Targacept Completes Recruitment in Phase 2b TC-5619; Abbott Announces FDA Approval of the TECNIS Toric Intraocular Lens Print E-mail
By Staff and Wire Reports   
Thursday, 18 April 2013 19:32
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 18, 2013.

Targacept (NASDAQ: TRGT)
, a clinical-stage biopharmaceutical company developing novel NNR Therapeutics™, announced it has completed recruitment of patients in the Phase 2b study of TC-5619 as a treatment for negative symptoms and cognitive dysfunction in schizophrenia. The company expects to report top-line results from the study by the end of 2013. TC-5619 is a highly selective modulator of the alpha7 neuronal nicotinic receptor.

“I would like to thank the patients, study sites and investigators who have helped us reach this important milestone in the development of TC-5619 as a potential new treatment for schizophrenia,” said Dr. Stephen A. Hill, Targacept's President and Chief Executive Officer. “Current schizophrenia therapies primarily impact positive symptoms of schizophrenia, leaving the negative symptoms and cognitive dysfunction largely untreated. A new and effective treatment that addresses this medical need would be critically important for the millions of schizophrenia patients unable to function in society.”

The ongoing Phase 2b study is a double blind, placebo controlled, randomized, parallel group trial being conducted at sites in Eastern Europe and the United States. The primary outcome measure is the Scale for the Assessment of Negative Symptoms (SANS). Key secondary outcome measures include the CogState Schizophrenia Battery (composite score), a computerized test battery, and the University of California, San Diego Performance-Based Skills Assessment, Brief Version. The study is designed to randomize 456 patients with stable schizophrenia who are taking a fixed dose of an atypical antipsychotic. The study includes a 4-week screening period, followed by a 24-week treatment period during which patients receive one of two doses of TC-5619 (5mg or 50mg) or placebo once daily.


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Abbott (NYSE: ABT)
announced that the TECNIS Toric 1-Piece intraocular lens (IOL) has received U.S. FDA approval and is launching in the United States for the treatment of cataract patients with pre-existing corneal astigmatism.

Corneal astigmatism is a condition where the curvature of the cornea is uneven, preventing light rays from focusing clearly on the retina, resulting in blurred vision. Intraocular lenses are implanted in a patient's eye after the removal of the natural lens that has become clouded by a cataract. Unlike conventional IOLs, the TECNIS Toric 1-Piece IOL can correct a patient's loss of focus due to pre-existing corneal astigmatism of one diopter (a unit of measurement of the refractive power of a lens) or greater.

The average age for the cataract surgery patient in the United States is approximately 68 years with more than 3.5 million procedures performed annually. As the U.S. population continues to age, the number of cataract surgeries is expected to grow nearly 3 percent each year, increasing patient demand for improved, precise visual outcomes and independence from glasses.

"The TECNIS Toric 1-Piece IOL represents the latest advancement in cataract technology and expands Abbott's portfolio of the TECNIS family of IOLs," said Murthy Simhambhatla, senior vice president, Medical Optics, Abbott. "The TECNIS Toric 1-Piece IOL allows surgeons to offer an additional lens option that provides proven visual outcomes to increase patient satisfaction."

Along with delivering precise visual outcomes for patients, rotational stability is an important attribute of a toric IOL. The TECNIS Toric 1-piece IOL remains very stable once inserted into the eye, and meets the new standard for toric IOL rotational stability, as approved by the American National Standards Institute (ANSI).

In addition to providing astigmatism correction, the TECNIS Toric 1-Piece lens minimizes imprecise light focusing (spherical aberration) to provide sharper distance vision for the patient.

"The TECNIS Toric IOL decreases astigmatism while improving visual quality, with improved functional vision," said Kevin Waltz, O.D., M.D., Eye Surgeons of Indiana, and clinical investigator for the TECNIS Toric IOL. "Having implanted several TECNIS Toric IOLs within clinical trials, I find it delivers excellent patient results."


Also Thursday:


Aethlon Medical, Inc. (OTCBB: AEMD)
, disclosed that a poster presentation entitled: "Extracorporeal Exosome Removal: A Therapeutic Strategy to Address an Evolutionary Survival Mechanism Shared by Cancer and Infectious Viral Pathogens," is being presented today at the International Society of Extracellular Vesicles  (ISEV) 2013 conference being held in Boston, MA.

Align Technology, Inc. (NASDAQ: ALGN)
today reported financial results for the first quarter ended March 31, 2013.

