MediGene Drug Candidate May Extend Pancreatic Cancer Survival

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MediGene, based in Germany, has a new product in late-stage development that may offer hope to patients with inoperable pancreatic cancer. Pancreatic cancer tends to be asymptomatic early on and is usually diagnosed in advanced stages. Thus, patients with pancreatic cancer often have a poor prognosis.

Preliminary results from a mid-stage phase II clinical trial indicates that patients with inoperable pancreatic cancer may live substantially longer when treated with the experimental drug EndoTAG-1 plus chemotherapy. Researchers found overall survival time for patients treated with a combination of EndoTAG-1 and gemcitabine (Gemzar) nearly doubled compared with patients who received gemcitabine monotherapy (13.6 mo vs 7.2 mo). “These results are the best I have ever seen in palliative treatment in pancreatic cancer,” Matthias Loehr, MD, Karolinska Institute, Stockholm, Sweden, told his colleagues at the annual ESMO meeting in Stockholm. A phase III study is being planned, which would be the final stage of testing before the drug could be submitted for approval. A clinical trial evaluating EndoTAG-1 as a treatment for breast cancer is also underway, with results expected in 2009.

According to its manufacturer, EndoTAG-1’s novel mechanism of action distinguishes it from other drugs (such as Avastin) that function similarly. EndoTAG-1 consists of charged particles that bind preferentially to blood vessel cells, after which paclitaxel (Taxol) is released and stops blood vessel growth.

MediGene believes EndoTAG-1 could generate global sales exceeding $1.4 billion a year if it progresses successfully through clinical investigations as a treatment for pancreatic and other types of cancer.

Last month, Reuters reported that Pfizer, Eli Lilly, and Roche have expressed interest in licensing EndoTAG-1. Novartis has also expressed interest in licensing the drug. Novartis hopes to start negotiations and has already obtained basic information, according to one source. Another source reported that Pfizer is considering a full takeover of MediGene.

Final analysis of the phase II study results of EndoTAG-1 in inoperable pancreatic cancer is critical to any licensing deal, and a MediGene spokesperson said these results should emerge in the last quarter of 2008.