|Pfizer's Phase 2 Study Demonstrates Safety, Tolerability and Immunogenicity of TRUMENBA®; FDA Accepts Supplemental New Drug Application for DALVANCE®|
|By William Kent|
|Friday, 09 October 2015 18:55|
Below is a look at some of the headlines for companies that made news in the healthcare sector on October 9, 2015.
Pfizer Inc. (NYSE: PFE) announced researchers presented for the first time data from a randomized, controlled Phase 2 study of its meningococcal serogroup B vaccine, TRUMENBA®, coadministered with routine meningococcal (groups A, C, Y and W) (MCV4) and tetanus, diphtheria and pertussis (Tdap) vaccines in adolescents. The data, which were released today in an oral presentation at IDWeek 2015TM in San Diego, are based on a study conducted in more than 2,600 healthy individuals 10 through 12 years of age that evaluated the safety, tolerability and immunogenicity of TRUMENBA when coadministered with MCV4 and Tdap. Data demonstrated that immune responses following TRUMENBA, MCV4 and Tdap vaccines given concomitantly were noninferior to immune responses to MCV4 and Tdap alone or TRUMENBA alone.
"These Phase 2 data, which are part of a substantial global clinical development program for TRUMENBA, demonstrated that two important routine adolescent vaccines can be coadministrated with TRUMENBA," said Kathrin Jansen, Ph.D., senior vice president of Vaccine Research and Development at Pfizer Inc. "In particular, the convenience associated with coadministration of these recommended vaccines – including allowing for vaccination against five of the most common meningococcal serogroups – is an important factor in helping to protect as many adolescents and young adults as possible from vaccine-preventable diseases."
Pfizer's TRUMENBA (Meningococcal Group B Vaccine) is FDA-approved for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.
Individuals participating in the study were assigned to one of three groups. Group 1 received TRUMENBA coadministered with MCV4 and Tdap vaccines; Group 2 received MCV4 and Tdap vaccines only; and Group 3 received TRUMENBA only. TRUMENBA immunogenicity was assessed by serum bactericidal assay using human complement (hSBA) with 2 meningococcal serogroup B (MenB) test strains expressing vaccine-heterologous factor H binding protein (fHBP) variants. The immunogenicity of MCV4 and Tdap antigens was assessed utilizing multiplexed Luminex assays and/or serum bactericidal assay using rabbit complement (rSBA).
Immune responses following TRUMENBA, MCV4 and Tdap vaccines given concomitantly were noninferior to immune responses to MCV4 and Tdap alone or TRUMENBA alone. Participants in the concomitant control group had hSBA responses to the 2 MenB test strains of 62.3 to 68 percent and 87.5 to 90 percent after 2 and 3 TRUMENBA doses, respectively. The administration of TRUMENBA alone induced similar responses. Coadministration of TRUMENBA, MCV4 and Tdap did not significantly increase local reactions or systemic events compared to TRUMENBA alone.
Allergan plc (NYSE: AGN) announced the U.S. Food and Drug Administration (FDA) has accepted for filing Allergan's supplemental New Drug Application (sNDA). This filing will expand the label to include single-dose administration of DALVANCE® (dalbavancin) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults caused by designated susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).
"With the FDA's acceptance of this supplemental application, Allergan is one step closer to providing a single-dose option of DALVANCE which may provide more flexibility to manage serious skin infections in an outpatient setting," said David Nicholson, Executive Vice President and President Global Brands Research and Development, Allergan. "DALVANCE is an important part of Allergan's anti-infective portfolio focused on addressing infections in multiple clinical settings to help improve outcomes for patients and the healthcare system."
The application was based on results from a Phase 3 study DUR001-303, which compared a single 1500 mg dose of DALVANCE with the two-dose regimen of 1000 mg followed one week later by 500 mg. Data demonstrated the 1500 mg single dose of DALVANCE achieved its primary endpoint of non-inferiority to the two-dose regimen (10% non-inferiority margin) at 48 to72 hours after initiation of therapy, as determined by a decrease of > 20% in lesion area relative to the baseline measurement (81.4% vs. 84.2% for the single dose vs. the two dose regimen, respectively; Difference -2.9; 95% CI: -8.5, 2.8).
