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LONDON, UK / ACCESSWIRE / February 26, 2018 / Active-Investors.com has just released a free research report on Kadmon Holdings, Inc. (NYSE: KDMN). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=KDMN as the Company's latest news hit the wire. On February 22, 2018, the Company announced on updated results from an ongoing Phase-2 clinical trial (KD025-208) evaluating KD025 in patients with chronic graft-versus-host disease (cGVHD), a serious complication following allogeneic bone marrow or stem cell transplantation. The results were presented at the BMT Tandem Meetings in Salt Lake City. Register today and get access to over 1,000 Free Research Reports by joining our site below:
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Updated Results in cGVHD
- Updated data from Cohort 2 of KD025-208 conducted in adults with steroid-dependent or steroid-refractory cGVHD and active disease (200 mg BID; n=16) showed an Overall Response Rate (ORR) of 69%, as of a data cutoff date of January 03, 2018.
- The ORR in Cohort 1 (n=17) remained 65%. Responses were rapid, with approximately 70% of patients across Cohorts 1 and 2 achieving responses by the first assessment after 8 weeks of treatment.
- Responses were observed across all affected organs, including in organs with fibrotic manifestations of the disease. In responders with four or more organs involved, 46% showed responses in at least four organs. 64% of patients were able to reduce steroid dose, and four patients completely discontinued steroid use.
- 83% of patients were able to reduce the dose of tacrolimus, another immunosuppressive agent used to treat cGVHD. KD025 was well tolerated, with no drug-related serious adverse events in either cohort were observed.
- Kadmon expects to enroll an expansion cohort of approximately 40 patients after the optimal dose has been determined.
Kadmon Reported Positive Data from Phase-2 Study of KD025 in Idiopathic Pulmonary Fibrosis
On February 12, 2018, the Company also announced topline results from an ongoing Phase-2 clinical trial evaluating KD025 in patients with idiopathic pulmonary fibrosis (IPF) who were previously treated with or offered pirfenidone and/or nintedanib. KD025 was well tolerated and demonstrated clinical benefit, with a median decline in forced vital capacity, a measure of lung function, of 48 mL at week 24, compared to a median decline of 175 mL in patients treated with best supportive care, an absolute difference of 127 mL, and a relative difference of 73%.
FDA Approved Drug for Treatment of cGVHD
In August 2017, the FDA approved IMBRUVICA® (ibrutinib) for the treatment of adult patients with cGVHD after failure of one or more lines of systemic therapy. IMBRUVICA is the first and only FDA-approved medication for adult patients with cGVHD. IMBRUVICA is a first-in-class Bruton's tyrosine kinase (BTK) inhibitor jointly developed and commercialized by Janssen Biotech, Inc., and Pharmacyclics LLC, an AbbVie company. The approval was based on results from an open-label, multi-center, single-arm Phase-1b/2 trial (PCYC-1129) evaluating the safety and efficacy of ibrutinib in 42 patients with cGVHD who failed first-line corticosteroid therapy and required additional therapy.
About Chronic Graft-Versus-Host Disease (cGVHD)
GvHD is a condition that might occur after an allogeneic transplant. In GvHD, the donated bone marrow or peripheral blood stem cells view the recipient's body as foreign, and the donated cells/bone marrow attack the body, leading to inflammation and fibrosis in multiple tissues, including skin, mouth, eye, joints, liver, lung, esophagus, and GI tract.
KD025 is an oral small molecule inhibitor of the Rho-associated coiled-coil kinase (ROCK) signaling pathway and the lead candidate in our ROCK inhibitor platform. In October 2017, the US Food and Drug Administration (FDA) granted orphan drug designation to KD025 for the treatment of cGVHD.
About Kadmon Holdings, Inc.
Founded in 2009 and headquartered in New York City, New York, Kadmon is a fully integrated biopharmaceutical company engaged in the discovery, development, and commercialization of small molecules and biologics to address disease areas of significant unmet medical need. The Company is developing product candidates within autoimmune and fibrotic diseases, oncology and genetic diseases.
Stock Performance Snapshot
February 23, 2018 - At Friday's closing bell, Kadmon Holdings' stock advanced 1.11%, ending the trading session at $3.64.
Volume traded for the day: 989.33 thousand shares, which was above the 3-month average volume of 926.35 thousand shares.
Stock performance in the last three-month – up 1.39%; previous six-month period – up 57.58%; and year-to-date - up 0.55%
After last Friday's close, Kadmon Holdings' market cap was at $283.08 million.
The stock is part of the Healthcare sector, categorized under the Biotechnology industry. This sector was up 1.4% at the end of the session.
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