Our Research Pipeline

Our goal is to establish chemosaturation via percutaneous hepatic perfusion (PHP) as the standard of care for the management of cancers in the liver. Toward this end we are developing a robust research pipeline that seeks to build on our existing body of research, improve the efficiency of our filtration methods, and ultimately expand the range of cancers suitable for treatment with chemosaturation therapy.

Clinical Development Program

• Goal
  • Expand indications for HCC and mCRC with US registration trials
  • Generate robust clinical data to support commercialization
• Potential 2012 clinical trials
  • HCC: Global Phase 2 randomized 1L CHEMOSAT Melphalan vs. Sorafenib
  • HCC: US registration – Global Phase 3 randomized 2L CHEMOSAT Melphalan vs. Best Supportive Care (BSC) for Sorafenib failure
  • HCC: Asia Phase 3 randomized 2L CHEMOSAT Doxorubicin vs. Best Supportive Care (BSC) for Sorafenib failure
  • mCRC: Global Phase 2 signal seeking/safety 2L CHEMOSAT Melphalan
  • mCRC: US registration – Global Phase 3 randomized 2L CHEMOSAT Melphalan vs. Approved Alternatives
• US Expanded Access Program (EAP) for metastatic Melanoma

CHEMOSAT Doxorubicin Development

• Multiple published phase I/II studies from MD Anderson Cancer Center and Yale with percutaneous hepatic perfusion (PHP) and Kobe University using doxorubicin show promising response rates for HCC
• Status:
  • First pass removal efficiency 95% in initial in vitro studies
  • Utilize new trade secret manufacturing process
  • Intend to file and seek CE Mark approval in 2H2012
  • Plan to use CHEMOSAT doxorubicin in Asia Phase III 2L HCC trials
• Expected Benefits
  • Multiple treatments
  • Reduced systemic toxicity for improved safety profile
  • Concomitant Therapy (complements systemic therapies)