On January 28, 2019 CStone Pharmaceuticals (CStone) reported that the National Medical Products Administration (NMPA) recently approved the clinical trial application (CTA) to start a Phase I clinical trial in China for BLU-554 (CS3008), an inhibitor of fibroblast growth factor receptor 4 (FGFR4) discovered by the company’s partner Blueprint Medicines (Press release, CStone Pharmaceauticals, JAN 28, 2019, View Source [SID1234532931]). CStone has exclusive rights to develop and commercialize BLU-554 in Mainland China, Hong Kong, Macau and Taiwan.

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The trial is part of a global Phase I trial for BLU-554 in patients with advanced hepatocellular carcinoma (HCC) not previously treated with a tyrosine kinase inhibitor (TKI). The aim is to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of BLU-554 in this patient subset. CStone and Blueprint Medicines expect to enroll the first patient in the Phase I clinical trial in China soon.

HCC is the most common form of liver cancer. In China, HCC is the third most significant cause of cancer-related death, with approximately 466,000 new diagnoses and 422,000 deaths caused by the disease each year. It is estimated that approximately 30% of patients with HCC have tumors with aberrantly activated FGFR4 signaling. The majority of Chinese HCC patients (55%) are not diagnosed until the advanced stages of the disease. Currently, treatment options for advanced HCC patients remain limited.

BLU-554 is a potent and highly selective small-molecule inhibitor of FGFR4. Blueprint Medicines announced preliminary Phase I clinical data of BLU-554 at the European Society of Clinical Oncology (ESMO) (Free ESMO Whitepaper) 2017 Congress, as of a data cutoff date of August 18, 2017. In heavily pre-treated patients with FGFR4-driven HCC (n=38), the data showed an objective response in 6 patients (16%; 1 complete response and 1 partial response pending confirmation), while disease control was achieved by 26 patients (68%), and 18 patients (49%) had a reduced tumor burden. In 5 patients who had not previously received TKI therapy, preliminary evidence of prolonged disease control was observed. BLU-554 was well-tolerated and most adverse events reported by investigators were Grade 1 or 2.

Dr. Frank Jiang, CEO and chairman of CStone, commented: "Compared with current treatments, BLU-554 has produced encouraging data in terms of tolerability and disease control rates. We also plan to conduct a Phase I trial of BLU-554 in combination with CS1001 for the treatment of advanced HCC patients in China in the second half of 2019. Our hope is to make more effective treatment options available to HCC sufferers."

About BLU-554

BLU-554 is an oral, highly selective and irreversible inhibitor of FGFR4 developed by Blueprint Medicines, with a precise selectivity for FGFR4 that spares the paralog kinases FGFR1, FGFR2 and FGFR3. Blueprint Medicines is developing BLU-554 for the treatment of HCC caused by FGFR4 activation, estimated to account for approximately 30% of patients with HCC tumors. BLU-554 has been granted orphan drug status by the U.S. Food and Drug Administration.

In June 2018, CStone and Blueprint Medicines entered into a license and collaboration agreement in which Blueprint Medicines granted CStone exclusive rights to develop and commercialize BLU-554 in Greater China. Blueprint Medicines retains development and commercial rights for BLU-554 in the rest of the world.

On January 28, 2019 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) approved the use of IMBRUVICA (ibrutinib) in combination with obinutuzumab (GAZYVA) for adult patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) (Press release, AbbVie, JAN 28, 2019, View Source;first-chemotherapy-free-anti-cd20-combination-regimen-approved-for-chronic-lymphocytic-leukemiasmall-lymphocytic-lymphoma-cllsll-in-previously-untreated-pati.htm [SID1234532914]). The latest FDA approval expands the use of IMBRUVICA, which can already be administered as a single agent or in combination with bendamustine and rituximab (BR) for adult CLL/SLL patients.1 IMBRUVICA is a once-daily, first-in-class Bruton’s tyrosine kinase (BTK) inhibitor that is administered orally, and is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc.

