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Home • Product Candidates • Our Pipeline
Our Pipeline

We have established a diverse portfolio of proprietary product development programs, that includes both biologics and pharmaceuticals. Our most advanced programs are in the area of regenerative medicine, applying a patented and proprietary stem cell product, MultiStem, that we believe has potential for treating multiple disease conditions, including in the cardiovascular, neurological, inflammatory and immune disease areas. Over the past several years, we have advanced several MultiStem programs to clinical development stage, and have also established preclinical programs through our internal efforts and broad network of collaborations, where we have worked with investigators at over 30 institutions across the United States and Europe. We believe that our pipeline can be broadened over time, driven by our technologies, capabilities and approach and that MultiStem has significant therapeutic potential across a broad range of clinical indications.

In addition to our programs in regenerative medicine, we are also focused on applying our other technologies and capabilities to develop new pharmaceutical based treatments for obesity, related metabolic conditions, and certain neurological disorders. By maintaining a lean infrastructure, and working collaboratively with others, including leading academic researchers, clinical centers, contract research organizations, and contract manufacturing organizations, we are able to efficiently and cost effectively advance multiple programs in parallel.
Development Status of Key Programs

 

MultiStem programs. We are evaluating the potential application of MultiStem for a range of indications across the inflammatory and immune, neurological, and cardiovascular disease areas. To date we have advanced four MultiStem programs to mid-stage clinical development.

Working with Pfizer, we have initiated a double blind, placebo controlled Phase 2 clinical study involving administration of MultiStem to individuals suffering from Inflammatory Bowel Disease (IBD). This study will be conducted at clinical sites in the U.S. and Europe, and will evaluate administration of MultiStem to patients suffering from Ulcerative Colitis, which is the most common form of Inflammatory Bowel Disease. IBD affects approximately 2.4 million individuals in the U.S., Europe and Japan, and more than 1.5 million people suffer from Ulcerative Colitis.

We have also established other clinical and preclinical programs in the inflammatory and immune area.  In September of 2010, we announced that we had received Orphan Drug designation by the FDA for administration of MultiStem to patients receiving a bone marrow, hematopoietic stem cell, or peripheral blood stem cell transplant that are at risk for Graft versus Host Disease (GVHD). In November, 2011, we announced that we had completed enrollment for an ongoing Phase I clinical trial designed to evaluate safety and other clinical parameters.

We and our collaborators have published numerous studies that illustrate how MultiStem can have an impact on treating various types of neurological injury.  We are currently conducting a Phase 2 clinical trial involving administration of MultiStem to patients that have recently suffered an ischemic stroke.  This trial is being conducted at leading stroke centers across the United States, and will involve approximately 140 patients.  Ischemic stroke affects an estimated 2 million individuals in the U.S., Europe and Japan each year, and represents a leading cause of death and disability.  We estimate that the market potential for a safe and effective therapy for ischemic stroke exceeds $15 billion annually. 

In the third quarter of 2010, we and our collaborators announced data from a Phase I clinical trial involving administration of MultiStem to patients that have suffered a heart attack. The results of this study demonstrated a consistent safety profile, as well as encouraging signs of improvement in several measures of cardiovascular function in patients that had received MultiStem treatment after experiencing severely compromised heart function following a myocardial infarction.

In addition to our current clinical stage programs, working with independent collaborators, we are conducting preclinical studies in a range of other indications. We are interested in evaluating the potential application of MultiStem toward treating conditions involving ischemic injury, neurological injury or disease, conditions involving inflammation or immune system function, and other indications.

Further information will be provided as appropriate when results are obtained from ongoing clinical studies, or when authorization is received to initiate new clinical trials, or at other important milestones.  Additional information about these and other trials is available at www.clinicaltrials.gov.

5HT2c Agonists for obesity and other indications.  In addition to our MultiStem programs, we are developing pharmaceuticals for the treatment of obesity and certain neurological conditions. In the obesity and metabolic area, we are developing compounds that selectively stimulate the 5HT2c serotonin receptor in the brain, which is known to play an important role in regulating appetite. These compounds, known as 5HT2c agonists, are designed to reduce appetite and food intake, in order to achieve substantial weight loss over time. Recent clinical data published by other groups also suggests that 5HT2c agonists can provide benefits in a diabetic population, such as by reducing HbA1c and fasting blood glucose levels.