Thallion Pharmaceuticals Inc. (TSX: TLN) announced today that it presented a scientific poster on its Phase II renal cell carcinoma clinical trial of TLN-232 at the 33rd European Society for Medical Oncology (ESMO) Congress held September 12-16, 2008 in Stockholm, Sweden.
The Company’s poster entitled Phase II Study of TLN-232, A Novel M2PK Targeting Agent, Administered by CIV to Patients with Advanced Renal Cell Carcinoma, was presented September 13, 2008 at the conference and discusses the anti-cancer activity, safety and pharmacokinetic data observed from the study. A copy is available on the Company’s website, www.thallion.com.
Ten patients were enrolled in this open label, single arm Phase II trial for patients with treatment-refractory advanced renal cell carcinoma. The results demonstrate that TLN-232 was generally safe and well tolerated. Of the three patients that completed three cycles of treatment, two patients demonstrated stable disease. Pharmacokinetics showed that the drug rapidly reached steady state levels at 320 ng/mL and was eliminated rapidly following the end of infusion. There was no observed accumulation of drug following multiple cycles of treatment.
The study evaluated a new formulation of TLN-232 administered via a novel route, a continuous intravenous regimen that was based on animal studies suggesting that continuous drug exposure represents a more effective treatment than intermittent exposure. Each cycle consisted of 0.48 mg/kg/day continuous infusion of TLN-232 for 21 days followed by one week of rest.
TLN-232 has a unique feature as it induces apoptosis, cell death, in cancer cells through the M2 isoform of pyruvate kinase (M2PK). Thallion’s studies suggest that the TLN-232’s anti-cancer activity is mediated through a novel mechanism involving the translocation of M2PK into the cancer cell nucleus, resulting in cell death. Earlier this year two peer-reviewed articles in the journal Nature described the importance of M2PK in cancer metabolism and tumor growth. The articles stated that M2PK mediates the Warburg effect, a process in which most cancer cells shift their cellular metabolism to aerobic glycolysis rather than use oxidative phosphorylation, which is typical of normal cells.
M2PK is expressed in a broad range of cancer cells, including kidney cancer, and an effective therapy that targets M2PK, like TLN-232, could have potential efficacy in multiple oncology indications. Thallion recently initiated a Phase II study to evaluate TLN-232 as a potential therapy for metastatic melanoma.
About TLN-232
TLN-232 is a novel seven amino-acid peptide with potential efficacy in multiple oncology indications and targets pyruvate kinase M2 (M2PK), a protein shown to be over-expressed in a number of different tumor types. The expression of M2PK during tumourigenesis has been shown recently to mediate the Warburg effect, a phenotype in which cancer cells utilize the glycolytic pathway to a far greater extent than do their non-malignant counterparts.
About Thallion Pharmaceuticals Inc.
Thallion Pharmaceuticals Inc. (TSX: TLN) is a biotechnology company developing pharmaceutical products in the areas of oncology and infectious disease. Thallion has three clinical programs at a Phase II, or later, stage of development. Two late stage Phase II oncology trials which include: TLN-4601, a novel anti-cancer therapy derived from a nonpathogenic microorganism and TLN-232, a targeted therapy with potential efficacy in multiple oncology indications. The Company’s third product candidate, Shigamabs(R), is a dual antibody product for the treatment of Shigatoxin-producing E. coli bacterial infections. Additional information about the Company can be obtained at
www.thallion.com.
About European Society for Medical Oncology Congress
The European Society for Medical Oncology (ESMO) Congress is one of the foremost multidisciplinary oncology events worldwide attracting medical, radiation and surgical oncologists, preclinical researchers and professionals from related specialties to a major European event. It is organized through the European Society for Medical Oncology (ESMO), the leading European non-profit professional organization for medical oncology, with a focus on promoting multidisciplinary cancer treatment around the world. For more information about the ESMO Congress, contact the Congress Department at [email protected].
Forward-Looking Statements
This press release contains certain forward-looking statements, including, without limitation, statements containing the words “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect” and other similar expressions which constitute “forward-looking information” within the meaning of applicable Canadian securities laws. Forward-looking statements reflect the Company’s current expectation and assumptions, and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated. These forward-looking statements involve risks and uncertainties including, but not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time-to-time in the Company’s ongoing filings with the Canadian securities regulatory authorities which filings can be found at www.sedar.com. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. The Company undertakes no obligation to publicly update or revise any forward-looking statements either as a result of new information, future events or otherwise, except as required by applicable Canadian securities laws.
Contacts: Thallion Pharmaceuticals Inc. Michael Singer Chief Financial Officer 514-940-3600 514-228-3622 (FAX) [email protected]www.thallion.com The Equicom Group Inc. Ross Marshall Investor Relations 416-815-0700 Ext. 238 416-815-0080 (FAX) [email protected]
SOURCE: Thallion Pharmaceuticals Inc.
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