MannKind Completes Phase 3 Clinical Study of AFREZZA; Rexahn Wins US Patent for Novel Anti-Cancer Compounds Print E-mail
By Staff and Wire Reports   
Monday, 17 June 2013 19:05
Below is a look at some of the headlines for companies that made news in the healthcare sector on June 17, 2013.

MannKind Corporation (Nasdaq: MNKD)
announced that all follow-up visits have been completed for the patients enrolled in Study 175, a Phase 3 clinical study of AFREZZA® (insulin human [rDNA origin]) inhalation powder, an investigational, ultra rapid-acting mealtime insulin therapy, administered using MannKind's next-generation inhaler. MannKind expects to release data from this study later this summer.

Study 175 assessed AFREZZA using the next-generation inhaler in patients with type 2 diabetes whose disease is inadequately controlled on metformin with or without a second or third oral medication. After a run-in period during which the subjects remained on their oral medication, 353 patients were randomized to additional treatment with AFREZZA or to Technosphere® inhalation powder (placebo). The study also had a titration period, followed by a 12-week evaluation period to assess HbA1c levels.

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Rexahn Pharmaceuticals, Inc. (NYSE: RNN)
, a clinical stage biopharmaceutical company developing potential best-in-class oncology therapies, announced it has significantly expanded its intellectual property around a series of novel anti-tumor quinazoline compounds. Rexahn has been issued patent No. 8,404,698 from the U.S. Patent and Trademark Office, covering these novel quinazoline compounds, their pharmaceutical composition, and method for producing an anti-tumor effect.

The series of compounds included in this issued patent are inhibitors of an epidermal growth factor receptor (EGFR). EGFRs are cell surface receptors and mutations in these receptors can cause accelerated cell growth leading to lung and colon cancer. Mutated EGFRs account for approximately 30% of epithelial cancers. In preclinical trials, Rexahn's patented compounds have demonstrated oral bioavailability and anti-tumor activity in an animal model that did not respond well to Taxol, an oncology drug used to treat lung, breast and ovarian cancer.

Also Monday:

AbbVie (NYSE: ABBV)
today announced preliminary results from a Phase I study of ABT-199/GDC-0199, an investigational BCL-2 (B-cell lymphoma 2) selective inhibitor, in patients with high-risk relapsed/refractory chronic lymphocytic leukemia (CLL), and in patients with relapsed/refractory non-Hodgkin's lymphoma (NHL).

Advaxis, Inc., (OTCBB: ADXS)
, a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced voting results from the Company's Annual Meeting of Stockholders, which was held in Princeton, NJ on June 14, 2013.

ALR Technologies (OTCBB: ALRT)
today announced that up to 500 patients would be utilizing ALRT's Health-e-Connect Diabetes Remote Monitoring Program as part of a diabetes management program run by Healing Our Village (HOV) (www.healingourvillage.com) in the District of Columbia.

Array BioPharma Inc. (NASDAQ: ARRY)
today announced that interim results from an ongoing ARRY-520 clinical trial in multiple myeloma (MM) were presented at the 2013 Congress of the European Hematology Association in Stockholm, Sweden.

At the 2013 International Paris Air Show, Astro-Med, Inc. (NASDAQ: ALOT) will demonstrate the new ToughWriter 5® flight deck printer as well as new next-generation print technologies in the CCI / FRENCH SME PAVILION, Hall 4, stand D 185 at Le Bourget from Monday 17 June - Sunday 23 June 2013.

Atossa Genetics, Inc. (NASDAQ: ATOS)
, The Breast Health Company™, has entered into a contractual agreement with HealthSmart, a Preferred Provider Organization (PPO) network serving clients in all 50 states.

BIOLASE, Inc. (NASDAQ: BIOL)
, the world's leading manufacturer and distributor of dental lasers, announced that Friday, June 14th as of 6:00 pm NYT it has been disclosed by Russell to have been preliminarily chosen to be added to the 2013 versions of the Russell 3000 Index (Russell Ticker: RUA, Bloomberg Ticker: RAY) and the Russell Global Index (Russell Ticker: RGIUSD, Bloomberg Ticker: RGI).

