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10-Q – Quarterly report [Sections 13 or 15(d)]

MultiCell Technologies has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing 10-Q , MultiCell Technologies, APR 14, 2014, View Source [SID1234500404]).

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8-K – Current report

On April 11, 2014, The Regents of the University of California (“UCLA”) filed a complaint against Medivation, Inc. and its subsidiary Medivation Prostate Therapeutics, Inc. (“MPT”) in the Superior Court of the State of California, County of San Francisco (Filing 8-K , Medivation, APR 14, 2014, View Source [SID:1234500414]). The complaint arises from the parties’ 2005 Exclusive License Agreement (“ELA”), which grants to MPT rights in certain UCLA patents, including the UCLA patents covering XTANDI. The complaint centers on two allegations. The first allegation is that Medivation and MPT have failed to pay UCLA ten percent of “Operating Profits” Medivation has received (and will continue to receive) from Astellas Pharma, Inc. as a result of the 2009 Collaboration Agreement between Medivation and Astellas. UCLA alleges that such Operating Profits are “Sublicensing Income” under the ELA and that UCLA is entitled to ten percent of such payments. The second allegation is that Medivation has breached its fiduciary duties to UCLA, as a minority shareholder of MPT. UCLA owns a fraction of one percent of the outstanding shares of MPT. The complaint seeks a declaration and judgment for breach of contract related to the allegation that “Operating Profits” payments received from Astellas are “Sublicensing Income” under the ELA, a judgment that Medivation has breached its fiduciary duties and an injunction requiring Medivation to comply with its fiduciary duties. The complaint does not seek termination of the ELA.

Medivation and MPT deny UCLA’s allegations and will vigorously defend the litigation.

ODM-201 offers a new therapeutic option for the treatment of prostate cancer

On April 14, 2014 Orion reported that ODM-201, a novel oral androgen receptor (AR) inhibitor for the treatment of advanced prostate cancer, is currently preparing for Phase III clinical trials. Data on ODM-201 from two clinical trials (ARADES and ARAFOR), reviewing safety and efficacy of ODM-201 in chemotherapy and CYP17-inhibitor naïve patients will be presented during the 29th Annual EAU Congress in Stockholm (11-15 April 2014) (Press release Orion Pharma, APR 14, 2014, View Source [SID:1234500401]).
The ARADES phase I/II trial (NCT01317641 and NCT01429064) assessed the efficacy and safety of three dose levels of ODM-201 (100mg, 200mg and 700mg given twice a day) in 124 patients.
The ARAFOR trial (NCT01784757) is a bioavailability study also evaluating efficacy and safety for ODM-201 in 30 patients. The current subgroup analysis included chemotherapy and CYP17i-naïve metastatic castration resistant prostate cancer patients from the two trials. It was shown that ODM-201 daily doses between 1200-1800 mg was well tolerated, and produce marked, long-lasting declines in PSA in majority of these patients.
Download poster presentation (29th Annual EAU Congress Stockholm, Sweden April 11-15, 2014) here, View Source .

(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.

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