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"This latest IMBRUVICA FDA approval gives the healthcare community the first chemotherapy-free, anti-CD20 combination to treat CLL and SLL patients who have not yet started therapy. Also, and importantly, this new treatment combination helps reduce the need for chemotherapy," said Carol Moreno, M.D., Ph.D., Consultant Hematologist, Hospital de la Santa Creu Sant Pau, Autonomous University of Barcelona, Barcelona, Spain, and lead investigator of the iLLUMINATE study.

The FDA approval is based on results from the Phase 3 iLLUMINATE (PCYC-1130) study, which showed the combination of IMBRUVICA plus obinutuzumab significantly improved progression-free survival (PFS) compared to chlorambucil plus obinutuzumab in previously untreated CLL/SLL patients who were 65 years or older, or less than 65 years old with coexisting conditions. Patients treated in the IMBRUVICA arm experienced a 77 percent reduction in risk of progression or death compared to the chlorambucil plus obinutuzumab arm (hazard ratio [HR] 0.23; 95% confidence interval [CI]: 0.15-0.37; P<0.0001). The chemotherapy-free, anti-CD20 combination regimen also showed an 85 percent reduction in risk of progression or death compared to chlorambucil plus obinutuzumab (HR 0.15; 95% CI: 0.09-0.27) when evaluating PFS in patients with high-risk disease (17p deletion/TP53 mutation, 11q deletion, or unmutated IGHV). The data were recently presented in an oral session at the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and simultaneously published in The Lancet Oncology.

"We are living in a time of significant advances in cancer treatment, particularly in blood cancers, and this latest IMBRUVICA FDA approval is an example. I am proud that we can now give physicians and patients a new option to treat CLL and SLL without the need for chemotherapy," said Danelle James, M.D., M.A.S., Head of Clinical Science, Pharmacyclics LLC, an AbbVie company.

The FDA also updated the IMBRUVICA label to include additional long-term efficacy follow-up supporting its use as a single agent in CLL/SLL from the Phase 3 RESONATETM (PCYC-1112) and RESONATETM-2 (PCYC-1115, PCYC-1116) international studies.

Warnings and Precautions include: hemorrhage, infections, cytopenias, cardiac arrhythmias, hypertension, second primary malignancies, tumor lysis syndrome, and embryo-fetal toxicity. The most common adverse reactions (occurring in 20% or more of patients) of all grades in patients treated with IMBRUVICA plus obinutuzumab in the iLLUMINATE study were neutropenia (48%), thrombocytopenia (36%), rash (36%), diarrhea (34%), musculoskeletal pain (33%), bruising (32%), cough (27%), infusion related reaction (25%), hemorrhage (25%), and arthralgia (22%).

The recommended dose of IMBRUVICA for CLL/SLL is 420 mg orally once daily until disease progression or unacceptable toxicity as a single agent or in combination with obinutuzumab, or BR. When administering IMBRUVICA in combination with rituximab or obinutuzumab, consider administering IMBRUVICA prior to rituximab or obinutuzumab when given on the same day.

About Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic lymphocytic leukemia (CLL) is one of the two most common forms of leukemia in adults and is a type of cancer that can develop from cells in the bone marrow that later mature into certain white blood cells (called lymphocytes).2 While these cancer cells start in the bone marrow, they then later spread into the blood. The prevalence of CLL is approximately 115,000 patients in the U.S. with approximately 20,000 newly diagnosed patients every year.3,4 Small lymphocytic lymphoma (SLL) is a slow-growing lymphoma biologically similar to CLL in which too many immature white blood cells cause lymph nodes to become larger than normal.5 Both CLL and SLL are predominately diseases of the elderly, with a median age of diagnosis ranging from 65-70 years.6

About IMBRUVICA
IMBRUVICA (ibrutinib) is a first-in-class, oral, once-daily therapy that mainly works by inhibiting a protein called Bruton’s tyrosine kinase (BTK). BTK is a key signaling molecule in the B-cell receptor signaling complex that plays an important role in the survival and spread of malignant B cells.7 IMBRUVICA blocks signals that tell malignant B cells to multiply and spread uncontrollably.

