Celsion Shares Moving Higher on Findings from ThermoDox HEAT Study; EnteroMedics Closes VBLOC Therapy Pre-PMA Meeting with FDA Print E-mail
By Staff and Wire Reports   
Friday, 17 May 2013 19:52
Below is a look at some of the headlines for companies that made news in the healthcare sector on May 17, 2013.

Celsion Corporation (NASDAQ: CLSN)
announced Professor Riccardo Lencioni, MD, FSIR, EBIR, 2013 WCIO Program Chairman and the Director of the Division of Diagnostic Imaging and Intervention at Pisa University School of Medicine in Italy and Lead European Principal Investigator for the HEAT Study and Professor Ronnie T.P. Poon, MD, MS, PhD, FRCS(Edin), FACS, Professor of Surgery at the University of Hong Kong and Lead Asia Pacific Principal Investigator for the HEAT Study conducted separate scientific discussions reviewing the clinical trial results from the Company's Phase III HEAT Study including new emerging findings from the HEAT Study post-hoc analysis at the 9^th Annual Meeting of the World Conference on Interventional Oncology, which is being held on May 16 to 20, 2013 in New York City.  The new post-hoc findings suggest that optimized heating cycles markedly improve radiofrequency ablation (RFA) plus ThermoDox's potential for clinically relevant improved progression free survival (PFS) and Overall Survival (OS) outcomes.  Professors Poon and Lencioni both concluded that the findings warrant further investigation and development of ThermoDox as a first line treatment for HCC when combined with RFA.  The slide presentations are available on the Events and Presentations page on the Celsion website.

The data from the HEAT Study post-hoc analysis presented by Professors Lencioni and Poon demonstrate that ThermoDox markedly improves PFS and OS in patients with a single lesion if their lesions undergo RFA for 45 minutes or more. These findings apply to HCC lesion regardless of size and represent a subgroup of approximately 300 patients or 42% of the patients in the HEAT Study. The post-hoc analysis completed by the Company to-date indicates that there may be a large patient cohort that benefited from RFA plus ThermoDox regardless of lesion size.

o In the patient subgroup treated in the ThermoDox arm whose RFA procedure lasted longer than 45 minutes and was completed within 90 minutes (40% of single lesion patients), Overall Survival improved by 66% (Hazard Ratio of 0.602) when compared to the control arm of RFA treatment only. o In the patient subgroup treated in the ThermoDox arm whose RFA procedure lasted longer than 90 minutes (23% of single lesion patients), Overall Survival almost doubled (Hazard Ratio of 0.508) when compared to the control arm of RFA treatment only. o When combined, these two subgroups show clinical results that indicated a 53% improvement in Overall Survival, a Hazard Ratio of 0.65, and a P[value] = 0.105. o In contrast, the patient subgroup treated with ThermoDox whose RFA procedure lasted less than 45 minutes in duration (37% of single lesion patients) indicated that the control arm had an improved Overall Survival benefit when compared to the ThermoDox arm.  o The Hazard Ratios reported above should be viewed with caution since they are not statistically significant and the HEAT Study has not reached its median point for Overall Survival analysis.  Celsion will continue following all patients enrolled in the HEAT Study to the secondary endpoint, Overall Survival, and update its subgroup analysis based on RFA heating duration.


EnteroMedics Inc. (NASDAQ: ETRM)
, the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced that the Company completed a pre-PMA (Premarket Approval) application meeting with the U.S. FDA on May 15, 2013 regarding the Maestro(R) Rechargeable System's VBLOC(R) vagal blocking therapy as a treatment for obesity.

In the meeting, the FDA indicated that, subject to acceptance of the application and validation and detailed review of the submitted data by the FDA, the Company can anticipate presenting the PMA before a future FDA Advisory Committee panel. The Company expects to submit a PMA for the Maestro Rechargeable System, based on the ReCharge Pivotal Trial, in the second quarter of 2013.

Also Friday:

Acorda Therapeutics, Inc. (Nasdaq: ACOR)
today announced that the Company’s Legal department has been selected by Corporate Counsel magazine as one of the four “Best Legal Departments 2013.”

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY)
, a leading RNAi therapeutics company, announced today that it has presented key pre-clinical proof-of-concept data from its RNAi therapeutic program targeting aminolevulinate synthase-1 (ALAS-1) for the treatment of porphyria including acute intermittent porphyria (AIP).

Arrhythmia Research Technology, Inc. (NYSE MKT: HRT)
(the "Company") reported today that it will not be able to file its quarterly report on Form 10-Q for the interim period ended March 31, 2013 within the automatic extension of its due date to May 20, 2013 afforded by its filing of a Form 12b-25 Notification of Late Filing with the Securities and Exchange Commission.