ALR Technologies (OTCBB: ALRT)
announced that it had become an Affiliate Organization Member of America's Health Insurance Plans (AHIP), the national trade association for the health insurance industry.

Astro-Med, Inc. (NASDAQ: ALOT)
announced today that it was awarded Parts Manufacturer Approval (PMA) by the FAA for a configuration of the ToughWriter® 4 ruggedized airborne printer.

BioMed Realty Trust, Inc. (NYSE: BMR)
announced today that its 2012 Online Annual Report and other proxy materials are now available at http://www.biomedrealty.com/12AR. BioMed Realty is posting its annual report in an online format following the SEC-approved electronic reporting guidelines for the fifth consecutive year.

Cempra, Inc. (Nasdaq: CEMP)
today announced that it will report first quarter 2013 financial results and provide a business update after the close of U.S. financial markets on April 25, 2013.

Cepheid (Nasdaq: CPHD)
today reported revenues for the first quarter of 2013 of $91.9 million, representing growth of 19% from $77.3 million for the first quarter of 2012.

La Jolla Pharmaceutical Company (OTCQB: LJPC)
("La Jolla"), a leader in the development of therapeutics targeting galectin proteins, announced today that the FDA Office of Orphan Products Development has granted an "Orphan Drug" designation to La Jolla's drug candidate LJPC-6417 for fibrodysplasia ossificans progressiva ("FOP").

Life Technologies Corporation (NASDAQ: LIFE)
announced today that it is partnering with Ridom GmbH (Munster, Germany) to make SeqSphere+ whole genome bacterial typing software available for Ion Torrent users.

Moog Inc. (NYSE: MOG.A) (NYSE: MOG.B)
will release its second quarter fiscal 2013 earnings for the period ended March 30, 2013 on Friday, April 26, 2013.

MusclePharm Corporation (OTCQB: MSLP)
, a nutritional supplement company focused on active lifestyles, is proud to announce an endorsement deal with Denver Broncos Wide Receiver Eric Decker.

Neuralstem, Inc. (NYSE MKT: CUR)
announced that CEO and President, Richard Garr, will take part in a comprehensive Bio Maryland panel, introduced by Lt. Governor, Anthony Brown, on Maryland's leadership in traumatic brain injury prevention, diagnosis and treatment at the BIO International Convention in Chicago, Ill., on April 24.

Northwest Biotherapeutics (NASDAQ: NWBO) (NW Bio)
, a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced today that Brad Silver, an All American swimming and water polo athlete who was diagnosed with Glioblastoma multiforme (GBM) brain cancer in late 2002, and was treated with DCVax-L in March of 2003, just celebrated the 10th anniversary of his continued cancer-free survival.

Nuvilex, Inc. (OTCQB: NVLX)
has "Cell-in-a-Box," the Diabetes Research Institute has BioHub. One is cell encapsulation technology, and the other is an integrated spongy wafer.

OncoSec Medical Inc. (OTCQB: ONCS)
, a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumors, is one of the first to partner with Smart Patients: a new online community where patients with life-threatening conditions who are looking for or participating in clinical trials can share their feedback and experiences.

OPKO Health, Inc. (NYSE:OPK)
announced that it has acquired an approximate ten percent stake in OAO Pharmsynthez (MICEX:LIFE), a growing, fully-integrated Russian pharmaceutical company and the only life science company listed on the Moscow Stock Exchange.

Rosetta Genomics Ltd. (NASDAQ: ROSG)
, a leading developer and provider of microRNA-based molecular diagnostics, today announced that the Company has negotiated a settlement with Sanra Laboratories ("Sanra") in connection with the previous sale of Parkway Clinical Laboratories ("Parkway") by Rosetta Genomics to Sanra.

RTI Biologics Inc. (RTI) (Nasdaq:RTIX)
, a leading provider of orthopedic and other biologic implants, announced today that it plans to release financial results from the first quarter 2013 on Thursday, April 25, 2013 prior to the market open.

Targacept, Inc. (NASDAQ: TRGT)
, a clinical-stage biopharmaceutical company developing novel NNR Therapeutics™, today announced that it has completed recruitment of patients in the Phase 2b study of TC-5619 as a treatment for negative symptoms and cognitive dysfunction in schizophrenia.

UMeWorld Limited (OTCQB: ALRXF) (OTCQB: UMEWF)
today announced that the company's new trading symbol "UMEWF" will become effective at the opening of trading on the OTC QB on April 18, 2013.



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