On February 19, 2018 Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR), a biopharmaceutical company focused on developing novel therapeutic antibodies for the treatment of migraine, reported that it will report its fourth quarter and year-end 2017 financial and operating results after the close of U.S. financial markets on Monday, February 26, 2018 (Press release, Alder Biopharmaceuticals, FEB 19, 2018, http://investor.alderbio.com/news-releases/news-release-details/alder-biopharmaceuticalsr-host-conference-call-discuss-fourth [SID1234524109]). Alder management will host a conference call and live audio webcast to discuss the results and provide a general business update at 5:00 p.m. ET the same day.

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The live call may be accessed by dialing (877) 430-4657 for domestic callers or (484) 756-4339 for international callers, and providing conference ID number 6943609. The webcast and any accompanying slides can be accessed from the Events & Presentations page in the investors section of Alder’s website at www.alderbio.com and will be available for replay following

On February 18, 2018 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), reported that an abstract regarding the completed SPRINT-MS Phase 2b Trial of MN-166 (ibudilast) in progressive multiple sclerosis (progressive MS), which was conducted through the National Institutes of Health (NIH)-sponsored NeuroNEXT network, has been selected for plenary presentation at the American Academy of Neurology (AAN) 70th Annual Meeting to be held April 21-27, 2018 in Los Angeles, California (Press release, MediciNova, FEB 18, 2018, View Source;p=RssLanding&cat=news&id=2333124 [SID1234524045]).

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The presentation entitled "A Phase II Trial of Ibudilast in Progressive Multiple Sclerosis" will be presented by Dr. Robert Fox, Staff Neurologist at the Cleveland Clinic and the principal investigator of this clinical trial.

Presentation details are as follows:

Date and Time: Tuesday, April 24, 2018, 9:15 am – 11:30 am

Session: Clinical Trials Plenary Session

Location: Los Angeles Convention Center, 1201 South Figueroa Street, Los Angeles, CA 90015

About the Progressive MS Trial

The Phase 2b Secondary and Primary Progressive Ibudilast NeuroNEXT trial in Multiple Sclerosis (SPRINT-MS) included 28 enrolling clinical sites across the U.S. and was designed to evaluate the safety, tolerability and activity of MN-166 (ibudilast) administered orally twice daily to subjects with primary progressive or secondary progressive multiple sclerosis (PPMS or SPMS, respectively). 255 qualifying subjects were randomly assigned 1:1 to inactive control (placebo) or MN-166 (ibudilast) administered at a dose of up to 100 mg/day (50 mg twice daily). The progressive MS subjects were either untreated with long-term disease modifying therapy (DMT) or continued on either glatiramer acetate (GA) or interferon beta (IFNβ-1a or IFNβ-1b) treatment. Hence, randomization was controlled (stratified) by two factors: therapy status (IFN/GA vs. no DMT) and disease status (PPMS vs. SPMS). The primary objectives of the study were to 1) evaluate the activity of ibudilast (MN-166) versus placebo at 96 weeks as measured by quantitative magnetic resonance imaging (MRI) analysis for whole brain atrophy using brain parenchymal fraction (BPF), and 2) evaluate the safety and tolerability of ibudilast (MN-166) versus placebo in subjects with PPMS or SPMS. Additional measures included disability, imaging analyses of brain and retinal tissue integrity, cortical atrophy, cognitive impairment, quality-of-life and neuropathic pain. Exploratory objectives included pharmacokinetic and biomarker analyses.

About the Cooperative Effort

The collaborating entities include NeuroNEXT, the Cleveland Clinic, the National MS Society and MediciNova. NINDS’s Network for Excellence in Neuroscience Clinical Trials, or NeuroNEXT, was created to conduct studies of treatments for neurological diseases through partnerships with academia, private foundations and industry. NeuroNEXT sites include many of the leading medical centers in the U.S. (www.neuronext.org). The goals of NeuroNEXT include testing of promising neurological therapies in Phase 2 clinical trials, optimizing drug development time and cost components through an established clinical trials infrastructure, and the coordination of public/private sector efforts by leveraging NINDS’s existing relationships with academic investigators and patient advocacy groups. A clinical coordinating center for NeuroNEXT is led by Dr. Merit Cudkowicz and is based at Massachusetts General Hospital and the data coordinating center is led by Dr. Chris Coffey at the University of Iowa. Principal Investigator Dr. Robert Fox and colleagues at the Cleveland Clinic collaborate with co-investigators at academic medical centers in the NeuroNEXT network. The National MS Society provided patient advocate input, trial enrollment awareness, and additional funding. MediciNova holds the trial IND with the FDA’s Division of Neurology Products and provides scientific and analytical support, as well as drug and placebo supply.

About Progressive Multiple Sclerosis

According to the National MS Society, MS affects approximately 2.3 million people worldwide. Approximately 85% of MS patients are initially diagnosed with relapsing remitting MS (RRMS). Most RRMS patients will eventually transition into SPMS in which there are fewer or no relapses but gradual worsening of neurologic function. Approximately 15% of MS patients are diagnosed with PPMS at onset and exhibit gradually increasing disability in walking, vision, mental acuity, and other bodily functions without experiencing relapses or remissions. Current therapies for MS affect the inflammatory response, but provide limited benefit for the neurodegeneration seen in progressive MS. There is a significant unmet medical need for agents that may provide neuroprotection in progressive MS.

About MN-166 (ibudilast)

MN-166 (ibudilast) has been marketed in Japan and Korea since 1989 to treat post-stroke complications and bronchial asthma. MediciNova is developing MN-166 for progressive multiple sclerosis (MS) and other neurological conditions such as ALS and substance abuse/addiction. MN-166 (ibudilast) is a first-in-class, orally bioavailable, small molecule phosphodiesterase (PDE) -4 and -10 inhibitor and a macrophage migration inhibitory factor (MIF) inhibitor that suppresses pro-inflammatory cytokines and promotes neurotrophic factors. It attenuates activated glia cells, which play a major role in certain neurological conditions. Ibudilast’s anti-neuroinflammatory and neuroprotective actions have been demonstrated in preclinical and clinical study results and provide the rationale for its therapeutic utility in neurodegenerative diseases (e.g., progressive MS and ALS), substance abuse/addiction and chronic neuropathic pain. MediciNova has a portfolio of patents which cover the use of MN-166 (ibudilast) to treat various diseases including progressive MS, ALS, and drug addiction.

Salarius’ lead molecule, Seclidemstat, is scheduled to begin enrollment for a Phase 1 trial in Ewing sarcoma in 2018. Ewing sarcoma is a devastating pediatric illness and represents a major unmet clinical need. Currently, chemotherapy, radiation and tumor resection surgery are the only options for patients, and in many cases the tumors reoccur or is in too delicate of a location to risk surgery. There is a 90% five-year mortality rate for patients whose tumors recur after treatment or who are initially diagnosed with metastatic disease. Translocations in the EWS protein are the sole driver for over 85% of Ewing sarcoma, and EWS must complex with LSD1 to induce a cancer phenotype. Seclidemstat blocks this LSD1 interaction to reverse cancer pathology resulting in cures in animal models.

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On February 16, 2018 Athenex, Inc. (Nasdaq:ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported Dr. Johnson Lau, Chief Executive Officer, will present at the 2018 RBC Capital Markets Healthcare Conference in New York City on Wednesday, February 21, 2017 at 11:00 am EST (Press release, Athenex, FEB 16, 2018, View Source;p=RssLanding&cat=news&id=2333004 [SID1234524025]).

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The presentation will be webcasted, and can be accessed at the Investor Relations section of the Company’s website, located at www.athenex.com. An archive will be available at this website until May 22, 2018.

On February 16, 2018 Castle Biosciences, Inc., a provider of molecular diagnostics to improve cancer treatment decisions, reported the presentation of two studies highlighting the clinical use of the DecisionDx-Melanoma gene expression profile test, which uses tumor biology to provide an individual risk of recurrence in cutaneous melanoma patients (Press release, Castle Biosciences, FEB 16, 2018, View Source [SID1234524026]). The data will be presented during the 74th Annual Meeting of the American Academy of Dermatology (AAD), held in San Diego, CA from February 16-18.

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The clinical impact study titled, "A Prospective Multicenter Study to Evaluate the Clinical Impact of a 31-Gene Expression Profile Test on Physician Recommendations for Management of Melanoma Patients," (Abstract 6798) will be presented during the Late-Breaking Research: Basic Science/Cutaneous Oncology/Pathology session at the meeting. Researchers found that physicians used test results to inform risk-appropriate changes in patient management while remaining within the context of established practice guidelines.

