On May 19, 2016 Stemline Therapeutics, Inc. (Nasdaq:STML) reported that its SL-401 Phase 2 clinical data in blastic plasmacytoid dendritic cell neoplasm (BPDCN) was selected for oral presentations at both the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting being held in Chicago, IL and the 21st Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) being held in Copenhagen, Denmark. The full abstracts are now available on the respective conference websites (Press release, Stemline Therapeutics, MAY 19, 2016, View Source [SID:1234512589]).

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Details on the ASCO (Free ASCO Whitepaper) presentation are as follows:

Title: Results from Phase 2 registration trial of SL-401 in patients with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN): Lead-in completed, Expansion stage ongoing
Presenter: Naveen Pemmaraju, M.D., MD Anderson Cancer Center
Abstract No.: 7006
Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Date/Time: Saturday, June 4, 2016; 5:00 – 5:12PM CT
Location: Arie Crown Theater

Details on the EHA (Free EHA Whitepaper) presentation are as follows:

Title: Results from ongoing Phase 2 registration study of SL-401 in patients with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
Presenter: Naveen Pemmaraju, M.D., MD Anderson Cancer Center
Abstract No.: S812
Session: Treatment in Specific AML Subgroups
Date/Time: Sunday, June 12, 2016; 9:00 – 9:15 AM CET
Location: Hall C13

Ivan Bergstein, M.D., Stemline’s Chief Executive Officer, commented, "We are honored that our trial results have been selected for oral presentation by both ASCO (Free ASCO Whitepaper) and the EHA (Free EHA Whitepaper). We believe this selection underscores the exciting clinical data we have witnessed with SL-401, and highlights the increased awareness of BPDCN, a devastating malignancy of high unmet medical need, across both the U.S. and Europe."

Dr. Bergstein continued, "We remain very encouraged by SL-401’s continued strong performance to date. And we plan to provide updated enrollment, response rates and duration, as well as preliminary progression-free and overall survival data from the trial at the upcoming conferences."

Dr. Bergstein concluded, "We look forward to continuing to advance SL-401 in an effort to provide patients this promising agent as rapidly as possible. Over the remainder of the year, we also plan to provide further clinical and regulatory updates from this study as well as our other clinical programs spanning multiple indications."

On May 19, 2016 Castle Biosciences, Inc., a provider of molecular diagnostics to improve cancer treatment decisions, reported new clinical data on DecisionDx-UM, its gene expression profile (GEP) test to predict metastasis in patients diagnosed with uveal melanoma (Press release, Castle Biosciences, MAY 19, 2016, View Source [SID:1234512612]). The new data will be highlighted in a presentation at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held in Chicago, IL from June 3-7.

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In a poster presentation titled, "A Prospective, Multi-Center Study to Evaluate the Performance and Clinical Utility of a 15-Gene Expression Profile for Uveal Melanoma" (Abstract #9575), Castle Biosciences researchers and collaborators will present findings from 70 patients in the prospective, multi-center CLEAR (Clinical Application of DecisionDx-UM Gene Expression Assay Results) study. The CLEAR study tracked clinical management and metastatic outcomes of patients with low-risk Class 1 or high-risk Class 2 gene test results who had no evidence of distant metastasis at the time of primary tumor treatment. Surveillance mode and frequency were independently determined by participating physicians as they deemed appropriate for low-risk Class 1 and high-risk Class 2 patients.

Study Results

37 patients (53%) had a low-risk Class 1 GEP test result; 33 patients (47%) had a high-risk Class 2 result;
Impact on clinical management:
All Class 2 patients were managed with high intensity surveillance (imaging and/or liver function tests every 3-6 months);
81% of Class 1 patients were managed with low intensity surveillance (imaging and/or liver function tests every year);
There was a significant difference in management of Class 1 and Class 2 patients (p=2.1×10-13);
33% of Class 2 patients were referred to a medical oncologist for surveillance and/or clinical trial enrollment, compared to 11% of Class 1 patients (p=0.04).
Clinical outcomes:
Overall, two Class 1 patients and 12 Class 2 patients developed metastasis (p=0.002) with a median follow-up of 27.3 months;
At 3 years, metastasis-free survival rates were 100% for Class 1 and 63% for Class 2 (p=0.003).
"This prospective study demonstrated clinically and statistically significant impact on follow-up treatment consistent with a previously published retrospective multi-center clinical utility study," commented Derek Maetzold, President and CEO of Castle Biosciences. "In addition, the clinical performance of the test is consistent with previously published prospective multi-center and single-center studies, confirming the robustness of the DecisionDx-UM test."

About Uveal Melanoma
Uveal melanoma, while rare, is the most common form of eye cancer in the United States with about 1,600 diagnoses per year. This form of eye cancer may occur in any of the three parts of the uvea. Similar to other melanomas, uveal melanoma begins in cells called melanocytes that help produce the pigments of the skin, hair and eyes. While more common in patients who are middle-aged with fair skin, uveal melanoma can affect people of all complexions and ages.
Although a small percentage (3%) of patients with uveal melanoma have detectable metastatic lesions at the time of diagnosis or treatment of the primary tumor, up to 50% of patients will subsequently develop metastatic disease. This necessitates a rigorously validated, accurate and reliable tool to identify patients likely to develop distant metastasis.

