StemCells, Inc. Reports Second Quarter 2013 Financial Results and Provides Business Update

NEWARK, Calif., Aug. 7, 2013 (GLOBE NEWSWIRE) -- StemCells, Inc. (STEM), a leading stem cell company developing and commercializing novel cell-based therapeutics and tools for use in stem cell-based research and drug discovery, today reported financial results for the second quarter ended June 30, 2013, and provided a business update.

"The data emerging from our clinical trials, including the two-year Pelizeaus-Merzbacher disease (PMD) data announced last week, continue to build our confidence that we are on the right track," said Martin McGlynn, President and CEO of StemCells, Inc. "Our operational priority right now is to accelerate patient enrollment, complete the ongoing Phase I/II trials and quickly initiate Phase II proof-of-concept trials. To that end, we took a number of important steps in the second quarter. First, we obtained authorization from Health Canada to expand our spinal cord injury trial into Canada and we are working diligently to initiate sites in the coming months. Second, we added the Byers Eye Institute at Stanford as a site in our dry age-related macular degeneration (AMD) trial, and are working to add others. Third, we brought Eliseo Salinas, MD, on board as Executive Vice President and Head of Research and Development, as well as other executives with deep expertise in CNS product development.

"At the same time, we executed a number of creative financing transactions to augment our capital resources and provide us with additional financial flexibility. We remain committed to the strategy of building shareholder value by generating meaningful clinical data in a cash-efficient manner."

Second Quarter and Recent Business Highlights

Second Quarter Financial Results

Total revenue during the second quarter of 2013 was $282,000, compared to $249,000 in the same period of 2012. Revenue from product sales was approximately $250,000 in the second quarter of 2013, an increase of 19% compared to the same period in 2012 due primarily to higher unit volumes.

Total operating expenses in the second quarter of 2013 were $6,425,000, which was 16% higher than the same period in 2012. This increase was driven by higher research and development expenses, which increased 28% compared to the same period in 2012 primarily due to increased costs for preclinical studies of our HuCNS-SC cells and activities to conduct and support our clinical trials. The increase in R&D expenses was partially offset by an 11% decrease in selling, general and administrative expenses compared to the same period of 2012. Loss from operations in the second quarter of 2013 was $6,221,000, a 16% increase compared to the second quarter of 2012.

Other income in the second quarter of 2013 was $353,000, compared to other income of $6,183,000 in the second quarter of 2012. This decrease in other income was primarily related to changes in the estimated fair value of our warrant liability, with increases in the warrant liability shown as an expense and decreases shown as income.

For the second quarter of 2013, net loss was $5,869,000, or $(0.15) per share, compared with a net income of $834,000, or $0.03 per share, for the second quarter of 2012. Net cash used in operating activities in the second quarter of 2013 was $3,778,000. For the six months ended June 30, 2013, net cash used in operating activities totaled $10,430,000, which was 3% lower than the comparable period in 2012.

At June 30, 2013, our cash, cash equivalents and marketable debt securities totaled $24,179,000. If we include the $3.8 million loan proceeds received from CIRM in July, our pro forma cash, cash equivalents and marketable securities at June 30, 2013, would have been $28.0 million.

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StemCells, Inc. Reports Second Quarter 2013 Financial Results and Provides Business Update

European Commission Approves VELCADE® as a Frontline Induction Therapy before Stem Cell Transplantation

BEERSE, Belgium--(BUSINESS WIRE)--

Janssen-Cilag International NV (Janssen) announced today that the European Commission (EC) has approved the use of VELCADE (bortezomib) as induction therapy (a first therapeutic option) in combination with dexamethasone (VD) or thalidomide and dexamethasone (VTD).1 This licence extension will apply to adult patients with previously-untreated multiple myeloma who are eligible for high-dose chemotherapy with haematological stem cell transplantation.

Until now, VELCADEs (bortezomib) indication has been limited to its use, in combination with melphalan and prednisone, in adult patients with multiple myeloma that are previously untreated and ineligible for stem cell transplant, and as a single agent in advanced multiple myeloma.2 Multiple myeloma, a type of blood cancer, currently affects around 60,000 people in Europe.3 This decision could mean significantly improved outcomes for many patients with this disease.

The approval by the EC was based on the analysis of data from two Phase III trials (IFM-2005-01, PETHEMA/GEM05) which demonstrated that treatment with VELCADE-based induction resulted in improvements in post-induction and post-transplant response rates and in progression-free survival (PFS); PFS and overall survival (OS) were secondary endpoints.

