Kadmon Announces that KD025 Met Primary Endpoint at Interim Analysis of Pivotal Trial in Chronic Graft-Versus-Host Disease – Yahoo Finance
By daniellenierenberg
NEW YORK / ACCESSWIRE / November 11, 2019 / Kadmon Holdings, Inc. (KDMN) today announced positive topline results from the planned interim analysis of ROCKstar (KD025-213), the fully enrolled pivotal trial evaluating KD025 in patients with chronic graft-versus-host disease (cGVHD) who have received at least two prior lines of systemic therapy. The trial met the primary endpoint of Overall Response Rate (ORR) at the interim analysis, which was conducted as scheduled two months after completion of enrollment.
KD025 showed statistically significant ORRs of 64% with KD025 200 mg once daily (QD) (95% Confidence Interval (CI): 51%, 75%; p<0.0001) and 67% with KD025 200 mg twice daily (BID) (95% CI: 54%, 78%; p<0.0001). KD025 has been well tolerated and adverse events have been consistent with those expected in the patient population.
"We are extremely pleased with the outcomes of the interim analysis, which showed that KD025 has already greatly exceeded the threshold for success in this pivotal trial," said Harlan W. Waksal, M.D., President and CEO of Kadmon. "We look forward to sharing these results with the FDA at a pre-NDA meeting, where we will also discuss the timing for a regulatory filing for KD025 in cGVHD, which we expect to occur in 2020, subject to FDA input."
"KD025 was shown to be a highly active and well-tolerated therapy across the spectrum of this complex, multi-organ disease," said Corey Cutler, MD, MPH, FRCPC, Associate Professor of Medicine, Harvard Medical School; Medical Director, Adult Stem Cell Transplantation Program, Dana-Farber Cancer Institute and a KD025-213 study investigator and Steering Committee member. "The response rates observed are particularly impressive since this study is being conducted in a real-world population with severe disease, supporting the potential role of KD025 in cGVHD patients who are in need of effective and well-tolerated therapies."
"It is highly encouraging to see the positive results from the pivotal trial are in line with those observed in the earlier Phase 2 study of KD025 in this difficult-to-treat disease," said Madan Jagasia, MD, Vanderbilt University, an investigator of the KD025-208 and KD025-213 studies and the KD025-213 Steering Committee chair. "These latest KD025 data continue to underscore the value that KD025 may offer to cGVHD patients."
KD025-213 is an ongoing open-label trial of KD025 in adults and adolescents with cGVHD who have received at least two prior lines of systemic therapy. Patients were randomized to receive KD025 200 mg QD or KD025 200 mg BID, enrolling 66 patients per arm. Statistical significance is achieved if the lower bound of the 95% CI of ORR exceeds 30%, which was achieved in both arms of the trial at the interim analysis.
While the ORR endpoint was met at the interim analysis, the primary analysis of the KD025-213 study will occur in the first quarter of 2020, six months after completion of enrollment. This analysis will include updated safety data and efficacy data, including ORRs and secondary endpoints, such as duration of response, changes in corticosteroid dose and changes in quality of life. Kadmon plans to submit results from the KD025-213 study for presentation at an upcoming scientific meeting.
Conference Call and Webcast
Kadmon will host a conference call and webcast on Monday, November 11, 2019, at 5:00 p.m., Eastern time, to discuss the topline results of the interim analysis of the KD025-213 study.
To participate in the conference call, please dial (866) 762-3021 (domestic) or (703) 925-2661 (international) and reference the conference ID: 6468498. The accompanying slides will be available for download on Kadmon's website beginning at 5:00 p.m. Eastern time.
To listen online via webcast, please visit: https://edge.media-server.com/mmc/p/9b9w8p38. The webcast will be archived and will be available at http://investors.kadmon.com/presentations-and-events.
About KD025
KD025 is a selective oral inhibitor of Rho-associated coiled-coil kinase 2 (ROCK2), a signaling pathway that modulates inflammatory response. In addition to cGVHD, KD025 is being studied in an ongoing Phase 2 clinical trial in adults with diffuse cutaneous systemic sclerosis (KD025-209). KD025 was granted Breakthrough Therapy Designation and Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of patients with cGVHD who have received at least two prior lines of systemic therapy.