IMBRUVICA is FDA-approved in six distinct diseases: chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), Waldenström’s macroglobulinemia (WM), along with previously-treated mantle cell lymphoma (MCL), previously-treated marginal zone lymphoma (MZL), and previously-treated chronic graft-versus-host disease (cGVHD).1

IMBRUVICA was first approved for adult patients with MCL who have received at least one prior therapy in November 2013.
Soon after, IMBRUVICA was initially approved in adult CLL patients who have received at least one prior therapy in February 2014. By July 2014, the therapy received approval for adult CLL patients with 17p deletion, and by March 2016, the therapy was approved as a frontline CLL treatment.
IMBRUVICA was approved for adult patients with WM in January 2015.
In May 2016, IMBRUVICA was approved in combination with bendamustine and rituximab (BR) for adult patients with CLL/SLL.
In January 2017, IMBRUVICA was approved for adult patients with MZL who require systemic therapy and have received at least one prior anti-CD20-based therapy.
In August 2017, IMBRUVICA was approved for adult patients with cGVHD who failed to respond to one or more lines of systemic therapy.
In August 2018, IMBRUVICA plus rituximab was approved for adult patients with WM.
In January 2019, IMBRUVICA plus obinutuzumab was approved for previously untreated adult patients with CLL/SLL.
Accelerated approval was granted for the MCL and MZL indications based on overall response rate. Continued approval for MCL and MZL may be contingent upon verification and description of clinical benefit in confirmatory trials.

IMBRUVICA has been granted four Breakthrough Therapy Designations from the U.S. FDA. This designation is intended to expedite the development and review of a potential new drug for serious or life-threatening diseases.8 IMBRUVICA was one of the first medicines to receive FDA approval via the new Breakthrough Therapy Designation pathway.

IMBRUVICA is being studied alone and in combination with other treatments in several blood and solid tumor cancers and other serious illnesses. IMBRUVICA has a robust clinical oncology development program, with more than 130 ongoing clinical trials. There are approximately 30 ongoing company-sponsored trials, 14 of which are in Phase 3, and more than 100 investigator-sponsored trials and external collaborations that are active around the world. To date, more than 135,000 patients around the world have been treated with IMBRUVICA in clinical practice and clinical trials.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hemorrhage: Fatal bleeding events have occurred in patients treated with IMBRUVICA. Grade 3 or higher bleeding events (intracranial hemorrhage [including subdural hematoma], gastrointestinal bleeding, hematuria, and post procedural hemorrhage) have occurred in 3% of patients, with fatalities occurring in 0.3% of 1,124 patients exposed to IMBRUVICA in clinical trials. Bleeding events of any grade, including bruising and petechiae, occurred in 44% of patients treated with IMBRUVICA.

The mechanism for the bleeding events is not well understood.

IMBRUVICA may increase the risk of hemorrhage in patients receiving antiplatelet or anticoagulant therapies and patients should be monitored for signs of bleeding.

Consider the benefit-risk of withholding IMBRUVICA for at least 3 to 7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding.

Infections: Fatal and non-fatal infections (including bacterial, viral, or fungal) have occurred with IMBRUVICA therapy. Grade 3 or greater infections occurred in 24% of 1,124 patients exposed to IMBRUVICA in clinical trials. Cases of progressive multifocal leukoencephalopathy (PML) and Pneumocystis jirovecii pneumonia (PJP) have occurred in patients treated with IMBRUVICA. Consider prophylaxis according to standard of care in patients who are at increased risk for opportunistic infections.

Monitor and evaluate patients for fever and infections and treat appropriately.

Cytopenias: Treatment-emergent Grade 3 or 4 cytopenias including neutropenia (23%), thrombocytopenia (8%), and anemia (3%) based on laboratory measurements occurred in patients with B‑cell malignancies treated with single agent IMBRUVICA.

Monitor complete blood counts monthly.

Cardiac Arrhythmias: Fatal and serious cardiac arrhythmias have occurred with IMBRUVICA therapy. Grade 3 or greater ventricular tachyarrhythmias occurred in 0.2% of patients, and Grade 3 or greater atrial fibrillation and atrial flutter occurred in 4% of 1,124 patients exposed to IMBRUVICA in clinical trials. These events have occurred particularly in patients with cardiac risk factors, hypertension, acute infections, and a previous history of cardiac arrhythmias.

