Fibrocell Extends Patent Protection for LAVIV® (azficel-T); Novavax Announces Positive Top-Line Results From Phase 1 Clinical Trial of RSV Vaccine Candidate in Elderly Print E-mail
By Staff and Wire Reports   
Tuesday, 02 July 2013 19:05

Below is a look at some of the headlines for companies that made news in the healthcare sector on July 2, 2013.
Fibrocell Science, Inc. (NYSE: FCSC), creator of the first FDA-approved autologous cellular product, LAVIV® (azficel-T) for aesthetics, announced the United States Patent and Trademark Office (USPTO) has awarded a patent to the Company which covers azficel-T fibroblast suspension, extending the patent exclusivity in the United States until 2031.

“The granting of this patent is a significant milestone for Fibrocell, further validating our autologous fibroblast technology,” said David Pernock, Chairman and Chief Executive Officer of Fibrocell Science. “We are focused on unlocking the potential of the autologous fibroblast and look forward to developing our cellular technology for a wide variety of applications.”


Novavax, Inc. (Nasdaq: NVAX) announced positive top-line safety and immunogenicity data for its respiratory syncytial virus (RSV) vaccine candidate from a dose-ranging Phase 1 study in elderly adults. All subject groups receiving the recombinant fusion (F) protein nanoparticle vaccine candidate exhibited antibody responses against RSV at 28 and 56 days post-immunization, with rises in serum anti-F immunoglobulin G (IgG) antibody levels. The highest response rates and greatest increases in antibody levels were observed in groups receiving RSV F antigen with aluminum phosphate as an adjuvant. All subjects simultaneously received a licensed seasonal trivalent influenza vaccine to ensure coverage over the influenza season. Local and systemic safety were monitored and together with the interim immunogenicity are provided here as top line data through Day 56.

The study examined the immunogenicity and safety of Novavax's RSV F nanoparticle vaccine in 220 healthy elderly adults (≥60 years of age, mean age of 68 years of age). Subjects received either 60µg or 90µg of the RSV F vaccine candidate, with or without adjuvant, or a placebo. The vaccine was well tolerated with no meaningful differences in the frequencies of adverse events (AEs) between the placebo (70%) and active vaccine groups (58-75%), and no dose-related trends in AEs. The adjuvant groups had a higher incidence rate of injection site AEs (43%) compared to placebo (23%), but all such AEs were reported as mild or moderate in severity. There were no vaccine-related serious AEs, and no subject withdrawals due to AEs.

Highlights of the interim immunogenicity results of the RSV F vaccine in elderly adults include:

The overall immune responses, in terms of both frequency and amplitude of antibody rises, were greater in the groups receiving the 90μg dose of RSV F vaccine compared to the groups dosed with 60µg. Significantly greater immune responses were observed in the groups receiving adjuvanted vaccine compared to those receiving unadjuvanted formulations. Increases in anti-F IgG were observed in all actively-vaccinated groups by Day 7 post-immunization. Antibody levels continued to rise through Day 28 among recipients of unadjuvanted vaccines, then plateaued. In contrast, anti-F IgG levels continued to rise through Day 56 in recipients of adjuvanted vaccine.

The greatest response was observed in the 90µg RSV F adjuvanted vaccine group, with a 5.6 fold rise in anti-F IgG and a sero-response rate of 79% at Day 56. Antibodies competing with palivizumab, a monoclonal antibody known to be efficacious in the prevention of severe RSV disease, were essentially undetectable in these elderly subjects at Day 0, but showed significant increases in 80 to 97% of active vaccine recipients by Day 28. In subjects receiving the adjuvanted vaccines, significant responses were sustained in 97% through Day 56. In the subjects receiving the 90µg RSV F vaccine with adjuvant, levels of competitive antibodies equivalent to 186µg/mL of palivizumab were achieved. Levels of antibodies specific for the antigenic site II peptide, representing the neutralizing epitope on the RSV F protein recognized by palivizumab, rose 5.6 to 12.5-fold, with best responses again in the 90µg RSV F adjuvanted vaccine group. RSV A and B microneutralizing antibody levels increased in all vaccinated subject groups, with greatest responses seen in the 90µg RSV F adjuvanted vaccine group. Geometric mean-fold increases in microneutralizing antibody titers ranged from 1.4 to 1.7-fold.

