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Hightlights
- Formed in partnership with the Cleveland Clinic in 2003, CBLI is now also partnered with Roswell Park Cancer Institute in Buffalo, NY.
- The Company currently has four programs in development for five primary indications, two of which have completed clinical trials.
- CBLI has filed more than 20 families of patents protecting its proprietary technologies, and was granted its first US patent for Protectan CBLB502
- CBLI science gained international recognition through a high-profile publication and editorial in one of the world’s leading scientific journals, Science (April 11, 2008 issue).
- CBLI has received almost $50 million in public equity investments and more than $40 million in US federal funding since 2003.
- CBLI’s long-term strategy is to pursue huge unmet medical needs for its compounds; however, the Company expects to receive additional benefit and near-term commercialization by capitalizing on ready defense opportunities for lead drug, Protectan, CBLB502 within the next two years.
- The key to CBLI’s science is a simple understanding that normal cells and cancer cells die thru two different mechanisms, which enables them to be treated separately.
- CBLI‘s lead compounds and target markets include:
Protectan CBLB502: Defense market for Acute Radiation Syndrome (ARS)
- $500 million market or more annually, within the first 2-3 years, based on published requirements
- US -Dept of Defense to protect military forces
- US- BARDA/HHS to protect civilian population
- Foreign governments such as Israel, the UK, Canada, China, India, Japan, and South Korea - to protect both military and civilian populations
- CBLI demonstrated efficacy in non-human primates by saving 70-80% of monkeys from killing doses of radiation (similar to that experienced at Chernobyl) when given up to 72 hours after exposure
- Abbreviated FDA approval pathway through Animal Efficacy Rule (for vaccines and other drugs where it is unethical to test efficacy in humans), when efficacy is demonstrated in two animal species and safety is demonstrated in humans along with biomarkers of efficacy corresponding to animals
- Data from initial human safety study indicates CBLB502 was well tolerated and that normalized biomarker results corresponded to previously demonstrated activity in animal models of ARS.
- The Company anticipates filing application for FDA approval in late 2010
- CBLI awarded an $8.9 million contract from the Department of Defense in April 2008, and a $13.3 million contract from BARDA/HHS in September 2008
Protectan CBLB502: Reduction of
radiation and chemotherapy side effects in cancer treatment
- Approximately $20 billion market, since about 40% of cancer market represents supportive care treatments to reduce toxicities of cancer treatments
- First medical indications are reduction of mucositis in head and neck cancer and bone marrow transplantation for acute leukemia
- Head and neck trial planned to start in late 2009/early 2010
Protectan CBLB612: Stem cell
induction – blood recovery during chemotherapy
- Potential to compete with or complement G-CSF or Neupogenâ, a $4 billion market drug from Amgen, or newly FDA approved Mozibil from Genzyme
- CBLI animal studies show effects 8-10 times greater than G-CSF, even in combination with Mozibil
- Initial manufacturing completed
- Formal manufacturing and pre-clinical studies in preparation for Phase I trial pending grant or partnership funding
- First human trial expected to demonstrate effect of drug on stem cells counts, a direct indication of efficacy potentially making subsequent clinical trials less risky
- Significant market interest in stem cell mobilizing drugs creates ideal positioning of CBLB612 for commercial partnering post Phase I/II
Curaxins: Anti-cancer drugs with
potential activity in broad range of cancer types
- Novel triple mechanism of action with novel target that effectively turns regulated cell death function back on in tumors
- Phase II trial in hormone refractory prostate cancer demonstrated safety and activity of first generation compound CBLC102
- Next generation lead Curaxin CBLC137 significantly exceeds CBLC102’s activity and efficacy in pre-clinical tumor models
- Manufacturing and pre-clinical studies in preparation for clinic trials pending completion of announced joint venture
- Potential licensing opportunity for CBLC137 following Phase II, with proof of concept established through CBLC102
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