X
Pharma Advancement
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development
    development of new antibiotics

    EMA guidance supports development of new antibiotics

    Thermo Fisher Scientific Announces Collaboration with Northeastern University to Advance Biopharmaceutical Characterization and Monitoring Workflows

    Commercial Success In New Biopharmaceutical Innovation Era

    Proteros and AstraZeneca Boost Collaboration Agreement

    Conver to wp

    AbbVie and Cugene Join Forces Concerning Autoimmune Disorders and Cancer

    Drug Imagent For Therapeutic Platform

    Japan Pharma Lobby Says-Price Scheme Is Causing Drug Lag

    Charles River and Valence Discovery Announce Strategic Partnership to Provide Clients with AI-Enabled Drug Design Capabilities

    Charles River and Valo Launch Logica, an Integrated AI-Powered Drug Discovery Solution to Rapidly Deliver Optimized Preclinical Assets

    AstraZeneca announces phase IV ASCENT trial of Tudorza Pressair in patients with COPD meets primary efficacy endpoint

    AstraZeneca announces plans for new strategic R&D centre and Alexion headquarters in Cambridge, Massachusetts

    Lynparza approved in the EU for BRCA-mutated metastatic pancreatic cancer

    Major Success Factors For Clinical Development Organizations

    ArisGlobal Expands LifeSphere Clinical Portfolio with Landmark Customer Wins in APAC & Middle East

    ArisGlobal Expands LifeSphere Clinical Portfolio with Landmark Customer Wins in APAC & Middle East

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development
    development of new antibiotics

    EMA guidance supports development of new antibiotics

    Thermo Fisher Scientific Announces Collaboration with Northeastern University to Advance Biopharmaceutical Characterization and Monitoring Workflows

    Commercial Success In New Biopharmaceutical Innovation Era

    Proteros and AstraZeneca Boost Collaboration Agreement

    Conver to wp

    AbbVie and Cugene Join Forces Concerning Autoimmune Disorders and Cancer

    Drug Imagent For Therapeutic Platform

    Japan Pharma Lobby Says-Price Scheme Is Causing Drug Lag

    Charles River and Valence Discovery Announce Strategic Partnership to Provide Clients with AI-Enabled Drug Design Capabilities

    Charles River and Valo Launch Logica, an Integrated AI-Powered Drug Discovery Solution to Rapidly Deliver Optimized Preclinical Assets

    AstraZeneca announces phase IV ASCENT trial of Tudorza Pressair in patients with COPD meets primary efficacy endpoint

    AstraZeneca announces plans for new strategic R&D centre and Alexion headquarters in Cambridge, Massachusetts

    Lynparza approved in the EU for BRCA-mutated metastatic pancreatic cancer

    Major Success Factors For Clinical Development Organizations

    ArisGlobal Expands LifeSphere Clinical Portfolio with Landmark Customer Wins in APAC & Middle East

    ArisGlobal Expands LifeSphere Clinical Portfolio with Landmark Customer Wins in APAC & Middle East

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
Pharma Advancement
No Result
View All Result
Home Drug Development Clinical Trials

DiscGenics Receives FDA Fast Track Designation for Cell Therapy for Disc Degeneration

Content Team by Content Team
31st August 2019
in Clinical Trials, Manufacturing, News
DiscGenics Cell Therapy for Disc Degeneration

 DiscGenics, Inc., a clinical stage biotechnology company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its investigational cell therapy, IDCT, currently being evaluated in regulator-allowed clinical trials in the U.S. and Japan for the reduction in pain and disability associated with degenerative disc disease (DDD), a major cause of chronic low back pain.

Fast Track is a special regulatory designation that companies can apply for once they have sufficient preclinical and clinical evidence that a product may be able to treat an unmet medical need for a serious medical condition. With this designation, Sponsors may benefit from early and frequent communication with FDA, eligibility for Accelerated Approval and Priority Review programs, as well as a Rolling Review application process for marketing licensure.

“We are thrilled to receive Fast Track designation for IDCT as it recognizes the extremely compelling preclinical (1) and safety data we have generated for IDCT through our robust research and development and clinical programs, and underscores FDA’s acknowledgement of low back pain as a serious medical condition with a profound lack of treatment options,” said Flagg Flanagan, Chairman and CEO of DiscGenics, Inc. “This Fast Track designation reinforces our commitment to working with regulators to identify ways to accelerate development and expedite approval of the therapy within existing regulatory frameworks to make IDCT available to patients as quickly as possible

IDCT is a homologous, allogeneic, injectable cell therapy that utilizes biomedically engineered progenitor cells, known as Discogenic Cells, that have been derived from intervertebral disc tissue to offer a non-invasive, potentially regenerative solution for the treatment of mild to moderate DDD. As a manufactured allogeneic cell therapy, IDCT is regulated by FDA’s Center for Biologics Evaluation and Research (CBER) under Section 351 of the Public Health Service Act (PHSA). As a result, DiscGenics is adhering to the rigors of a regulated drug pathway that require the Company to not only prove that the product has a therapeutic effect through clinical evaluation, but also that it meets critical safety standards and is produced consistently from lot to lot through adherence to current good manufacturing practice (cGMP) standards for a cell therapy.

