(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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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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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.

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On January 9, 2014 APEIRON Biologics reported the signing of two transactions as part of the worldwide commercialization of APN311, an antibody-based immunotherapy in development for the treatment of children suffering from high-risk neuroblastoma (Press release, Apeiron Biologics, APR 9, 2014, View Source [SID:1234502250]).

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Medison Pharma ("Medison"), Israel’s leading marketing group for innovative niche healthcare solutions, and Gen İlaç ve Sağlık Ürünleri ("Gen Ilac"), a leading supplier of orphan drugs for the treatment of rare diseases in Turkey, entered into license agreements with Apeiron, under the terms of which they receive the exclusive rights to market and sell APN311 in Israel and Turkey, respectively.

Today Apeiron announced the signing of license agreements with Medison and Gen Ilac. The two deals grant Medison and Gen Ilac exclusive rights to market and sell APN311 in Israel and Turkey, respectively. These transactions are part of Apeiron’s ongoing activities for worldwide commercialization of its immunotherapy portfolio against high-risk neuroblastoma. APN311 is the most advanced biologic in Apeiron’s development pipeline that focuses on immunologic therapies of cancer. Further details or financial terms of the transaction were not disclosed.

Hans Loibner, PhD, CEO of Apeiron, commented, "Based on very positive clinical data and the advanced development status of APN311 we are actively engaged in discussions with potential partners around the world for commercialization of this immunotherapy. After a first agreement with Paladin Labs we are pleased to now close these two deals with Medison and Gen Ilac. This represents a further important step in Apeiron’s efforts and commitment to improve therapeutic options for children suffering from life-threatening high-risk neuroblastoma."

Meir Jakobsohn, Medison’s Founder & CEO, commented, "We are proud of the new agreement with Apeiron that reflects Medison’s continuous ambition to provide breakthrough and lifesaving treatments for today’s most urgent medical needs. One of Medison’s main focuses is providing medications in the field of pediatric oncology, in niches with unmet need. Apeiron’s treatment fits exactly to Medison’s mission."

Abidin Gülmüs, CEO of Gen Ilac, added, "We are proud of our reputation as one of Turkey’s leading specialty pharma companies, but even more important to us is the difference we make to the lives of people with life-threatening conditions. We look forward to a successful partnership with Apeiron, together providing oncologists with the opportunity to treat high-risk neuroblastoma patients. We aspire to make APN311 available for Turkish patients as soon as possible."

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]).

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On April 8, 2014 Janssen Research & Development reported the submission of a supplemental New Drug Application (sNDA) for IMBRUVICA (ibrutinib) to the U.S. Food and Drug Administration (FDA) by its collaboration partner Pharmacyclics, Inc (Press release Johnson & Johnson, APR 8, 2014, View Source [SID:1234500380]). This regulatory submission is based on data from the Phase 3 RESONATE study in relapsed or refractory chronic lymphocytic leukemia (CLL). IMBRUVICA is being jointly developed and commercialized by Janssen and Pharmacyclics.
In February 2014, IMBRUVICA received FDA approval to treat patients with CLL who have received at least one prior therapy. This indication is based on an overall response rate (ORR) from Phase 2 data and an improvement in survival or disease-related symptoms has not been established. The current approval was granted under the FDA’s Accelerated Approval regulations and required the completion of an additional, larger Phase 3 trial to verify clinical benefit.
The Phase 3 PCYC-1112 (RESONATE) study is a randomized, multi-center, open-label study, which compares once-daily oral IMBRUVICA versus intravenous ofatumumab in 391 patients with CLL or small lymphocytic lymphoma (SLL), who had received at least one prior therapy. The RESONATE trial was halted early in January 2014 based on the recommendation of an Independent Data Monitoring Committee (IDMC) at the formal pre-planned interim analysis, which found IMBRUVICA was associated with a significant improvement in progression-free survival (the primary endpoint of the study) versus ofatumumab, and in overall survival (a key secondary endpoint of the trial). Data from this study were accepted and will be presented at the upcoming 50th annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper).