On December 5, 2016 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, reported positive Phase 2a correlative data, as well as detailed mechanism-of-action data, for BL-8040, the Company’s leading oncology platform at the ongoing 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exhibition in San Diego, California (Press release, BioLineRx, DEC 5, 2016, View Source;p=RssLanding&cat=news&id=2227400 [SID1234516915]).

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As previously announced, in an oral presentation at 10:30am PST today, entitled, "The High Affinity CXCR4 Inhibitor, BL-8040, Induces Apoptosis of AML Blasts and their Terminal Differentiation by Blocking AKT/ERK Survival Signals and Downregulating BCL-2, MCL-1 and Cyclin-D1 through Regulation of miR-15a/16-1 Expression," BioLineRx reports detailed data on the mechanism-of-action by which BL-8040 directly induces apoptosis of AML cells. The data, presented by Prof. Amnon Peled, are from in vitro studies using human AML cell lines and human primary AML samples, as well as in vivo studies using human primary AML cells engrafted in NOD scid gamma (NSG) mice.

In addition, yesterday, in a poster titled, "The Selective Anti Leukemic Effect of BL-8040, a Peptidic CXCR4 Antagonist, is Mediated by Induction of Leukemic Blast Mobilization, Differentiation and Apoptosis: Results of Correlative Studies from a Ph2a Trial in Acute Myeloid Leukemia," BioLineRx reported the final correlative results from its Phase 2a trial in acute myeloid leukemia (AML). The trial consisted of 45 AML patients receiving BL-8040 monotherapy on days 1-2, followed by the same dose of BL-8040 plus chemotherapy (Cytarabine) on days 3-7. All patients had poor-risk disease and had been heavily pretreated, with 19% having relapsed after a short first remission (≤12 months), 17% having 2 or more relapses, while 45% were refractory to 1-2 induction treatments. The composite complete remission rate, including both complete remission (CR) and complete remission with incomplete blood count recovery (CRi), was 38% in subjects receiving BL-8040 dose ≥1.0 mg/kg (n=39). These response rates are superior to the historical response rate of approximately 20% reported for high-risk AML patients treated with Cytarabine alone.

Philip Serlin, CEO of BioLineRx, commented, "We are excited to take part in the world’s premier event in malignant and non-malignant hematology, with over 20,000 hematology professionals from every subspecialty in attendance. At this event, we are pleased to present additional positive results about BL-8040. This includes clinical data that supports the rational for incorporation of BL-8040 in front-line AML treatment settings, such as AML consolidation and maintenance. In this regard, we are currently running a large Phase 2b study in consolidation AML, and we expect to initiate a Phase 1b study in maintenance AML under our collaboration with Genentech in mid-2017. We are also pleased to see pre-clinical data that support the mechanism of action of BL-8040 and show synergistic effects of BL-8040 with drugs that are also being investigated as AML treatments. We continue to anticipate that BL-8040, in combination with a growing repertoire of drugs, will be able to offer hope in this difficult to treat condition."

About BL-8040

BL-8040 is a short peptide for the treatment of acute myeloid leukemia, solid tumors, and certain hematological indications. It functions as a high-affinity antagonist for CXCR4, a chemokine receptor that is directly involved in tumor progression, angiogenesis, metastasis and cell survival. CXCR4 is over-expressed in more than 70% of human cancers and its expression often correlates with disease severity. In a number of clinical and pre-clinical studies, BL-8040 has shown robust mobilization of cancer cells from the bone marrow, thereby sensitizing these cells to chemo- and bio-based anti-cancer therapy, as well as a direct anti-cancer effect by inducing apoptosis. In addition, BL-8040 has also demonstrated robust stem-cell mobilization, including the mobilization of colony-forming cells, and T, B and NK cells. Furthermore, scientific findings in the field of immuno-oncology suggest that CXCR4 antagonists may be effective in inducing the infiltration of anti-tumor T cells into the tumor. Therefore, when combined with immune checkpoint inhibitors, BL-8040 has the potential to enable activated T cells to better reach tumor cells. BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was previously developed under the name BKT-140.

On December 5, 2016 Dynavax Technologies Corporation (NASDAQ: DVAX) reported clinical data from an ongoing Phase 1/2, two-part clinical trial evaluating intratumoral administration of SD-101 in the treatment of low-grade lymphoma (Press release, Dynavax Technologies, DEC 5, 2016, View Source [SID1234516916]). The combination of intratumoral SD-101 and low-dose irradiation resulted in tumor regression in untreated tumor sites as well as in the treated tumors. Treatment was well-tolerated and changes in T cell populations consistent with stimulation of anti-tumor immunity were observed in the treated lesions. These data were presented in a poster session on Sunday at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in San Diego, California.