BioMed Realty Trust, Inc. (NYSE: BMR)
today announced that its board of directors has declared a second quarter 2013 dividend of $0.235 per share of common stock.

Boston Scientific Corporation (NYSE: BSX)
announces the first implantation of its Vercise™ DBS System as part of the INTREPID clinical trial.

CytoSorbents Corporation (OTCBB:CTSO)
, a critical care focused company using blood purification to treat life-threatening illnesses in the intensive care unit, announced today that the United States Food and Drug Administration (FDA) has granted approval to begin a U.S.-based human pilot study using CytoSorb® for the treatment of rhabdomyolysis as a result of trauma under an Investigational Device Exemption (IDE).

Edwards Lifesciences Corporation (NYSE: EW)
, the global leader in the science of heart valves and hemodynamic monitoring, today announced unprecedented long-term durability results for bovine pericardial heart valves, based on a study of the Carpentier-Edwards PERIMOUNT aortic valve in a subset of patients aged 60 or younger at the time of operation.

Generex Biotechnology Corporation (OTCBB:GNBT)
today announced that it entered into a securities purchase agreement with certain institutional investors on June 17, 2013.  The investors have agreed to purchase in a private placement an aggregate of 1,225 shares of the Company's newly designated non-voting Series E 9% Convertible Preferred Stock ("convertible preferred stock") and warrants to purchase up to an aggregate of 100% of the shares of its common stock issuable upon conversion of the convertible preferred stock ("warrants") at the closing.

InSite Vision Incorporated (OTCBB:INSV)
today announced that it will join Merck (NYSE:MRK), known as MSD outside the United States (U.S.) and Canada, and Pfizer Inc. (NYSE:PFE) in filing a patent infringement lawsuit against Mylan Pharmaceuticals, Inc.

Intercept Pharmaceuticals, Inc. (NASDAQ: ICPT)
, a clinical stage biopharmaceutical company focused on the development and commercialization of novel bile acid therapeutics to treat chronic liver diseases, today announced that it has commenced an underwritten public offering of 1,730,000 shares of its common stock.

KaloBios Pharmaceuticals, Inc. (Nasdaq: KBIO)
today announced the appointment of Donald R. Joseph as Chief Legal Officer.

Michigan-based natural products developer Health Enhancement Products (OTCBB: HEPI) was advised by the US Patent Office that a US patent will be issued for Application No. 12/067,735 regarding "Composition and Use of Phyto-Percolate for Treatment of Disease" thereby establishing its claims on novel methods of producing and administering products derived from its proprietary algal cultures.

MannKind Corporation (Nasdaq: MNKD)
today announced that all follow-up visits have been completed for the patients enrolled in Study 175, a Phase 3 clinical study of AFREZZA® (insulin human [rDNA origin]) inhalation powder, an investigational, ultra rapid-acting mealtime insulin therapy, administered using MannKind’s next-generation inhaler. MannKind expects to release data from this study later this summer.

Medicago Inc. (TSX: MDG; OTCQX: MDCGF)
, a biopharmaceutical company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), announced today it was granted a patent from the European Patent Office (EPO) providing Medicago the exclusive rights to produce influenza VLPs in plants.

MELA Sciences, Inc. (Nasdaq:MELA)
, the medical device company that has developed MelaFind®, today announced that Joseph V. Gulfo has resigned as Chairman, President, Chief Executive Officer, and member of the Board of Directors effective June 15, 2013. Robert C. Coradini, a member of the Board of Directors since December 2011, will serve as interim CEO while the board conducts a search for a new CEO.

MMRGlobal, Inc. (OTCQB: MMRF)
, a leading provider of Personal Health Records (PHRs), MyEsafeDepositBox storage solutions, and electronic document management and imaging systems for healthcare professionals, today announced that it will offer a program for healthcare providers they can use to offset the entire cost of a 4medica Certified for Meaningful Use Integrated Electronic Medical Record (EMR) system for any size practice.

NeoStem, Inc. (NYSE MKT:NBS)
, a leader in the emerging cellular therapy market, today announced the geographic expansion of intellectual property protection around its lead product candidate, AMR-001, with the notice of a patent allowance in Canada.