Story continues
About cGVHD
cGVHD is a common and often fatal complication following hematopoietic stem cell transplantation. In cGVHD, transplanted immune cells (graft) attack the patient's cells (host), leading to inflammation and fibrosis in multiple tissues, including skin, mouth, eye, joints, liver, lung, esophagus and gastrointestinal tract. Approximately 14,000 patients in the United States are currently living with cGVHD, and approximately 5,000 new patients are diagnosed with cGVHD per year.
About Kadmon
Kadmon is a biopharmaceutical company developing innovative products for significant unmet medical needs. Our product pipeline is focused on inflammatory and fibrotic diseases as well as immuno-oncology.
Forward Looking Statements
This press release contains forward-looking statements. Such statements may be preceded by the words "may," "will," "should," "expects," "plans," "anticipates," "could," "intends," "targets," "projects," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar expressions. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. We believe that these factors include, but are not limited to, (i) the initiation, timing, progress and results of our preclinical studies and clinical trials, including KD025-213, and our research and development programs; (ii) our ability to advance product candidates into, and successfully complete, clinical trials; (iii) our reliance on the success of our product candidates, including KD025; (iv) the timing or likelihood of regulatory filings and approvals, including in connection with KD025-213; (v) our ability to expand our sales and marketing capabilities; (vi) the commercialization of our product candidates, if approved; (vii) the pricing and reimbursement of our product candidates, if approved; (viii) the implementation of our business model, strategic plans for our business, product candidates and technology; (ix) the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology; (x) our ability to operate our business without infringing the intellectual property rights and proprietary technology of third parties; (xi) costs associated with defending intellectual property infringement, product liability and other claims; (xii) regulatory developments in the United States, Europe and other jurisdictions; (xiii) estimates of our expenses, future revenues, capital requirements and our needs for additional financing; (xiv) the potential benefits of strategic collaboration agreements and our ability to enter into strategic arrangements; (xv) our ability to maintain and establish collaborations or obtain additional grant funding; (xvi) the rate and degree of market acceptance of our product candidates; (xvii) developments relating to our competitors and our industry, including competing therapies; (xviii) our ability to effectively manage our anticipated growth; (xix) our ability to attract and retain qualified employees and key personnel; (xx) our ability to achieve cost savings and other benefits from our efforts to streamline our operations and to not harm our business with such efforts; (xxi) the use of proceeds from our recent public offerings; (xxii) the potential benefits of any of our product candidates being granted orphan drug designation; (xxiii) the future trading price of the shares of our common stock and impact of securities analysts' reports on these prices; and/or (xxiv) other risks and uncertainties. More detailed information about Kadmon and the risk factors that may affect the realization of forward-looking statements is set forth in Kadmon's filings with the U.S. Securities and Exchange Commission (the "SEC"), including Kadmon's Annual Report on Form 10-K for the fiscal year ended December 31, 2018 and subsequent Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC's website at http://www.sec.gov. Kadmon assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
Contact Information
Ellen Cavaleri, Investor Relations646.490.2989ellen.cavaleri@kadmon.com
SOURCE: Kadmon Holdings, Inc.
