October 1, 2010
AVEO Pharmaceuticals’ Tivozanib Featured at Ninth International Kidney Cancer Symposium
Tivozanib Clinical Data and Pipeline Overview Presented
CAMBRIDGE, Mass., Oct 01, 2010 (BUSINESS WIRE) — AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO), a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced that previously reported results from its Phase 2 study evaluating tivozanib for the treatment of advanced renal cell carcinoma (RCC) will be presented at the Ninth International Kidney Cancer Symposium (IKCS) in Chicago, Illinois, October 1-2, 2010. Additionally, data from an ongoing Phase 1b trial evaluating tivozanib in combination with temsirolimus (Torisel(R)), an approved mTOR inhibitor, in patients with RCC will be presented at the meeting.
“The Kidney Cancer Association has made tremendous strides in their effort to improve the treatment and care of patients living with kidney cancer, and we are honored to have the opportunity to share tivozanib clinical data with key constituents of the kidney cancer community,” said William Slichenmyer, M.D., Sc.M., chief medical officer at AVEO. “We believe that there is an urgent need for a differentiated kidney cancer therapy with strong efficacy and favorable tolerability, and we look forward to continued collaboration with the Kidney Cancer Association, clinicians and patients as we make efforts to advance tivozanib toward regulatory approval.”
The Phase 2 clinical trial evaluated tivozanib in 272 patients with advanced RCC. Data showed that the median PFS achieved by patients with advanced clear cell RCC who had undergone a prior nephrectomy was 14.8 months – comparing favorably to historical data from trials testing other currently approved multikinase inhibitors in RCC. Hypertension was the most commonly reported treatment-related adverse effect, and was observed in 50% of treated patients. Development of hypertension was directly associated with improved clinical outcomes among patients overall and in the subset of patients with clear cell RCC who had undergone a prior nephrectomy. Off-target toxicities commonly associated with other targeted therapies, such as mucositis, fatigue and hand-foot syndrome, were notably low in the tivozanib group, which AVEO believes underscores a potential tolerable safety profile and potential for combinability with other therapeutic agents.
“A growing body of evidence suggests that tivozanib is highly differentiated in its ability to potently and selectively target VEGF, which may result in favorable tolerability, increased combinability and extended median progression-free survival in patients,” said Thomas E. Hutson, D.O., Pharm.D., Baylor University Medical Center, Sammons Cancer Center, Dallas, and the co-primary investigator for TIVO-1, AVEO’s Phase 3 tivozanib trial in advanced kidney cancer. “TIVO-1, the first-ever Phase 3 study in RCC designed to evaluate superiority in a head-to-head comparison against a widely prescribed anti-angiogenesis therapy in first-line treatment, has been designed to equip oncologists with the information necessary to make the most appropriate treatment decisions for their patients battling kidney cancer.”
Results from a Phase 1 clinical study evaluating tivozanib in combination with the mTOR inhibitor temsirolimus (Torisel), a rapamycin pro-drug, in patients with advanced kidney cancer will be presented in an oral session by Fairooz Kabbinavar, M.D., professor of medicine and urologic oncology, Henry Alvin and Carrie L. Meinhardt chair in Kidney Cancer Research, director, Hematology-Oncology Fellowship Program, medical director, Thoracic Oncology and Kidney Cancer Programs, David Geffen School of Medicine, University of California, Los Angeles. Study results showed tumor shrinkage in 12 out of 16 patients evaluated, and two partial responses as assessed by RECIST criteria. The combination was well-tolerated with no dose limiting toxicities (DLT).
Murray Robinson, Ph.D., senior vice president, translational medicine at AVEO, will also be making a presentation titled, “Tivozanib: clinical progress and response biomarkers,” highlighting AVEO’s ongoing tivozanib clinical research efforts, and the company’s commitment to exploring how protein biomarker research may help clinicians determine optimal treatment combinations for patients battling kidney cancer and other tumor types.
“Understanding how predictive biomarkers fit into the kidney cancer landscape, and how they may help inform optimal treatment decisions for patients, is new and exciting ground for us in the oncology medical community,” added Dr. Hutson. “I applaud AVEO’s research efforts, and the company’s goal of further advancing our understanding of how biomarkers may ultimately improve the treatment and care of patients living with kidney cancer.”
AVEO recently completed patient enrollment in TIVO-1, a global Phase 3 clinical trial of tivozanib in patients with advanced RCC who have not received prior VEGF-targeted therapy. Initiated in February of this year, TIVO-1 successfully reached the target enrollment of 500 patients in August 2010, ahead of schedule.
