The fourth major infusion of capital into Tengion Inc. in 4½ years is more than a vote of confidence in the biotechnology company, officials said yesterday.
They say they also believe that the $21 million will take the company a significant step closer toward getting approval from the Food and Drug Administration for a clinical trial on humans for its neo-bladder technology in 2009.
"It is very expensive to run human clinical trials because they have to be extremely closely managed," said Gary Sender, the chief financial officer of Tengion, which is based in East Norriton, Pa.
Tengion is best known for the regenerative-medicine research of Dr. Anthony Atala, its founder, who runs the Wake Forest Institute for Regenerative Medicine in Winston-Salem's Piedmont Triad Research Park. About 45 of its 100 employees are based locally.
The company uses biocompatible materials and a patient's own cells to create a functional neo-organ or neo-tissue that is designed to catalyze the body's innate ability to regenerate.
With the $21 million in capital, Tengion has attracted $143 million since August 2004. The company also attracted a new investor in Safeguard Scientifics Inc.
"Investors want to see a biotechnology company hitting milestones, completing results, producing effective research and effective and safe products," Sender said.
Both Dr. Steven Nichtberger, the president and chief executive of Tengion, and Bill Dean, the director of the research park, said that the additional capital enhances the company's reputation in the biotechnology sector.
"During this challenging time across the debt and equity markets, we feel that our ability to attract additional financing from leading biotech investors -- both new and existing -- exemplifies the strength of our data, the experience of our management team and the promise and potential for Tengion's products to meet the critical need of patients with organ failure," Nichtberger said.
Dean said that Tengion's success "demonstrates that the research park's strategy for diversity is paying off in the technology and research being developed on the campus."
"Gaining another round of funding is definitely a testament to how well Tengion's science, technology and research are being received in the life-sciences community," Dean said.
Dr. Gary Kurtzman, the managing director of Safeguard's Life Sciences Group, has joined Tengion's board of directors as part of the investment.
"Safeguard Scientifics looks to partner with life-sciences companies that are poised to dramatically revolutionize and improve upon today's standards in patient care," Kurtzman said.
"Tengion is a leader in the emerging field of regenerative medicine, addressing the most critical issues facing organ-failure patients," he said.
"With late-stage products in development, we believe that Tengion is well-positioned for success."
■ Richard Craver can be reached at 727-7376 or at rcraver@wsjournal.com.
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