The second study titled, "Factors Impacting Dermatologists’ Decision to Utilize a 31-Gene Expression Profiling Test to Assess Metastatic Risk for Melanoma Patients," (Abstract 7061) examined clinicopathologic factors that impact dermatologists’ decisions to recommend the DecisionDx-Melanoma test for patients. The study found that a majority of clinicians would order the DecisionDx-Melanoma test for tumor thickness of 0.5 mm or greater with or without ulceration, and for thinner tumors if a factor such as ulceration were present.

Clinical Impact Study

This multicenter, prospective clinical impact study included 247 patients from 15 dermatology, medical oncology or surgical oncology centers. Patients were clinical Stage I or II at time of enrollment. The patient cohort has a median age of 63 years and median Breslow thickness of 1.1 mm.

Pre and post-test management recommendations were collected, including laboratory tests, imaging, frequency of clinical visits, adjuvant treatment discussion, and plans for referral to surgical or medical oncology. To assess clinical impact of the test, changes between pre- and post-test plans were categorized as an increase, decrease or no change in care.

Key Study Findings:

181 patients (73%) had a Class 1 (low-risk) result and 66 (27%) had a Class 2 (high-risk) result.
Overall 49% of patients tested experienced a change in clinical management recommendations following the receipt of the DecisionDx-Melanoma test.
Class 1 patients showed a 36% post-test change in management plans, while 85% of Class 2 patients had a change following the DecisionDx-Melanoma test.
79% of management changes were assessed to be in a risk-appropriate direction based on test result, with 91% of decreases in care documented for low-risk (Class 1) patients, and 72% of increases in care provided for high-risk (Class 2) patients.
The most significantly changed management modalities were follow-up frequency and imaging.
"Across the different practice settings in this study, the DecisionDx-Melanoma test informed risk-appropriate patient management decisions, consistent with previous publications demonstrating that the test impacts one in two clinical management decisions," said Federico Monzon, MD, Chief Medical Officer, Castle Biosciences. "These findings align with national guidelines, which recommend that a patient’s individual risk of recurrence should drive management decisions."

Utilization of Clinicopathologic Factors for Decision-Making

Results from a clinical utility study designed to determine which factors impact clinicians’ decisions to use the DecisionDx-Melanoma prognostic test were also presented during the AAD meeting. The impact on use of the test by Breslow thickness, ulceration, and sentinel lymph node biopsy (SLNB) status were evaluated using clinical vignettes and an interactive response methodology. The vignettes included tumors with Breslow thicknesses of 0.26, 0.50, 0.76 and 2.10 mm, with or without ulceration or knowledge of SLNB status. A total of 181 dermatologists completed the study.

Key Study Findings:

87% of dermatologists in this study would recommend the DecisionDx-Melanoma test for all tumors with a Breslow thickness of 0.5 mm or greater in the absence of ulceration and 78% in the presence of ulceration.
Presence of ulceration was associated with an increase in the number of dermatologists who would recommend the test for all but the thickest tumor assessed (2.10 mm).
For the thinnest tumor assessed (0.26 mm) the presence of ulceration significantly increased the number of dermatologists who would recommend the test from 22% to 67% (p<0.001).
SLNB negative status was associated with an increase in the number of physicians recommending the test for the thinnest tumors from 22% to 34% (p=0.033).
"Overall, tumor thickness and presence of ulceration were found to be the most impactful factors influencing clinicians’ decisions to order the DecisionDx-Melanoma test," said study co-author Darrell S. Rigel, M.D., M.S., Clinical Professor at New York University School of Medicine. "The study shows that dermatologists are making appropriate decisions to use the test as an important part of metastatic risk assessment in early stage patients."

About DecisionDx-Melanoma
The DecisionDx-Melanoma test uses tumor biology to provide a prediction of individual risk of melanoma recurrence beyond traditional factors. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in three multi-center studies that have included 690 patients and have demonstrated consistent results. Performance has also been confirmed in four prospective studies including 702 patients. The consistent high performance and accuracy demonstrated in these studies, which combined have included over 1300 patients, provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. Prediction of the likelihood of sentinel lymph node positivity has also been validated in two prospective multi-center studies which included over 1400 patients. Clinical impact has been demonstrated in multi-center and single-center studies showing that test results change approximately 50% of management decisions. More information about the test and disease can be found at www.SkinMelanoma.com.