Research Desk Line-up: Forward Pharma Post Earnings Coverage
LONDON, UK / ACCESSWIRE / October 9, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO) ("AVEO"), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=AVEO. The Company announced on October 05, 2017, the completion of its pre-planned futility analysis of the Phase-3 TIVO-3 trial, which is a randomized, controlled, multi-center, open-label study to compare FOTIVDA (Tivozanib) to Sorafenib in subjects with refractory advanced renal cell carcinoma (RCC). The futility analysis will bear no changes in the study protocol. For immediate access to our complimentary reports, including today's coverage, register for free now at:
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About Tivozanib (FOTIVDA)
Tivozanib is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI). Kyowa Hakko Kirin discovered Tivozanib which was subsequently approved for the treatment of adult patients with advanced renal cell carcinoma in the European Union plus Norway and Iceland. It is a potent, selective, and long half-life inhibitor of all three VEGF receptors. It has been specifically designed to optimize VEGF blockage while minimalizing off-target toxicities. This results in improved efficacy as well as minimal dose modifications. As of now, Tivozanib has been investigated in numerous tumors types, such as renal cell, colorectal, and breast cancers.
About TIVO-3 Trial
The TIVO-3 trial has enrolled patients with recurrent RCC who have failed at least two prior regimens, including VEGFR-TKI therapy. These eligible patients could have also received checkpoint inhibitor therapy in earlier lines of treatment. Patients are selected on 1:1 random basis to take either Tivozanib or Sorafenib, with no crossover between arms. The primary endpoint of the study is progression free survival while secondary endpoints comprise overall survival, overall response rate, as well as safety and tolerability.
About the TiNivo trial
The TiNivo trial is a Phase-1/2 study of Tivozanib in combination with Bristol-Myers Squibb's OPDIVO® (nivolumab), an immune checkpoint, or PD-1, inhibitor, for the treatment of RCC. Paris-based Institut Gustave Roussy is leading the TiNivo trial, under the guidance of Bernard Escudier, MD, and Chairman of the Genitourinary Oncology Committee. Post the successful completion of the Phase-1 dose escalation phase, the trial has now advanced into the Phase-2 expansion phase, which would probably enroll 20 additional subjects. The results from the ongoing Phase-1 study have been submitted for presentation at a scientific meeting, scheduled to take place in the fourth quarter of this year. As per the results, the combination was well tolerated to the full dose and schedule of single-agent Tivozanib, with no dose-limiting toxicities.
About the Futility Analysis
An independent statistician has reviewed the futility analysis. As per its results, the study would continue as planned without any modification. In fact, the analysis did not permit early stopping due to efficacy to guarantee suitable follow-up for the key secondary endpoint of overall survival. The reporting of 128 progression events in early August this year was the main trigger for this pre-planned futility analysis. Moreover, additional events recorded as a part of the data management process, which led to the futility analysis, resulted in a revised data cut-off date for the analysis of May 29, 2017.
CEO's Comments on Tivozanib's Efficacy and TIVO-3 Study Results
Michael Bailey, President and Chief Executive Officer (CEO) of AVEO, stated that currently the treatment of advanced renal cell cancer is rapidly changing, with immunotherapy and combination regimens providing improved outcomes for patients. This is, in turn, shaping a new treatment paradigm. Bailey believes that AVEO's Tivozanib clinical strategy places it well in the ever-evolving industry landscape, especially when the TIVO-3 study is on track for providing the first post-immunotherapy pivotal datasets for a VEGF-TKI. Moreover, the TiNivo study is also set for providing early and encouraging combination data. The TIVO-3 trial, along with the formerly completed TIVO-1 trial of Tivozanib in the first line treatment of RCC, is designed to back the regulatory approval of Tivozanib in the US as a first and third line treatment for RCC.
Bailey also shared that he looks forward to readout of the TIVO-3 trial in the first quarter of 2018. Likewise, AVEO intends to present Phase-1 results from the Phase-1/2 TiNivo study of Tivozanib in combination with OPDIVO® at a medical conference this fall. More importantly, the Company would continue to work towards leveraging Tivozanib's unique safety and efficacy profile in future potential therapy combinations.
About AVEO Pharmaceuticals, Inc.
AVEO is a leading biopharmaceutical Company that works towards developing a broad portfolio of targeted therapeutics for oncology and other areas of unmet medical need. The Company seeks to develop and commercialize its lead candidate Tivozanib in North America as a treatment for renal cell carcinoma as well as other cancers. It is leveraging multiple partnerships for developing and commercializing Tivozanib in oncology indications outside of North America as well, and also at progressing its pipeline of novel therapeutic candidates in cancer and cachexia (wasting syndrome).
Last Close Stock Review
On Friday, October 06, 2017, the stock closed the trading session at $3.84, falling 2.78% from its previous closing price of $3.95. A total volume of 6.82 million shares have exchanged hands, which was higher than the 3-month average volume of 5.58 million shares. AVEO Pharma's stock price soared 21.90% in the last three months, 553.06% in the past six months, and 346.56% in the previous twelve months. Furthermore, since the start of the year, shares of the Company have skyrocketed 611.11%. At Friday's closing price, the stock's net capitalization stands at $453.12 million.
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