Arqule and Daiichi Sankyo Announce Discontinuation of Phase 3 Trial; Astex Announces Initiation of SGI-110 Phase 2 Trial Print E-mail
By Staff and Wire Reports   
Tuesday, 02 October 2012 19:03
Below is a look at some of the headlines for companies that made news in the healthcare sector on October 2, 2012.

ArQule (Nasdaq: ARQL)
and Daiichi Sankyo, Co., Ltd. (TSE 4568) announced the independent Data Monitoring Committee (DMC) of the Phase 3 MARQUEE (Met inhibitor ARQ 197 plus Erlotinib vs Erlotinib plus placebo in NSCLC) trial recommended the study be stopped early following a planned interim analysis, when they concluded that the study would not meet its primary endpoint of improved overall survival. Although the interim analysis showed a statistically significant improvement in progression-free survival (PFS) in the intent-to-treat (ITT) population, this benefit did not carry over to overall survival. There were no safety concerns identified by the DMC to Daiichi Sankyo or ArQule during this interim analysis.

MARQUEE is a randomized, double-blind, controlled pivotal trial to evaluate the investigational selective MET inhibitor, tivantinib (ARQ 197), in combination with erlotinib in previously treated patients with locally advanced or metastatic, non-squamous NSCLC.

ArQule and Daiichi Sankyo are providing information regarding the study discontinuation to health authorities and those clinical investigators participating in studies of tivantinib. Data from this study will be presented at an upcoming scientific meeting.

“We are disappointed that the MARQUEE trial did not provide statistically significant results for overall survival in a disease and treatment setting which remains a major unmet medical need,” said Paolo Pucci, chief executive officer of ArQule.

“Fighting cancer is a complex process in that therapies work differently in different tumor settings, so we will continue to investigate tivantinib in other tumor types,” said Glenn Gormley, MD, PhD, global head, R&D and senior executive officer, Daiichi Sankyo Co., Ltd.

Approximately 1,000 patients were recruited in MARQUEE from more than 200 clinical sites worldwide. The primary endpoint in the trial is overall survival (OS) in the overall intent-to-treat population. Secondary endpoints include OS in the subpopulation of patients with epidermal growth factor receptor (EGFR) wild type, progression-free survival (PFS) in the ITT population, and further assessment of the safety of tivantinib in combination with erlotinib. Tivantinib has not been approved for any indication in any country.


Astex Pharmaceuticals, Inc. (Nasdaq:ASTX)
, a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics, announced that it has initiated a Phase 2, open label, randomized, multi-center, controlled clinical trial, evaluating SGI-110 in combination with carboplatin in platinum-resistant recurrent ovarian cancer patients.

Also Tuesday:

Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ)
(the "Company") today announced that preclinical data on its oral prostate cancer vaccine candidate, AEZS-120, were presented over the weekend at the 32nd Congress of the Société Internationale d'Urologie, which is being held in Fukuoka, Japan.

Alimera Sciences, Inc. (Nasdaq: ALIM)
("Alimera"), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that it has completed the sale of $40 million of Series A Convertible Preferred Stock (the "Series A Preferred") and warrants to purchase Series A Preferred (the "Warrants") to a group of institutional investors, including both existing and new investors, in a private placement.

Bristol-Myers Squibb Company (NYSE: BMY)
will present at the UBS Global Life Sciences Conference on Thursday, September 20, 2012, in New York.

Cell Therapeutics, Inc. (NASDAQ and MTA: CTIC)
announced that OPAXIO (paclitaxel poliglumex) has been granted orphan-drug designation by the U.S Food and Drug Administration ("FDA") for the treatment of glioblastoma multiforme ("GBM"), a malignant brain cancer.

Eli Lilly and Company (NYSE: LLY)
and Boehringer Ingelheim today announced patient-reported health outcomes data from a Phase II study of their investigational novel basal insulin analogue, LY2605541, in patients with type 2 diabetes.

Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (NYSE: LLY) today announce data from three pooled analyses for linagliptin at the 48th European Association for the Study of Diabetes (EASD) Annual Meeting in Berlin.

GenVec, Inc. (Nasdaq: GNVC)
announced today that it has signed an agreement worth approximately $3.5 million with the Naval Medical Research Center (NMRC) to support malaria vaccine development.

Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY)
, today announced that ENGAGE, the first Phase 3 trial of its investigational oral therapy, eliglustat tartrate, in previously untreated patients with Gaucher disease type 1, met its primary endpoint.

Insight Management Corporation (PINKSHEETS: ISIM)
and Relox Medical LLC, agreed in principle to the acquisition of Relox Medical LLC, subject to final contract documents.

MMRGlobal, Inc. (OTCBB: MMRF)
("MMR") a leading provider of Personal Health Records (PHRs) through its suite of products and services and professional document management and imaging systems through its MMRPro solution for healthcare professionals, today announced a new program to help hospitals mitigate administrative costs arising out of regulations under the Patient Protection and Affordable Care Act (PPACA) that will reimburse part of the administrative portion of costs arising out of patient readmissions.

, is pleased to announce its intention to file a supplemental new drug application (sNDA) for the high dose bolus (HDB) dosing regimen of AGGRASTAT® (tirofiban HCl).

Neogen Corporation (Nasdaq: NEOG)
announced today that it has acquired the stock of Macleod Pharmaceuticals, an animal health company headquartered in Fort Collins, Colorado.

OncoSec Medical Inc. (OTCBB: ONCS)
, a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapies to treat solid tumor cancers, announced today that the company will be presenting at the 3rd Annual Cancer Immunotherapy: A Long-Awaited Reality conference taking place from 8:00 a.m. to 6:30 p.m. EDT on October 4, 2012, at the New York Academy of Medicine in New York.

Organovo Holdings, Inc. (OTCQB: ONVO)
("Organovo"), a developer and manufacturer of functional human tissues using a novel three-dimensional  bioprinting technology, today announced that Keith Murphy, Chairman and Chief Executive Officer, will present at the upcoming 11th Annual BIO Investor Forum in San Francisco, CA.

Pfizer Inc. (NYSE: PFE)
announced today that 14 abstracts for tofacitinib, an investigational oral Janus kinase (JAK) inhibitor for the treatment of adults with moderate-to-severe active rheumatoid arthritis (RA), will be presented at the American College of Rheumatology (ACR) / Association of Rheumatology Health Professionals (ARHP) 2012 Annual Meeting, which is being held November 9-14 in Washington, D.C.

pSivida Corp. (NASDAQ:PSDV) (ASX:PVA)
, a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, today announced that its financial results for the fourth quarter and fiscal year 2012 will be released after the market close on Monday, September 24, 2012, followed the same day by a conference call and live webcast scheduled for 4:30 p.m. ET.

"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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