DiscGenics is conducting two parallel prospective, randomized, double-blinded, controlled, multicenter clinical trials of IDCT in the U.S. and Japan. IDCT is being evaluated in the U.S. under an investigational new drug (IND) allowance by the FDA and will be regulated as a drug-biologic through a biologics license application (BLA). In Japan, the trial is supported by a Clinical Trial Notification (CTN) approved by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). Primary outcome measures include safety and reduction in pain. Secondary outcome measures include reduction in disability and radiographic improvement. Importantly, the U.S. study has shown safety in the first cohort of patients. For both studies, enrollment is ongoing.

About Chronic Low Back Pain and Degenerative Disc Disease

Chronic low back pain is a serious medical condition that represents a leading cause of disability worldwide (2) and is the most common non-cancer reason for opioid prescription in the U.S. (3). It affects 12-30% of U.S. adults at a given time (4) and is estimated to cost the U.S. healthcare system over $100 billion each year (2), creating a significant burden on the economy and individual patients dealing with the condition. In nearly 40% of patients, low back pain is caused by DDD (5-7), a chronic and progressive condition where the intervertebral disc breaks down and causes pain.

About DiscGenics

DiscGenics is a privately held, clinical stage biotechnology company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine. As the only company in the world to develop an allogeneic cell therapy derived from intervertebral disc cells to treat diseases of the disc, DiscGenics believes it has a unique opportunity to harness the restorative potential of the human body to heal millions of patients suffering from the debilitating effects of back pain. DiscGenics’ first product candidate, IDCT, is a homologous, allogeneic, injectable cell therapy that utilizes biomedically engineered progenitor cells derived from intervertebral disc tissue, known as Discogenic Cells, to offer a non-surgical, potentially regenerative solution for the treatment of patients with mild to moderate degenerative disc disease. For more, visitwww.discgenics.com.

 

Previous Post

Sonnet BioTherapeutics Announces Acquisition Agreement with Relief Therapeutics Holding SA for Atexakin Alpha

Next Post

ADC Therapeutics and Freenome Enter Biomarker Development Collaboration

Related Posts

Dupixent From Sanofi Delivers Another Fantastic Performance
Manufacturing

Sanofi Sets Up Fund To Enable Firms In Low-Income Countries

5th July 2022
GSK commences phase III study of Benlysta and rituximab combination in systemic lupus erythematosus
Manufacturing

Singapore Authorises New Ovarian Cancer Treatment By GSK

5th July 2022
Abbott Is Named Global Industry Leader in Sustainability for the Sixth Consecutive Year on the Dow Jones Sustainability Index (DJSI)
Manufacturing

Abbott India Affirms That The Medicines Are Not Their Own

5th July 2022
Global Biopharmaceutical Bioseparation Market Eyeing $20bn
Manufacturing

Global Biopharmaceutical Bioseparation Market Eyeing $20bn

4th July 2022
FDA Advises Adding Omicron BA.4, 5 To COVID-19 Boosters
Manufacturing

FDA Advises Adding Omicron BA.4, 5 To COVID-19 Boosters

4th July 2022
COVID-19 Omicron-Specific Vaccines Could Be Used As Boosters
Manufacturing

COVID-19 Omicron-Specific Vaccines Could Be Used As Boosters

4th July 2022
Next Post
ADC Therapeutics

ADC Therapeutics and Freenome Enter Biomarker Development Collaboration

Latest News

Dupixent From Sanofi Delivers Another Fantastic Performance
Manufacturing

Sanofi Sets Up Fund To Enable Firms In Low-Income Countries

5th July 2022
GSK commences phase III study of Benlysta and rituximab combination in systemic lupus erythematosus
Manufacturing

Singapore Authorises New Ovarian Cancer Treatment By GSK

5th July 2022
Abbott Is Named Global Industry Leader in Sustainability for the Sixth Consecutive Year on the Dow Jones Sustainability Index (DJSI)
Manufacturing

Abbott India Affirms That The Medicines Are Not Their Own

5th July 2022
Global Biopharmaceutical Bioseparation Market Eyeing $20bn
Manufacturing

Global Biopharmaceutical Bioseparation Market Eyeing $20bn

4th July 2022
FDA Advises Adding Omicron BA.4, 5 To COVID-19 Boosters
Manufacturing

FDA Advises Adding Omicron BA.4, 5 To COVID-19 Boosters

4th July 2022
Pharma Advancement

About Us

Pharma Advancement is a leading Pharma information centric website. On one side Pharmaadvancement.com has established itself as one of the most efficient and comprehensive source of Pharma information online, dedicated to providing decision makers in all the Pharma industry sectors with reliable, accurate and useful insights into happenings in the Pharma sector.

Qucik Links

  • Drug Development
  • Manufacturing
  • News
  • Events & Conferences
  • Newsletter Archive

Resources

  • Advertise with us
  • Contact Us
  • Download Mediapack

System

  • Search
  • Sitemap
  • RSS Feed

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

No Result
View All Result
  • Home
  • Drug Development
  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

Login to your account below

Forgotten Password?

Fill the forms bellow to register

All fields are required. Log In

Retrieve your password

Please enter your username or email address to reset your password.

Log In