TIVO-1 is evaluating the efficacy of tivozanib compared to Nexavar(R) (sorafenib), an FDA and EMA approved therapy for RCC. Tivozanib is the only therapy currently in late-stage development for first-line treatment of kidney cancer. The primary endpoint of the trial is to compare the progression-free survival (PFS) of tivozanib vs. Nexavar. Secondary endpoints include overall survival, objective response rate, safety and quality of life. Patients who demonstrate disease progression during treatment with Nexavar will have the opportunity to be treated with tivozanib by participating in a separate long-term treatment protocol. This trial is being led by Robert Motzer, M.D. from the Memorial Sloan-Kettering Cancer Center. Topline efficacy data are expected mid-2011.
Tivozanib, an investigational new drug, is a highly potent and selective inhibitor of VEGF receptors 1, 2 and 3, exhibiting picomolar inhibitory activity against all three receptors. Due to its potency and specificity, AVEO believes tivozanib may enable optimal inhibition of the VEGF pathway, while minimizing side effects associated with off-target activity. Such a profile may enable tivozanib to be more readily combined with standard chemotherapy as well as other targeted therapies, potentially increasing the breadth of its clinical utility. The European Medicines Agency has granted AVEO orphan medicinal product designation for tivozanib for the treatment of RCC.
AVEO recently completed patient enrollment ahead of schedule in TIVO-1, a global, randomized (1:1), controlled Phase 3 clinical trial evaluating tivozanib compared to sorafenib (Nexavar(R)) in patients with RCC. The company has initiated a series of clinical trials evaluating tivozanib in combination with other agents in multiple solid tumor settings, including an ongoing Phase 1b trial in combination with temsirolimus (Torisel(R)), an approved mTOR inhibitor, in patients with metastatic renal cell carcinoma; a Phase 1b trial in combination with the FOLFOX6 chemotherapy regimen in patients with advanced colorectal cancer and other gastrointestinal cancers; and, a Phase 1b trial in combination with paclitaxel (Taxol(R)) in patients with metastatic breast cancer. A Phase 1b trial evaluating tivozanib as monotherapy in patients with non-small cell lung cancer is also being conducted.
AVEO is also utilizing its Human Response Platform(TM) in its efforts to help identify rational drug combinations and patient populations most likely to be responsive to these combination therapies.
AVEO Pharmaceuticals (NASDAQ: AVEO) integrates a proprietary cancer biology platform with drug development and commercial expertise in its efforts to discover and develop targeted cancer therapeutics. The company’s lead product, tivozanib, is an oral, triple VEGF receptor inhibitor with a highly differentiated profile. Tivozanib is currently being investigated in a global, randomized Phase 3 clinical trial called TIVO-1 comparing tivozanib to sorafenib in advanced kidney cancer, as well as additional clinical studies in other solid tumor types. AVEO’s proprietary, integrated cancer biology platform offers the company a unique advantage in oncology drug development and has provided a discovery engine for high-value targets. This approach has resulted in a promising pipeline of monoclonal antibodies against novel targets including HGF, ErbB3, RON, Notch and FGFR. For more information, please visit the company’s website at www.aveopharma.com.
Any statements in this press release about our future expectations, plans and prospects, including statements about our continued collaboration with the Kidney Cancer Association, clinicians and patients; theadvancement of tivozanib toward potential regulatory approval;tivozanib’s potentially tolerable safety profile and potential for combinability with other therapeutic agents; TIVO-1’s ability to equip oncologists with the information necessary to make appropriate treatment decisions; clinical evidence suggesting that use of tivozanib may result in favorable tolerability, increased combinability and extended median progression-free survival; our contribution to the advancement of understanding of how biomarkers may ultimately improve the treatment and care of patients living with kidney cancer and how protein biomarker research may help clinicians determine optimal treatment combinations; our cancer biology platform offering a unique advantage in oncology drug development, and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: our ability to successfully research, develop and obtain and maintain regulatory approvals for AV-299 and tivozanib,tivozanib and our other product candidates; the possibility that favorable data from our Phase 1 clinical trials of AV-299 may not be predictive of the results in our future clinical trials; delays in data availability, or negative results from our Phase 2 clinical trial of AV-299; our inability to obtain and maintain adequate protection for intellectual property rights relating to our product candidates and technologies; unplanned operating expenses; our inability to raise substantial additional funds to achieve our goals, including with respect to the further development of tivozanib and AV-299; competition; general economic and industry conditions; and other factors discussed in the “Risk Factors” section of our most recent Form 10-Q filed with the Securities and Exchange Commission, and in other filings that we periodically make with the SEC. In addition, the forward-looking statements included in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
SOURCE: AVEO Pharmaceuticals, Inc.
AVEO Pharmaceuticals, Inc.
Monique Allaire, 617-299-5810
Caton Lovett, 910-232-7166