CALGARY, Alberta - Synsorb Biotech Inc. was founded on its carbohydrate technology expertise, which it has applied to the development of therapeutics for the gastroenterology (GI) segment of the pharmaceutical market. Specifically, its synsorbs - sugars linked to an inert silica-like substrate that have the ability to mop up disease-causing toxins in the body - have led to the development of two orally delivered, carbohydrate-based GI anti-infective therapies currently in advanced clinical trials. Synsorb Pk, for the treatment of Escherichia coli O157:H7 infections and the prevention of hemolytic uremic syndrome, is undergoing Phase III clinical trials in North America and Argentina. Synsorb Cd(R), for recurring or relapsing antibiotic-associated diarrhea, is in Phase II clinical trials in Canada and the U.S. Compounds for the treatment of viral infections, inflammatory conditions and cancer also are being synthesized and tested.
Although both lead drug candidates have shown significant potential, the company has said that it intends to broaden its product pipeline. According to Brad Thompson, chairman and CEO of Synsorb, to further enhance shareholder value the company is now expanding its drug development focus into new areas as a result of opportunities that have arisen in the current biotechnology arena. The company's core expertise in clinical development and management puts Synsorb in a position to acquire and develop products from emerging biotechnology companies that traditionally have limited knowledge in clinical development.
This broadened focus allows the company to consider both carbohydrate and non-carbohydrate therapies for anti-infectives and cancer indications. Synsorb is in discussions with several groups to acquire suitable drug candidates in late preclinical or clinical stages of development, Thompson said.
Arising from its examination of promising technologies, Synsorb is reviewing the potential acquisition of GeneSense Technologies Inc., of Winnipeg, Manitoba, whose initial products are antisense oligonucleotides being developed as anticancer therapeutics.
GeneSense has two drug candidates. One, GTI 2040, is in formal preclinical development and a Phase I clinical trial is scheduled to start toward the middle of the year. The target is the R2 component of ribonucleotide reductase (RNR), an enzyme that is essential for cell proliferation and known to be elevated in cancer cells. Mammalian RNR is composed of two dissimilar dimeric protein components, proteins R1 and R2, which are required to catalyze the direct reduction of ribonucleoside diphosphates to the corresponding deoxyribonucleotides, a rate-limiting step in the synthesis and repair of DNA. The mechanisms that control RNR gene expression are therefore important for understanding DNA synthesis and repair and cell proliferation.
The preclinical efficacy data are very positive, said Wayne Schnarr, GeneSense chairman. When used as monotherapy, GTI 2040 showed highly statistically significant reductions in tumor growth in all nine human cancers tested to date in animal models. In the preclinical toxicology program, no major clinical toxicity has been observed.
Formal preclinical development of GeneSense's second drug candidate, GTI 2501, which targets the R1 component of RNR, will start when financing arrangements are complete. GTI 2501 has shown similar success to GTI 2040 in animal models for a broad range of human cancers and has produced complete tumor regression in all animals in two human cancer models (breast cancer and renal cell carcinoma).
GeneSense also is developing antisense molecules against other gene targets, including selected bacterial gene targets for use in treating infectious diseases.
Synsorb has agreed to acquire one-third of the issued and outstanding shares of GeneSense, subject to completion of due diligence, regulatory approval and the completion of a private financing by GeneSense which is expected to close in the first quarter of this year. Synsorb also will have the option to acquire the remaining shares of GeneSense after completion of the Phase I/II clinical trial of GeneSense's lead drug candidate, GTI 2040.
The option will be based on a fair market valuation at that time, within certain prearranged limits, for cash or stock at Synsorb's option. The initial one-third purchase of GeneSense shares will be funded by the issuance of Synsorb common shares. Synsorb's current burn rate will remain unaffected, as GeneSense is and will continue to be both financially and operationally self-sustaining to the end of the option period. This independence enables Synsorb's management team to remain focused on the strategic goals and business of Synsorb.
The agreement creates a win-win situation for investors in both companies, Schnarr said. Synsorb acquires an interest in two excellent drug candidates and the other technologies developed by GeneSense's founders, Jim Wright and Aiping Young, of the Manitoba Institute for Cell Biology. GeneSense shareholders benefit from an affiliation with a public company that has two unique products in advanced clinical trials. n