View source version on accesswire.com: https://www.accesswire.com/566116/Kadmon-Announces-that-KD025-Met-Primary-Endpoint-at-Interim-Analysis-of-Pivotal-Trial-in-Chronic-Graft-Versus-Host-Disease
See the article here:
Kadmon Announces that KD025 Met Primary Endpoint at Interim Analysis of Pivotal Trial in Chronic Graft-Versus-Host Disease - Yahoo Finance
- Colossal Creates Elephant Stem Cells for the First Time in Quest to Revive the Woolly Mammoth - Singularity Hub - March 18th, 2024
- Vitamin A could have a key role in both stem cell biology and wound healing: Study - Medical Dialogues - March 10th, 2024
- A dive into the genetic history of India, and the role of vitamin A in skin repair - Science - March 10th, 2024
- Herbosa: Clinic under probe after skin treatments linked to womans death - Philstar.com - January 22nd, 2024
- These Will Be the Biggest Skin-Care Trends of 2024 - Allure - December 28th, 2023
- Sorry, But These 10 Skincare Products Are A Scam - Refinery29 - December 12th, 2023
- Cyclerion Strengthens Board of Directors with Experienced Company Builder and Cutting-edge Innovator - December 4th, 2023
- Aptose Appoints Fletcher Payne Chief Business Officer, Expanding his Executive Role - December 4th, 2023
- Opthea to Present at the FLORetina 2023 Congress - December 4th, 2023
- HUTCHMED Highlights Clinical Data to be Presented at 2023 ESMO Asia and ESMO Immuno-Oncology Congresses - December 4th, 2023
- AC Immune Strengthens Management, Appoints Madiha Derouazi as CSO and Christopher Roberts as CFO - December 4th, 2023
- Publication of a transparency notification received from Tolefi SA (Article 14 §1 of the Law of 2 May 2007) - December 4th, 2023
- Annovis Bio Appoints Andrew Walsh as Vice President Finance - December 4th, 2023
- Foghorn Therapeutics Announces Clinical Data from Phase 1 Study of FHD-286, a Novel BRG1/BRM Inhibitor, in Patients with Advanced Hematologic... - December 4th, 2023
- Akari Therapeutics Appoints Experienced Life Sciences Entrepreneur Samir R. Patel, M.D. to Board of Directors - December 4th, 2023
- Ovid Therapeutics to Present Five Abstracts Supporting its Epilepsy Programs at the 77th American Epilepsy Society Annual Meeting (2023) - December 4th, 2023
- Spectral Medical Announces CFO Departure - December 4th, 2023
- Are STEM CELL EXOSOMES the secret to a 'snatched' jawline? Discover the products that influencers are claiming - Daily Mail - November 18th, 2023
- Defence Mechanisms: Four ways your body is protecting you every time you fall sick - indulgexpress - May 16th, 2023
- Treat Yourself to a Spa Day With a $100 Deal on $600 Worth of Products From Elemis, 111SKIN, Nest & More - E! NEWS - May 16th, 2023
- INTERNATIONAL STEM CELL CORP MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS (form 10-K) - Marketscreener.com - April 5th, 2023
- Skin Regeneration: The Science and How to Boost It - Healthline - March 9th, 2023
- Treat Yourself to a Spa Day With a $100 Deal on $600 Worth of Products From Elemis, U Beauty, Nest & More - E! NEWS - March 1st, 2023
- 7-year-old vows to find a cure for brother in need of bone marrow transplant - WJLA - February 21st, 2023
- World's most radioactive man 'cried blood' as his skin melted in 83-day nightmare - Times Now - February 4th, 2023
- How old are you, really? The answer is written on your face. - National Geographic UK - February 4th, 2023
- Skin: Layers, Structure and Function - Cleveland Clinic - January 27th, 2023
- Human skin | Definition, Layers, Types, & Facts | Britannica - January 27th, 2023
- Skin Disorders: Pictures, Causes, Symptoms, and Treatment - Healthline - January 27th, 2023
- Skin care: 5 tips for healthy skin - Mayo Clinic - January 27th, 2023
- Skin Care and Aging | National Institute on Aging - January 27th, 2023
- Wrinkles - Symptoms and causes - Mayo Clinic - January 27th, 2023
- Dry skin - Symptoms and causes - Mayo Clinic - January 27th, 2023
- Stem cells: a brief history and outlook - Science in the News - January 3rd, 2023
- Still Drinking Green Tea? Doctor Reveals A Healthier Drink With Proven Benefits For Diabetes, Aging, Oxidative Stress, And Cancer - Revyuh - January 3rd, 2023
- RUDN Physician And Russian Scientists Investigate Long-term Effects Of Treating Diabetic Ulcers With Stem Cells - India Education Diary - December 25th, 2022
- The Use of Stem Cells in Burn Wound Healing: A Review - Hindawi - December 1st, 2022
- FACTORFIVE Skincare The Power of Stem Cells for Skin - December 1st, 2022
- Embryonic Stem Cells - The Definitive Guide | Biology Dictionary - December 1st, 2022
- From pro soccer hopeful to hip hop artist with illness and addiction along the way, Tymaz Bagbani releases debut album - Toronto Star - December 1st, 2022
- Stem Cells | The ALS Association - November 22nd, 2022
- What is a stem cell? YourGenome - October 29th, 2022
- Skin Cell - The Definitive Guide | Biology Dictionary - October 29th, 2022
- Explora Journeys Plans Extensive Fitness And Well-Being Initiatives At Sea, Right On Trend - Forbes - October 29th, 2022
- Ahead of the holiday shopping season, Amazon kicks off second annual Holiday Beauty Haul on Oct. 24 - KXAN.com - October 21st, 2022
- Human skin color - Wikipedia - October 13th, 2022
- Mesenchymal Stem Cells | Properties, Process, Functions, & Therapies - October 13th, 2022
- Skin Grafting, Cryopreservation, and Diseases: A Review Article - Cureus - October 13th, 2022
- Anti-ageing cosmetics: Can they turn back the hands of the clock? - The Sunday Guardian Live - The Sunday Guardian - October 13th, 2022
- Brennand named Elizabeth Mears and House Jameson Professor of Psychiatry - Yale News - October 13th, 2022
- The Switch to Regenerative Medicine - Dermatology Times - October 13th, 2022
- Last Chance to Get The Collagen-Infused Massage Oil That Moisturizes Skin & Diminishes Cellulite For Less Than $20 - msnNOW - October 13th, 2022
- Addison's Disease Explained: Causes, Symptoms, And Treatments - Health Digest - October 13th, 2022
- Stem Cells Therapy for Autism: Does it Work? - October 5th, 2022
- Stem-like CD8 T cells mediate response of adoptive cell ... - PubMed - October 5th, 2022
- 6 Under Eye Products You Need To Have STAT - Grazia India - October 5th, 2022
- CellResearch Corporation (CRC) to present promising new stem cell products for the treatment of chronic diabetic foot ulcers at the world's premier... - September 27th, 2022
- Reprogramming pig cells leads way for new regenerative therapies - National Hog Farmer - September 27th, 2022
- A glimpse into Indian consumers expectations for cosmetic treatments and consumption insights - The Financial Express - September 27th, 2022
- Tajmeel redefines beauty to give its patients the best results - Gulf News - September 27th, 2022
- Here Is Why You Heal Slower As You Age - Health Digest - September 27th, 2022
- Creating stem cells from minipigs offers promise for improved treatments - University of Wisconsin-Madison - September 19th, 2022
- Israeli Biotech Firm Plans to Create Human Embryos to Harvest Organs, Field Experts Say There are Ethical Concerns - CBN.com - September 19th, 2022
- CellResearch Corporation (CRC) announces positive results of Phase I study for CorLiCyte - PR Newswire - September 19th, 2022
- The best CBD and hemp products for pampering your skin this fall - Leafly - September 19th, 2022
- Benjamin Button For Real? Scientists Are Close To Cracking The Code To Reverse Aging - Worldcrunch - September 19th, 2022
- I took an international trip with my frozen eggs to learn about the fertility industry - MIT Technology Review - September 19th, 2022
- Propanc Biopharma Reports Significant Effects of PRP Against the Tumor Microenvironment - Business Wire - September 11th, 2022
- 6 Ingredients to Avoid Putting on Your Skin - Healthline - September 3rd, 2022
- Regenerative Properties of the Newborn Heart Offers Hope for Those With Congenital Heart Disease - The Epoch Times - September 3rd, 2022
- Meet White Orange: The Vitamin C Skin Care Brand For Sensitive Skin - Bustle - September 3rd, 2022
- Rejuvenation Roundup August 2022 - Lifespan.io News - September 3rd, 2022
- To better understand Parkinson's disease, this San Diego expert sent her own cells to space - The San Diego Union-Tribune - August 26th, 2022
- Inside the race to make human sex cells in the lab - MIT Technology Review - August 26th, 2022
- Global Biomaterials Market to Reach Value of $372.7 Billion by 2028 | Demand For Biomaterials in the Healthcare Industry will Grow by 53% Over the... - August 26th, 2022
- A Groovy Guide to Anti-Aging Products With CBD and Mushrooms - Out Magazine - August 26th, 2022
- New milestone organoid synthesis will boost disease and drug development research - RegMedNet - August 10th, 2022
- Victoria Beckham and Kim Kardashian are fans of Augustinus Baders skincare range - and you can get 20% off - The Mirror - August 10th, 2022
- Mutant T Cells That Drive Amyotrophic Lateral Sclerosis (ALS) Progression May React To a Brain Antigen - The Scientist - August 10th, 2022
- Why Glucose Restrictions Are Essential in Treating Cancer - The Epoch Times - August 10th, 2022