LONDON, UK / ACCESSWIRE / January 23, 2018 / Active-Investors.com has just released a free research report on AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO) ("AVEO"). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=AVEO as the Company's latest news hit the wire. On January 19, 2018, the Company, which is a biopharmaceutical organization dedicated towards developing targeted therapeutics for oncology and other areas of unmet medical need, declared that it has presented positive results from the Phase-1b/2 study of FOTIVDA® (tivozanib) for patients with advanced, unresectable hepatocellular carcinoma (HCC). Register today and get access to over 1000 Free Research Reports by joining our site below:
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Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, AVEO Pharmaceuticals most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:
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AVEO presented the data in a poster session titled ‘Phase-1b/2 study of tivozanib in patients with advanced inoperable hepatocellular carcinoma' (Abstract #364) at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium 2018, held from January 18 to January 20, 2018, in San Francisco. The shares of AVEO were up on 30% higher volume in response to this development.
HCC, Third Leading Cause of Cancer Deaths
HCC is a primary malignancy of the liver that mostly occurs in patients with underlying chronic liver disease and cirrhosis. The origin cells are known to be the hepatic stem cells, although this remains the subject of investigation. In case of HCC, tumors progress with local expansion, intrahepatic spread, and distant metastases.
HCC now affects more than 500,000 people and has become the third leading cause of cancer deaths worldwide. Its incidence is highest in Asia and Africa, as the high prevalence of hepatitis B and hepatitis C leads to development of chronic liver diseases and subsequent development of HCC.
About FOTIVDA® (tivozanib)
AVEO's lead candidate FOTIVDA® (tivozanib) is an oral, once daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) discovered by Kyowa Hakko Kirin. Tivozanib has been approved for the treatment of adult patients with advanced renal cell carcinoma in the European Union, Norway, and Iceland. It is a potent, selective, and long half-life inhibitor of all three VEGF receptors, which has been specifically designed to optimize VEGF blockade while minimizing off-target toxicities, which leads to improved efficacy and minimal dose modifications. Up till now, tivozanib has been investigated in many tumors types such as renal cell, colorectal, and breast cancers.
Study Design
The study has been designed to assess the safety and efficacy of tivozanib in advanced HCC. The study enrolled a total of 21 patients at three study sites. The Phase-1b portion used a modified 3+3 dose escalation design wherein 8 patients were dosed with tivozanib starting at 1.0 mg daily for 21 days, followed by 7 days off drug, with inter-patient escalation to 1.5 mg daily or de-escalation to 0.5 mg daily based on cumulative dose-limiting toxicities (DLT). It must be noted that the Phase-1b/2 study was one of several studies funded by AVEO's grant to the National Comprehensive Cancer Network.
Study Findings
- In the study, tivozanib was generally well tolerated at 1.0 mg daily, with adverse events consistent with those observed in previous tivozanib trials.
- The median progression-free survival (PFS) in 19 evaluable patients, at week 24, was 5.5 months and 47% (n=9/19) had stable disease.
- The disease control rate (DCR) for responders plus those with stable cancer was 63% (n=12/19). This included a partial response (PR) in 4/19 patients (21%) and stable disease (SD) in 8/19 patients (42%). Moreover, four patients have remained progression-free for over two years. Overall survival (OS) at 6 and 12 months was 58% and 25%, respectively, with a median OS of 7.5 months.
- When the dosage was increased to 1.5 mg, two patients had on target dose limiting toxicities (i.e. grade 3 mucositis and hypertension) and came off study without completing the DLT period. This happened due to the high potency of tivozanib.
- It must be noted that there were no significant changes in HBV or HCV viral load during study treatment.
A Significant Development for HCC Patients
At present, there are only a few therapies for increased levels of hepatotoxicity and thus advanced HCC represents an area of high unmet medical need. This study validates that low doses of tivozanib could yield comparable PFS and a favorable response rate to current first line standards of care for HCC patients. It also demonstrates tivozanib's favorable safety profile, which may enable therapeutic combinations with immunotherapy. AVEO intends to initiate the clinical investigation of the combination of VEGF and checkpoint inhibition for the treatment of HCC. The Company looks forward to reporting preliminary Phase-2 data from the TiNivo combination trial of tivozanib and nivolumab in the lead indication of renal cell cancer at the forthcoming ASCO GU conference. Alongside, it also plans to explore more options for pursuing similar combinations in HCC.
Stock Performance Snapshot
January 22, 2018 - At Monday's closing bell, AVEO Pharmaceuticals' stock rose 1.37%, ending the trading session at $2.97.
Volume traded for the day: 2.64 million shares, which was above the 3-month average volume of 1.69 million shares.
Stock performance in the last month – up 0.68%; previous six-month period – up 19.76%; past twelve-month period – up 336.89%; and year-to-date - up 6.45%
After yesterday's close, AVEO Pharmaceuticals' market cap was at $350.48 million.
The stock is part of the Healthcare sector, categorized under the Biotechnology industry. This sector was up 0.9% at the end of the session.
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