Periodically monitor patients clinically for cardiac arrhythmias. Obtain an ECG for patients who develop arrhythmic symptoms (e.g., palpitations, lightheadedness, syncope, chest pain) or new onset dyspnea. Manage cardiac arrhythmias appropriately, and if it persists, consider the risks and benefits of IMBRUVICA treatment and follow dose modification guidelines.

Hypertension: Hypertension of any grade occurred in 12% of 1,124 patients treated with IMBRUVICA in clinical trials. Grade 3 or greater hypertension occurred in 5% of patients with a median time to onset of 5.9 months (range, 0.03 to 24 months).

Monitor blood pressure in patients treated with IMBRUVICA and initiate or adjust anti-hypertensive medication throughout treatment with IMBRUVICA as appropriate.

Second Primary Malignancies: Other malignancies (10%) including non-skin carcinomas (4%) have occurred in 1,124 patients treated with IMBRUVICA in clinical trials. The most frequent second primary malignancy was non-melanoma skin cancer (6%).

Tumor Lysis Syndrome: Tumor lysis syndrome has been infrequently reported with IMBRUVICA therapy. Assess the baseline risk (e.g., high tumor burden) and take appropriate precautions.

Monitor patients closely and treat as appropriate.

Embryo-Fetal Toxicity: Based on findings in animals, IMBRUVICA can cause fetal harm when administered to a pregnant woman. Advise women to avoid becoming pregnant while taking IMBRUVICA and for 1 month after cessation of therapy. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. Advise men to avoid fathering a child during the same time period.

ADVERSE REACTIONS

B-cell malignancies: The most common adverse reactions (≥20%) in patients with B-cell malignancies (MCL, CLL/SLL, WM and MZL) were thrombocytopenia (58%)*, diarrhea (41%), anemia (38%)*, neutropenia (35%)*, musculoskeletal pain (32%), rash (32%), bruising (31%), nausea (26%), fatigue (26%), hemorrhage (24%), and pyrexia (20%).

The most common Grade 3 or 4 adverse reactions (≥5%) in patients with B-cell malignancies (MCL, CLL/SLL, WM and MZL) were neutropenia (18%)*, thrombocytopenia (16%)*, and pneumonia (14%).

Approximately 7% (CLL/SLL), 14% (MCL), 14% (WM) and 10% (MZL) of patients had a dose reduction due to adverse reactions. Approximately 4-10% (CLL/SLL), 9% (MCL), and 7% (WM [5%] and MZL [13%]) of patients discontinued due to adverse reactions.

cGVHD: The most common adverse reactions (≥20%) in patients with cGVHD were fatigue (57%), bruising (40%), diarrhea (36%), thrombocytopenia (33%)*, muscle spasms (29%), stomatitis (29%), nausea (26%), hemorrhage (26%), anemia (24%)*, and pneumonia (21%).

The most common Grade 3 or higher adverse reactions (≥5%) reported in patients with cGVHD were pneumonia (14%), fatigue (12%), diarrhea (10%), neutropenia (10%)*, sepsis (10%), hypokalemia (7%), headache (5%), musculoskeletal pain (5%), and pyrexia (5%).

Twenty-four percent of patients receiving IMBRUVICA in the cGVHD trial discontinued treatment due to adverse reactions. Adverse reactions leading to dose reduction occurred in 26% of patients.

*Treatment-emergent decreases (all grades) were based on laboratory measurements.

DRUG INTERACTIONS

CYP3A Inhibitors: Modify IMBRUVICA dose as described in USPI sections 2.4 and 7.1.

CYP3A Inducers: Avoid coadministration with strong CYP3A inducers.

SPECIFIC POPULATIONS

Hepatic Impairment (based on Child-Pugh criteria): Avoid use of IMBRUVICA in patients with severe baseline hepatic impairment. In patients with mild or moderate impairment, reduce IMBRUVICA dose

On January 28, 2019 Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies, reported the appointment of Linda S. Grais, M.D., J.D., to the Company’s Board of Directors and Mehrdad Mobasher, M.D., M.P.H., as Vice President and Chief Medical Officer, effective immediately (Press release, Corvus Pharmaceuticals, JAN 28, 2019, View Source [SID1234532933]).

