CuraGen says it will select drug candidates for regulatory development by end of 2007

By Jennifer Lanning Drey

Eugene, Ore., June 22 - CuraGen Corp.'s goal is to have made decisions by the end of 2007 about which of its three drug candidates will advance toward regulatory development, said Dr. Frank M. Armstrong, chief executive officer of CuraGen, at the Piper Jaffray London Health Care Conference on Thursday.

The company's three drug candidates, PXD101, CR11, and velafermin, target various forms of cancer.

"Our overall goal for our portfolio is to deliver choices - to be able to make choices about taking one, two, or three of those products into regulatory development by the end of 2007," Armstrong said Thursday.

CuraGen is most excited about CR11, its fully human monoclonal antibody drug conjugate for treatment of metastatic melanoma, Armstrong said.

The company dosed the first patient in a phase 1 clinical trial on Wednesday and expects to release results from the trial before the end of the year, he said.

"Metastatic melanoma is a cancer with very limited treatment options at the present moment and consequently, the survival rate is quite appalling for a cancer in this day and age," Armstrong said.

CuraGen also began patient dosing at the end of May in its second phase 2 clinical trial evaluating a single dose velafermin for the prevention of oral mucositis, a common side effect of cancer treatments.

The trial will evaluate the safety and efficacy of velafermin for oral mucositis through 30 days post dosing and will follow patients for one year to evaluate any potential effects of velafermin on the outcome of cancer treatment.

The company expects to have the 30-day post-treatment results in the third quarter of 2007 and the one-year follow-up results in the third quarter of 2008, Armstrong said Thursday.

"We see velafermin with its single dose regiment as a real driver of the oral mucositis market going forward," he said.

First PXD101 phase 2 data in Q3

Armstrong also said Thursday that CuraGen plans to provide an update on its PXD101 program in the third quarter.

PXD101 is a small molecule histone deacetylase inhibitor with leading indications in monotherapy in myeloma and lymphoma. The company's third quarter update will include preliminary data from a phase 2 myeloma study, Armstrong said.

PXD101 is also being tested in combination with other treatments for colorectal and ovarian cancer and with Velcade as a treatment for myeloma.

The company plans to deliver preliminary results on the data from combination trials for colorectal and ovarian cancer, as well as phase 2 lymphoma data, by the middle of 2007.

CuraGen will also provide an update on its 454 Life Sciences program, which is the side of the business focused on commercializing gene-sequencing technologies, when it announces its second quarter results on July 27, Armstrong said.

CuraGen is a Branford, Conn., biopharmaceutical company developing a pipeline of novel protein, antibody and small molecule therapeutics in the areas of oncology, inflammatory diseases and diabetes.

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