1stOncology™: Cancer Intelligence Service – Page 18247 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

(Company Web Page Green Cross, APR 11, 2014, View Source;table=board_change_eng&m_code=&m_id=&ad=&page=1&str1=&str2=&str3=&str4=&str5=&str6=&str7=&str8=&str9=&m_no=1 [SID:1234501558])

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6-K – Report of foreign issuer [Rules 13a-16 and 15d-16]

On April 10, 2014 BioLineRx reported that Prof. Arnon Nagler, Director of the Hematology Division and Bone Marrow Transplantation Center at Sheba Medical Center, Israel, has received final regulatory approval to evaluate BioLineRx’s BL-8040 as a treatment for chronic myeloid leukemia (CML) in a Phase 1/2 clinical study (Filing 6-K, BioLineRx, APR 10, 2014, View Source [SID:1234500387]). BioLineRx is currently developing BL-8040 in a Phase 2 study for treating acute myeloid leukemia (AML), and in a Phase 1 study for stem cell mobilization, as a pre-treatment for stem cell transplantation. The Company has received orphan drug designation for both these indications.
The study is designed as a Phase 1/2, randomized, dose-escalation study to assess the combination of BL-8040 with standard-of-care Imatinib for improving the response of CML patients in the first chronic phase of the disease who have achieved a less than optimal response with Imatinib alone. Primary endpoints of the study are the safety and tolerability of BL-8040 in combination with Imatinib, and the secondary endpoints include assessing the efficacy of the combination therapy in achieving improved cytogenetic and molecular response in CML patients. The study will be performed at the Sheba Medical Center, and will include up to 40 patients.

highlights from Innate Pharma’s R&D update

On April 10, 2014 Innate Pharma reported its clinical development plan for IPH2201 (Press release Innate Pharma, APR 10, 2014, View Source [SID:1234500393]). Clinical trials are expected to begin in 2014, and three indications have been prioritized:

Head and Neck cancer:
* Single-arm single-agent Phase II trial of IPH2201 in patients with metastatic or recurrent platinum refractory squamous cell carcinoma of the Head and Neck;
* Single-arm Phase II trial of IPH2201 combined with cetuximab in patients with metastatic or recurrent platinum refractory squamous cell carcinoma of the Head and Neck;

Chronic Lymphocytic Leukemia (CLL):
* Single-arm Phase II trial of IPH2201 combined with ibrutinib in relapsed/refractory CLL patients;

Ovarian cancer:
* Single-arm single-agent Phase II trial of IPH2201 in platinum resistant ovarian cancer patients;

* Single-arm Phase II trial of IPH2201 combined with physician choice in platinum resistant ovarian cancer patients.

AVEO and Biodesix Partner to Co-Develop and Commercialize Ficlatuzumab with a Companion Diagnostic for Treatment of NSCLC

On April 10, 2014 AVEO Oncology and Biodesix announced that they have entered into a worldwide agreement to develop and commercialize AVEO’s hepatocyte growth factor (HGF) inhibitory antibody ficlatuzumab, with a Biodesix companion diagnostic test (Press release AVEO, APR 10, 2014, View Source [SID:1234500386]). This agreement and the clinical development program will leverage VeriStrat, a serum protein test that is commercially available to help physicians guide treatment decisions for patients with advanced non-small cell lung cancer (NSCLC). VeriStrat will be used as the selection assay to identify NSCLC patients most likely to benefit from ficlatuzumab.
An exploratory analysis from AVEO’s Phase 2 study in first-line NSCLC suggested that VeriStrat was prognostic for outcome in the epidermal growth factor receptor (EGFR) tyrosine-kinase inhibitor (TKI)-treated patients and predicted differential treatment benefit for the combination of ficlatuzumab plus TKI over TKI alone. The predictive effect was observed in both progression-free survival and overall survival endpoints.
Under the terms of the agreement, AVEO will conduct a proof of concept study of ficlatuzumab in combination with erlotinib in advanced NSCLC patients selected using the VeriStrat test. Biodesix will fund up to $15 million of the cost of the study. The companies expect to initiate this clinical study later this year. Any additional development, regulatory and commercial costs for ficlatuzumab beyond the proof of concept study will be shared equally as will any potential profits. Subject to regulatory approval, AVEO will lead worldwide commercialization of ficlatuzumab. Biodesix will be responsible for all development, including FDA engagement activities, sales and marketing costs for VeriStrat, and will retain total revenues for sales of VeriStrat.

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Immune Pharmaceuticals has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Press release Immune Pharmaceuticals, APR 9, 2014, View Source [SID1234500392]).