Virotherapy is a new strategy to treat cancer by selectively transducing and killing tumor cells. The viruses used in virotherapy can either kill tumor cells by bursting them open or deliver genes that make the cells more susceptible to traditional chemotherapies. Initial efforts are focused on intratumorally- and regionally-administered virotherapeutics for ovarian and brain cancers.
VLI's lead product, a transduction enhanced conditionally replicative vector is the first efficiency enhanced targeted adenovector entering clinical trials. The coat protein modifications incorporated into this vector can transduce a large number of clinically relevant tumor cell types that include ovarian, brain and pancreatic cells. VLI's lead clinical candidate has a built-in safety feature that allows the vector to discriminate between malignant tissue and healthy tissue. It replicates more effectively in rapidly dividing cancer cells while sparing the more slowly dividing normal cells from damage.
The first Phase I clinical trial, involving the enrollment of 21 patients has taken place at The University of Alabama at Birmingham (UAB)
Comprehensive
Cancer
Center . The first patient was dosed in June 9, 2007 and the trial was concluded at the beginning of 2009. The trial was designed to investigate the feasibility and utility of intraperitoneally-administered VLI-01A for patients with recurrent epithelial ovarian cancer who have persistent or recurrent disease after debulking and paclitaxel/platinum based chemotherapy. Preliminary clinical findings have underscored the safety of this agent in the human clinical context, as there were no observed adverse events to this point. Initial evaluation of the clinical parameters suggests some of the data trends consistent with clinical response. Seven of 20 evaluable patients had decrease in CA125 marker from pretreatment values approximately one month after Ad∆24‑RGD treatment; four of these patients had a >20% drop in CA125 values.
VLI have evaluated all options to support a Phase I/II ovarian cancer clinical trial whereby the lead agent (VLI-01A) would be delivered in conjunction with chemotherapy. This would allow treatment of patients at a much earlier disease stage thereby fostering the possibility of defining clinical responses.
Kimball, K.J.,
Preuss, M.A., Barnes, M.N., Wang, M., Siegal, G.P., Wan, W., Kuo, H., Saddekni, S., Stockard, C.R., Grizzle, W.E., Harris, R.D., Aurigemma, R., Curiel, D.T., and Alvarez, R.D. (2010) A Phase I Study of a
Tropism-Modified Conditionally Replicative Adenovirus for Recurrent Malignant
Gynecologic Diseases. Clin Cancer Res 16(21): 5277-87.
Dirk M. Nettelbeck, Ronald D. Alvarez and David T. Curiel, (July 2008) Tumor-Busting Viruses. Scientific American, Special Editions, New Answers for Cancer. p.72.
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