VANCOUVER, British Columbia -- In the wake of the rapid decline in the financial markets that caused many investors to stampede to conservative holdings and away from high-risk sectors such as development-stage biotech companies, James Miller, president and CEO of Inex Pharmaceuticals Inc., saw his company's share price on the Toronto Stock Exchange decline from a C$6 (US$3.88) range to unprecedented low levels of around C$1. The situation was not helped by corporate announcements of a reduction in monthly burn rate to approximately C$700,000 from C$1 million, or by the halt in development with partner Schwarz Pharma AG, of Monheim, Germany, of candidate drug INX-3280 for the treatment of cardiovascular restenosis in Europe and North America.
Inex is commercializing drugs that utilize the company's Transmembrane Carrier System (TCS) to treat cancer and inflammatory diseases. The company is focused on gene-based drugs, such as antisense oligonucleotides, which regulate or block genes that produce a disease-causing protein, and gene plasmids, which replace defective genes to achieve a therapeutic effect.
However, along with the perceived disappointments come the highs. Miller told BioWorld International he is particularly delighted with the early Phase II results for the company's anticancer drug, Onco TCS, which has demonstrated the capacity to significantly reduce the size of tumors in patients with advanced-stage non-Hodgkin's lymphoma (NHL), a form of blood cancer, after standard chemotherapy treatments had failed.
The Phase II clinical trials are under way at the University of Texas M.D. Anderson Cancer Center, in Houston. According to the lead investigator, Andreas Sarris, early results indicate Onco TCS has promising activity. The overall response rate was 45 percent for the first 21 evaluable patients. In each of the patients who responded to Onco TCS treatment, tumor size was reduced at least 50 percent.
All trial participants were diagnosed to have either low- or intermediate-grade NHL. Included in the response group were patients with B-cell and T-cell lymphomas as well as a patient with mantle-cell lymphoma, which is a particularly serious form of B-cell NHL. The study has also shown that Onco TCS is well tolerated in the patients.
The active agent in Onco TCS is the off-patent chemotherapeutic vincristine. Inex holds three issued U.S. patents and international patent applications that cover the combination of vincristine with TCS. The administration of optimal doses of the free drug is often impossible, due to the severe toxicities that result. In preclinical studies, when the therapeutic agent was combined with TCS, it was demonstrated that the drug was carried to disease sites and into diseased cells in higher concentration and for a longer duration than when it was administered alone. The result of TCS encapsulation, the company believes, is more effective dosing with reduced toxicity. The free form of vincristine is part of several standard chemotherapy "cocktails" employed as first-line treatment of NHL. In the M.D. Anderson trial, patients who had relapsed following these chemotherapy regimens were then treated with Onco TCS alone. The trials will continue until 70 patients have been evaluated, with results available in mid-1999.
Three gene-based products also are in the company's pipeline.
In addition, Miller said the company's reduced burn rate will provide financial flexibility over the next 18 months to bring the company's most promising product candidates to clinical trials. As of Sept. 30, the company had cash and short-term investments of C$12.75 million. *