vMiMedx Files With The FDA To Initiate Its Investigational New Drug Achilles Tendonitis Phase 3
Friday, August 04, 2017 12:00 AM

MARIETTA, Ga., Aug. 4, 2017 /PRNewswire/ -- MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare, announced today that the Company has filed with the Food and Drug Administration (FDA) to initiate its Investigational New Drug (IND) Phase 3 Achilles Tendonitis clinical study. 

The Achilles Tendonitis clinical trial will study MiMedx's AmnioFix® Injectable in a Phase 3, Prospective, Double Blinded, Randomized Controlled Trial of the Micronized dHACM Injection as Compared to Saline Placebo Injection in the Treatment of Achilles Tendonitis. The Company expects patient enrollment to commence in the next few months. 

The trial will enroll approximately 158 study patients with moderate to severe pain due to Achilles Tendonitis with failed conservative treatment for at least one month. The IND Phase 3 clinical study objective is to determine the safety and effectiveness of AmnioFix Injectable as compared to the 0.9% Sodium Chloride USP placebo injection control for the treatment of moderate to severe pain due to Achilles tendonitis. 

The filed primary efficacy endpoint of this study will be the change in Visual Analog Scale (VAS) score for patients between baseline and Day 90 expressed as the difference in means between the AmnioFix Injectable versus placebo-treated group. The primary safety endpoint will be the incidence of Adverse Events, Serious Adverse Events, and Unanticipated Adverse Events during the first 180 days post injection in the AmnioFix Injectable group versus the placebo-treated group.

The Achilles Tendonitis study will be the second IND Phase 3 trial for MiMedx AmnioFix Injectable. MiMedx plans to submit a Biologic License Application (BLA) to the FDA for tendonitis when the Company's Plantar Fasciitis Phase 3 trial completes.

Parker H. "Pete" Petit, CEO, said, "In addition to this IND study, we are planning to file for another IND study by the end of this quarter. This additional IND study will be for the use of our micronized dHACM in the treatment of Osteoarthritis Knee Pain.  With the commencement of the Osteoarthritis study, we will have three IND studies ongoing. We are excited about our progress in moving our focus into the biopharmaceutical market, and we look forward to keeping our shareholders appraised on our future study results. We will continue to keep shareholders very well informed of our new biopharmaceutical initiatives. Later this year, we will hold a meeting in New York that will include presentations by MiMedxexecutives and the physicians involved with our various IND studies to better inform analysts and our shareholders of these important activities."

MiMedx previously reported that the Company will be hosting a webcast on Monday, August 7, 2017 beginning at 2:00 p.m. Eastern Time. This Achilles Tendonitis study will also be included in the presentation. As previously announced, a listen-only simulcast of the shareholder call will be available on-line at the Company's website at www.mimedx.com beginning at 2:00 p.m. eastern time, August 7, 2017. A 30-day on-line replay will be available approximately one hour following the conclusion of the live broadcast on the Company's website at www.mimedx.com.

About MiMedx
MiMedx® is a biopharmaceutical company developing and marketing regenerative biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. "Innovations in Regenerative Medicine" is the framework behind our mission to give physicians products and tissues to help the body heal itself.  We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization.  MiMedx is the leading supplier of placental tissue, having supplied over 900,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com

Important Cautionary Statement
This press release includes forward-looking statements, including statements regarding the timing, results, and publication of clinical studies; and the potential safety and efficacy, and additional approved uses and markets for our products. These statements also may be identified by words such as "believe," "except," "may," "plan," "potential," "will" and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements. Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include the risk that unexpected concerns may arise from additional data or analysis from our clinical trials; regulatory submissions may take longer or be more difficult to complete than expected; and that regulatory authorities may require additional information or further studies or may fail to approve or may delay approval or grant marketing approval that is different than anticipated. For more detailed information on the risks and uncertainties associated with new product development and commercialization activities, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.

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SOURCE  MiMedx Group, Inc.

BIO: Senate Passage of FDA User Fee Package Important Victory for Patients, Medical Innovation
Thursday, August 03, 2017 12:00 AM
Biotechnology Innovation Organization (BIO) President and CEO James C. Greenwood issued the following statement regarding passage of the Food and Drug Administration Reauthorization Act (FDARA) by the U.S. Senate today:  “The user fee program reauthorization package passed by the Senate today is an important victory for patients and for the next generation of medical innovation. This legislation will advance patient involvement in drug development and bring patient perspectives more clearly to bear on regulatory decisions. It also ensures that the FDA continues to have the resources necessary to carry out its critical human drug review programs, and takes steps to modernize and improve the clinical trial process, which remains the most time-consuming, complex and expensive stage of drug development.

