluristem is so important. Of course, we work hard on increasing shareholder value, but there is a different kind of impact to be felt if we are able to successfully develop our product candidates. The first therapy that Pluristem is focusing on is for CLI, where in the United States (U.S.) alone, patients undergo more than 160,000 major limb amputations per year. Current data suggest that approximately 20% of CLI patients will die within the first 6 to12 months after disease onset and many others will require amputation within six months of diagnosis. Approximately half of all diabetes patients diagnosed with CLI will undergo a major amputation following diagnosis, and many will require a second amputation within 3 to 5 years.

The overall U.S. hospitalization and amputation rate associated with CLI has increased since 1985, suggesting a growing incidence of CLI and a substantial unmet medical need to improve outcomes for these patients beyond conventional treatments.

All this adds up to a total annual cost of between $10 billion and $20 billion for treating U.S. CLI patients. Economic modeling indicates that even a 25% reduction in amputations has the potential to create annual savings for the U.S. health care system of up to $3 billion. This is just a conservative model and for one therapy only.

In conclusion, Pluristem has an opportunity to impact society, and it is important for our shareholders to understand that through the development of our CLI product, we are working towards fulfilling our mission of bringing significant changes to the lives of patients around the world.

We thank you for your continued support, and we look forward to providing you with more exciting news in the coming months on both the business and the technology aspects of Pluristem.

Thank you very much,

Zami Aberman
Chairman and CEO

About Pluristem Therapeutics

Pluristem Therapeutics Inc. (NasdaqCM: PSTI; TASE: PLTR) is a leading developer of standardized cell therapy products for the treatment of life threatening diseases. The company’s patented PLX (PLacentaleXpanded) cells drug delivery platform releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory diseases. PLX cells are grown using the company’s proprietary 3D micro-environmental technology and are an off-the-shelf product that requires no tissue matching prior to administration. Data from two phase I studies indicate that Pluristem’s first PLX product candidate, PLX-PAD, is safe and potentially effective for the treatment of end stage peripheral artery disease. Pluristem’s pre-clinical animal models have demonstrated PLX cells are also potentially effective in nerve pain and muscle damage, when administered locally, and in inflammatory bowel disease, MS and stroke, when administered systemically.

Pluristem has a strong patent portfolio, GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team.

For more information visit www.pluristem.com, or follow us on Twitter @Pluristem, the contents of which are not part of this press release.

3 Contenders To Be The First Profitable Stem Cell Company

By Ryan Pollack, SeekingAlpha.com

Every day is a day closer to a disease being treated, or even cured, by a stem cell therapy. The medical field is in a transition with clinical trials that are ongoing using adult, embryonic, and other forms of stem cells derived and differentiated using various laboratory techniques. These three companies have the potential to be the first self-sustaining, profitable regenerative medical companies.

See complete article at SeekingAlpha.com regarding Advanced Cell Technology (ACTC), Geron (GERN), and International Stem Cell Corporation (ISCO)

The Promising Cells Presented by International Stem Cell Corporation

Ken Aldrich of International Stem Cell Corporation (ISCO.OB) speaks on the latest research involving stem cell technology utilizing unfertilized eggs, as a basis for cell generation with a goal toward organ transplants which are immune to rejection by the body.

See complete article at the International Stem Cell Corporation blog

FDA Approves Fibrocell’s Stem Cell Wrinkle Smoother

Fibrocell Science Inc. (FCSC) won U.S. approval for an injectible wrinkle treatment that uses a patient’s own stem cells to restore elasticity to the skin. The Food and Drug Administration cleared azficel-T, the company said today in a statement. Fibrocell plans to sell the drug under the name LaViv. Shannon Pettypiece reports on Bloomberg Television’s “Fast Forward.” (Source: Bloomberg)

See Fibrocell Science Website for more information.

Stem cells from body fat promising

A San Diego-based company is breaking new ground in the field of regenerative medicine with a system that uses patients’ own body fat to generate stem cells and repair tissue and organs. Ben Gruber reports.

Neuralstem Announces First Patient Treated in ALS Stem Cell Trial

ROCKVILLE, Md., Jan. 21 /PRNewswire-FirstCall/ — Neuralstem, Inc. (NYSE Amex: CUR) announced that the first ALS patient was treated with its spinal cord stem cells yesterday at the Emory ALS Center at Emory University, in Atlanta, GA.  A total of up to 18 patients is planned to be treated in this first U.S. clinical trial to evaluate human neural stem cells for the treatment of ALS (Amyotrophic Lateral Sclerosis, or Lou Gehrig’s disease).  ALS affects roughly 30,000 people in the U.S., with about 5,600 new diagnoses per year, according to the ALS Association.

“The treatment of the first patient with our spinal cord stem cells represents a significant milestone for the Company,” said Neuralstem President and CEO, Richard Garr.

Click here for complete article.