EDMONTON, Oct 31, 2006 - Biomira Inc. (Nasdaq: BIOM) (TSX: BRA) announced today that it has acquired ProlX Pharmaceuticals Corporation, of Tucson, Arizona, and Houston, Texas, a privately-held biopharmaceutical company focused on the development of novel therapeutics for the treatment of cancer. ProlX is developing small-molecule drugs that inhibit redox and cell-survival signaling proteins.
The acquisition will give Biomira a broadly-based portfolio of oncology products, including one product candidate expected to enter phase 3 by year end (Stimuvax®), one product expected to enter phase 2 in the current quarter (PX-12), and two products expected to begin clinical trials over the next 6 to 12 months, as well as several additional pre-clinical candidates.
"The acquisition of ProlX is a transformative event for Biomira, expanding and diversifying our pipeline of cancer therapies in development," said Robert L. Kirkman, M.D., President and CEO. "The combined programs will give us products in several phases of clinical development directed against multiple targets, diversifying risk while retaining our focus on the treatment of solid tumors. This is a major step toward our goal of building a leading oncology franchise."
Lynn Kirkpatrick, Ph.D., President and CEO of ProlX, who will join Biomira as Chief Scientific Officer, noted, "ProlX has built a diversified pipeline of novel drugs through structural design and targeted combinatorial chemistry, based on our research on targets which regulate cancer cell growth and cell death. I am delighted to be joining with Biomira and excited by the opportunity this transaction creates to accelerate the development of our drugs."
Promptly following closing Biomira will pay U.S. $3 million in cash and approximately 17,878,000 shares of Biomira common stock (subject to certain resale restrictions) in return for all of the outstanding stock of ProlX. In addition, and subject to applicable regulatory requirements, there may be up to three future payments based on the achievement of specified milestones. A payment in Biomira common stock (with registration rights) of U.S. $5 million is due upon the initiation of the first phase 3 trial of a ProlX product. Another payment in Biomira common stock (with registration rights) of U.S. $10 million is due upon regulatory approval of a ProlX product in a major market. Finally, under certain circumstances, ProlX shareholders may also receive a share of revenue from a potential collaboration agreement for a ProlX product in a specified non-oncology indication.
ProlX Products in Development
PX-12 is an inhibitor of thioredoxin. Increased thioredoxin levels in cancer cells have been linked to the aggressive proliferation of solid tumors, including colon, lung, and gastric cancers. PX-12 is currently being evaluated in a phase 1b trial in patients with advanced gastrointestinal cancers. A randomized phase 2 trial comparing two dose levels of PX-12 in patients with advanced pancreatic cancer who have progressed on gemcitabine or a gemcitabine containing regimen is expected to start in the current quarter. An initial phase 1 trial involving 38 patients with advanced metastatic cancer showed that PX-12 was well tolerated and produced a decrease in plasma concentrations of thioredoxin that was significantly correlated with increased patient survival. Seven of the 38 patients achieved stable disease of up to 322 days.
PX-478 is an inhibitor of hypoxia inducible factor-1a (HIF-1a), a protein responsible for initiating the process of tumor blood vessel growth, or angiogenesis. PX-478 is the first direct inhibitor of this protein to be described. PX-478 is effective when delivered orally, and has shown marked tumor regressions and growth inhibition in model systems across a range of cancers, including ovarian, renal, prostate, colon, pancreatic, and breast cancer. PX-478 is in late stage pre-clinical development and is expected to begin its first clinical trial in the first half of 2007.
PX-866 is an inhibitor of the phosphatidylinositol-3-kinase (PI-3-kinase)/PTEN/Akt pathway, an important survival signaling pathway that is activated in many types of human cancer. PI-3-kinase is over expressed in a number of human cancers, especially ovarian, colon, head and neck, urinary tract, and cervical cancers, where it leads to increased proliferation and inhibition of apoptosis. The PI-3-kinase inhibitor PX-866 induces prolonged inhibition of tumor PI-3-kinase signaling following both oral and intravenous administration and has been shown to have good in vivo anti-tumor activity in human ovarian and lung cancer, as well as intracranial glioblastoma, tumor models. PX-866 is in late pre-clinical development.
PX-316 is the first in a new class of chemical inhibitors of Akt-mediated survival signaling, has shown anti-tumor activity in animal models of colon and breast cancer, and is undergoing more extensive pre-clinical development.
Formerly known as BLP25 Liposome Vaccine (L-BLP25), Stimuvax® is a synthetic MUC1 peptide vaccine. Stimuvax® incorporates a 25-amino acid sequence of the MUC1 cancer mucin, encapsulated in a liposomal delivery system. The liposome enhances recognition of the cancer antigen by the immune system and facilitates better delivery. Stimuvax® is designed to induce an immune response to cancer cells. In a phase 2b trial conducted by Biomira in patients with Stage IIIb and IV non-small cell lung cancer, the median survival in the subset of patients with locoregional Stage IIIB disease was 30.6 months for patients receiving Stimuvax, compared with 13.3 months for patients in the control arm. A phase 3 trial of Stimuvax in patients with Stage III non-small cell lung cancer is expected to begin by year end. The trial will be conducted by Merck KGaA of Darmstadt, Germany, under terms of a licensing arrangement with Biomira.
ProlX Pharmaceuticals Corporation is a private biotechnology company located in Tucson, AZ and Houston, TX, dedicated to the discovery of novel therapies for the treatment of cancer. The Company's small molecule drug pipeline and discovery efforts target redox and survival signaling pathways.
Biomira is a biotechnology company specializing in the development of innovative therapeutic approaches to cancer management. Biomira's commitment to the treatment of cancer currently focuses on the development of synthetic vaccines and novel strategies for cancer immunotherapy.
This release may contain forward-looking statements. Various factors could cause actual results to differ materially from those projected in forward-looking statements, including those predicting the timing, duration and results of clinical trials, particularly the phase 3 clinical trial of L-BLP25 and the possible additional phase 2 trials for its use in other indications, trial reviews and analyses and regulatory reviews, the safety and efficacy of the product, the ability to secure and manufacture vaccine supplies and the resolution of a recent manufacturing problem by an outside vendor of the vaccine, and the ability of Biomira to acquire new pipeline product candidates. Although the Company believes that the forward-looking statements contained herein are reasonable, it can give no assurance that the Company's expectations are correct or that the Company will have sufficient resources to fund clinical trials and in-license new product candidates. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.
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