NPS Pharmaceuticals, Inc. (NASDAQ:NPSP)
, a biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases worldwide, yesterday presented findings supporting the therapeutic potential of Natpara® (recombinant full-length human parathyroid hormone or rhPTH [1-84]) in poster sessions at ENDO 2013, The Endocrine Society’s 95th Annual Meeting in San Francisco, CA.

PAREXEL International Corporation (NASDAQ: PRXL)
, a leading global biopharmaceutical services provider, today announced that it will provide a live webcast of its Investor Day on Wednesday, June 26, 2013, from 8:30 a.m. to 12:30 p.m. (EDT).

PositiveID Corporation (OTCBB:PSID)
, a developer of biological detection and diagnostics solutions, today announced its Chief Executive Officer, William J. Caragol, is featured in an interview on StockTradersTalk.com to discuss the Company's M-BAND (Microfluidic Bio-agent Autonomous Networked Detector) and Firefly Dx system ("Firefly") technologies. The interview can be heard through this link.

Prothena Corporation plc (Nasdaq:PRTA)
, a clinical stage biotechnology company focused on the discovery and development of novel antibodies for the potential treatment of a broad range of diseases, announced that the trading of its ordinary shares will be included in the Russell Global Index when Russell Investments reconstitutes its comprehensive set of U.S. and global equity indexes on June 28, 2013, according to a preliminary list of additions posted June 14, 2013 on www.russell.com/indexes.

Santarus, Inc. (NASDAQ:SNTS)
today announced that Gerald T. Proehl, president and chief executive officer, received the Ernst & Young Entrepreneur Of The Year® 2013 award for the Life Sciences category in the San Diego region.

Tauriga Sciences, Inc. (OTCQB:TAUG)
("Tauriga" or "the Company"), a diversified life sciences company focused on investing in proprietary biotherapeutics and diagnostics, novel medical devices and consumer healthcare, has today announced that the Company and Green Hygienics, Inc. ("Green Hygienics"), in the coming week, will commence presentations to key distribution groups in the southeast United States who have a mission for the conversion to environmentally friendly products for the hospitals that they supply.

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA)
today announced that it has entered into a definitive agreement to acquire MicroDose Therapeutx, a privately-held pharmaceutical and drug delivery company focused on inhalation technologies and products for lung diseases and infections with the potential to dramatically improve efficacy and patient compliance.

TG Therapeutics, Inc. (Nasdaq:TGTX)
, an innovative, clinical-stage biopharmaceutical company focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of cancer and other underserved therapeutic needs, today announced two clinical posters on ublituximab (TG-1101) and one pre-clinical poster on TGR-1202 were presented at the European Hematology Association (EHA) Meeting which was held in Stockholm, Sweden.

Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA)
presented additional data today at ENDO 2013, the Endocrine Society's 95th Annual Meeting, demonstrating that tasimelteon can entrain (synchronize) both melatonin and cortisol rhythms.

VistaGen Therapeutics, Inc. (OTCQB: VSTA)
, a biotechnology company applying stem cell technology for drug rescue, predictive toxicology and drug metabolism assays, presented key developments involving its CardioSafe 3D™ and LiverSafe 3D™ bioassay systems in poster presentations at the 11th Annual Meeting of the International Society of Stem Cell Research (ISSCR), the largest forum for stem cell and regenerative medicine professionals from around the world, held June 12 to 15, 2013, in Boston, Massachusetts.

Virogen Inc. (OTC Pink: VRNI)
, a holding company that owns Tiger Team Technologies and The Cannabis Connection, today announced that it has partnered with California's TheMedMen, a medicinal marijuana consulting firm, in a venture that is intended to bring broader exposure to both firms. VRNI expects that, by venturing with TheMedMen, it will be in a position to gain a foothold in the medical marijuana industry, particularly in the lucrative areas of retail supply, support and consulting.

VIVUS, Inc. (Nasdaq:VVUS)
today announced that a review article has been published online in Expert Opinion on Drug Safety examining the efficacy and safety of Qsymia® (phentermine and topiramate extended-release) capsules CIV. The article presents a complications-centric model for the treatment of obesity, including weight-loss pharmacotherapies, such as Qsymia.



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