On October 10, 2017 4SC AG (4SC, FSE Prime Standard: VSC) reported that it is currently investigating resminostat as maintenance therapy in the pivotal RESMAIN study in advanced-stage cutaneous T-cell lymphoma (CTCL) and this new preclinical data provides a better understanding of the molecular basis of resminostat’s anti-itching potential in patients with CTCL (Press release, 4SC, OCT 10, 2017, View Source [SID1234520869]).

Itching in CTCL
CTCL is a blood cancer that arises from the malignant transformation of T cells – a specialized immune cell – where patients suffer from disfigurement and severe itching. To date, the underlying molecular mechanism of itching in CTCL has not been well understood and established anti-itching drugs such as anti-histamines have proven ineffective in CTCL patients.

Resminostat down-regulates itching-associated molecule in CTCL cell line
“From historical data we know that the messenger molecule IL-31 is produced by malignant T-cell populations in CTCL and high levels of IL-31 correlate with itching. It has also been established that in comparison to other treatment options, inhibitors of histone deacetylases (HDAC) can more effectively reduce itching in these patients,” explained Roland Baumgartner, Ph.D., Chief Scientific Officer of 4SC.

“Resminostat is an HDAC inhibitor that reactivates silenced genes in cancer cells and downregulates excessively active genomic areas. We performed a genome-wide analysis of a CTCL cell line before and after addition of resminostat and found that the expression of IL-31 was significantly reduced after treatment with resminostat. These new data provide an important addition to our understanding of how resminostat can alleviate itching in these patients, and in addition, given that time to symptom worsening is one of the major endpoints in our RESMAIN study, these data support our clinical development plans to advance resminostat to market authorization and to offer a new and effective treatment option to CTCL patients and physicians.”

Poster presentation at the EORTC CLTF Meeting
Matthias Borgmann, Ph.D., Product Manager (Resminostat) of 4SC, will present the scientific details at the EORTC CLTF Meeting | Cutaneous Lymphomas: Insights & Therapeutic Progress 2017 Meeting.
Posters Resminostat’s action in CTCL – hints from a genome-wide study
A multicentre, double blind, randomised, placebo controlled, Phase II trial to evaluate Resminostat for maintenance treatment of patients with advanced stage (Stage IIB IVB) mycosis fungoides (MF) or Sézary Syndrome (SS) that have achieved disease control with systemic therapy – the RESMAIN Study
Time Poster Session, 15 October 2017, 9:00 to 10:15 a.m. (BST)
Location Hilton London Tower Bridge Hotel, United Kingdom
Related articles
13 September 2017, Phase I study of 4SC’s resminostat indicates efficacy in biliary tract cancer
30 May 2017, Resminostat enhances immune cell cancer cell interaction
3 May 2017, Progress update on pivotal RESMAIN study of resminostat in CTCL at 13th Congress of the EADO

About resminostat
Resminostat is orally administered and potentially offers a novel approach for the treatment of a wide variety of cancers, both as monotherapy and in combination therapy with other anti-cancer drugs. Resminostat inhibits tumor growth and proliferation, causes tumor regression, and strengthens the body’s immune response to cancer.
Resminostat has been shown to be well tolerated in several clinical trials. Resminostat is currently being investigated in a Phase II pivotal study in cutaneous T-cell lymphoma (CTCL) by 4SC. A Phase II study in biliary tract cancer is planned by 4SC’s development partner Yakult Honsha in Japan. Amongst others, resminostat has previously been investigated in biliary tract or pancreatic cancer and hepatocellular carcinoma (HCC).

About cutaneous T-cell lymphoma (CTCL)
CTCL is a rare disease with approximately 5,000 patients being newly diagnosed in Europe each year. The disease arises from malignant transformation of T cells, a specialized subgroup of immune cells, primarily affects the skin, but may ultimately involve lymph nodes, blood and visceral organs.

Currently, CTCL is not curable and treatment options for advanced-stage CTCL are limited. Although patients respond to the available treatment options, the duration of response is often short-lived and declines as the severity of the disease increases. The key therapeutic challenge in advanced-stage CTCL is therefore to make remissions more durable, halting disease progression, improving quality of life and prolonging progression free and overall survival.

About the RESMAIN study – Resminostat for maintenance treatment of CTCL
The RESMAIN pivotal study is open for recruitment since November 2016 and is being conducted at more than 50 clinical centers in 11 European countries. It will include 150 patients who suffer from advanced-stage cutaneous T-cell lymphoma (CTCL) and have achieved disease control with systemic therapy. The patients are randomized 1:1 to receive either resminostat or placebo. Patients who experience disease progression – while being on placebo – will be offered resminostat in an open label treatment arm.

The primary goal of the study is to determine whether maintenance treatment with resminostat prolongs progression-free survival and the key secondary objective is to prolong the time to symptom worsening (itching). A comprehensive biomarker program is also included in the study to ensure vital knowledge about the biological background of resminostat treatment and CTCL is acquired. 4SC anticipates top-line data to be available in 2019.

On October 10, 2017 ERYTECH Pharma (Paris:ERYP) (ADR:EYRYY), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported that it has resubmitted to the European Medicine Agency (EMA) its Marketing Authorization Application (MAA) for eryaspase (GRASPA) for the treatment of patients with relapsed or refractory (R/R) acute lymphoblastic leukemia (ALL) (Press release, ERYtech Pharma, OCT 10, 2017, View Source [SID1234520866]). The MAA resubmission includes the data from ERYTECH’s GRASPALL 2009-06 Phase 2/3 clinical trial in children and adults with R/R ALL as well as additional data to address the outstanding questions of the Committee for Medicinal Products for Human Use (CHMP) of the EMA.

