According to a press release from Danish biotechnology company Bavarian Nordic, ten individuals with chordomas have been successfully recruited for a Phase 2 study of the drug candidate BN-Brachyury.
About Chordomas
Chordomas or chordomatas are highly rare (affecting about one person out of a million) but aggressive cancerous tumors that occur along the length of the spine. As the tumors grow, they push against the spine and the areas surrounding it, potentially causing a number of serious symptoms that vary depending on where the chordoma has formed.
Chordomas, when they can be treated, often recur chronically over time. In about 40% of cases, chordomas metastasized to other areas of the body – including the lungs. They typically affect older adults, but about 5% of cases are in children. For reasons not yet completely understood by scientists, men are almost twice as likely to develop chordomas than women.
The recurring nature of the tumors, as well as their strong tendency to metastatize, makes chordomas a dire medical concern for anyone affected. Existing treatments show poor success rates – radiation therapy alone yielding a historical objective response rate lower than 5%.
About BN-Brachyury
BN-Brachyury is Bavarian Nordic’s hopeful drug candidate for the treatment of advanced chordoma.
The drug is now set to begin the first part of its phase 2 clinical trial, where ten individuals with chordomas will be treated with a combination of standard radiation therapy and doses of the still-experimental pharmaceutical over the course of a year.
If just one of the ten patients shows an objective response before the end of the first 12-month period, the second part of the phase 2 trial will begin. That involves the recruitment of 19 more individuals, with the goal of producing at least four objective responses over the course of the trial.
Signups for the trial filled up quickly, Bavarian Nordic noted. The ten subjects required to begin phase 2 testing were all recruited ahead of schedule. Patients are eager for an effective treatment, as no drug exists that has yet been approved for chordomas.
Results Yet to Come
Despite the promising publication, phase 2 testing is still relatively early in the clinical trial process. Most drugs that are brought to trial successfully pass phase 1 – and most that fail (and most do) typically do so around phase 2.
This phase of testing is usually associated with efficacy – proving that the drug candidate actually works as intended.
While it may be early to call Bavarian Nordic’s announcement a victory, it’s certainly a step in the right direction for the eventual treatment of this aggressive form of cancer.
What do you make of this exciting news? Do you want us to continue to following this drug through its development? Tell Patient Worthy what you think!