Hemagglutination-inhibiting (HAI) responses to the seasonal influenza vaccine were unaffected by co-administration with the RSV F vaccines; an important feature given that the two vaccines would likely be given to the elderly contemporaneously in clinical practice. "These data provide further evidence that our RSV F nanoparticle vaccine is well-tolerated and immunogenic," said Gregory Glenn, Chief Medical Officer of Novavax. "As seen in our previous trials in younger subjects, the vaccine induced an important functional immune response in the palivizumab-like antibodies, as well as enhancing microneutralization antibodies to levels that are in excess of the range expected to reduce hospitalizations resulting from RSV. In addition, the co-administration of the RSV F vaccine candidate with a licensed seasonal influenza vaccine did not appear to negatively impact or interfere with induction of immunity in the influenza vaccine."

"Protecting the elderly from respiratory ailments is an important part of both our RSV and our seasonal influenza vaccine development programs," noted Stan Erck, President and CEO of Novavax. "These data suggest a path forward for a Novavax combination RSV and seasonal influenza vaccine to improve the coverage for respiratory infections in elderly and high-risk adults."

Also Tuesday:

3DIcon Corporation (OTCQB: TDCP)
, a developer of three-dimensional projection display technologies, today announced that it has won first place and secured $300,000 in grant funding in this year's Oklahoma Applied Research Support (OARS) competition sponsored by the Oklahoma Center for the Advancement of Science and Technology (OCAST).

Arch Therapeutics, Inc. (OTCQB: ARTH)
("Arch" or the "Company"), a life science company and developer of AC5™, a novel product aimed at controlling bleeding and fluid loss in order to provide faster and safer surgical and interventional care, is pleased to introduce Dr. Avtar Dhillon as Board Chair, Dr. Arthur Rosenthal as Director, and Dr. Terrence W. Norchi as President & CEO.

Atossa Genetics, Inc. (NASDAQ: ATOS)
, The Breast Health Company™, announced today that Michael H. Kalnoski, M.D., has joined the Company as Medical Director, a newly created position.

Bioheart, Inc. (OTCQB: BHRT)
announced today the successful enrollment and randomization of the first patient in the Phase III MIRROR Trial using MyoCell® or muscle derived stem cells.

Depomed, Inc. (Nasdaq: DEPO)
today announced that it has received a Paragraph IV certification notice from Banner Pharmacaps Inc. advising Depomed that Banner has filed an Abbreviated New Drug Application (ANDA) with the FDA seeking approval to market a generic version of Zipsor® (diclofenac potassium) liquid filled capsules, 25 mg.

Express Scripts Holding Company (Nasdaq:ESRX)
, the largest pharmacy benefit management company in North America, announced today its intention to release its second quarter earnings on Monday, July 29, 2013 after the market closes and will hold its quarterly conference call to discuss second quarter results on Tuesday, July 30, 2013, at 8:30 a.m. Eastern Time (7:30 a.m. Central Time).

Flexpoint Sensor Systems, Inc. (OTCQB: FLXT)
, today announced that following the recently announced favorable universal settlement in the legal case involving a series of products featuring technologies that use Bend Sensor® technology, Flexpoint has resumed development of two projects with BendTech, LLC, which feature Flexpoints' Patented Bend Sensor® technology.

Fresh Start Private Management Inc. (OTCQB: CEYY)
, a leader in alcohol treatment and rehabilitation programs, announced it has entered into a letter of intent to sell the exclusive license and distribution rights of its proprietary implant formula and alcohol treatment program to Fresh Start NoCal, LLC.

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for the use of a Perjeta® (pertuzumab) regimen before surgery (neoadjuvant treatment) in people with HER2-positive early stage breast cancer.

InSite Vision Incorporated (OTCBB: INSV) today announced that Timothy Ruane, InSite’s Chief Executive Officer, will be presenting at the 8th Annual JMP Securities Healthcare Conference on Tuesday, July 9, 2013, at 12:00 pm ET at the St. Regis Hotel in New York City, NY.

