Vital Signs: The Weekly Roundup

Welcome to Kendra Marr's new blog-in-a-blog on the Washington area's biotech and health care scene. We're calling it Vital Signs.

By Kendra Marr

Here's a roundup of recent biotech and health care news in the area:

*Tracey Schmitt, spokeswoman for Emergent Biosolutions of Rockville, is joining Alaska Gov. Sarah Palin's team as her press secretary. Schmitt was a former Republican National Committee spokeswoman.

Her first task? Address a Washington Post story the Republican vice presidential nominee billed taxpayers for 312 nights spent in her own house, charging a daily allowance typically used for business travel.

"This is part of her job and it's only reasonable her travel expenses -- which were reduced dramatically from the previous administration -- would be covered," Schmitt told the AP.

*Lentigen Corp. relocated its corporate headquarters, along with its manufacturing and research labs, from the University of Maryland, Baltimore County incubator to a 26,000-square-foot facility in Gaithersburg. Lentigen develops lentiviral vectors, which deliver new genes into cells. The privately owned company focuses on designing and manufacturing this technology, while its partners test and commercialize potential products.

*The Food and Drug Administration held a public meeting at The Universities at Shady Grove Conference Center in Rockville to get feedback on its Nanotechnology Task Force Report. The meeting discussed the safety and effectiveness of nano-scale materials in products that would be subject to FDA regulation.

Lawrence Tamarkin, chief executive and co-founder of CytImmune Sciences in Rockville, presented his biotech's cancer nano-medicine that targets tumors without harming healthy tissue.

*Regenerx Biopharmaceuticals of Bethesda completed an early clinical trial to determine the safety of RGN-352, a drug that would reduce cardiac damage in patients after a heart attack, in 40 healthy volunteers. Regenerx found RGN-352 was safe at the four different doses tested. In a follow-up trial, 40 subjects will be dosed once daily for 14 days, instead of taking just a single dose.

*Rexahn Pharmaceuticals of Rockville received FDA approval to start a second phase tests for Serdaxin, the company's treatment for depression and anxiety. Rexahns forecasts a big market for Serdaxin, which taken in tablet form, as 45 million Americans are afflicted with major depressive disorders.

*The Maryland Department of Business and Economic Development is re-structuring its office to better grow the state's biotech industry, among other sectors. Secretary David W. Edgerley wrote about the changes in his electronic newsletter, saying "a new organizational framework better aligns DBED staff and resources with its core missions."

The Maryland Biotechnology Center -- what Governor Martin O'Malley dubbed the state's "one stop shop to promote and support biotechnology innovation and entrepreneurship" in his recent $1.1 billion Bio 2020 Initiative -- falls under DBED's new jurisdiction. Scheduled to open in January 2009, the center will coordinate biotech activities between the state, private sector and local universities. Take a look at a chart of DBED's new organization here.

*Montgomery County Chamber of Commerce's 2008 Business Awards are out. David Mott, former chief executive of MedImmune in Gaithersburg, is Business Leader of the Year. Qiagen Sciences, a Dutch biotech that opened a Germantown manufacturing facility in 2002 and purchased Gaithersburg's Digene last year, won the Corporate Achievement Award. Click here for the full list of winners.

*Vanda Pharmaceuticals met with the FDA to discuss the recent rejection of iloperidone, the Rockville biotech's schizophrenia treatment. In July, regulators sent the company a letter saying iloperidone was too similar to a drug already on the market. Vanda's stock plunged 73 percent, and chief executive Mihael Polymeropoulos told investors he would put all development activities related to iloperidone on hold until he sat down with the FDA. Today, development is still on hold while Vanda prepares a response to the FDA's letter. While the FDA suggested this response was a useful next step, the agency did not promise to change its decision, cautioned Polymeropoulos. "This is not a commitment for any positive or negative discussion," he said. "It's just a process."

*Northwest Biotherapeutics, a Betheseda biotech, revealed follow-up data for patients in early DCVax-Brain tests, which began in 2000 and 2003. DCVax-Brain treats glioblastoma multiforme, a type of brain cancer. Northwest said 84 percent of patients in these trial lived longer than 14.6 months, the median survival rate. But, Northwest has said it only has enough cash to support day-to-day operations through the end of September. It will need to raise additional capital for further clinical trials.

By Dan Beyers  |  September 12, 2008; 11:30 AM ET  | Category:  Vital Signs
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