DALVANCE was first approved in the U.S. in May 2014 for the treatment of ABSSSI in adults. DALVANCE is the first and only once-weekly IV antibiotic approved for the treatment of ABSSSI with a two-dose regimen of 1000 mg followed one week later by 500 mg.
DALVANCE is marketed in the European Union as XYDALBA™ (dalbavancin) for injection for the treatment of adult patients with ABSSSI caused by susceptible Gram-positive bacteria, including MRSA.
BioCorRx, Inc. (OTCQB:BICX), developer of the BioCorRx® Recovery Program, a Medication-Assisted Treatment (MAT) program, announces a new distribution agreement with an existing wellness center in the Atlanta area. The agreement is part of the Company’s continued focus to distribute its addiction treatment program specific to long-lasting Naltrexone therapy to wellness centers nationally through a partnership with Myriad Medical Marketing (MMM). The new center, Superior Health Care LLC, is run by Dr. Steve Peyroux and is located at 2050 Cumming Way, #100 Canton, GA 30115. “The availability of our newly rebranded program, the BioCorRx® Recovery Program, in this new clinical setting in the heavily populated Southeast is great news for those suffering from addiction in that area of the country. These individuals will soon have access to the benefits of our program in an environment that offers many other services that can be beneficial to them during their recovery,” says BioCorRx COO & interim CEO, Brady Granier.
Caladrius Biosciences, Inc. (NASDAQ:CLBS), a company combining a leading cell therapy service provider with a therapeutics pipeline including a Phase 3 clinical program in immuno-oncology and a portfolio of earlier clinical phase projects in immune modulation and ischemic repair, announces the promotions of Joseph Talamo from Vice President, Corporate Controller and Chief Accounting Officer to Chief Financial Officer and Todd Girolamo, Esq. from Vice President, Legal to General Counsel. In addition, the Company announces that Robert S. Vaters, is no longer serving as an employee of the Company and has resigned from the Company’s board of directors. “Bob Vaters joined Caladrius in January 2015 to help me accelerate the Company’s near-term organizational and strategic evolution. He has been instrumental in identifying and affecting multiple changes that have contributed to the Company’s new course. We greatly appreciate the contributions he made and wish him continued success in his future endeavors,” said David J. Mazzo, Ph.D., Chief Executive Officer of Caladrius Biosciences. “We are delighted to promote Joe and Todd, both experienced executives who have demonstrated their leadership, competence and diligence in the execution of their duties. I am confident each will continue to contribute meaningfully to the Company’s success as we expand our leadership position as the premier cell therapy service provider and advance our pipeline of clinical development programs,” added Dr. Mazzo.
CymaBay Therapeutics, Inc. (NASDAQ:CBAY), a clinical-stage biopharmaceutical company developing therapies to treat metabolic diseases with high unmet medical need, today announced that Robert J. Wills, Ph.D., a member of the Board of Directors since March 2015, has been appointed Chairman of the Board of Directors. Dr. Wills replaces retiring Chairman, Louis G. Lange, M.D., Ph.D. Dr. Lange has been a member of CymaBay's Board since 2003 and has served as Chairman since 2009. "I would like to thank Dr. Lange for his 12 years of valued leadership and service to CymaBay," said Harold Van Wart, Ph.D., Chief Executive Officer of CymaBay Therapeutics. "On behalf of the Board of Directors, we wish him well in his future endeavors. It is also my pleasure to welcome Dr. Wills as our new Chairman of the Board. Dr. Wills has had a distinguished career in the pharmaceutical industry and has already been a significant strategic asset to CymaBay since he joined our Board in March of this year. We look forward to his continued contributions to CymaBay as we remain focused on further advancing our clinical pipeline, including arfhalofenate in gout and MBX-8025 in high unmet need and orphan diseases."
