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no DNA-based vaccine has been approved for human use, and flu shots using the technology still face multiple layers of human testing and regulatory scrutiny. Inovio’s quarterly filing describes the swine flu program as pre-clinical; vaccines against cancer, HPV and HIV are in human trials.
—Vical (NASDAQ: VICL), the granddaddy of DNA vaccine companies, was one month ahead of Inovio in announcing that its swine flu vaccine looked effective in animal studies. The pre-clinical research was supported by the Navy, and Vical says it is working with the Navy to advance the vaccine to clinical trials. But Vical won’t proceed to human tests without outside support. As is the case with Inovio, Vical also faces substantial regulatory hurdles for its novel DNA-based technology. In short, the swine flu pandemic could be history before any DNA-based swine flu shots received FDA approved.
When I talked with CEO Vijay Samant in June, he said his aim in taking on swine flu was to demonstrate the effectiveness of Vical’s technology against a difficult target. A government order for vaccine would be an upside, he said. Still, Vical’s shares have jumped more than 80 percent since the official start of the pandemic. It should be noted that during this period Vical also reported promising interim data from a mid-stage trial of its cytomegalovirus vaccine in hematopoietic stem cell transplant patients. Not as sexy as swine flu, perhaps, but closer to reaching the market.
— Worries about swine flu could even give a lift to Pure Biosciences (NASDAQ: [[ticker: PURE]]), the El Cajon, CA, developer of the antimicrobial silver dihydrogen citrate, or SDC. In May, the Environmental Protection Agency added SDC-containing disinfectants to its list of antimicrobial products effective against swine flu and other strains of the influenza A virus.
The EPA already had registered the substance as a disinfectant for use on hard surfaces, like countertops. A spray containing the silver-based germ killer, called PureGreen 24, is available in Home Depot. CEO Michael Krall said a national drug store chain and a national warehouse chain will soon stock silver dihrydrogen citrate-containing disinfectants. This month, Pure also raised $3 million from investors. Things are looking up—except the company’s stock price, which is off 17 percent since the pandemic got underway. Krall is unperturbed. “This could be a big year for us,” he told me.
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