Tag Archives: stem cells

StemCells, Inc. Receives FDA Authorization to Expand Spinal Cord Injury Trial to the United States

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Last week, StemCells, Inc. received FDA authorization to expand its spinal cord injury trial to the United States.

The arrival of this Phase 1/2 study, which is currently ongoing in Switzerland and Canada and involves patients with chronic spinal cord injury, will significantly ease the travel burden for North American patients. Early results from the trial have been promising, showing two patients had gains in sensory function, first seen at 6 months and persisting 12 months after transplantation. No safety issues have been seen.

To date, seven patients from Germany, Norway, Italy, Israel, Canada and the United States have been transplanted at Balgrist University Hospital in Zurich. StemCells is now focused on opening up trial sites in the United States. Information about the clinical trial is available at the ClinicalTrials.gov website of the National Institutes of Health at http://www.clinicaltrials.gov/ct2/show/NCT01321333?lead=StemCells+Inc.&rank=4.

Russo Partners secured coverage of the announcement across industry publications, including Scrip, as well as regional publications, including the San Francisco Chronicle and the San Francisco Business Times. Read more about this announcement in the San Francisco Chronicle article below.

San Francisco Chronicle    

StemCells Presents First Data to Demonstrate Gains in Sensory Function of Chronic Spinal Cord Injury Patients Treated with Stem Cells

This week, StemCells presented the first data demonstrating gains in sensory function of chronic spinal cord injury patients treated with stem cells. These improvements were seen in two of the three patients in the first cohort of the Phase I/II study after six months of treatment, with the third patient remaining stable. These patients had the most severe injury, leaving them initially with no neurological function below the level of injury.

These gains in sensory function were measured by electrical impulse transmission across the site of injury during different tests of sensory perception, including a touch test, pin prick test and heat perception test. StemCells is focused on enrolling the next cohort of patients that have incomplete spinal cord injury.

The data were presented by Armin Curt, M.D., principal investigator for the clinical trial, at the 51st Annual Scientific Meeting of the International Spinal Cord Society in London.

StemCells is also evaluating its human neural stem cells in clinical trials of other neurological disorders, including Pelizaeus-Merzbacher disease (PMD), a fatal myelination disorder, and dry age-related macular degeneration (AMD). In addition, the company announced this week that it was awarded $20 million in funding from the California Institute for Regenerative Medicine (CIRM) to advance its preclinical Alzheimer’s program through IND-enabling activities.

Russo Partners worked to secure coverage of the data announcement across UK-based publications including The Telegraph; top-tier outlets including CNN and CBSNews.com; newswires including Reuters; science-focused publications including New Scientist; and regional publications including the San Francisco Business Times.

Read more about the results and a patient involved in the study in the articles below from CNN and The Telegraph:

CNN

The Telegraph

StemCells Awarded $20 Million from the California Institute for Regenerative Medicine

Last week, StemCells was awarded $20 million from the California Institute for Regenerative Medicine (CIRM) to fund preclinical development of the company’s human neural stem cells as a potential treatment for cervical spinal cord injury. In sum, the agency awarded over $150 million to promising stem cell therapeutics, with StemCells being the only company to receive an award.

Disease advocates speak on July 26, 2012, in Burlingame, Calif., where the California Institute for Regenerative Medicine decided whether to approve more than $100 million in funding. Photo: Liz Hafalia, The Chronicle / SF

Funds from this award will be applied over a four-year period, with the goal of filing an investigational new drug (IND) application in that time. Currently, StemCells is evaluating the same neural stem cells in a Phase 1/2 clinical trial in chronic spinal cord injury, a Phase 1 clinical trial in a rare myelination disorder, Pelizaeus-Merzbacher disease (PMD), which holds applications for multiple sclerosis and cerebral palsy, as well as a Phase 1 trial in dry age-related macular degeneration (AMD).

A decision on an Alzheimer’s disease application submitted by the company was deferred to CIRM’s Grants Working Group for further consideration, and is expected to be reviewed at the next meeting of its governing board currently scheduled for September 6th.

Read more about the StemCells’ award as well as other projects funded by CIRM in the article below from the San Francisco Chronicle.

San Francisco Chronicle

StemCells, Inc., Announces Its Human Neural Stem Cells Restore Memory in Mouse Models of Alzheimer’s Disease

This week StemCells, Inc. (Nasdaq: STEM), announced that its human neural stem cells restored memory in two mouse models of Alzheimer’s disease, which has never been shown before. Following the announcement, the stock jumped and ended the day up more than 100%.

