The Company plans to conduct one more study of efficacy of the IGF-methotrexate conjugate in mice, and then conduct
preclinical animal studies of safety in one rodent and one non-rodent species. The timeline for completing these can be 6-18 months.
The cost will be up to $150,000 for efficacy studies and up to $300,000 for animal safety studies.
Concurrently with the later stages of preclinical animal testing, the company will submit an Investigational New Drug Application
to the FDA. This can be accomplished in 6 months at a cost of $130,000.
The Company will then conduct a Phase I clinical trial in humans with 20-30 patients having Non-Hodgkin's lymphoma or metastatic
prostate cancer. The cost will be up to about $1.5 million. The trial can be completed in 12-18 months.
Concurrently, the Company will test one or more other of its proprietary agents in mice for efficacy from among the group of
IGF-doxorubicin, IGF-paclitaxel, IGF-chlorambucil, an IGF-toxin conjugate, and an IGF-radionucleotide conjugate.
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