KaloBios Pharmaceuticals, Inc. (Nasdaq: KBIO)
today announced that the company will present at the 2013 JMP Securities Healthcare Conference on July 10 in New York City.

La Jolla Pharmaceutical Company (OTCBB: LJPC)
("La Jolla" and "Company"), announced today that the FDA Division of Cardiovascular and Renal Products has accepted the Company's Investigational New Drug ("IND") application for LJPC-501. La Jolla will start a Phase 1 clinical trial of LJPC-501 in patients with hepatorenal syndrome ("HRS"), Type 1 and Type 2.

Life Technologies Corporation (NASDAQ: LIFE)
today announced that its new Ion AmpliSeq™ Exome Kit delivers the best exome sequencing performance in the industry*, with up to 98 percent of bases covered at 10x, and up to 96 percent of bases covered at 20x, for a single exome.

MiMedx Group, Inc.  (NASDAQ: MDXG)
, an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today that it has been included in the Russell 2000®, the Russell 3000 and the Russell Global Indexes effective at the start of trading on July 1, 2013.

MMRGlobal, Inc. (OTCQB: MMRF)
, through its wholly owned subsidiary MyMedicalRecords, Inc. (collectively, "MMR"), today announced that pursuant to an order dated July 1, 2013, the Appellate Court dismissed an appeal by Surgery Center Management, LLC ("SCM") filed May 17, 2012.

While Medtronic, Inc. and Johnson & Johnson are developing devices that can essentially act as a type of "artificial pancreas," Nuvilex, Inc.'s (OTCQB: NVLX) unique cell encapsulation technology has shown it too can develop a type of "artificial pancreas" in preclinical diabetes studies.

Omeros Corporation (NASDAQ: OMER)
today announced that the European Medicines Agency (EMA) approved a positive opinion issued by the European Pediatrics Committee (PDCO) agreeing to the Company's Pediatric Investigation Plan (PIP) for OMS302. EMA's approval of PDCO's positive opinion is a prerequisite for submission of the OMS302 Marketing Authorization Application (MAA) and, on completion of the post-marketing pediatric study, leads to an additional six months of patent exclusivity for OMS302 in Europe.

Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP)
, a developer of oral drug delivery systems, announced today that the company's CEO, Nadav Kidron, will present at the JMP Securities 2013 Healthcare Conference on Tuesday, July 9, 2013, at 3:30pm EDT. The event will take place at the St. Regis Hotel in New York City.

Sarepta Therapeutics (NASDAQ: SRPT)
, a developer of innovative RNA-based therapeutics, announced today that it is scheduled to present at the JMP Securities Healthcare Conference in New York, New York on Wednesday, July 10, 2013 at 11:00 a.m. Eastern Time.

TESARO, Inc. (Nasdaq:TSRO)
announced today that Lonnie Moulder, Chief Executive Officer, will present at the 8th Annual JMP Securities 2013 Healthcare Conference at The St. Regis Hotel in New York City on Tuesday, July 9, 2013 at 1:30 p.m. EDT.

Vascular Solutions, Inc. (Nasdaq:VASC)
today announced that it will host a live Webcast of its second quarter conference call on Tuesday, July 23rd at 3:30pm CDT. Vascular Solutions' Chief Executive Officer, Howard Root, Chief Financial Officer, James Hennen, and VP of Corporate Development, Phil Nalbone, will discuss the company's second quarter results.

West Pharmaceutical Services, Inc. (NYSE: WST)
, a leading global developer and manufacturer of components and systems for injectable drug delivery, today announced the expansion of the NovaGuard portfolio of needle safety products.

XOMA Corporation (Nasdaq:XOMA)
, a leader in the discovery and development of therapeutic antibodies, announced today that Dr. Paul Rubin, the company's Senior Vice President, Research and Development and Chief Medical Officer, is scheduled to present at JMP Securities 2013 Healthcare Conference on July 9, 2013 at 3:30 p.m. ET.

"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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