On March 24, 2014 Taiho Pharmaceutical reported that it has obtained approval in Japan from the Ministry of Health, Labour and Welfare to manufacture and market the oral combination anticancer drug ”Lonsurf combination tablet T15, T20” (nonproprietary names: trifluridine and tipiracil hydrochloride; development code: TAS-102), for the treatment of patients with unresectable advanced or recurrent colorectal cancer (only if refractory to standard therapies) (Press release Taiho, MAR 24, 2014, View Source [SID:1234501245]).

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Japan is the first country in the world to grant marketing authorization for Lonsurf. The approval is based primarily on the results of a randomized, double blind placebo controlled Phase II clinical trial conducted in Japan (J003-10040030). Taiho is conducting a global Phase III clinical trial (RECOURSE) on patients with metastatic colorectal cancer refractory to standard chemotherapies.

Lonsurf is a combination drug of trifluridine (FTD) and tipiracil hydrochloride (TPI). FTD is an antineoplastic nucleoside analog, which is incorporated directly into DNA, thereby interfering with the function of DNA. The blood concentration of FTD is maintained via TPI, which is an inhibitor of the FTD-degrading enzyme thymidine phosphorylase.

Taiho Pharmaceutical is proud to make Lonsurf available to physicians in Japan as a new treatment option for patients with metastatic colorectal cancer refractory to standard therapies.

Product Summary (for the Japanese market)

Brand name
Lonsurf combination tablet T15, T20
Nonproprietary name
Trifluridine and tipiracil hydrochloride combination tablet
Indications & Efficacy
Unresectable advanced or recurrent colorectal cancer (only if refractory to standard therapies)
Use & Dosage
Usually, the initial dose (single dose) for adults is defined as the standard dose (approximately 35 mg/m2/dose of FTD) according to body surface area. Lonsurf is administered twice daily, after breakfast and after the evening meal, for five consecutive days, followed by a two-day rest. After repeating the above twice, a 14-day rest follows, completing one course, which is then repeated.The dose can be decreased or increased according to the patient’s condition.

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.

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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On March 29, 2014 Nordic Nanovector reported that the European Patent Office has granted patent no. 2528627, entitled "RADIOIMMUNOCONJUGATES AND USES THEREOF" (Press release Nordic Nanovector, MAR 19, 2014, View Source [SID:1234500624]). The issued claims cover Nordic Nanovector’s proprietary radioimmunotherapy technology including the company’s lead product candidate Betalutin. The expiry date for the patent is 2031.

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"The granting of this patent is an important step in securing market protection of our investment in Betalutin, which is currently being developed as a treatment for patients with relapsed B-cell Non-Hodgkin lymphoma," said Jan A. Alfheim, Chief Executive Officer. "We now have patent protection for Betalutin in the two most important geographical markets for radio-immunotherapies, the USA and Europe."

(Press release, KAEL-GemVax, MAR 19, 2014, View Source [SID:1234506839])

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