New Drug Information: Lucatumumab Anti-CD40 Monoclonal Antibody

Also known as: HCD122

Drug Information: Lucatumumab is one of several experimental anti-CD40 monoclonal antibodies. CD40 is a cellular surface protein involved in immune system signaling, which is present on cancerous B cells. The drug's developer, Novartis, believes that it both blocks proliferation of malignant cells and attracts other immune system cells to attack the cancer. It is given intravenously on a weekly basis for multi-week treatment cycles.

95% of Statistics are Bogus (Including This One)

My own Statistics page still languishes in its unstarted state, but a new article in Science News manages to present, more or less in layman's terms, precisely the sorts of problems that I wanted to highlight for readers here. So in the meantime, it's a useful starting point.

Tom Siegfried explains very well that the scientific method and statistical analysis are not necessarily natural bed-partners, and that even the games we play to make statistics seem "reliable" can end up, in certain cases, actually making them more misleading. Most of this will be old news to people with stats training, but it's still a good refresher. There's also a section specifically on the problems inherent in clinical trials:

Statistical problems also afflict the “gold standard” for medical research, the randomized, controlled clinical trials that test drugs for their ability to cure or their power to harm. Such trials assign patients at random to receive either the substance being tested or a placebo, typically a sugar pill; random selection supposedly guarantees that patients’ personal characteristics won’t bias the choice of who gets the actual treatment. But in practice, selection biases may still occur, Vance Berger and Sherri Weinstein noted in 2004 in Controlled Clinical Trials. “Some of the benefits ascribed to randomization, for example that it eliminates all selection bias, can better be described as fantasy than reality,” they wrote.

Clinical Trial Information: RO4929097 Gamma-Secretase Inhibitor

Trial Information: 40 patients are being recruited for a Phase I study of the experimental new gamma-secretase inhibitor RO4929097 in combination with capecitabine, an oral DNA synthesis inhibitor already used in colon cancer and breast cancer. Eligible patients include those with any metastatic solid tumor cancer or lymphoma.

Clinical Trial Information: AEG35156

Trial Information: 51 patients are being recruited for a Phase I/II trial of the XIAP antisense AEG35156 in indolent lymphomas (including follicular lymphoma) and chronic lymphocytic leukemia (CLL). Patients must meet criteria for third-line treatment (or beyond) to enter the trial.

New Clinical Trial Information: GA101 Monotherapy

Trial Information: 180 patients with relapsed indolent lymphoma, including follicular lymphoma, will be recruited to test GA101 (aka RO5072759) monotherapy. Although this is a Phase II trial, patients will be randomized to receive either GA101 monotherapy or rituximab monotherapy.

New Drug Information: Galiximab

Drug Information: Galiximab is a chimeric human-macaque anti-CD80 monoclonal antibody which targets B-cells, including malignant cells. Blocking this site with antibodies appears to produce a range of anti-cancer effects. It is taken intravenously, weekly for four weeks.

New Drug Information: Bortezomib

Also known as: Velcade

Drug Information: Bortezomib is a proteasome inhibitor, a type of drug which targets structures inside the cell responsible for breaking down proteins. It has been theorized that cancerous cells are particularly vulnerable to this sort of induced dysfunction. It is typically given twice-weekly; weekly regimens were attempted in trials, and had fewer side effects but limited response rates.