OXiGENE Announces Granting of Orphan Drug Status in Europe for ZYBRESTAT; Anacor to Present Pivotal Phase 3 Data of Tavaborole Print E-mail
By Staff and Wire Reports   
Thursday, 18 July 2013 19:16

Below is a look at some of the headlines for companies that made news in the healthcare sector on July 18, 2013.
OXiGENE (Nasdaq: OXGN), a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, announced the European Medicines Agency (EMA) has granted orphan drug designation for ZYBRESTAT® (fosbretabulin tromethamine) for the treatment of ovarian cancer. Orphan drug designation in the European Union (EU) is given to products that are designed for the diagnosis, prevention or treatment of rare diseases that are life-threatening or very serious. A disease is defined as rare in the EU if it affects fewer than five in 10,000 people. Granting of orphan drug designation in the EU provides companies with development and commercial incentives, including a period of market exclusivity, access to a centralized review process, protocol assistance (scientific advice) and waiving of marketing and post-marketing authorization fees.

OXiGENE is developing ZYBRESTAT as a potential treatment for patients with advanced ovarian cancer. Data from a randomized, two-arm Phase 2 clinical trial testing the combination of ZYBRESTAT and Avastin® (bevacizumab) to treat patients with advanced ovarian cancer could be available in early 2014, and, if positive, could provide the basis for a registration program.

"Obtaining orphan drug status for ZYBRESTAT in the EU is an important milestone in advancing OXiGENE's clinical strategy in ovarian cancer," said Peter Langecker, M.D., Ph.D., OXiGENE's Chief Executive Officer. "We are particularly excited about the ongoing GOG Phase 2 trial, as it is the first, and currently the only, randomized trial to test an anti-angiogenic therapeutic agent combined with a vascular disrupting agent in ovarian cancer, without including any cytotoxic chemotherapy. Both preclinically and clinically this combination has been shown to result in more significant reduction in blood flow that can starve and kill the tumor than either drug alone. Strategically it is important to note that in the EU Avastin® is already approved for the treatment of ovarian cancer as a single agent. We have been gratified by the broad interest in ZYBRESTAT within the worldwide oncology community, and look forward to advancing this program toward registration, either with the support of a corporate partner or on our own."

The Phase 2 clinical trial of ZYBRESTAT and Avastin, called GOG186I, is being conducted by the Gynecologic Oncology Group under the sponsorship of Cancer Therapy Evaluation Program of the National Cancer Institute. This trial is also being performed in collaboration with Genentech, the manufacturer of Avastin. A total of 107 patients with advanced, platinum-sensitive and resistant ovarian cancer have been enrolled in this trial at over 80 clinical sites in the US. The primary endpoint of the trial is progression-free survival, and the trial is designed to detect a level of reduction in the hazard ratio of arm 2 to arm 1 of 37.5%. This result would be comparable to an increase of 50% to 65% in the cumulative proportion of patients alive and progression-free at five months in the arm treated with ZYBRESTAT plus Avastin. Secondary endpoints include safety, overall survival and objective responses by treatment. OXiGENE expects that an interim efficacy analysis will be conducted during the third quarter of 2013. The company will remain blinded to the data from this interim analysis.



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Anacor Pharmaceuticals (NASDAQ: ANAC)
announced its abstract “Pivotal Phase 3 Safety and Efficacy Results of Tavaborole (Formerly AN2690), a Novel Boron-Based Molecule for the Topical Treatment of Toenail Onychomycosis” was accepted for oral presentation at the 2013 APMA Annual Scientific Meeting (The National) to be held in Las Vegas, Nevada. Max Weisfeld, DPM, will present the data from tavaborole's Phase 3 studies on Monday, July 22, 2013 during the Evidence-Based Medicine and Oral Abstracts session.

As announced earlier this year, tavaborole achieved statistically significant and clinically meaningful results on all primary and secondary endpoints in two Phase 3 pivotal studies without concomitant debridement. Anacor is seeking approval for tavaborole from the Food and Drug Administration (FDA) and will file a New Drug Application imminently. Currently, there is only one FDA-approved topical treatment for onychomycosis, a fungal infection of the nail and nail bed, which affects approximately 35 million people in the United States.

“I'm impressed with tavaborole's safety and efficacy data. There is no FDA-approved topical treatment for onychomycosis with tavaborole's range of efficacy and ability to penetrate the nail to reach the site of the infection,” said Dr. Weisfeld. “Tavaborole's Phase 3 results demonstrate its ability to clear the nail and eliminate the infection which is important to both patients and the physicians who treat them. In addition, tavaborole is easy to apply and dries quickly which makes it convenient for patients to use.”

“We are pleased to present these positive data at the APMA's Annual Scientific Meeting, the leading annual meeting of podiatrists. As we seek FDA approval for tavaborole, we look forward to developing relationships with podiatrists to potentially offer them a new treatment option for the large number of patients who seek treatment for onychomycosis,” said David Perry, Chief Executive Officer of Anacor Pharmaceuticals.

