Protein Sciences Corp. said Thursday that it has received federal approval to conduct clinical trials of its H1N1 swine flu vaccine, an essential step in the drug approval process.
Chief Executive Dan Adams said the company has been cleared by the Food and Drug Administration to proceed with human trials of its PanBlok vaccine and trials could begin at several U.S. sites within weeks.
Human trials of PanBlok are already underway in Australia, Adams said.
"It's winter in Australia, and they're a lot more worried than we are," he said Thursday at the company's headquarters.
The FDA would not confirm or deny its approval of clinical trials for PanBlok, saying that it is confidential information.
Accelerated trials involving other H1N1 vaccines are in process in the U.S. Several major pharmaceutical companies are also developing vaccines for the virus, including Novartis, Sanofi Pasteur, and GlaxoSmithKline.
The U.S. Centers for Disease Control and Prevention believes that about 45 million doses of an H1N1 vaccine will be ready by mid-October.
Assuming that Protein Sciences' trials start by summer's end and that they're successful, the earliest the company could win U.S. approval for PanBlok is mid-2010. The trials take six months. The government could expedite the process through an emergency order, Adams said.
In June, Protein Sciences won a five-year, $147 million federal grant for producing vaccines for seasonal and pandemic flu viruses. The company is using the first installment of $35 million to pay for development costs, including the trials, and an expansion of its manufacturing capacity.
Protein Sciences can currently produce 100,000 doses of vaccine per week, and is planning a dramatic expansion of its Meriden manufacturing operations by 2011. If necessary, the company could contract with other vaccine producers to achieve greater volume.
"Pandemic viruses are going to be the rule rather than the exception," Adams said Thursday, as he gave U.S. Rep. Chris Murphy, D-5th District, a tour of the company's Research Parkway operations.
Murphy, who represents Meriden in Congress, pushed for federal funding for Protein Sciences.
Unlike most vaccine developers, Protein Sciences derives its vaccines from cell cultures instead of eggs, allowing faster production.
Clinical trials of PanBlok would begin "within a couple of weeks," Adams initially said Thursday. He later allowed that this timetable is "optimistic." An independent firm would conduct the trials, which would involve 600 to 1,200 human subjects and help determine appropriate doses, Adams said.
Protein Sciences has already completed trials for a seasonal flu vaccine, FluBlok, and is awaiting FDA approval to sell it.
Adams said Protein Sciences plans to price doses of PanBlok at $10 each overseas. The company has not settled on a price for doses that would be sold in the United States. In addition to the PanBlok doses sent to Australia, Protein Sciences plans to ship some to China.