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Data from the dose escalation and expansion phase of the study were reported from 28 evaluable patients. None of the patients had received prior treatment for their low-grade lymphoma. The primary endpoints of the trial are maximum tolerated dose (MTD) and evaluation of the safety of intratumoral SD-101 in combination with low dose radiotherapy. In addition, the trial is evaluating anti-tumor activity, pharmacodynamics, and duration of response. Doses ranged from 1 mg to 8 mg per injection in successive cohorts.

Key findings presented include:

Of the 28 evaluable patients treated across all dose levels, 3 had a partial response (PR) and1 had a complete response (CR) as measured by Cheson criteria.
Durable abscopal tumor shrinkage was observed in the majority of patients.
Confirming observations in the dose escalation phase, the most common treatment-related treatment emergent adverse events (TEAEs) in the expansion phase were flu-like symptoms, consistent with the engagement of TLR9 and the induction of interferon-alpha.
Increases in CD8+ cells were observed in the injected tumor, and correlated with an increased abscopal tumor shrinkage
"The clinical data emerging from our SD-101 program continues to be encouraging. We look forward to providing updates from our ongoing clinical trials," stated Eddie Gray, chief executive officer of Dynavax Technologies. "We will discuss this program and our oncology pipeline in our cancer R&D Day which will be webcast live on December 9th at 8:30 a.m. EST."

About SD-101

SD-101 is Dynavax’s proprietary, second-generation, Toll-like receptor 9 (TLR9) agonist CpG-C class oligodeoxynucleotide. SD-101 is being studied for its multiple anti-tumor activities in innate immune cells and activation of plasmacytoid dendritic cells to stimulate T cells specific for antigens released from dying tumor cells. TLR9 agonists such as SD-101 enhance T and B cell responses and provide potent Type 1 interferon induction and maturation of plasmacytoid dendritic cells to antigen-presenting cells. SD-101 is being evaluated in several Phase 1/2 oncology studies to assess its safety and activity.

For information about SD-101 trials that are currently recruiting patients, please visit www.clinicaltrials.gov.

On December 5, 2016 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported preliminary safety and efficacy data from a phase 1 study of DS-3032, an investigational oral selective MDM2 inhibitor, suggesting that DS-3032 may be a promising treatment for hematological malignancies including relapsed/refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS) (Press release, Daiichi Sankyo, DEC 5, 2016, View Source [SID1234516945]). Preliminary results from the dose esclation part of the phase 1 study of DS-3032 were presented in an oral presentation at the 58th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper).

A total of 38 patients with relapsed/refractory AML or high-risk MDS were enrolled into the study. Five dose levels of DS-3032 (60 mg, 90 mg, 120 mg, 160 mg and 210 mg) were given. The maximum tolerated dose of DS-3032 was determined to be 160 mg once daily for 21 days in a 28 day cycle based on results from 37 patients who received at least one dose of DS-3032.

Clinical activity of DS-3032 was observed by a reduction of bone marrow blasts at the end of the first cycle of treatment in 15 out of 26 patients who had at least one post-dose bone marrow evaluation. Complete remission was seen in two patients with relapsed/refractory AML receiving 120 mg and 160 mg of DS-3032 with a duration of approximately four months and 13 months, respectively. One patient with high-risk MDS receiving the 120 mg dose of DS-3032 achieved marrow complete remission with platelet improvement for four months. Each of the three patients experiencing a complete response showed a TP53 gene mutation while receiving treatment, which was not identified at the start of the study.

"MDM2 inhibitors such as DS-3032 represent a promising approach in cancer therapy as they have the potential to restore the tumor suppressor protein function of p53 via release from the inhibitory effects of MDM2. Wild-type p53 plays an important role in preventing the uncontrolled growth of cancer cells," said Courtney DiNardo, MD, MSCE, Assistant Professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX. "While these findings are encouraging in that single-agent clinical activity in refractory hematologic malignancies was demonstrated with DS-3032, further study with optimized dosing regimens including combination strategies is needed."

Five patients experienced dose limiting toxicities including two patients in the 160 mg cohort (grade 3 hypokalemia and diarrhea) and three patients in the 210 mg cohort (grade 3 nausea/vomiting, grade 3 anorexia/fatigue and grade 2 creatinine elevation/renal insufficiency leading to early discontinuation of treatment). The most common treatment-emergent adverse events (TEAEs) of any grade (greater than 20 percent) included nausea (73 percent), diarrhea (57 percent), vomiting (33 percent), fatigue (37 percent), anemia (33 percent), thrombocytopenia (33 percent), neutropenia (20 percent), hypotension (30 percent), hypokalemia (23 percent), and hypomagnesemia (20 percent).

"Additional research is currently underway to further explore the appropriate dose and treatment schedule of DS-3032 as well as determine how it can be combined with other therapies," said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. "We are committed to investigating novel approaches to treat AML and MDS in hopes of changing the standard of care for these patients."