About the Studies

Anacor conducted two separate Phase 3 studies of tavaborole on patients with distal subungual onychomycosis affecting 20 to 60 percent of the target great toenail. Approximately 600 patients aged 18 years and older with no upper age limit (the oldest subject was 88 years old) were enrolled in each study and randomized two-to-one to receive either tavaborole or the vehicle control. Patients were instructed to apply tavaborole solution or the vehicle to the toenail once daily for 48 weeks.

A copy of the presentation will be available on Anacor's website following the oral session.




Also Thursday:

 


Align Technology, Inc. (NASDAQ: ALGN) today reported financial results for the second quarter ended June 30, 2013.

athenahealth, Inc. (Nasdaq:ATHN)
, a leading provider of cloud-based electronic health record (EHR), practice management, and care coordination services to medical groups and health systems, today announced financial and operational results for the second quarter of fiscal year 2013.

Align Technology, Inc. (NASDAQ: ALGN)
today announced that a patent chamber of the District Court of Dusseldorf in the Federal Republic of Germany granted permanent injunctions against Hamm-based Ortho Caps GmbH and Rastede-based Rasteder KFO Spezial-Labor GmbH.

Cepheid (Nasdaq: CPHD)
today reported revenues for the second quarter of 2013 of $96.0 million, representing growth of 19% from $81.0 million for the second quarter of 2012.

Complete Genomics, Inc. (formerly NASDAQ: GNOM)
, a wholly-owned subsidiary of BGI-Shenzhen ("BGI"), a leading international genomics organization based in Shenzhen, China, today announced that it has entered into a settlement agreement with Illumina, Inc. under which Illumina will dismiss with prejudice both lawsuits it had brought against Complete:  Illumina, Inc. and Solexa, Inc. v. Complete Genomics, Inc., Case No. 10-cv-05542 EDL (N.D. Cal.); and Illumina, Inc. and Illumina Cambridge Ltd. v. Complete Genomics, Inc., Case No. 12-cv-01465 BEN BGS (S.D. Cal).

Endocyte, Inc. (Nasdaq:ECYT)
, a biopharmaceutical company and leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging diagnostics for personalized therapy in cancer and other serious diseases, today announced that the company will host a conference call on Thursday, Aug. 1, at 4:30 p.m. EDT to discuss its second quarter 2013 financial results and provide an operational update.

Health Insurance Innovations (Nasdaq:HIIQ)
today announced the acquisition of Secured Health and Life ("Secured"), a leading health and life insurance marketer and an important distributor of Health Insurance Innovations ("HII") products with a focus on short-term medical plans, lead management systems, and cutting edge call center technology.

ICU Medical, Inc., (Nasdaq:ICUI)
, a leader in the development, manufacture and sale of innovative medical devices used in infusion therapy, oncology and critical care applications, announced today results for the second quarter ended June 30, 2013.

Intuitive Surgical, Inc. (Nasdaq:ISRG)
, the industry leader in robotic-assisted surgery, today reported second quarter of 2013 revenue, consistent with its July 8th release, of $579 million, up approximately 8% compared with $537 million for the second quarter of 2012.

Medical Action Industries Inc. (Nasdaq:MDCI)
, announced today that it will hold a conference call on Thursday, August 1, 2013 at 10:00 a.m. (ET) to present its financial results for the quarter ended June 30, 2013.

MediciNova, Inc.,  (Nasdaq:MNOV)
, and the Jasdaq Market of the Tokyo Stock Exchange (Code Number: 4875), today announced the funding and regulatory approvals of a NIH-based grant for a Phase 2b trial of MN-166 (ibudilast) in subjects with progressive multiple sclerosis (progressive MS).

Neurocrine Biosciences, Inc. (Nasdaq: NBIX)
announced today that the Company will report its second quarter 2013 financial results after the Nasdaq market closes on Thursday, July 25, 2013.

OPTIMIZERx Corp (OTCQB: OPRX)
today announced record preliminary 2013 second quarter results.

OXiGENE, Inc. (Nasdaq:OXGN)
, a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, announced that the European Medicines Agency (EMA) has granted orphan drug designation for ZYBRESTAT® (fosbretabulin tromethamine) for the treatment of ovarian cancer.

Pacific Biosciences of California, Inc. (Nasdaq:PACB), provider of the PacBio® RS II DNA Sequencing System, today announced that John F. Milligan, Ph.D. has joined the Company's Board of Directors.

TelVue® Corporation (PINKSHEETS: TEVE)
, the innovation leader in Television and Internet Broadcasting for media companies, cable operators, and communities has launched The Knowledge Network (tKN) channel for the National Science Foundation (NSF).




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