About DecisionDx-UM
The DecisionDx-UM test measures the gene expression profile (GEP), or molecular signature, of an individual’s tumor and identifies with high accuracy the likelihood of metastasis.
The DecisionDx-UM test is standard of care in the management of uveal melanoma in the majority of ocular oncology practices. It is the only test for uveal melanoma that has achieved National Cancer Institute/National Comprehensive Cancer Network Level of Evidence 1A, a critical factor in test adoption and clinical decision-making. Additionally, the American Joint Committee on Cancer recommends gene expression profile testing for use as the results are "clinically significant." The American Joint Committee on Cancer (AJCC, version 7, 2010) is the only national organization that reviews uveal melanoma and the DecisionDx-UM test is the only clinically available GEP test for use in the U.S. The test has been validated in multiple prospective and retrospective studies. More information about the test and disease can be found at www.MyUvealMelanoma.com.

On May 19, 2016 Bio-Path Holdings, Inc., (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported an upcoming poster discussion presentation at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place from June 3-7, 2016 in Chicago, IL (Filing, 8-K, Bio-Path Holdings, MAY 19, 2016, View Source [SID:1234512709]). Dr. Maro Ohanian, Assistant Professor at the University of Texas MD Anderson Cancer Center will present data from the Company’s completed Phase I clinical trial and from the safety segment of the Phase II trial of BP1001 in combination with low-dose cytarabine (LDAC), including initial efficacy results. Notably, there were no dose-limiting toxicities observed in the safety segment and three of the six evaluable acute myeloid leukemia (AML) patients achieved complete remission, suggesting possible AML disease inhibition.

Details for the poster presentation are as follows:

Date: Monday, June 6, 2016
Presentation Time: 8:00 am – 12:45 pm Central Time
Location: Hall A, McCormick Place
Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Abstract: 7010
Title: "Phase I Study of BP1001 (Liposomal Grb2 Antisense) in Patients with Hematologic Malignancies" (Link to abstract)
. Dr. Maro Ohanian, Assistant Professor at the University of Texas MD Anderson Cancer Center will present data from the Company’s completed Phase I clinical trial and from the safety segment of the Phase II trial of BP1001 in combination with low-dose cytarabine (LDAC), including initial efficacy results. Notably, there were no dose-limiting toxicities observed in the safety segment and three of the six evaluable acute myeloid leukemia (AML) patients achieved complete remission, suggesting possible AML disease inhibition.

Details for the poster presentation are as follows:

Date: Monday, June 6, 2016
Presentation Time: 8:00 am – 12:45 pm Central Time
Location: Hall A, McCormick Place
Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Abstract: 7010
Title: "Phase I Study of BP1001 (Liposomal Grb2 Antisense) in Patients with Hematologic Malignancies" (Link to abstract)

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On May 19, 2016 BioLineRx Ltd. (NASDAQ/TASE: BLRX) reported that BL-8040, its lead platform for the treatment of multiple cancer and hematological indications, will be presented at two upcoming scientific conferences (Press release, BioLineRx, MAY 19, 2016, View Source;p=RssLanding&cat=news&id=2169697 [SID:1234512569]).

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An abstract titled "Clinical response in relapsed/refractory AML patients correlates with leukemic blast mobilization and differentiation induced by BL-8040, a potent CXCR4 antagonist; results of a Phase 2a study" was accepted for a poster presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) 21st Congress, to be held June 9-12, 2016 in Copenhagen, Denmark. Full detailed results from this Phase 2a study will be presented at an upcoming US-based scientific conference.

An abstract titled "CXCR4 Controls BCL-2 Expression and Function by Regulating miR-15a/16-1 Expression in Tumor Cells," illustrating BL-8040’s mechanism of action, was accepted for an oral presentation at Chemotactic Cytokines Gordon Research Conference, to be held between May 29 – June 3, 2016, in Girona, Spain.

On May 19, 2016 Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS) reported an oral presentation on vosaroxin at the 21st Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) to be held June 9-12, 2016 at the Bella Center in Copenhagen, Denmark (Press release, Sunesis, MAY 19, 2016, View Source;p=RssLanding&cat=news&id=2169705 [SID:1234512590]).

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The details for the oral presentation are as follows:

Date & Time: Saturday, June 11, 2016, 5:00 p.m. to 5:15 p.m. Central European Time
Poster Title: Phase I/II study of vosaroxin and decitabine in newly diagnosed older patients (PTS) with acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS)
Abstract Number: S505
Session Title: New Compounds in AML Treatment
Location: Hall A3

The full abstract can be viewed here.

The company will also publish data that will be on display as an E-poster:

Date & Time: Friday, June 10, 9:30 a.m. – Sunday, June 12, 11:00 a.m. Central European Time
Poster Title: Characterization of patients with relapsed or refractory AML in continued follow-up after treatment with vosaroxin/cytarabine vs placebo/cytarabine in the VALOR trial
Abstract Number: E930
Location: E-Poster Screens

The full abstract can be viewed here.