Fibrocell Science, Inc., (NASDAQ:FCSC), an autologous cell and gene therapy company focused on developing first-in-class treatments for rare and serious skin and connective tissue diseases with high unmet needs, and Intrexon Corporation (NYSE:XON), a leader in synthetic biology, today announced that a poster entitled “Pre-Clinical Development of a Genetically-Modified Human Dermal Fibroblast (FCX-007) for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)” will be presented at the American Society of Human Genetics Annual Meeting from October 6-10, 2015 in Baltimore, Maryland. The poster contains additional details of the previously reported positive in vivo pre-clinical data for FCX-007, Fibrocell’s orphan gene-therapy product candidate for the treatment of RDEB. RDEB is caused by a mutation of the COL7A1 gene—the gene which encodes for type VII collagen (COL7), a protein that forms anchoring fibrils to hold together the layers of skin. Without these fibrils, skin layers separate causing severe blistering, open wounds and scarring in response to any kind of friction, including normal daily activities like rubbing or scratching.
Heat Biologics, Inc. (Nasdaq:HTBX), a clinical-stage cancer immunotherapy company, announced that it has completed enrollment of the full 75 patients in the blinded, randomized, placebo-controlled arms of the Phase 2 clinical trial of HS-410 (vesigenurtacel-L) for the treatment of high-risk, non-muscle invasive bladder cancer (NMIBC). In these three arms of the Phase 2 trial, Heat is evaluating the ability of HS-410 in combination with standard of care, Bacillus Calmette-Guerin (BCG), to stimulate the immune system and eliminate remaining cancer cells to prevent recurrence. The primary endpoint for the Phase 2 trial is one-year disease free survival. As previously announced, Heat is enrolling an additional 25 patients to evaluate HS-410 as a monotherapy in an unblinded, open-label arm, which the company expects to complete by late 2015/early 2016. "This enrollment of the 75 randomized patients represents a significant milestone for the company and we continue to remain on track to report topline efficacy, immune-response and safety results in the fourth quarter of 2016," said Melissa Price, Ph.D., Vice President of Product Development, Heat Biologics. "These data will help guide the trial design, including patient selection and biomarker strategy, for our registration-directed trial as we move forward in our commitment to address the unmet needs of patients living with bladder cancer."
K2M Group Holdings, Inc. (Nasdaq:KTWO), a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine technologies, techniques and minimally invasive procedures, today announced plans to release third quarter of fiscal year 2015 financial results after market close on November 3rd. Management will host a conference call at 5:00 p.m. Eastern Time on November 3rd to discuss the results of the quarter and to host a question and answer session. Those who would like to participate may dial 888-430-8705 (719-325-2402 for international callers) and provide access code 376216 approximately 10 minutes prior to the start of the call. A live webcast of the call will also be provided on the investor relations section of the Company's website at http://Investors.K2M.com/. For those unable to participate, a replay of the call will be available for two weeks at 888-203-1112 (719-457-0820 for international callers); access code 376216. The webcast will be archived on the investor relations section of the Company's website.
LDR Holding Corporation (NASDAQ:LDRH), a global medical device company focused on designing and commercializing novel and proprietary surgical technologies for the treatment of patients suffering from spine disorders, today announced preliminary estimated revenue results for the third quarter ended September 30, 2015. For the third quarter ended September 30, 2015, the company expects to report: Total revenue of approximately $39.3 million, an increase of 9.5% over the third quarter of 2014, or an increase of 14.2% on a constant currency basis -- revenue from exclusive technology products of approximately $36.7 million, an increase of 14.5% over the third quarter of 2014, or an increase of 18.0% on a constant currency basis -- Revenue in the United States of approximately $32.3 million, an increase of 15.0% over the third quarter of 2014, and representing 82.2% of total revenue -- International revenue of approximately $7.0 million, a decrease of 10.3% over the third quarter of 2014. On a constant currency basis, international revenue increased 11.4% -- Revenue from the Company’s exclusive cervical products is expected to be approximately $27.5 million, an increase of 21.0% over the third quarter of 2014, or an increase of 25.2% on a constant currency basis, due principally to the growth from sales of the Mobi-C® Cervical Disc. Additionally, revenue from LDR's exclusive lumbar products is expected to be approximately $9.2 million, a decrease of 1.5% over the third quarter of 2014, or an increase of 0.5% on a constant currency basis.
