On March 24, 2014 Astellas Pharma reported that Astellas has obtained the marketing approval of oral androgen receptor signaling inhibitor, XTANDI capsules 40mg for the treatment of patients with castration-resistant prostate cancer in Japan. Astellas filed an application for approval in Japan in May 2013 (Press release Astellas, MAR 24, 2014, View Source [SID:1234500315]).
Upon receiving this marketing authorization in Japan, Astellas will provide Medivation with a $15 million milestone payment.
ATL1103 Acromegaly Phase II Trial Recruitment Completed
Antisense Therapeutics reported that 24 acromegalic patients have been successfully enrolled and randomized to one of the two treatment regimens of dosing in the Phase II trial of ATL1103 for the growth disorder, acromegaly (Press release Antisense Therapeutics, MAR 21, 2014, View Source [SID:1234501494]). This satisfies the necessary patient numbers proposed for the trial.
Following from the positive results achieved from the interim analysis of the serum Insulin-like Growth Factor-I (sIGF-I) data from the 8 patients who had completed the full 13 weeks of dosing in the trial, a further 8 (16 in total) have now completed dosing. Notably to date no patients dosed with ATL1103 have withdrawn from the study nor have there been any reports of serious adverse events identified as treatment related.
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With patient enrollment now complete, ANP anticipates reporting the results of the statistical analysis of the sIGF-I data from all patients by mid 2014. Reducing sIGF-I levels is the primary marker of ATL1103 activity in this trial as acromegaly patients have elevated sIGF-I levels compared to the normal population, and reduction of sIGF-I to within a normal range in a significant proportion of patients is the goal in Phase III registration trials for acromegaly treatments.
Mark Diamond, Managing Director and CEO of Antisense Therapeutics said "Completion of patient recruitment into a clinical trial is a major milestone and especially in the case of trials involving patients with a rare or orphan status disease such as acromegaly and so we are very pleased to report this significant achievement. We now look forward to completing the dosing in all patients and to the reporting of the results."
ATL1103 Phase II trial is a randomised, open-label, parallel group study of the safety, tolerability, pharmacokinetics and efficacy of two subcutaneous dosing regimens of ATL1103 in 24 adult patients with acromegaly dosed with ATL1103 for 13 weeks (3 months) with two months of follow up. Two ATL1103 dosing regimens are being tested (a) 200 mg 3 times in the first week then once weekly thereafter (200 mg/week) or (b) 200 mg 3 times in the first week then twice weekly thereafter (400 mg/week). The primary endpoints or main purposes of the trial as listed on the trial protocol are (i) to evaluate the safety and tolerability of ATL1103 in patients with acromegaly, and (ii) to evaluate the single dose and multiple dose pharmacokinetic profiles of ATL1103 via the subcutaneous route in patients with acromegaly. A secondary, but important endpoint that is also on the trial protocol is the evaluation of ATL1103’s effect on serum insulin like growth factor I (IGF-I) levels in patients. The secondary endpoint is the average percentage reduction in serum IGF-I levels at the end of treatment compared to baseline levels for each of the two dosing regimens used in the Phase II study.
Merck and Endocyte Announce European CHMP Positive Opinions for VYNFINIT� (vintafolide) and Companion Imaging Agents FOLCEPRI� (etarfolatide) and NEOCEPRI� (Intravenous (IV) folic acid) in Patients with Platinum-Resistant …
On March 21, 2014 Merck and Endocyte reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued positive opinions for the Conditional Marketing Authorisations of VYNFINIT (vintafolide) and companion imaging components, imaging agent FOLCEPRI (etarfolatide), and NEOCEPRI (intravenous (IV) folic acid), for the treatment of adult patients with folate receptor-positive, platinum-resistant, ovarian cancer, in combination with pegylated liposomal doxorubicin (PLD) (Press release Merck & Co, MAR 21, 2014, View Source [SID:1234500311]).
Vintafolide is proposed for use in combination with PLD for the treatment of adult patients with platinum-resistant ovarian cancer who express the folate receptor on all target lesions. Folate receptor status should be assessed by a diagnostic medicinal product approved for the selection of adult patients for treatment with vintafolide, using Single Photon Emission Computed Tomography (SPECT) imaging, in combination with Computed Tomography (CT) or Magnetic Resonance Imaging (MRI).
The applications for Conditional Marketing Authorisation for vintafolide, etarfolatide and IV folic acid were submitted based on results in platinum-resistant ovarian cancer patients who express the folate receptor on all target lesions as evaluated in the PRECEDENT Phase 2 study (ClinicalTrials.gov Identifier: NCT00722592).
The CHMP positive opinions will be reviewed by the European Commission (EC). If approved, the EC grants a centralized marketing authorization with unified labeling that is valid in the 28 countries that are members of the European Union, as well as European Economic Area members Iceland, Liechtenstein and Norway. The EC usually issues a final legally binding decision within three months of a CHMP opinion.
20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)]
AstraZeneca has filed a 20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Press release AstraZeneca, MAR 20, 2014, View Source [SID1234500310]).
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Investigational MAGE-A3 antigen-specific cancer immunotherapeutic does not meet first co-primary endpoints in MAGRIT, a phase III non-small cell lung cancer clinical trial
On March 20, 2014 GlaxoSmithKline reported that analysis of the MAGRIT trial (NCT00480025), a phase III trial of its MAGE-A3 cancer immunotherapeutic in non-small cell lung cancer (NSCLC) patients, showed that the trial did not meet its first or second co-primary endpoint as it did not significantly extend disease-free survival (DFS) when compared to placebo in either the overall MAGE-A3 positive population (first co-primary endpoint) or in those MAGE-A3-positive patients who did not receive chemotherapy (second co-primary endpoint) (Press release GlaxoSmithKline, MAR 20, 2014, http://www.gsk.com/media/press-releases/2014/investigational-MAGE-A3-antigen-specific-cancer-immunotherapeutic-does-not-meet-first-co-primary-endpoints-in-MAGRIT.html [SID:1234500307]). GSK currently remains blinded to the overall trial data from the analysis of the first two co-primary endpoints to allow for the unbiased generation of a mathematical model to assess the third co-primary endpoint.
The Independent Data Monitoring Committee (IDMC) indicated that its review of the current safety information raised no specific concern for the continuation of the trial and is in line with the known safety information for the MAGE-A3 cancer immunotherapeutic. As planned GSK will continue the trial in order to assess the third co-primary endpoint. This endpoint is designed to identify a subset of MAGE-A3 positive patients that may benefit from the treatment with the MAGE-A3 cancer immunotherapeutic. Results from a final analysis are expected in 2015.
MAGRIT, a randomised, double-blind, placebo-controlled trial, is evaluating the efficacy and safety of the MAGE-A3 cancer immunotherapeutic in Stage IB, II and IIIA completely resected NSCLC patients whose tumors expressed the MAGE-A3 gene. Patients were given up to 13 intramuscular injections of either the MAGE-A3 immunotherapeutic or placebo over a period of 27 months.
MAGE-A3 is a tumor-specific antigen expressed in a variety of cancers but not in normal cells. In NSCLC, it is expressed in approximately one third of tumors in patients diagnosed with Stage IB-IIIA disease. The MAGRIT trial enrolled 2,312 MAGE-A3-positive patients across more than 400 sites in 34 countries worldwide.