Adamis Announces Positive Results For Its Dry Powder Inhaler Product; Biota Commences Dosing in Vapendavir SPIRITUS Phase 2b Trial Print E-mail
By Mary Davila   
Tuesday, 03 March 2015 19:11
Below is a look at some of the headlines for companies that made news in the healthcare sector on March 3, 2015.
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) announced the results of its pharmacokinetic (PK) study for its dry powder inhaler product, APC-5000. The study was a Phase I PK study comparing the bioavailability of Adamis' APC-5000 Dry Powder Inhaler (DPI) to GlaxoSmithKline's Advair® Diskus® DPI.

This PK study was designed as an open-label, randomized, single-dose, 4 period (2 sequence, 2 treatment, fully replicated) crossover relative bioavailability study comparing APC-5000 (Fluticasone Propionate (FP) 186 µg and Salmeterol Xinafoate (SX) 44.7 µg; 3 inhalations; total dose 558/134.1 μg FP/SX) and Advair® Diskus® 250/50 µg (3 inhalations; total dose 750/150 μg FP/SX). Sixteen healthy male and female subjects who met the study inclusion criteria were enrolled into the study. The study involved a screening period and four treatment periods separated by four days. After completion of screening procedures, subjects were randomized to receive two doses of each Test and Reference product in four treatment periods. All sixteen subjects completed the study.

APC-5000 utilizes the patented Taper DPI inhaler device which, in this case, has been developed to eliminate the need for complex powder treatments and additive substances such as lactose, i.e. there is no need for excipients. It was also developed to deliver a higher percentage of fine particles to the airways with better delivery efficiency, and by doing so, decrease the drug deposition in the throat and mouth. Because of this increased efficiency, less amount of drug is loaded into the device thereby reducing the amount of drug given to the patient while still maintaining the same theoretical therapeutic dose. The study results confirm that systemic exposure to the drugs FP and SX is reduced after treatment with APC-5000, as compared to Advair® Diskus®, thereby potentially increasing the overall safety of the product.

Dr. Dennis J. Carlo, President and CEO of Adamis, stated, "Based on the study conclusions and the extent of PK similarities between APC-5000 and Advair®, we predict that our product (APC-5000), while using less drug, will still be as efficacious as Advair® for the treatment of asthma and chronic obstructive pulmonary disease (COPD). This hypothesis will be tested in a Phase III study comparing the efficacy of APC-5000 and Advair® for non-inferiority."




Biota Pharmaceuticals, Inc. (NASDAQ: BOTA)
announced it has commenced dosing of patients in its Phase 2b SPIRITUS trial of vapendavir. The goal of the study is to enroll approximately 150 laboratory-confirmed human rhinovirus (HRV) infected patients with moderate-to-severe asthma from the United States and multiple European countries over the next 12 months and to report top-line data in mid-2016.

"There are no antivirals currently approved for the treatment of HRV infection, which is a major cause of disease exacerbation among patients with asthma and COPD. Therefore, the initiation of this important trial of vapendavir in moderate-to-severe asthmatics is truly exciting, and based on the positive outcome from the Phase 2 study in mild asthmatics, I am looking forward to the data from this trial next year," stated Dr. Jonathan Matz, allergist-immunologist and Principal Investigator of the SPIRITUS trial.

"The commencement of dosing in our SPIRITUS trial represents a significant achievement in our ongoing effort to further define the efficacy and safety profile of vapendavir in patient populations with respiratory disease, whose disease control is at risk due to viral respiratory infection," commented Anna Novotney-Barry, Vice President of Clinical Development at Biota.

The primary endpoint of this multi-center, randomized, double-blind, placebo-controlled dose-ranging study is the change from baseline to study day 14 measured by an asthma control questionnaire (ACQ)-6 total score. The secondary endpoints are focused on safety and tolerability, lung function assessments such as forced expiratory volume in one second (FEV1), incidence of asthma exacerbations, assessments of the severity and duration of cold symptoms measured by the Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) and virological assessments such as changes in viral load.

Also Tuesday:

Amicus Therapeutics (Nasdaq:FOLD)
, a biopharmaceutical company at the forefront of therapies for rare and orphan diseases, today announced financial results for the full-year ended December 31, 2014.

CareDx, Inc. (Nasdaq:CDNA)
, a molecular diagnostics company focused on the development and commercialization of clinically differentiated, high value, non-invasive surveillance solutions for transplant recipients, today announced that it will release financial results for the fourth quarter 2014 after the close of trading on Tuesday, March 17, 2015.

Celldex Therapeutics, Inc. (Nasdaq:CLDX)
announced today that the Company is scheduled to present a corporate overview at the Cowen and Company 35th Annual Health Care Conference on Wednesday, March 4, at 8:40 am ET at the Boston Marriott Copley Place Hotel in Boston, MA.