The GRASPALL Phase 2/3 trial, showed positive efficacy and safety results with GRASPA in combination with chemotherapy as compared to native L-asparaginase in patients with R/R ALL. The patients treated with GRASPA experienced a mean duration of L-asparaginase activity that was almost twice as long as for patients receiving native L-asparaginase. GRASPA also had a favorable safety profile in the trial and no patients who received GRASPA experienced an allergic reaction, as compared to 46% of the patients who received native L-asparaginase. Patients in the GRASPA treatment arm also had overall higher complete remission rates during induction, and GRASPA was associated with fewer drug-related adverse events.

In November 2016, ERYTECH withdrew its original MAA to allow sufficient time to provide the additional data requested in the CHMP’s Day 180 List of Outstanding Issues. ERYTECH has now resubmitted its MAA with additional data from studies on comparability, immunogenicity, and pharmacodynamic effects.

Gil Beyen, CEO and Chairman of ERYTECH, said: “Our teams have worked hard over the past weeks and months to address and compile additional data for the resubmission of the MAA for potential approval of GRASPA as a treatment for ALL. We believe these data have further strengthened our dossier for European marketing authorization. We strongly believe in the potential of our drug candidate and are looking forward to working with the EMA during the review process.”

Dr. Iman El-Hariry, Chief Medical Officer of ERYTECH, added: “We are delighted to complete the resubmission of the MAA for GRASPA in R/R ALL. Asparaginase continues to play an important role in treatment of newly diagnosed patients with R/R ALL. ERYTECH is committed to developing an effective therapy to patients with ALL and improving patient outcomes.”

About Acute Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia (ALL) is a blood cancer affecting mainly the white blood cells. ALL is most prevalent in children between the ages of two and five, although adults are also affected. The American Cancer Society estimates that approximately 5,970 new cases of ALL will be diagnosed in the United States in 2017, resulting in approximately 1,440 deaths. Based on incidence data published in scientific literature, ERYTECH estimates that there are at least as many new cases of ALL diagnosed each year in Europe as in the United States. The risk for developing ALL declines slowly after the age of five until the mid-20s and then begins to rise again slowly after the age of 50. Although most cases of ALL occur in children, approximately 80% of deaths from ALL occur in adults. Pediatric ALL patients have a five-year survival rate of approximately 90%, while the five-year survival rate for adults drops to approximately 30% and for seniors to approximately 15%.

On October 10, 2017 Horizon Pharma plc (Nasdaq:HZNP), a biopharmaceutical company focused on improving patients’ lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs, reported that its third-quarter 2017 financial results will be released on Monday, Nov. 6, 2017 (Press release, Horizon Pharma, OCT 10, 2017, View Source [SID1234520910]). Following the announcement, Horizon’s management will host a live conference call and webcast at 8 a.m. Eastern Time to review the Company’s financial and operating results.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The live webcast and a replay may be accessed at View Source Please connect to the Company’s website at least 15 minutes before the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call 1-888-338-8373 (U.S.) or 973-872-3000 (international) to listen to the conference call. The conference ID number for the live call is 96805714. Telephone replay will be available approximately two hours after the call. To access the replay, please call 1-855-859-2056 (U.S.) or 404-537-3406 (international). The conference ID number for the replay is 96805714.

On October 10, 2017 Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) reported that it will release its third quarter 2017 financial results on Thursday, November 2, 2017 at 7:00 a.m. ET(Press release, Teva, OCT 10, 2017, View Source [SID1234520906]).

Teva will host a conference call and live webcast on the same day, at 8:00 a.m. ET to discuss its third quarter 2017 results and overall business environment. A Question & Answer session will follow this discussion.

In order to participate, please dial the following numbers (at least 10 minutes before the scheduled start time): United States 1-866-869-2321; Canada 1-866-766-8269 or International +44(0) 203 0095710; passcode: 91932782. For a list of other international toll-free numbers, click here.

A live webcast of the call will also be available on Teva’s website at: www.ir.tevapharm.com Please log in at least 10 minutes prior to the conference call in order to download the applicable audio software.

Following the conclusion of the call, a replay of the webcast will be available within 24 hours on the Company’s website. The replay can also be accessed until November 30, 2017, 9:00 a.m. ET by calling United States 1-866-247-4222; Canada 1-866-878-9237 or International +44(0) 1452550000; passcode: 91932782.

On October 10, 2017 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported that it will webcast its Quarterly Update Conference Call for the third quarter 2017 on Tues., Nov. 7 at 4:30 p.m. ET/1:30 p.m. PT (Press release, Halozyme, OCT 10, 2017, View Source [SID1234520908]). Dr. Helen Torley, president and chief executive officer, will lead the call. On the same date, Halozyme will release financial results for the third quarter 2017 following the close of trading.

The call will be webcast live through the “Investors” section of Halozyme’s corporate website and a recording will be made available following the close of the call. To access the webcast and additional documents related to the call, please visit the Investors page of www.halozyme.com approximately fifteen minutes prior to the call to register, download and install any necessary audio software. The live call may be accessed by dialing (877) 410-5657 (domestic callers) or (334) 323-7224 (international callers) using passcode 769890. A telephone replay will be available after the call by dialing (877) 919-4059 (domestic callers) or (334) 323-0140 (international callers) using replay ID number 19320711.