Public HealthBayer Schering Pharma Announces New Data On Novel Anti-cancer Compound BAY 73-4506
Bayer Schering
Pharma AG announced results from Phase I and II trials of BAY
73-4506, a potent oral multi-kinase inhibitor currently being studied in
multiple tumor types. These data were presented at the 45th Annual Meeting
of the American Society of Clinical Oncology (ASCO).
"Bayer is committed to discovering new cancer-fighting therapies," said
Kemal Malik, MD, member of the Board of Management and Head of Global
Development at Bayer Schering Pharma AG. "We are encouraged by these Phase
I and II data being presented on BAY 73-4506. These data will help further
determine our next steps as we move forward with a comprehensive Phase III
clinical development program in various tumor types for this new drug
candidate."
Preliminary data from the Phase II, open-label study in renal cell
carcinoma (RCC) demonstrated a 27 percent partial response (PR) rate
according to the Response Evaluation Criteria in Solid Tumors (RECIST) and
a disease control rate of 79 percent. The most common drug-related adverse
events were hand-foot skin reaction, fatigue, hypertension, mucositis,
dysphonia, rash, diarrhea, and anorexia. The Phase II study enrolled 49
previously untreated patients with predominantly clear cell RCC. BAY
73-4506 (160 mg) was administered once daily on a three weeks on/one week
off schedule. The primary endpoint was to evaluate response rate according
to RECIST.
"We are encouraged by these data of BAY 73-4506," said lead investigator
Professor Tim Eisen, F.R.C.P., PhD, of Addenbrooke"s Hospital at the
University of Cambridge, UK. "These data provide a rationale to move into a
Phase III trial in one of the multiple tumor types that may be responsive
to BAY 73-4506."
Additional data presented on BAY 73-4506 include a Phase I study of
patients with advanced refractory colorectal carcinoma (CRC). The data were
presented by lead investigator Dirk Strumberg, MD, Department of Hematology
and Medical Oncology, Marienhospital Herne, University Medical School of
Bochum, Germany.
Data from the Phase I dose-finding study in CRC showed BAY 73-4506, dosed
at 160 mg daily, using a treatment schedule of 21 days on/7 days off, was
feasible in patients with advanced refractory CRC. Disease control rate (PR
+ SD) was 74 percent in evaluable patients. The most common drug-related
adverse events were hand-foot skin reaction, fatigue, hoarseness,
mucositis, diarrhea, anorexia and hypertension. Data presented are based on
38 patients with actively progressing CRC enrolled in a Phase I study.
Patients were treated with BAY 73-4506 at doses of 60 mg, 120 mg, 160 mg,
and 220 mg once daily.
About BAY 73-4506 (DAST-Inhibitor)
BAY 73-4506 is a dual targeted VEGFR2-TIE2 anti-angiogenic oral tyrosine
kinase inhibitor (TKI) with a kinase inhibition profile targeting
angiogenic, stromal and oncogenic receptor tyrosine kinases (TK). In
preclinical studies, BAY 73-4506 has been shown to inhibit tumor growth by
hitting targets along a spectrum of angiogenic pathways, including VEGFR
and TIE2. BAY 73-4506 has also been shown in preclinical studies to prevent
the proliferation of tumor cell lines while promoting apoptosis (cell
death) by directly targeting several oncogenic TK receptors. The clinical
significance of these studies is not known and warrant further
investigation in a broad spectrum of tumors.
Bayer Schering Pharma AG