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Brain Researchers Gather in San Diego for Annual Conference

San Diego recently hosted the 2013 annual meeting of the American Academy of Neurology, attracting thousands of brain researchers from around the country. Several San Diego companies made key announcements during the conference, including San Diego’s International Stem Cell Corp.

The company is developing stem cell therapies to treat brain disorders like Parkinson’s disease, and reported positive results in grafting stem cells into monkey brains. It’s the first real step toward bringing stem cell therapy for Parkinson’s disease to clinical trials, said the study’s co-author Evan Snyder, director of stem cells and regenerative biology program at the Sanford Burnham Medical Research Institute.

The company artificially induced Parkinson’s disease in African green monkeys, which depleted certain areas of the brain. The ISCC then planted a large dose of its stem cells in the monkeys’ brains, and studied them to see if there were any behavioral modifications.

The researchers found no adverse side effects, and no development of tumors, which is a big concern of such stem cell grafts as they could potentially grow unchecked wherever planted. And, further, the cells did adapt and function.

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The company was founded in 2006, with a corporate office in Carlsbad and a laboratory in Oceanside. It works with in vitro fertilization clinics to collect unfertilized eggs that women have donated to science, and reverts them back into stem cells.

“They behave in a similar manner to embryonic stem cells, but bypass any of the ethical dilemmas,” said Simon Craw, the company’s executive vice president. “We’re the only company who is using this technology. We’ve patented it as much as we can, and are now building a therapeutic line of products based on this stem cell platform.”

The publicly traded company is listed on the OTC Market, with shares around 30 cents. It employs about 50, and its market capitalization is about $26.2 million.

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Antibiotic-resistant bacterial infections have shot up over the past decade, with the incidence of some strains increasing tenfold, according to a report last month from the Centers for Disease Control.

Because of this, San Diego’s Trius Therapeutics Inc. was granted a fast track status in January for its drug that targets these “superbugs” — and the company has now announced positive results from a key study. The new antibiotic has shown in a second phase III clinical trial that it is both safe and effective.

Trius said that in the second half of 2013 it plans to file for U.S. and European regulatory approval for its new antibiotic tedizolid phosphate, which treats Methicillin-resistant Staphylococcus Aureus (MRSA).

The powerful antibiotic requires a tenth of the dosage needed in Zyvox, which is a blockbuster next-generation antibiotic from Pfizer Inc. that also treats MRSA infections. Zyvox has shown impressive sales figures since its U.S. Food and Drug Administration approval in 2000 — it earned, for example, $1.3 billion in revenue in 2011.

“For years, large pharmaceutical companies have been trying to come up with a better Zyvox,” Trius CEO Jeff Stein said. “Our results confirm this is a fast acting drug. In the era of rising hospital costs, this will help doctors discharge patients from the hospital faster.”

The clinical trials for tedizolid phosphate showed fewer adverse reactions than patients taking Zyvox, and it was just as effective.

The company could, however, face some competition from a generic version of Zyvox, which will likely come out in 2015 when the Pfizer patent for the antibiotic expires.

Since its launch in 2007, Trius has accumulated about $60 million in government contract revenue to fund its early stage programs. It raised about $34 million in January in a secondary public offering. The publicly traded company has a $332.6 million market capitalization, trading roughly around $7 a share.

Stein said the company expects to grow dramatically over the next year. He said that tedizolid phosphate, the company’s flagship drug, is on a path to be approved potentially by the end of 2014 in the U.S. and early 2015 in Europe. Trius has partnered with Bayer AG to commercialize the drug in Asia Pacific and other emerging markets.

“The consistently strong results of the two Phase III studies support the promise of tedizolid as a safe and effective new antibiotic, especially in an era of increasing multi-drug resistant Staphylococcus aureus,” Andrew Shorr, associate professor of medicine at Washington Hospital Center, said in Trius’s release. “The potential to treat severe MRSA infections with a novel once-daily agent and a shorter course of therapy offers substantial benefits to patients and, potentially, payers and the health care system.”

Send any news about locally based health care organizations, biotech and clean-tech to Meghana Keshavan at mkeshavan@sdbj.com. She can be reached at 858-277-6359.


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