“The reauthorization of the biosimilars user fee program, including steps to improve communication between the FDA and Sponsors throughout application review, will create a more robust and competitive marketplace for biosimilar therapies, following an appropriate period of exclusivity for innovator biologic products.”

“The legislation also contains a number of provisions that will accelerate and incentivize the entry of generic medicines to the market, which will help to contain costs through increased competition while improving consumer choice. These provisions are consistent with proposals endorsed by BIO to drive smarter spending within our healthcare system without harming incentives for innovation.

“We commend the leadership of Senate HELP Committee Chairman Lamar Alexander and Ranking Member Patty Murray for their tireless bipartisan efforts in advancing this important legislation, as well as that of their counterparts on the House Energy and Commerce Committee, Chairman Greg Walden and Ranking Member Frank Pallone.

“We look forward to working with the FDA and other stakeholders to ensure that the important patient-centric advances contained in this legislation are most effectively implemented.”  

Georgia State Sets Research Funding Record For Sixth Consecutive Year Georgia State Sets Research...
Wednesday, August 02, 2017 12:00 AM

ATLANTA—Georgia State University received $147 million in research funding in fiscal year 2017, setting a record for the sixth consecutive year.

The total exceeds last year’s record of $120.1 million. Externally funded research activity at the university has climbed 81 percent over the past three years. This year one of the largest funding increases came from industry research grants and contracts, which grew nearly fivefold.

The university experienced a particularly large spike in funding for health and biomedical research. Of the $147 million, more than $20 million went toward research in the Institute for Biomedical Sciences and more than $16 million to research in the School of Public Health.

“As one of the nation’s fastest growing research institutions, Georgia State has rapidly developed a reputation for scientific innovation,” said James Weyhenmeyer, vice president for research and economic development at Georgia State. “Achieving this funding benchmark shows that we’ve been adept at cultivating monetary support for our innovative work, which helps drive economic development and transformative research at the university and throughout the metro Atlanta region.”

This year’s key awards included:

  • A $7.7 million grant from the National Institutes of Health awarded to Margo Brinton (College of Arts and Sciences) to investigate the consequences of West Nile and Zika virus infections on the human central nervous system.
  • More than $4 million from the NIH awarded to Christopher Basler (Institute for Biomedical Sciences) to develop a drug targeting the Ebola virus.
  • A $3.9 million grant from the Laura and John Arnold Foundation awarded to Tim Sass and Dan Kreisman (Andrew Young School of Policy Studies) to create the Georgia Center for Education Policy, which will work to improve academic, career and life outcomes for students across the state.
  • More than $3 million from the NIH awarded to Kathleen Baggett (School of Public Health) to test the effectiveness of Mom and Baby Net, a mobile phone app combining two programs to decrease maternal depression and build parenting skills.
  • A $2.8 million grant from NIH awarded to Zhoglin Xie and Ming-Hui Zou (Center for Molecular and Translational Medicine) to study diabetic cardiomyopathy, changes in the heart’s structure and function related to diabetes.
  • A $1.8 million grant from the NIH awarded to Andrew Gewirtz (Institute for Biomedical Sciences) to study how changes in gut bacteria could lead to obesity and metabolic syndrome.
  • A $1.8 million grant from the NIH awarded to Anne Murphy (Neuroscience Institute) to investigate pain management therapies for people age 65 and older.
  • An $867,000 grant from Pfizer Inc. awarded to Michael Eriksen and the School of Public Health to continue their work to implement tobacco control programs in five major Chinese cities.

“Georgia State’s record-high levels in research funding validate the strategy of long-term investment in talent and technology,” said Mike Cassidy, president and chief executive officer of the Georgia Research Alliance (GRA). “The GRA stands committed to helping Georgia State continue to expand its capacity to discover more and launch more enterprises around the most promising inventions.”

Georgia State earned its designation as a major research institution in 1995, and it now ranks among the nation’s top 108 public and private universities in the Carnegie Foundation’s elite category of Highest Research Activity.

For more information about research at Georgia State, visit research.gsu.edu.

Biomedical Researcher Gets $1.9 Million To Study Influenza Vaccines Biomedical Researcher Gets $1.9
Monday, July 31, 2017 12:00 AM

ATLANTA—Dr. Sang-Moo Kang, professor in the Institute for Biomedical Sciences at Georgia State University, has renewed a four-year, $1.9 million federal grant to develop influenza vaccines that offer enhanced protection against a broad range of influenza virus strains.