MedAssets (NASDAQ:MDAS) today announced that Scripps Health, a non-profit regional integrated health system based in San Diego, Calif., has expanded its relationship with MedAssets to include Invoice Management Services, powered by Ariba, an SAP company. This is MedAssets newest component of its procure-to-pay solution set, and builds on Scripps Health's comprehensive program with MedAssets to reduce the total cost of care, enhance operational efficiency, align clinical delivery and improve revenue performance. MedAssets Invoice Management Services is a best-in-class solution that leverages Ariba's cloud-based invoice management applications to enable a "smart invoicing" process through which invoices are automatically validated against 80+ provider-customized validation rules to ensure that only accurate and approved invoices reach accounts payable. "Many companies have implemented solutions to digitize invoices. But with one in five invoices still containing an overcharge or other error, it's clear that digitization only leads to inaccurate invoices being delivered faster," said Alex Atzberger, president, Ariba. "MedAssets delivers an intelligent invoicing process using Ariba's Invoice Management solutions that reduces the number of invoice exceptions materially and provides true "touchless" invoice processing, resulting in significant labor efficiency gains to providers."
Marrone Bio Innovations, Inc. (NASDAQ:MBII), a leading provider of bio-based pest management and plant health products for the agriculture, turf and ornamental and water treatment markets, announced today that the U.S. Environmental Protection Agency has approved its latest product, MAJESTENE™, a broad spectrum, high performance natural bionematicide for controlling nematodes (roundworms) on a wide range of agricultural crops. MAJESTENE was developed from MBI's in-house discovery screening process and provides growers with a new mode of action for safely controlling nematodes by reducing or stopping eggs from hatching, preventing root galling and reducing nematode population density. Nematodes cause approximately $80 billion annually in damages to crops globally. "We are pleased with MAJESTENE'S approval by the EPA, as this new bionematicide meets a large market need due to heavy restrictions on toxic chemicals used to control nematodes and the need for easier-to-use biologicals that reduce multiple species of nematode populations," said Pam Marrone, MBI's CEO. "Today's growers are faced with ever-increasing regulatory restrictions on existing conventional products to reduce exposure to people nearby, to protect non-target beneficial insects, to reduce air and water pollution, to ensure worker safety and to be export-ready. Growers who traditionally employ conventional nematicides for crop protection can now use MAJESTENE, which has multiple modes of action, a low risk to beneficial insects, and an exemption from residue tolerances. MAJESTENE brings growers expanded options for an environmentally responsible and effective solution for managing pests in conventional and organic crops," said Brian Ahrens, MBI's Vice President of Sales.
Medical Marijuana, Inc. (OTC Pink:MJNA), the first-ever publicly traded U.S. cannabis company, is pleased to announce to shareholders and the general public that Stuart W. Titus, PhD and Chief Executive Officer of Medical Marijuana, Inc. will be presenting on the Cannabis Investor Webcast on Thursday, October 8 at 4:00 – 4:45 PM ET (1:00 – 1:45 PM PT). companying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/33929850-3617-4167-b4c4-c0fa38ee93c4 The Cannabis Investor Webcast will include presentations from both privately held and publicly traded industry companies and industry professionals. Medical Marijuana, Inc.’s presentation on hemp industry innovations will be 30 minutes long and will then be followed by a 15-minute Q&A. Along with learning about economic potential of re-introducing hemp into American culture, attendees at the Cannabis Investor can research Medical Marijuana, Inc. without taking time off from work, paying registration fees and incurring travel-related expenses. “Medical Marijuana, Inc. is very excited to share an overview on the company, hemp industry innovations and other recent developments with the Cannabis Investor Webcast,” states Stuart W. Titus, PhD and Chief Executive Officer of Medical Marijuana, Inc. “With our flagship product Real Scientific Hemp Oil generating global headlines and other exciting developments from our portfolio companies that are conducting clinical research, it’s a very exciting time for the company.”
Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, today announced that new clinical outcomes and clinical utility data for myPath® Melanoma will be featured at the American Society of Dermatopathology (ASDP) 52nd meeting being held Oct. 8 to 11, 2015 in San Francisco, Calif. The findings add to the growing body of knowledge for myPath Melanoma and will support the Company's clinical reimbursement dossier for the product. "The accurate diagnosis of melanoma can be challenging based on histologic findings alone and there are potentially severe consequences of a misdiagnosis, including the under-treatment or overtreatment of patients," said Loren Clarke, M.D., vice president, Medical Affairs for Dermatology, Myriad Genetic Laboratories. "Our studies show that myPath Melanoma accurately differentiates malignant melanoma from benign skin lesions and helps physicians deliver a more objective and confident diagnosis for their patients." A list of the myPath Melanoma presentations at ASDP (#ASDP2015) follows: Podium Presentation -- Title: Correlation of myPath Melanoma gene expression score with clinical outcome on a series of melanocytic lesions. -- Date: Saturday, Oct. 10, 2015: 3:00 p.m. PT -- Location: Hilton Union Square, Continental 4-6.
The National Patient Safety Foundation (NPSF), a central voice for patient safety since 1997, recently welcomed DuPont Sustainable Solutions as a member of the NPSF Patient Safety Coalition. Building on DuPont's vast experience in managing hazards, DuPont Sustainable Solutions works with a variety of industries to provide customized approaches to reduce risk and improve workforce safety and efficiency. "You cannot deliver excellence in patient safety without caregivers who consistently practice safe behaviors in the workplace," said Mark Wagner, regional president, U.S. and Canada, DuPont Sustainable Solutions. "Joining the NPSF Patient Safety Coalition enables us to work closely with the Foundation and other member organizations to develop innovative solutions to help break down the organizational and behavioral barriers that are perpetuating safety issues today."
SANUWAVE Health, Inc. (OTCQB:SNWV) today announced top line and preliminary data analysis from the Company's pivotal Phase III, Investigational Device Exemption (IDE) supplemental clinical trial comparing the rates of 100% wound closure at 12 weeks between dermaPACE® and Sham control (non-active treatment), when both are combined with the current standard of care for the treatment of diabetic foot ulcers (DFUs). This study supplemented the Company's earlier 206 patient Phase III trial of identical endpoints which demonstrated the exceptional safety profile and clinical benefit of the dermaPACE device for the treatment of diabetic foot ulcers; an area of significant unmet medical need and represents a $2 billion market in the United States alone. The design of this randomized, double-blind, parallel-group, Sham-controlled, multicenter, 26-week clinical trial was intended to quantify the effectiveness of up to eight, non-invasive procedures with dermaPACE, delivered over a 10-week period. This supplemental study ultimately enrolled and randomized 130 subjects and was run under a Bayesian statistical plan, designed with FDA input and utilizing the strength of the results from the first clinical trial as an informative prior. As previously reported, the Company announced the results of two separate Data Monitoring Committee (DMC) analyses of the primary objective. In both cases, the DMC reported that the study did not meet the Monitoring Success Criterion at Week 12 necessary to stop enrollment in the trial. In essence, there was insufficient separation in the rates of closure between the dermaPACE and Sham-control patients to demonstrate statistical significance. On June 6, 2015, the company met with FDA to discuss potential analysis changes for the trial. FDA was fully aware of the DMC findings that we wouldn't meet the12 week endpoint. FDA's response at the meeting was for SANUWAVE to submit the data, and they would judge dermaPACE on the totality of the clinical results when reviewing the PMA. The clinical data was frozen and the associated database was locked in August, 2015. Subsequently the top line datasets were submitted to the Company's statisticians for analysis.