This data was presented at a poster presentation at the Alzheimer’s Association International Conference 2012 in Vancouver, Canada. Importantly, these results didn’t involve reductions in beta amyloid or tau, the current targets of most therapeutics in development, providing a potentially novel approach to treating Alzheimer’s. The study was funded in part by the California Institute of Regenerative Medicine.

StemCells plans to continue clinical investigation of its human neural stem cells in humans with Alzheimer’s disease. The company is also evaluating its neural stem cell therapeutics in a Phase 1/2 clinical trial in chronic spinal cord injury as well as a Phase 1 trial in Pelizaeus-Merzbacher disease, a fatal myelination disorder related to multiple sclerosis and cerebral palsy.

Russo Partners worked to secure coverage of the announcement in business-focused trade publications, including Scrip, science-focused publications, including Technology Review, as well as regional publications, including The Orange County Register.

Cellular Dynamics International and Life Technologies to Commercialize Novel Stem Cell Reagents to Improve Consistency and Reproducibility of Human iPS Cell and Somatic Cell Output

ImageImageLast week Cellular Dynamics International (CDI) and Life Technologies announced a partnership to commercialize a set of three novel products that are optimized to consistently develop and grow human induced pluripotent stem (iPS) cells for both research and bioproduction purposes. This partnership combines CDI’s leadership in human iPS cell development and manufacturing as well as Life Technologies’ expertise in the commercialization of stem cell research tools

By creating a consistent, defined reagent system, these products overcome the limitations associated with commonly-used stem cell culture products, such as bovine serum albumin (BSA) and lipids, by reducing the variability in results inherent with other reagents. Generating consistent performance supports the advancement of translational stem cell research and drug discovery efforts. These products also further research efforts by enabling large-scale production of human iPS cells to be conducted.

Recent studies published in Nature Methods and PLoS One validated the effectiveness of CDI’s products, and presentations by customers of studies using the company’s human iPS cells at the Society of Toxicology (SOT) Annual Meeting demonstrated the superiority of CDI’s products compared to other cell models.

In addition, CDI was named last year’s overall Gold winner in The Wall Street Journal Technology Innovation Awards based on the ability of its iPS cell manufacturing technology to facilitate understanding of human biology, improve the drug discovery process and develop cell-based therapies to treat human diseases.

Read more about The Wall Street Journal Technology Innovation Awards in the following article:

The Wall Street Journal

First Study Demonstrating Safety of Embryonic Stem Cell (ESC)-Derived Cells in Humans Reported by Advanced Cell Technology, Results Published in The Lancet

For the first time, a study by Advanced Cell Technology (“ACT”; OTCBB: ACTC)

Dr. Steven Schwartz, a retina specialist at the University of California, Los Angeles, conducted the trial with two patients. (Monica Almeida/The New York Times)

demonstrated the safety of the transplantation of human embryonic stem cells (hESC) derived from retinal pigment epithelium (RPE) into patients. Additionally, the injected cells survived and continued to persist during the study period.  Results were reported for two patients, the first in each of the Phase 1/2 clinical trials, and were published in The Lancet, representing an important milestone for the field of embryonic stem cell research.

A patient said her vision improved in a meaningful way after the treatment, which used embryonic stem cells. (Monica Almeida/The New York Times)

In the study, patients with Stargardt’s macular dystrophy (SMD) and dry age-related macular degeneration (dry AMD) were treated with ACT’s embryonic stem cell (ESC)-derived cells. Both patients were legally blind, and both had measurable improvements in their vision that persisted for more than four months. No treatments currently exist for either indication.

Through extensive media outreach coordinated by Russo Partners, coverage of this announcement was secured across all levels of print and broadcast media, including top tier, national, international, newswire, trade and regional outlets.

Below are links to samples of media coverage of the announcement:

CBS

CNN

NPR

New York Times

USA Today

BBC News

AFP

Nature

The Telegraph

TIME

Bloomberg

Associated Press

Reuters

Los Angeles Times

The Scientist

WebMD

MedPage Today

FierceBiotech

Advanced Cell Technology, Leader in the Human Embryonic Stem Cell Space

Two weeks ago our client, Advanced Cell Technology (ACT), strengthened their position as a leader in the field of embryonic stem cell research when Geron, citing economic conditions, announced that it would shift its focus to developing the company’s later-stage oncology therapeutics and no longer pursue its human embryonic stem cell (hESC) programs. Geron and ACT were the first two companies to initiate clinical trials in the United States using hESCs.