This is the second grant renewal from the National Institute for Allergy and Infectious Diseases of the National Institutes of Health. The project will explore novel approaches to improve the cross-protective properties of licensed seasonal influenza vaccines, with results expected to be applicable to the clinic and have a significant impact on public health.

Dr. Richard Plemper, a professor in the Institute for Biomedical Sciences, will be a co-investigator for the research project.

Influenza, a contagious respiratory illness caused by influenza viruses, can cause mild to severe illness and even lead to death. Influenza vaccines, such as inactivated split virus vaccines and live attenuated influenza virus vaccines, that are based on immunity to the hemagglutinin (HA) hypervariable protein, do not provide effective cross protection against new influenza virus strains that develop through changes in the virus’ genes as it replicates over time. Developing a novel vaccine that improves the efficacy and extent of cross protection is a high priority.

“With this project, we’ve proposed groundbreaking approaches to increase the capacity of current influenza vaccine platforms to give cross protection against new influenza virus strains,” Kang said. “We will achieve this by incorporating M2e epitopes, which are found among all influenza strains, into HA and engineering a M2e-HA molecule.”

This project has three aims. First, the researchers will test the hypothesis that recombinant seasonal inactivated split virus vaccines and live attenuated influenza virus vaccines with M2e-HA molecules will enhance the efficacy of cross protection by inducing immunity to M2e and HA.

Secondly, the research team will study recombinant influenza virus vaccines and investigate the role of cellular and humoral immune mechanisms in cross protection in mice. Lastly, the researchers will validate the efficacy of cross protection by recombinant influenza virus vaccines in ferrets, the most relevant small-animal model for the assessment of influenza vaccines, in collaboration with a team led by Dr. Ian York at the Centers for Disease Control and Prevention in Atlanta.

An abstract of the grant, 2R01AI093772-07A1, is available at NIH’s Project RePORTer website.

For more information about the Institute for Biomedical Sciences, visit http://biomedical.gsu.edu.

New Workflow Is First End-to-End Solution For Extrusion-Based Drug Implant Production
Thursday, July 27, 2017 12:00 AM

Thermo Scientific Pharma mini implant line is an automated, integrated system designed for continuous production of drug implants

KARLSRUHE, Germany (JULY 26, 2017) – To meet growing demand for innovative drug delivery systems in the pharmaceutical industry, drug formulation scientists can now use the first commercially available, fully-integrated solution for polymer-based drug implant development and production using hot melt extrusion (HME). This new drug development workflow provides pharmaceutical manufacturers with a complete end-to-end manufacturing line from a single supplier.

The Thermo Scientific Pharma mini implant line is built around the Thermo Scientific Pharma mini HME twin-screw micro compounder. It provides drug developers, process manufacturing scientists and engineers with a continuous and fast production process designed to improve product quality, maximize operator safety and reduce the risk of contamination. This integrated production line is also designed to allow contract research and manufacturing organizations (CRO/CMO) to develop and optimize small-scale formulations before engaging in larger-scale production.

“With a single subcutaneous injection, advanced drug implants can release a therapeutic substance that can provide patients with improved drug compliance, effective disease treatment or controlled hormonal regulation for weeks or even months,” said Hanna Granö-Fabritius, senior business director, material characterization for Thermo Fisher Scientific. “Pharmaceutical manufacturers are seeking fast, reliable solutions for continuous production of novel drug delivery systems. Our new, automated implant line offers a hot melt extrusion solution designed to minimize formulation development time.”

The Thermo Scientific Pharma mini implant line incorporates a range of components in an innovative configuration. In addition to the Pharma mini HME micro compounder, components include:

• A containment valve to add the active pharmaceutical ingredient (API) and the polymer, designed to protect the operator from exposure to the API and preventing contamination of the API;
• A gravimetric feeder to deliver the API/polymer into the micro compounder for heating and mixing before the melt is extruded through a die that creates a continuous filament;
• New bi-axial lasers that measure the thickness or diameter of the filament to adjust the stretching or “take-off” speed of the conveyor belt; and
• Proprietary equipment that cuts the filament to a desired implant length while maintaining “roundness” without deforming the implant shape.
For more information on the Thermo Scientific Pharma mini implant line, please visit www.thermofisher.com/implantline.

About Thermo Fisher Scientific 
Thermo Fisher Scientific Inc. is the world leader in serving science, with revenues of $18 billion and more than 55,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support. For more information, please visit www.thermofisher.com.

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