The trials studied the use of VELCADE-based regimens VD and VTD, compared to non-VELCADE-based regimens of vincristine plus doxorubicin and dexamethasone, or thalidomide and dexamethasone, respectively, as induction therapy prior to autologous stem cell transplant in adult patients with previously-untreated multiple myeloma.4,5

# ENDS #

Overview of the IFM-2005-01 and PETHEMA/GEM05 studies4,5

Study IFM-2005-01 evaluated VELCADE (bortezomib) in combination with dexamethasone (VD) compared to vincristine, plus doxorubicin and dexamethasone (VAD). The study included patients aged 65 or under with untreated symptomatic multiple myeloma, with measurable paraprotein in serum (over 10 g/L or urine over 0.2 g/24h).

Results demonstrated that complete response or near complete response rate was significantly improved in the VD group, with a 14.8 percent response rate compared to 6.4 percent [p = 0.004] in patients treated post induction therapy, and 35.0 percent compared to 18.4 percent [p

PFS was 36.0 months in the VD group compared to 29.7 months [p = 0.064] in the VAD group. The OS rate at the 3 year follow up was 81.4 percent in those receiving VD compared to 77.4 percent [p = 0.508] in those treated with VAD.

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European Commission Approves VELCADE® as a Frontline Induction Therapy before Stem Cell Transplantation

PRESS RELEASES

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Total views: 8708 August 2013 09:32:54 AM Writer: Jazmin S. Camero, Media Relations Service-PRIB Send Feedback

A bill establishing a government agency tasked to handle the accreditation and licensing of stem cell therapy practitioners has been filed at the House of Representatives.

Rep. Eufranio Eriguel (2nd District, La Union), author of House Bill 212, said with the proper government intervention, stem cell practice might be enhanced and made accessible to the public while also regulating the people and institutions involved in its practice.

Eriguel said the bill seeks to intensify stem cell research and therapy in the country by conducting research and studies under established standards of open scientific exchange, peer review, and public oversight.

Eriguel said the past decade has seen stem cell science reach new heights and has been allegedly proven effective in treating diseases such as strokes, autism, Parkinson's diseases, diabetes, spinal cord injuries and a host of other ailments.

"Stem cell science has been in existence for almost half a century and is already the standard of care in certain procedures such as bone marrow transplants. Diseases once considered as incurable are responding well to stem cell treatment and are restoring hope to patients who thought they had lost their lives forever," Eriguel said.

Eriguel said there should be more intensive research, including clinical trials, to further discover its uses and to develop novel techniques and more promising procedures.

"There is much to be learned from stem cell therapy, its benefits and application in the cure of some of the most devastating diseases and conditions. As of now, the full promise of stem cell treatment remains unknown," Eriguel said.

Eriguel said the benefits of stem cell treatment are a major breakthrough in the field of biotechnology, "but the cost far outweighs its benefits because it is very expensive and only a few physicians are trained to do stem cell procedures here in the Philippines."

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PRESS RELEASES

Hera Nalbandian – High School Stem Cell Research Intern – Summer 2013, Video Project 2 – Video

Hera Nalbandian - High School Stem Cell Research Intern - Summer 2013, Video Project 2
Visit our Through Their Lens page for photos and more videos from students and grantees: http://www.cirm.ca.gov/instagram-CIRMStemCellLab-feed Hera Nalbandia...

By: California Institute for Regenerative Medicine

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Hera Nalbandian - High School Stem Cell Research Intern - Summer 2013, Video Project 2 - Video

Capitol Pain Austin – Dr. Schocket – Stem Cell Treatment for Low Back Pain – Video

Capitol Pain Austin - Dr. Schocket - Stem Cell Treatment for Low Back Pain
Patient discussing her stem cell treatment for low back pain performed by Dr. Schocket at Capitol Pain Institute, your Austin Pain Management Specialists.

By: Matt Schocket

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Capitol Pain Austin - Dr. Schocket - Stem Cell Treatment for Low Back Pain - Video

Whoifwhat: Stem Cell Therapy- Knees, Hip, Back, etc.! – Video

Whoifwhat: Stem Cell Therapy- Knees, Hip, Back, etc.!
It works: Now in St. Louis, New York Phily: coming to your town soon ! Using stem cells from belly fat ( got any) platelets to mark area an injection is ...

