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Biotech / Medical : CuraGen (CRGN) -- Ignore unavailable to you. Want to Upgrade?

To: keokalani'nui who wrote (375)	1/11/2005 7:09:38 AM
From: Jim Oravetz	Respond to of 478

Pipeline to profits Maria Garriga , New Haven Register Staff 01/09/2005 BRANFORD — CuraGen Corp., the region’s oldest biotechnology firm, originated in 1993 as a knowledge company devoted to mapping human genes. Today, CuraGen is using those maps to transform itself into a drug producer, and the company has reached a critical stage. "We’ve got five drugs in the pipeline, (including) three in humans," Chief Executive Officer Jonathan Rothberg said. "These are real drugs in real people." CuraGen has had to refocus and make major changes in order to make the transition from pure research to drug development. Since Rothberg switched the company’s focus to product development and commercialization, the company has shed more than 250 jobs. Employment peaked at 500 in 2002, and today stands at about 240. To further refine its mission, the company split off its genomics research into a spin-off called 454 Life Sciences. Both are in Branford, although CuraGen maintains a New Haven office as well. Rothberg envisions 454 Life Sciences as a company that will find a way to make gene mapping for individuals as common as CT scans are today. About 100 of CuraGen’s 240 employees now work at 454 Life Sciences. The rest are working at CuraGen itself on the company’s quest to mine its genomic maps for a treasure trove of future drugs. On track "The lead time for a new medicine is 15 years from concept to marketable product. CuraGen is two-thirds of the way there," said Paul Pescatello, president of Connecticut United for Research Excellence, the state biotech industry group. Pescatello pointed out that CuraGen is a knowledge-based company, which means it can sell the intellectual license for its research and discoveries to raise money or enter into lucrative partnerships with pharmaceutical companies, biotech companies or venture capital firms. CuraGen now has five drugs in the pipeline for development, 20 other viable candidates for development, and roughly 80 genomic targets that it can explore for potential treatments. One of the drugs is in phase II clinical trials and two are in phase I, which means they are being tested in human subjects. Two more are in the pre-clinical stage, which includes testing on animals, meeting manufacturing guidelines and preparing large enough batches for clinical trials. In phase I trials, drugs are tested for safety, side effects and appropriate dosage in a pool of 20 to 80 patients. In phase II, drugs are then tested on their effectiveness and again safety, in a pool of 100 to 300 patients. In phase III, the drug is tested on 1,000 or more people to monitor side effects and gather more information about how the drug works. After completing three phases, the company applies for approval to market the drug from the federal Food and Drug Administration. In the race Here are the five drug candidates vying to become CuraGen’s first drug on the market: CuraGen’s lead horse is CG53135, which has entered Phase II clinical trials, with 200 patients at 20 sites across the nation. The drug, a protein, may help prevent oral mucositis. Cancer patients often get oral mucositis after radiation treatment, which can cause sores to open up on their mouths and throats, making eating and swallowing painful and in some cases, impossible. PXD 101 is a chemical designed to treat solid cancer tumors and cancers that infect the blood. It may be able to modulate the genes of cancer cells. Most cells have a growth control mechanism, but cancer cells want to grow forever, said Dr. Timothy Shannon, CuraGen’s chief medical officer Shannon. PXD 101 may be able to sneak into cancer cells and switch the growth control mechanism back on, allowing cancer cells to die like normal cells. CuraGen officials envision PXD 101 as part of a combination therapy to treat cancer. It’s in phase I clinical trials. CR-002, also in phase I, is an antibody that can be used to treat kidney inflammation known as IgA nephropathy. Shannon envisions CR-002 neutralizing a cell growth factor that can cause kidney inflammation and ultimately kidney failure. CR 011 is in the pre-clinical stages of development as a treatment for metastatic melanoma, a deadly form of skin cancer. CT 052, a treatment for Type 2 diabetes, is also in the preclinical stages, and company officials said they hope to start Phase I human trials as early as next year. -------------------------------------------------------------------------------- Maria Garriga can be reached at mgarriga@nhregister.com or 789-5685.