AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO) announced that the first patient has been dosed in the Company’s pivotal TIVO-3 trial, a randomized, controlled, multi-center, open-label study to compare tivozanib to sorafenib in subjects with refractory advanced renal cell carcinoma (RCC). Tivozanib is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI).

The Phase 3 trial is expected to enroll approximately 322 patients with recurrent or metastatic RCC who have failed at least two prior regimens, including VEGFR-TKI therapy (other than sorafenib). Eligible patients may also have received checkpoint inhibitor therapy in earlier lines of treatment. Patients will be randomized 1:1 to receive either tivozanib or sorafenib, with no crossover between arms. The primary endpoint of the study is progression free survival. Secondary endpoints include overall survival, overall response rate, and safety and tolerability. Top line readout of the study is currently projected for the first quarter of 2018.

The TIVO-3 trial, together with the previously completed TIVO-1 trial of tivozanib in the first line treatment of RCC, is designed to support a first and third line indication for tivozanib in the U.S. Marketing authorization applications seeking approval of tivozanib as a treatment for first line renal cell cancer are currently pending in Europe and Russia based on applications submitted by AVEO’s partners EUSA Pharma and Pharmstandard in those respective territories.

“While significant advances have been made in the treatment of renal cancer, there remains a need for effective yet more tolerable treatments, both for single agent and combination use,” said Brian Rini, M.D., Professor of Medicine at the Cleveland Clinic Lerner College of Medicine. “In past studies, tivozanib has demonstrated a unique tolerability profile among VEGF targeted therapies, owing to its high selectivity for the VEGF pathway, that have resulted in fewer dose interruptions or reductions. I am pleased to see tivozanib return to the clinic, with the goal of better understanding its single agent potential through TIVO-3, and I look forward to realizing its potential for combination use with checkpoint inhibitors in future studies.”

“Launch of the pivotal TIVO-3 trial marks a vital step forward for our North American development and registration strategy for tivozanib, and is a defining moment in the turnaround story unfolding at AVEO,” said Michael Bailey, president and chief executive officer of AVEO. “In less than 18 months, we have meaningfully progressed our defined clinical development and regulatory paths forward for tivozanib in the US and Europe, executed multiple partnerships to advance and de-risk our pipeline while retaining substantial North American rights to our three oncology therapeutic assets, and strengthening our balance sheet. We look forward to diligently executing on this study, and to a number of potential value creating milestones, including those that could arise from tivozanib approval decisions, in the quarters ahead.” (Original Source)

Shares of AVEO Pharmaceuticals closed yesterday at $0.9176, up $0.04 or 4.21%. AVEO has a 1-year high of $2.90 and a 1-year low of $0.82. The stock’s 50-day moving average is $0.94 and its 200-day moving average is $1.02.

On the ratings front, AVEO Pharma has been the subject of a number of recent research reports. In a report issued on May 19, Piper Jaffray analyst Jason Deleeuw initiated coverage with a Buy rating on AVEO. Separately, on May 13, FBR’s Vernon Bernardino reiterated a Buy rating on the stock and has a price target of $3.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason Deleeuw and Vernon Bernardino have a total average return of 6.6% and -16.1% respectively. Deleeuw has a success rate of 68.1% and is ranked #653 out of 3869 analysts, while Bernardino has a success rate of 34.0% and is ranked #3841.

AVEO Pharmaceuticals, Inc. operates as a biopharmaceutical company dedicated to advancing a broad portfolio of targeted therapeutics for oncology and other areas of unmet medical need. Its proprietary human response platform provides the company unique insights into cancer and related disease biology and is being leveraged in the discovery and clinical development of its therapeutic candidates. The company’s product candidates include AV-203, ficlatuzumab, tivozanib and AV-380. AVEO Pharmaceuticals was founded by Ronald A. DePinho, Lynda Chin and Kenneth E. Weg on October 19, 2001 and is headquartered in Cambridge, MA.