By: whoifwhat

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Whoifwhat: Stem Cell Therapy- Knees, Hip, Back, etc.! - Video

Gold 'nanoprobes' hold the key to treating killer diseases

Aug. 7, 2013 Researchers at the University of Southampton, in collaboration with colleagues at the University of Cambridge, have developed a technique to help treat fatal diseases more effectively. Dr Sumeet Mahajan and his group at the Institute for Life Sciences at Southampton are using gold nanoprobes to identify different types of cells, so that they can use the right ones in stem cell therapies.

Stem cell therapy is in its infancy, but has the potential to change the way we treat cancer and other life-threatening diseases, by replacing damaged or diseased cells with healthy ones. One of the key limitations of stem cell therapy is identifying the right cells to use for different therapies. This fundamental problem with the treatment is being tackled by this new research.

Dr Mahajan, Senior Chemistry Lecturer in Life Science Interface, says: "Stem cells could hold the key to tackling many diseases. They develop into all the various kinds of cells needed in the body -- blood, nerves and organs -- but it is almost impossible to tell them apart during their initial development without complex techniques, even with the most advanced microscopes. Up to now, scientists have used intrusive fluorescent markers to tag molecules and track each cell, a process which can render them useless for therapeutic purposes anyway. By using a technique discovered at Southampton in the 1970s, known as Surface Enhanced Raman Spectroscopy (SERS), we have been able to look at adult stem cells on a molecular scale to distinguish one from another, meaning we can still use the cells for therapeutic purposes."

The team who discovered SERS in the 1970s found that by roughening a metal surface upon which they had placed molecules to be examined, they could increase the signal by which they could detect these molecules, by a million times. This allowed them to detect molecules in far smaller quantities than ever before. SERS has been used in many different capacities around the world and across industries, but this new research marks the first time it has been used in the field of cell therapeutics. Dr Mahajan's research could mean that stem cell and other cell-based therapies could be advanced much further than the current most common uses, such as bone marrow transplants.

Dr Mahajan comments: "Scientists studying neurodegenerative diseases such as Parkinson's disease believe replenishing a patient's depleted dopamine-generating cells, may be an effective treatment. However, in order to avoid fatal complications, we must be sure we are using the right type of replacement cells, which the work we are doing at Southampton is enabling us to do. In addition, the technique can also allow us to see if drugs are working effectively in cells, and can also be used to diagnose diseases as well as treat them."

The results of Dr Mahajan's work, funded by the Engineering and Physical Sciences Research Council (EPSRC), have been published in the influential journal Nano Letters. He is collaborating with major pharmaceutical companies to further develop more effective drugs using this technique.

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Gold 'nanoprobes' hold the key to treating killer diseases

Foreign doctors need permit for stem cell therapy

MANILA - Foreign doctors are now required to secure a permit to perform stem cell therapy in the country or face criminal liability.

The Professional Regulation Commission (PRC)s Board of Medicine (BOM) made the announcement yesterday, explaining that the requirement is part of government efforts to regulate the practice of stem cell therapy in the country to ensure the safety of patients.

In a statement, the BOM said foreign physicians who intend to practice stem cell therapy here must obtain special temporary permit from the PRC to avoid being charged with medical malpractice.

Even local doctors who have aided foreign physicians illegal practice of stem cell therapy shall be also held criminally liable, the BOM added.

To secure the special temporary permit, a foreign doctor must submit proof of education and actual practice in the field of stem cell therapy and current license authenticated by the Philippine embassy and the embassy in the country of origin.

The board said physicians should have acquired the necessary education, supervised training and extensive clinical experience prior to performing the treatment. It noted that the argument that stem cell therapy falls under the general practice of medicine since it only involves injection of stem cell solution is erroneous.

As professionals, physicians should be able to conduct self-assessment and self-evaluation regarding what they can and what they should not do, they added.

The BOM also noted that stem cell therapy should be practiced only in hospitals and clinics licensed by the Department of Heath for assurance that these medical facilities have the necessary manpower and equipment to prevent risks and hazards to patients.

The board also warned patients desiring to undergo stem cell therapy abroad to first verify the status of clinics and hospitals as well as practitioners from regulatory authorities.

Earlier, the Food and Drug Administration and the Philippine Medical Association (PMA) reported receiving numerous complaints of foreign doctors performing stem cell therapy in hotels and other non-medical facilities. The PMA said foreign doctors injected patients with animal-based stem cells at P1 million per shot, but these foreigners are not even licensed to practice medicine in the country.

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Foreign doctors need permit for stem cell therapy