Codexis, Inc. (Nasdaq:CDXS)
, a leading developer of biocatalysts for the pharmaceutical and fine chemical industries, announces financial results for the fourth quarter and year ended December 31, 2014, and introduces financial guidance for 2015.

CollabRx, Inc. (Nasdaq:CLRX)
today announced that on March 2, 2015, the Company received the formal determination of the NASDAQ Listing Qualifications Panel indicating that the Company has satisfied all requirements for continued listing on The NASDAQ Capital Market, including the minimum $2.5 million stockholders' equity requirement. Accordingly, the hearing matter has been closed.

Cryo-Cell International, Inc. (OTCQB:CCEL)
, the world's first private cord blood bank to separate and store stem cells in 1992, announced results for its fiscal year 2014.

Curis, Inc. (Nasdaq:CRIS)
, a biotechnology company focused on the development and commercialization of innovative drug candidates for the treatment of human cancers, today announced that Dr. Mani Mohindru, Vice President, Corporate Strategy and Investor Relations, will present at the 27th Annual Roth Conference on Tuesday, March 10, 2015, at 12:00 p.m. Pacific Time in Dana Point, CA.

Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP)
, a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders, today announced that it intends to offer shares of common stock in a public offering. H.C. Wainwright & Co., LLC will serve as the sole book runner for the offering.

Entellus Medical, Inc. (Nasdaq:ENTL)
, a medical technology company focused on products for the minimally invasive treatment of chronic and recurrent sinusitis patients in the physician office setting or operating room, today announced that it will release its financial results for the fourth quarter and full year of 2014 after the close of trading on Tuesday, March 17, 2015.

iKang Healthcare Group, Inc. (Nasdaq:KANG)
, today announced that it had completed the acquisitions of Tianjin Hexi Kangmeng Hezhong Clinic Co., Ltd. and Tianjin Hedong District REMAHO Clinic Co., Ltd., which were set up in 2008 and 2009, respectively.

InterDigital, Inc. (Nasdaq:IDCC)
, a mobile technology research and development company, and Lamprey Networks, Inc. (LNI), a leading provider of standards-based connected health solutions, today announced a demonstration that merges the use of Continua and oneM2M technologies in a connected health solution at Mobile World Congress running from March 2-5, 2015.

Islet Sciences, Inc. (OTCQB:ISLT)
, a biopharmaceutical company developing new medicines and technologies for the treatment of metabolic disease, announced today that it has entered into a license agreement with Brighthaven Ventures, LLC ("BHV") for exclusive rights to develop and commercialize SGLT2 inhibitor remogliflozin etabonate ("remogliflozin").

MacroGenics, Inc. (Nasdaq:MGNX)
, a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, as well as autoimmune disorders and infectious diseases, today provided a corporate progress update and reported financial results for the year ended December 31, 2014.

Nanosphere, Inc. (Nasdaq:NSPH)
, a company enhancing medicine through targeted molecular diagnostics, today announced that it will conduct a special meeting of stockholders on Tuesday, April 7, 2015.

Natural Health Trends Corp. (Nasdaq:NHTC)
, a leading direct selling company that markets premium quality personal care, wellness and "quality of life" products under the NHT Global brand, today announced financial results for the quarter and twelve month periods ended December 31, 2014.

Praxsyn Corporation (OTCQB:PXYN)
announces that its wholly owned subsidiary, Mesa Pharmacy Inc. (Mesa), has final committed amounts in excess of $4 million for approved preferred provider organization (PPO) claims dating from February 1, 2015 through February 28, 2015 from 15 of its 28 licensed states across the country.

Quotient Limited (Nasdaq:QTNT)
, a commercial-stage diagnostics company, today announced that the company's Chairman & CEO, Paul Cowan, will present at the Cowen and Company 35th Annual Health Care Conference in Boston at 10:00 a.m. Eastern Time on Wednesday, March 4.

Relypsa, Inc. (Nasdaq:RLYP)
, a biopharmaceutical company, today announced the closing of its public offering of 4,485,000 shares of its common stock at a price to the public of $38.50 per share for gross proceeds of approximately $172.3 million, which includes the exercise in full by the underwriters of their option to purchase up to 585,000 shares of common stock.

, today reported financial results for the year ended December 31, 2014 and provided a business update. The Company will host a conference call tomorrow, March 4, 2015, at 10:00 a.m. Eastern Time.

TriVascular Technologies, Inc. (Nasdaq:TRIV)
, manufacturer of the Ovation Prime® Abdominal Stent Graft System, today reported financial results for the fourth quarter and year ended December 31, 2014.

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