Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.US biotech company SciClone Pharmaceuticals has submitted an investigational new drug application to the FDA for the compound SCV-07, thought to be a potential treatment for infectious diseases. The application is designed to allow SciClone to begin clinical trials of the drug.
Subscribe to our email newsletter
Pending FDA review and clearance, SciClone expects to initiate a phase I clinical trial of SCV-07 in healthy volunteers during the second half of 2005. SCV-07 is a synthetic dipeptide that has demonstrated activity against a broad range of viral and infectious diseases.
“Filing the IND for SCV-07 is an important milestone for us as we broaden our product pipeline beyond our lead drug candidate Zadaxin,” said Ira Lawrence, president and CEO of SciClone. “We believe that we will be able to move quickly through the phase I trial and begin dose-ranging, disease-specific phase II clinical trials in 2006.”
Earlier studies have indicated that SCV-07 stimulates the body’s immune response by promoting T-cell differentiation into T helper 1 (Th1) cells, a critical process in the body’s fight against infection. SciClone acquired the worldwide rights, outside of Russia, to SCV-07 from Verta, a biotechnology company located in St. Petersburg.
SciClone’s lead product Zadaxin is currently being evaluated in two phase III hepatitis C clinical trials in the US and one phase III trial in Europe. Zadaxin is also being evaluated in other late-stage clinical trials for the treatment of hepatitis B and certain cancers. The company’s other drug development candidate is SCV-07, which is being evaluated for the treatment of viral and infectious diseases.