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Sorafenib

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Sorafenib (sorafenib tosylate) Tablets, a novel investigational agent, is the first oral multi-kinase inhibitor that targets kinases in both the tumor cell and its vasculature. In preclinical models, Sorafenib blocked kinases known to be involved in proliferation (tumor growth) and angiogenesis (tumor blood supply) - two important cancer growth activities. These kinases included RAF kinase, VEGFR-2, VEGFR-3, PDGFR-иж?, KIT, FLT-3, and RET.

1. Sorafenib New Drug Application - 11 July 2005, for detail information, please click here!!!!

2. Bayer and Onyx Announce FDA Acceptance of New Drug Application for Sorafenib for Individuals with Advanced Renal Cell Carcinoma (14 September 2005) For detail information please click here !!!!! Information!

3. Investigator Presents Update on Phase III Sorafenib Trial in Patients with Advanced Kidney Cancer. For detail information, please Click here!!!

European Cancer Conference in Paris

Bayer Pharmaceuticals Corporation (NYSE: BAY) and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX)
announced that Dr. Bernard Escudier provided an update on the Sorafenib Phase III trial in patients with advanced renal cell carcinoma (RCC), or kidney cancer, during the thirteenth European Cancer Conference (ECCO). Dr. Escudier reported, based on an interim analysis, that there was an estimated 39 percent improvement in survival for patients receiving Sorafenib versus those receiving placebo (p=0.018, hazard ratio 0.72).

Phase III Summary
In June 2005, Dr. Escudier presented data from the same study, which demonstrated that Sorafenib significantly prolonged progression-free survival. As independently reviewed, progression-free survival was doubled to a median value of 24 weeks in patients who received Sorafenib as compared to 12 weeks for patients receiving placebo (p < 0.000001). In addition, 74 percent of Sorafenib patients had tumor shrinkage as compared to 20 percent of placebo patients.

Based on the statistical and clinical significance of the progression-free survival data, Bayer and Onyx filed a New Drug Application (NDA) in July 2005 requesting approval in advanced renal cell cancer by the U.S. Food and Drug Administration (FDA). Subsequently, the FDA granted the Sorafenib filing priority review status, which means the agency will review the application with a goal of taking action within six months of receipt of the NDA. Additionally in September 2005, a Marketing Authorization Application (MAA) was submitted to the European Medicines Agency (EMEA) to market Sorafenib in Europe.

In the Phase III trial, the rate of significant adverse events (grade 4) was comparable for patients receiving Sorafenib or placebo. Grade 3 adverse events were modestly elevated in the Sorafenib-treated group (31 percent) as compared to placebo patients (22 percent). Drug-related adverse events (all grades) were consistent with those observed in previous clinical trials and included: rash, diarrhea, hand foot syndrome, hair loss, itching, nausea, hypertension, and fatigue.

Other report about sorafenib as following:

1. Sorafenib offers hope in the battle for liver cancer survival

The outlook for hepatocellular carcinoma (HCC) sufferers is bleak - current medication has a five-year survival rate for those with liver cancer of less than 5% in the developed world and even lower in developing countries. However, patients in trials of a new drug called Sorafenib have seen their survival times double. Datamonitor's Dr Lorna Fern investigates...

Liver cancer is currently the fifth most common cancer in the world, responsible for about one million cases and half a million deaths globally every year. HCC is a tumor of the liver that arises from focal scarring points in cirrhotic liver tissue, and its global incidence is on the increase, concurrent with a global increase in the number of cases of viral hepatitis and of alcoholic cirrhosis in developed countries.

Some specialists have described it as a 'waiting epidemic'. In the US alone there has been a three-fold increase in the incidence of HCC over the last decade. Similar trends have been seen in four other pharmaceutical markets including the United Kingdom, France and Canada.

Bleak outlook

Furthermore, opinion leaders predict that the full effect of hepatitis B (HBV) vaccination programs will not be felt for another 10-15 years. There is no hepatitis C (HCV) vaccine and the effect of blood screening programs introduced in the 1990s will not curb the rising incidence of HCV-related HCC for at least two decades.

The effects of binge drinking on the increasing incidence of HCC remains to be seen. However, today's binge drinking culture has already been linked to an increase in liver cirrhosis in developed countries, and thus may in turn increase the numbers of HCC cases. Studies have found that liver cirrhosis is becoming a major public health concern in the UK, and it is affecting men and women at younger ages than ever seen before. Datamonitor predicts the incidence of HCC will continue to increase resulting in a large, clinically underserved patient population.

The treatment of liver cancer presents a formidable challenge to physicians as it frequently presents in the setting of liver cirrhosis. HCC is often described as two diseases in one - a virulent malignant disorder arising in the setting of chronic liver disease. Between 70-90% of HCC patients will have liver cirrhosis at the time of diagnosis.

