Topotarget has announced that the BELIEF study with its HDACi (histone deacetylase inhibitor)
belinostat in relapsed/refractory peripheral T cell lymphoma (PTCL) met its primary endpoint by
achieving an objective response rate (ORR) of between 25% and 27%, above the level of 20%
Why has this post not been discussing how great of news this is. It has a better safety and around the same efficacy: From Edison
Topotarget’s key asset belinostat remains on track to be filed with the FDA for the treatment of peripheral T-cell lymphoma (PTCL) in mid-2013 and be approved in H114. Data from the BELIEF trial shows its efficacy is at least similar to that seen with two other drugs approved in recent years in PTCL and it has a better safety profile. The successful filing of the NDA will lead to Topotarget receiving $10m in cash and one million shares from its partner Spectrum. This will enable Topotarget to develop the product in other orphan indications. We increase our valuation to DKK1,285m.
I really liked this statement
"Also the final data could suggest belinostat is more efficacious than its peers as the BELIEF trial included more poorly patients (with low platelet levels) than comparable trials."
And their new approach is interesting, it could be an approach Spectrum could follow as well.
"Topotarget has indicated that it is now most interested in following an orphan strategy with belinostat…Potential indications that are under consideration by Topotarget are:
Myelodysplastic syndrome (MDS),
Hepatocellular carcinoma (HCC), and
Soft tissue sarcoma (STS).
The rationale of developing belinostat in these indications is laid out in Exhibit 2. The sizes of these markets in Europe are also sufficiently small, being orphan indications, that Topotarget could market the products itself."
Thanks iome70. Good news since we know Belinostat has a good safety profile, easyer on a patients body, and still has a very good ORR. If approved, it could become a preferred HDACi.
Sentiment: Strong Buy