Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.BiPar Sciences, a biopharmaceutical company, has announced positive interim safety data from an ongoing Phase II clinical trial of the company's PARP inhibitor, BSI-201, in combination with chemotherapy in patients with triple negative metastatic breast cancer.
Subscribe to our email newsletter
The company presented data from the Phase II trial of BSI-201 in metastatic breast cancer patients whose tumors were negative for three common breast cancer markers: estrogen receptor, progesterone receptor, and HER2.
The trial participants were randomized into two different trial arms; one group who received chemotherapy (gemcitabine/carboplatin) alone and one group who had BSI-201 added to their gemcitabine/carboplatin regimen. The 89 clinical trial subjects (out of a targeted 120 patients) were treated for up to 12 cycles of therapy.
According to the company, the frequency and nature of reported adverse events did not differ between the two trial arms, and no added toxicities were attributable to BSI-201. In addition, gene expression profiling from the first 50 patients enrolled confirmed that the patients’ tumors had significant upregulation of PARP, compared with normal breast tissue, supporting the targeting of this enzyme with BSI-201.
The company has also reported gene expression data that confirmed significant upregulation of poly (ADP-ribose) polymerase (PARP) in the tumors of the first 50 patients enrolled in the Phase II trial.
Hoyoung Huh, president and CEO of BiPar Sciences, said: We are very encouraged by the results of BSI-201 to date. Our PARP inhibitor appears to be well tolerated, and our findings show that PARP is an important target in solid tumors including triple negative metastatic breast cancer. We look forward to reporting Phase II efficacy data for this trial in mid-2009.