The problem in patients with liver cirrhosis is that the cirrhosis itself severely compromises liver function. This increases the toxicity of anticancer drugs as the pivotal role that the liver plays in their detoxification and removal is diminished. Indeed it is often the condition of the remaining liver that dictates the final treatment options.

HCC patients not only require effective agents to treat the tumor, but there is also significant unmet need for drugs that will stabilize and treat the underlying liver disease. Surgical resection of the primary tumor or liver transplantation are the only potentially curative options for HCC patients. However, because it is complicated by underlying liver cirrhosis, only 10% of patients are eligible for surgery.

Current chemotherapy agents only offer a modest response rate of up to 20% at best, with no significant benefit to the overall survival rate.

New therapies to capitalize on unmet need

Any new therapy for HCC will gain rapid up take if it shows even a modest increase in efficacy or reduction in toxicity over current regimes. Bayer's Sorafenib has shown potential in early trials to double patient survival time through its novel mechanism of action that cuts off blood supply to the cancer cells.

The demonstrated increase in survival time with Sorafenib is significant in HCC patients as current therapeutic options offer a modest four months survival with considerable toxicity. For HCC patients Sorafenib doubles this survival time to approximately 9 months, and, although this could be described as only a minor improvement for HCC patients, Sorafenib's favorable toxicity profile makes this drug even more appealing, Furthermore the additional time gained for patients to spend with their families and loved ones is invaluable.

Although this is exciting data it needs to be confirmed in larger trials, which are planned. Assuming trials with Sorafenib continue to go well, Datamonitor expects it to hit the US market in 2006.

In the meantime, Eximias Pharmaceutical's Thymitaq and Amgen's T67 are the only agents currently in phase III trials for HCC, however, opinion leaders predict that while these agents provide alternatives to current therapy options they would be unlikely to provide significant improvement in survival for HCC patients. There is optimism that innovative-targeted therapies, which target pathways critical to cancer cell survival, such as Sorafenib, hold promise for HCC patients. Well designed controlled trials of these agents in HCC patients are warranted.

2. Sorafenib Shows Benefits in Combination with Gemcitabine in Recurrent Epithelial Ovarian Cancer: Presented at AACR-NCI-EORTC

By Maggie Schwarz

PHILADELPHIA, PA -- November 22, 2005 -- A phase 2 study is evaluating the efficacy and toxicity associated with the use of sorafenib plus gemcitabine in patients with recurrent epithelial ovarian cancer.

In a presentation here on November 16th, Amit Oza, MD, Associate Professor of Medicine, Princess Margaret Hospital, University of Toronto, Toronto, Canada, discussed the study.

Sorafenib (BAY 43-9006) is a novel multi-targeted tyrosine kinase inhibitor that targets the RAF/MEK/ERK signaling pathway, vascular endothelial growth factor (VEGF) receptor, platelet derived growth factor receptor, and flt-3.

Phase 1 studies previously demonstrated the safety and tolerability of sorafenib in combination with gemcitabine, with preliminary activity seen in recurrent ovarian cancer.

VEGF is over-expressed in human ovarian tumours and is associated wit poor prognosis and development of ascites, Dr. Oza said. Gemcitabine is known to have single-agent activity in recurrent ovarian cancer. Therefore, sorafenib and gemcitabine are thought to make a rational therapeutic strategy for combination in recurrent ovarian cancer.

The ongoing phase 2, two-stage clinical trial is assessing the activity of sorafenib 400 mg BID administered continuously in combination with gemcitabine 1000 mg/m2 weekly.

Cycle 1 consists of gemcitabine administration for 7 weeks followed by a 1-week break, then weekly administration for the first 3 weeks of each subsequent 4-week cycle.

Twenty-five patients have been enrolled to date; 21 are evaluable for toxicity having received 42 cycles of treatment, and nine are evaluable for response.

Of patients evaluable for objective response, one patient has had a confirmed partial response and eight have had disease stabilization. These nine patients received a median of five cycles of treatment (range, one to 10 cycles).

Five patients are not evaluable for objective response; two patients had symptomatic disease progression in cycle 1, two patients withdrew consent in cycle 1 and one patient had a grade 3 bowel obstruction in cycle 1.

Grade 3 toxicities that have been seen in more than two patients to date are lymphopenia (n = 6), thrombocytopenia (n = 5), hand-foot syndrome (n = 3), pain (n = 3) and hypokalemia (n = 3).

Dr. Oza presented the study at the International Conference on Molecular Targets and Cancer Therapeutics, organized jointly by the American Association for Cancer Research, the National Cancer Institute, and the European Organisation for Research and Treatment of Cancer (AACR-NCI-EORTC).