The Spectranetics Corporation (Nasdaq:SPNC) today announced that the Company will release 2015 third quarter financial results after market close on Thursday, October 22, 2015. Company management will host an investment-community conference call beginning at 2:30 p.m. Mountain Time (4:30 p.m. Eastern Time) on Thursday, October 22 to discuss those results and to answer questions. Individuals interested in listening to the conference call may do so by dialing (877) 561-2747 for domestic callers, or (973) 409-9689 for international callers (Conference ID: 48806203), or from the webcast on the investor relations section of the Company's website at: www.spectranetics.com. The webcast will be available on the Company's website for 14 days following the completion of the call.
Sunrise Health System, along with Catholic Charities of Southern Nevada, The Salvation Army, Serving Southern Nevada and Nevada Homeless Alliance, are excited to announce the premier of theater sensation STAND, written by Jim Reyland, on Oct. 16 and 17 at the Clark County Library's Theater. Named best new play by the Nashville Scene, STAND raises funds and awareness countrywide for communities and organizations working with the homeless. "STAND is an inspired play that will benefit those that struggle with homelessness in our Las Vegas community," said Phillip Hollon, Director of Social Services for The Salvation Army. "The production sparks conversation, putting a face to those that are sometimes invisible. Our veterans, our students, our neighbors are all among those in our community struggling with homelessness." STAND is the true story of Johnny "JJ" Ellis, who spent two drug-addicted decades on the streets of Nashville, and a Good Samaritan who helped him through the struggles and trials homeless individuals endure. David Compton, award-winning director and actor, directs the play and renowned stage actors Barry Scott and Henry Arnold star in this heartfelt production. "We are fortunate and excited to be a part of this national initiative with the play STAND, said Deacon Tom Roberts, President and CEO of Catholic Charities of Southern Nevada. "The funds raised by these performances allow us to continue to serve the many men, women and children who are homeless in our community."
VBI Vaccines Inc. (Nasdaq:VBIV) today announced that it has applied its eVLP Platform in the development of a novel therapeutic vaccine candidate for glioblastoma multiforme ("Glioblastoma" or "GBM"). Columbia University's Brain Tumor Center is performing research to evaluate VBI's GBM immunotherapy candidate in ex vivo studies using GBM patient samples. Glioblastoma is among the most common and aggressive malignant primary brain tumors in humans. In the U.S. alone, 12,000 new cases are diagnosed each year. The current standard of care for GBM is surgical resection, followed by radiation and chemotherapy. Even with aggressive treatment, GBM progresses rapidly and is exceptionally lethal, with median patient survival of less than sixteen months. A growing body of research has demonstrated that GBM tumors are particularly susceptible to infection by cytomegalovirus ("CMV"), with over 90% of GBM tumors expressing CMV antigens. In addition, recent research has demonstrated that dendritic cell priming combined with dendritic cell vaccination against CMV can extend overall survival in patients with glioblastoma. "Recent advances in this field are promising, but there is still need for improved CMV vaccination approaches for GBM," said Dr. David E. Anderson, Ph.D., VBI's Chief Scientific Officer. "Our eVLP approach has allowed for the efficient delivery of multiple CMV antigens, and in the case of GBM, we believe could be capable of mobilizing a broad and robust anti-tumor immune response against GBM. Further, we have demonstrated the ability to manufacture eVLP-derived vaccine candidates with yields and purity that are expected to be suitable for production at a commercial scale." VBI is seeking to leverage its eVLP Platform and its expertise in CMV to develop a therapeutic vaccine candidate that has been designed to direct an immune response against glycoprotein B and pp65, two CMV antigens that are highly immunogenic targets during natural infection. The vaccine candidate includes an adjuvant that mobilizes dendritic function and enhances Th1-type immunity.