SciClone plans to pursue development of SGX942 in the Greater China market

SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today announced plans to pursue development and registration of SGX942 in the Greater China market, for the treatment of oral mucositis. SGX942 is being developed by Soligenix, Inc. (OTCQB: SNGX), which recently reported positive preliminary results from its Phase 2 clinical trial for the treatment of oral mucositis in head and neck cancer. SGX942 is an innate defense regulator (IDR), a new class of short, synthetic peptides, with a novel mechanism of action in that it modulates the body's reaction to both injury and infection towards an anti-inflammatory and an anti-infective response. The Phase 2 preliminary results reported by Soligenix showed a significant reduction in the duration of severe oral mucositis in patients receiving chemoradiation therapy for treatment of their head and neck cancer.

In April 2013, SciClone and Soligenix established a commercial collaboration in which Soligenix received access to SciClone's oral mucositis clinical and regulatory data library in exchange for commercialization rights to SGX942 in the People's Republic of China, including Hong Kong and Macau. The data library derived from SciClone's development of SCV-07 for the treatment of oral mucositis caused by chemoradiation therapy in head and neck cancer which targeted the same patient population Soligenix is pursuing in its oral mucositis program. SciClone discontinued development of SCV-07 in 2012.

Friedhelm Blobel, PhD, SciClone Chief Executive Officer, commented: "The positive results demonstrated in the Phase 2 study of SGX942 are compelling, representing promise for an intervention for patients with head and neck cancer treated with chemoradiation who are suffering with oral mucositis. Cancer is one of China's most pressing healthcare challenges. We have significant development, regulatory and commercial expertise in the China oncology market, and believe that SGX942 could be a valuable addition to our oncology portfolio in the future. Our plans are to develop SGX942 for the Greater China market, and to work with Soligenix to define both a business and development path forward toward that goal."

"We were very excited with the outcome of the Phase 2 clinical study of SGX942, as oral mucositis is a devastating side effect of chemoradiation and represents a significant unmet medical need and commercial opportunity worldwide," said Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "Access to SciClone's data library was of significant value to Soligenix in designing our Phase 2 program. We are delighted that SciClone intends to pursue development of SGX942 in the China market, where they have a significant commercial presence, and look forward to our companies continuing to work in collaboration."

Specific terms of the collaboration between SciClone and Soligenix have not been disclosed at this time.


The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
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