Cellular Biomedicine Group (OTCQB: CBMG)
today announced that it has achieved 50% enrollment of the total projected enrollment required for its Phase I trial to evaluate the safety and preliminary efficacy of the medical technology haMPC (Human Adipose-derived Mesenchymal Progenitor Cells) therapy for Knee Osteoarthritis (KOA).

Cytomedix, Inc. (OTCQX: CMXI)
, a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies, announced today that Edward Field, the Company's Chief Operating Officer, has been invited to make a presentation on Partnering & Collaboration at the World Stem Cells & Regenerative Medicine Congress 2013, which will be held May 21-23, 2013 in London, United Kingdom.

First Choice Healthcare Solutions, Inc. (OTCQB: FCHS) (OTCBB: FCHS)
announced today the 2013 first quarter financial and operational results.

Forest Laboratories, Inc (NYSE: FRX)
today announced that they will present data related to aclidinium bromide and roflumilast at the American Thoracic Society (ATS) International Conference on May 17-22 in Philadelphia, PA.

Galapagos NV (Euronext: GLPG) and AbbVie (NYSE: ABBV) announced today an extension of their GLPG0634 clinical development collaboration to include Crohn's disease.

Harbor Island Development Corp. (OTCQB: HIDC)
, (the “Company”), through its wholly owned subsidiary BrandSeed Media Services LLC. (“BrandSeed”), a multi-channel direct marketing service provider, announces that the initial results for its NxUltra campaign have greatly exceeded the performance targets set by BrandSeed and its exclusive marketing partner American Enhancement Products, Inc. (“AEP”).

is pleased to announce that, through its wholly owned subsidiary HPIL ART&CULTURE, INC., it is officially sponsoring and participating at the W.T.F.S.K.F. European Traditional Fudokan Shotokan Karate-Do Championship.

Impax Laboratories, Inc. (NASDAQ: IPXL)
today announced that its generics division, Global Pharmaceuticals, commenced shipment of authorized generic Zomig® (zolmitriptan) tablets and orally disintegrating tablets, 2.5 mg and 5 mg, in the U.S., as part of a Distribution, License, Development and Supply Agreement with AstraZeneca UK Limited (AstraZeneca).

MMRGlobal, Inc. (OTCQB: MMRF)
("MMR"), a leading provider of Personal Health Records (PHRs) MyEsafeDepositBox storage solutions and MMRPro document management and imaging systems for healthcare professionals, today announced the addition of two new members to its Medical Board of Advisors.

Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP) (http://www.oramed.com), a developer of oral drug delivery systems, announced today that the United States Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug application(IND) for ORMD-0801, its oral insulin capsule.

Orexigen® Therapeutics, Inc. (Nasdaq: OREX) today announced that management will present a company overview at the UBS Global Healthcare Conference in New York.

Santarus, Inc. (NASDAQ: SNTS) today announced that additional data from two pivotal clinical studies with UCERIS® (budesonide) extended release tablets will be featured in two poster presentations at the Digestive Disease Week® (DDW®) Meeting being held in Orlando, Fla. from May 18 – 21, 2013.

Shire plc (LSE: SHP, NASDAQ: SHPG)
, the global specialty biopharmaceutical company, announces that it will present scientific data in 7 poster presentations at the American Psychiatric Association (APA) 166th Annual Meeting in San Francisco, May 18-22.

Sinovac Biotech Ltd. (Nasdaq: SVA)
, a leading provider of vaccines in China, today announced that it will release its unaudited financial results for the first quarter ended March 31, 2013, before market on Tuesday, May 28, 2013.

Verisante Technology, Inc. (TSX VENTURE:VRS) (OTCQX:VRSEF)
(the "Company" or "Verisante"), announced today that it has closed its brokered private placement of 2,357,500 units ("Units") at a price of $0.40 per Unit for gross proceeds of $943,000 led by sole agent Raymond James Ltd. (the "Agent").

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX)
announced that it has called for redemption of its outstanding $400.0 million in aggregate principal amount of 3.35% Convertible Senior Subordinated Notes due 2015, pursuant to the provisional “soft call” redemption right in the indenture governing the 2015 Notes.

XenoPort, Inc. (Nasdaq: XNPT)
announced today that shipments of Horizant® (gabapentin enacarbil) Extended-Release Tablets to its distributor in the United States have commenced.

Yongye International, Inc. (NASDAQ: YONG)
("Yongye" or the "Company"), a leading developer, manufacturer, and distributor of crop nutrient products in the People's Republic of China, today announced that, on May 16, 2013, the special committee (the "Special Committee") of the board of directors (the "Board of Directors") was provided a letter (the "Letter") issued by Abax Global Capital (Hong Kong) Limited ("Abax") to Full Alliance International Limited ("Full Alliance").

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