Man kan så undre sig lidt over hvorfor de ikke vil give os ORR, PFS eller OS data. Men lad det nu være 🙂


Til NASDAQ OMX Copenhagen A/S Meddelelse nr. 01-13 / København, 24. januar 2013

Topotarget A/S (NASDAQ OMX: TOPO) meddeler, at der vil blive offentliggjort kliniske data om belinostat på det 5. årlige T-Cell Lymphoma Forum, som afholdes 24.-26. januar 2013 i San Francisco, USA.

I det videnskabelige resumé præsenteres foreløbige sikkerhedsdata fra det pivotale fase II BELIEF-studie (CLN-19) med belinostat som enkeltstofbehandling af patienter med recidiverende og/eller resistent perifert T-celle lymfekræft. Det konkluderes, at belinostat er veltolereret og har en favorabel sikkerhedsprofil i behandlingen af patienter med PTCL, samt at belinostat potentielt kan være et veltolereret alternativ i behandlingen af PTCL. Poster-præsentationen vil blive præsenteret den 26. januar.

Teksten fra det videnskabelige resumé er gengivet nedenfor:

Belinostat in relapsed and/or refractory peripheral T-cell lymphoma (R/R PTCL): Preliminary safety results

Authors: Owen O’Connor, Steve Horwitz, Tamas Masazi, Lauren Pinter-Brown, Shanta Chawla, Andrei Shustov

Background: The prognosis for patients with R/R PTCL remains poor. Romidepsin and pralatrexate are approved in the US; with overall response rates (ORR) of 25% and 27% respectively1, 2. Pralatrexate, an anti folate, causes myelosuppression and mucositis. Fatigue was prominent with romidepsin, an HDACi. This class has been implicated in QTc prolongation. Belinostat, a novel pan-HDACi, in preliminary study has similar ORR in R/R PTCL and is well tolerated with common grade 1-2 toxicities, gastrointestinal and constitutional3. These toxicities were not attenuated in  combination studies4.  BELIEF is the pivotal Ph 2 study that evaluated the safety and efficacy of belinostat in R/R PTCL. We present the preliminary safety data from the BELIEF study.

Methods: BELIEF is an open-label, multicenter, single-arm efficacy and safety study in patients with R/R PTCL after failure of at least one prior systemic therapy. PTCL diagnosis was confirmed by central pathology review. EKGs were centrally reviewed. Major inclusion criteria were: platelet counts ≥ 50,000/µL, no prior HDACi therapy, measurable disease and adequate organ function. Belinostat was given as a 30 min IV infusion at 1000 mg/m2 on days 1—5 of a 3 week cycle until disease progression or unacceptable toxicity. The primary endpoint was ORR. Safety was  monitored through 30 days from the last dose of belinostat. Efficacy determinations are ongoing.

Results: Total of 129 patients, 53% men, median age 63 yr (range 29—81 yr) were treated. The median number of cycles was 2 (range 1—31). One dose reduction occurred in 11% of patients and 1% had two dose reductions. AEs resulted in dose delays in 21% of patients, and 18% discontinued for AEs, including death. Grade 3/4 non hematologic AEs observed in >3% of patients included asthenia/fatigue 9%, pneumonia 7%, dyspnea 6%, infection 4%, febrile neutropenia 4%, pruritus 3%, deep vein thrombosis 3%, and hypotension 3%. Grade 3 QTc prolongation was reported in 2% of patients. Grade  3/4 hematologic toxicities were: thrombocytopenia 6% in patients with platelet counts of ≥100,000, anemia, leukopenia and neutropenia each 13%. A total of 23 patients (18%) died on treatment or within 30 days of last dose, predominantly due to PTCL progression. No death was attributed to belinostat.

Conclusions: Belinostat is well tolerated with a favorable safety profile in patients with R/R PTCL. Based on efficacy in the earlier Ph 2 study and safety in the BELIEF trial, belinostat is a putative well-tolerated option for the treatment of PTCL. Other studies show that full doses of belinostat can be combined with other cytotoxic regimens making combination therapy for patients with PTCL feasible.

About Investor1989

Investor in stocks in about 5 years with some very good profits. Focusing on Biotech and Value stocks. Active investor...


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