ACT recently initiated the first-ever European clinical trial using stem cells, specifically using retinal pigment epithelium (RPE) derived from hESCs to treat Stargardt’s Macular Dystrophy (SMD).  Additionally, the company is currently conducting two Phase 1/2 clinical trials in the United States using hESC-derived RPE cells to treat SMD and dry age-related macular degeneration, respectively.

When Russo Partners received the news that Monday morning, we immediately sprang into action, knowing this was a key opportunity for ACT to control the company’s messages surrounding Geron’s announcement when the public would want to know what implications this industry shift would have on ACT’s clinical programs. We proactively reached out to the media, securing interviews with multiple top-tier outlets, as well as financial wires, scientific magazines and trade publications.

By speaking with the media, ACT was able to communicate core messages surrounding the announcement, including emphasizing the strengths of its ongoing hESC programs and the company’s future development plans. In addition, the company was able to provide insight into Geron’s decision as well as information about the stem cell space in general.

Below are links to sample coverage we secured for ACT following Geron’s news:

New York Times

AFP

Bloomberg

The Scientist

January Wrap-Up: Biotech, Medtech Companies Off to Fast Start

January 2009 has come and gone. A wrap-up report of Russo Partners’ activities shows that biotech and medtech companies kicked off the year with a fast start.  Here are some of the January highlights:

S*BIO, Singapore’s most advanced biotech company, celebrated success on the business-development front with the announcement of two significant deals. The agreements, with Onyx Pharmaceuticals and Tragara Pharmaceuticals, involved different types of kinase inhibitors in early stages of development. Russo Partners worked closely with the communications teams at Onyx and Tragara to maximize publicity for the respective announcements. With the successful navigation of the media landscapes in the U.S. and Singapore, Russo Partners generated significant media coverage for all companies involved.  S*BIO’s executive team was inundated by calls and e-mails from other possible partners worldwide.

Anadys Pharmaceuticals’ stock price soared by 114% following the announcement of viral load reduction data from an early study of ANA598 in chronic Hepatitis C patients. By working with the data and select media under embargo prior to the distribution of a news release and the company’s hosting of a conference call with investors, Russo Partners lifted the curtain on the data in a big way. This PR approach produced a tremedous return in the form of in-depth media coverage that contained the key messages developed for the announcement. The PR results were far greater than any others of comparable Phase I trials.

Many of Russo Partners’ clients spent the second week of the month navigating the hotels and restaurants in San Francisco’s Union Square for JPMorgan Healthcare Conference activities. Russo Partners scheduled and coordinated close to 100 meetings for clients with VCs, investment bankers, fund managers and journalists. For new clients CorNova and Molecular Insight Pharmaceuticals, the conference was their first agency outing and involved high-powered meetings with members of the investment and media communities.

Other conference participants with Russo Partners included BIOCOM, San Diego’s life science industry organization, and the Burnham Institute for Medical Research. Media interviews conducted at the agency’s base camp in the Hotel Nikko along with TV interviews taped at a nearby studio added to the lively mix of activities.

Corthera, which is developing the hormone relaxin as a treatment for acute heart failure, took the podium at the JPMorgan Healthcare Conference and presented an update on the Phase II/III study.  In late-2008, Russo Partners unveiled an interim analysis of the Phase II data to journalists at the American Heart Association’s Scientific Sessions — a story that Cardiovascular Business reported as one of the most significant developments announced at the conference thanks to Russo Partners’ aggressive pursuit of media coverage.

Radi Medical Systems, which St. Jude Medical acquired in December, enjoyed broad media coverage of the New England Journal of Medicine‘s publication of the FAME one-year follow-up data. See the January 20 blog entry to read more about this successful PR campaign.

In typical Russo Partners fashion, the agency continued its handling of the game-changing events in healthcare.  This time the event was the FDA’s clearance for Geron to initiate the world’s first clinical trial of a human embryonic stem cell therapy. Take a look at the January 28 blog entry.

Russo Partners looks forward to maintaining the fast PR pace in February with major client and industry events around the corner.