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Dr. Grais has more than 20 years of experience with emerging companies in the biopharmaceutical industry. As a member of Corvus’ Board of Directors, she is replacing Peter Moldt, Ph.D., who has served as a director since January 2015 and resigned his position. Dr. Mobasher, a board-certified medical oncologist, joins Corvus from Genentech/Roche, where he spent more than eight years in hematology/oncology drug development, including holding the position of Venetoclax Global Development Team Leader and Global Clinical Leader. At Corvus, Dr. Mobasher will oversee the Company’s pipeline of precisely-targeted investigational oncology therapies.

"Dr. Grais is a highly-trained physician with extensive operational, clinical, business development and drug development experience in the biopharmaceutical industry," said Richard A. Miller, M.D., an oncologist and co-founder, president and chief executive officer of Corvus. "Her background is particularly relevant for Corvus as we continue to advance and expand our pipeline of therapies for patients with difficult-to-treat cancers. With her broad expertise, Dr. Grais will broaden the scope of talent on our Board and provide important insights and perspective. We also would like to thank Dr. Moldt for his many contributions to Corvus."

Dr. Miller added, "As Corvus continues to advance the clinical and preclinical development of our five proprietary product candidates with differentiated mechanisms of action across a range of hematologic malignancies and solid tumors, with some nearing late-stage clinical development, it is necessary to deepen our clinical and regulatory capabilities. Dr. Mobasher is ideally suited to be our chief medical officer given his training in hematology and oncology and his recent leadership role in the development and approval of venetoclax at Genentech. We are thrilled to add him to our executive team as we continue to evaluate our two most advanced investigational medicines, which target the adenosine pathway, in ongoing Phase 1/1b and Phase 1b/2 clinical trials, and expect to initiate a Phase 1/1b trial of our ITK inhibitor in lymphoma in the first quarter of 2019."

Dr. Grais currently serves on the Board of Directors of PRA Health Sciences, a large contract research organization, and also serves on its Audit Committee. She also is on the Board of Directors of ARCA biopharma and Zosano Pharma. Previously, Dr. Grais served as president and chief executive officer of Ocera Therapeutics, Inc., a biopharma company developing new treatments for serious liver disease, until its acquisition by Mallinckrodt. Prior to that, she served as a partner at InterWest Partners, a venture capital firm focused on biotechnology and medical device companies. Previously, Dr. Grais was a founder and executive vice president of Structural GenomiX, Inc., a drug discovery company focusing on new treatments for cancer that was acquired by Eli Lilly & Co. Earlier in her career, she was a corporate attorney at Wilson Sonsini Goodrich & Rosati, where she represented life science companies in venture financings, public offerings and strategic partnerships. Before practicing law, Dr. Grais worked as an assistant professor in the Department of Internal Medicine at the University of California, San Francisco. Dr. Grais received a B.A. in philosophy from Yale University, an M.D. from Yale Medical School, and a J.D. from Stanford Law School.

"I’m excited to join Corvus’ Board and look forward to collaborating with the other Board members and the talented leadership team," said Dr. Grais. "During my career in the life sciences industry, I’ve had numerous opportunities to help companies grow. I look forward to bringing my experience and expertise to Corvus to help it advance its pipeline of promising oncology therapies, which have the potential to improve the lives of patients with cancer."

Dr. Mobasher joined Genentech in 2010 and has held several positions of increasing responsibility. Most recently, he was a Group Medical Director and Venetoclax Development Lead, where he oversaw and led the strategy for the global development of venetoclax with several phase 1, 2, and 3 clinical trials in numerous hematologic cancers, as well as solid tumors. Dr. Mobasher led the clinical development efforts for venetoclax, a novel drug through four successful Breakthrough Therapy designations from the U.S. Food and Drug Administration (FDA) and three approvals granted under FDA’s priority review, two of which were under accelerated approval. Venetoclax is approved in more than 50 countries for the treatment of several types of hematologic malignancies. He also was an adjunct clinical faculty member in the Division of Medical Oncology at Stanford University. Dr. Mobasher is the author of numerous papers published in peer-reviewed medical journals, including The New England Journal of Medicine, Lancet Oncology and the Journal of Clinical Oncology, and multiple abstracts presented at medical conferences. He is a member of the American Society of Hematology (ASH) (Free ASH Whitepaper), the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), the American College of Physicians (ACP), and the American Public Health Association (APHA). Dr. Mobasher received an M.D. from Tehran University of Medical Sciences in Iran, and an M.P.H. in general epidemiology from the School of Public Health at the University of Michigan. He completed an internship and residency in internal medicine at the University of California, Irvine, Medical Center, and post-doctoral fellowships in hematology and medical oncology at Stanford University.

"I’m excited to take on the role of Chief Medical Officer for Corvus as it’s a rare opportunity to join a young company with such a deep and diverse pipeline of product candidates, strong research capability, and a team of talented and experienced executives with proven track records," said Dr. Mobasher. "Having worked in hematology/oncology drug development for nearly a decade, I’ve seen many different approaches, but I’m truly impressed by Corvus’ focus on developing medicines that precisely modulate molecular targets that are well-defined and measurable. I’m excited about the clinical data I’ve seen to date for Corvus’ lead investigational drugs, CPI-444 and CPI-006, and look forward to potentially bringing them to patients in need, while advancing our other pipeline products into the clinic."

On January 28, 2019 Cancer Genetics, Inc. (Nasdaq: CGIX), a leader in enabling precision medicine for immuno-oncology and genomic medicine through molecular markers and diagnostics, reported that it intends to offer and sell, subject to market and other conditions, shares of its common stock in a public offering (Press release, Cancer Genetics, JAN 28, 2019, View Source [SID1234533045]). The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering. The offering is being conducted as a "best efforts" offering and the placement agent is not obligated to purchase any securities.

Cancer Genetics intends to use the net proceeds from this offering to pay any amounts we are required to pay to our lenders, and if any proceeds remain available, to pay certain costs previously incurred by us in connection with our strategic initiatives and to fund working capital and other general corporate purposes.

A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock described above was filed with the Securities and Exchange Commission ("SEC") and was declared effective on June 5, 2017. A preliminary prospectus supplement describing the terms of the offering will be filed with the SEC and will form a part of the effective registration statement. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, from H.C. Wainwright & Co., LLC, 430 Park Avenue 3rd Floor, New York, NY 10022, or by calling (646) 975-6996 or by emailing [email protected] or at the SEC’s website at View Source The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.

On January 28, 2019 4SC AG (4SC, FSE Prime Standard: VSC) reported that the Data Safety Monitoring Board (DSMB), an independent committee of clinical and drug safety experts, again recommends continuation of the ongoing pivotal RESMAIN study without modification of the study protocol (Press release, 4SC, JAN 28, 2019, View Source [SID1234532918]). Per the protocol’s pre-specified DSMB charter, the second DSMB meeting was scheduled recently to review cumulative safety data after 100 patients have been enrolled and completed at least one treatment cycle.

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RESMAIN is conducted as a multi-center, double blind, randomized, placebo-controlled study. It evaluates resminostat for maintenance treatment of patients with advanced-stage cutaneous T-cell lymphoma (CTCL) who have achieved disease control with prior systemic therapy, at more than 50 clinical centers in 11 European countries and Japan. The study is progressing on track, recruitment is expected to complete in 2019 and top-line results are expected in the first half of 2020.

Susanne Danhauser-Riedl, M.D., Chief Medical Officer of 4SC, commented: "We are encouraged by the positive outcome of the second independent DSMB safety review and aim to bring resminostat to patients as quickly as possible to achieve an improvement in their quality of life.

Advanced-stage CTCL patients usually respond to available treatment options but the duration of response is often short-lived and declines as the severity of the disease increases. The aim of a maintenance therapy and thus of our RESMAIN study is to make such remissions more durable, halting disease progression."