About the Study
The primary objectives of the dose escalation part of the phase l study are to assess the safety, tolerability, and maximum tolerated dose or the tentative recommended phase 2 dose of DS-3032 in several hematological malignancies including refractory or relapsed acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), chronic myleoid leukemia (CML) in blast phase, and myelodysplastic syndrome (MDS). Secondary objectives include evaluating the pharmacokinetics and pharmacodynamic effects of DS-3032. Exploratory objectives include evaluating the efficacy of DS-3032. Further evaluation of alternative dosing schedules of DS-3032 is currently underway. For more information about the study visit ClinicalTrials.gov.

About DS-3032
DS-3032 is an investigational oral selective inhibitor of the murine double minute 2 (MDM2) protein currently being investigated in three phase 1 clinical trials for solid and hematological malignancies including acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), chronic myeloid leukemia (CML) in blast phase, lymphoma and myelodysplastic syndrome (MDS). DS-3032 has not been approved by any regulatory authority for uses under investigation.

MDM2 is a ubiquitously expressed protein that plays an important role in tissue development and tightly regulates p53, a protein that functions as a tumor suppressor.1 Overexpression or oncogenic activation of MDM2 can disrupt the balanced MDM2 and p53 interaction, blocking the tumor suppressor activity and leading to solid tumors and hematological malignancies.1,2 Small molecules designed to block the MDM2-p53 interaction, reactivating p53 to suppress tumors, may be a promising therapeutic approach for the treatment of wild-type (non-mutant) p53 cancer.1

Unmet Need in AML and MDS
Acute myeloid leukemia (AML) is the most common type of acute leukemia, accounting for about 33 percent of all new cases of leukemia.3 The five-year survival rate of AML is approximately 26 percent, which is the lowest of all leukemias.3 In the U.S., each year there are about 13,000 new cases of myelodysplastic syndrome (MDS), a type of cancer that can occur when the blood-forming cells in the bone marrow are damaged.4 In about one in three patients, MDS progresses to AML.4 Currently, there are no approved targeted treatments for AML, with little progress in approval of new drugs for AML over the past 30 years.5,6

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On December 5, 2016 Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported the presentation of updated results from the VALOR trial examining overall survival in patients age 60 years and older with relapsed/refractory AML (Press release, Sunesis, DEC 5, 2016, View Source;p=RssLanding&cat=news&id=2227712 [SID1234516964]). The results are being presented today at 3:15 PM PT in an oral session titled "Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Clinical trials of Novel Drugs and Combinations in AML" taking place from 2:45 PM – 5:45 PM PT at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in San Diego, California. The presentation (abstract 903, Marriott Marquis San Diego Marina, Ballroom AB), titled "Durable Overall Survival Benefit in Patients ≥ 60 Years with Relapsed or Refractory AML Treated with Vosaroxin/Cytarabine Vs Placebo/Cytarabine: Updated Results from the Valor Trial," is available at www.sunesis.com.

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"Clinical outcomes among patients with relapsed/refractory AML remain abysmal, particularly among older patients," said Farhad Ravandi, M.D., Professor of Medicine, Department of Leukemia, University of Texas MD Anderson Cancer Center, and a principal investigator of the VALOR study. "Results from the updated survival data from VALOR and the post-hoc analyses presented today, show compelling durable survival outcomes among older patients, and support the use of vosaroxin, in combination with cytarabine, as an important treatment option for this group of AML patients desperately in need of new therapies."

VALOR is a randomized, double-blind, placebo-controlled Phase 3 trial that enrolled 711 adult patients with first relapsed or refractory AML at 124 sites in 15 countries. Patients were stratified for age, geographic region and disease status and randomized one to one to receive either vosaroxin and cytarabine or placebo and cytarabine. At the time of the primary analysis in October 2014, the overall survival (OS) was significantly improved with vosaroxin/cytarabine versus placebo/cytarabine in patients age 60 years and older (7.1 months vs 5.0 months, HR=0.75, p=0.0030), with a complete remission (CR) rate of (31.9% vs 13.8%, p < 0.0001).

The new data presented today from the VALOR trial include an updated survival analysis in the 451 patient subset age 60 and older, sensitivity analyses of OS in patients age 60 and older, and analyses examining the differences in treatment effect by age. The results demonstrate that, after a median of 39.9 months of follow-up, OS for patients age 60 years and older remains significantly improved for the vosaroxin/cytarabine arm compared to the placebo/cytarabine arm (figure 1), with survival curves remaining separated through 48 months.

Figure 1.

A graph accompanying this announcement is available at View Source

Treatment Arm Patients, n Events, n (%) Censored, n (%) Median OS (95% CI) P value (2-sided)
Pla+Cyt 225 212 (94.2%) 13 (5.8%) 5.0 (3.8-6.4) 0.0017
Vos+Cyt 226 199 (88.1%) 27 (11.9%) 7.1 (5.8-8.1)
Of note, twice as many patients were alive on the vosaroxin-containing arm at both the 24 and 36 months’ time points highlighting the durability of benefit observed in this patient group.

An OS benefit with the addition of vosaroxin was observed consistently across smaller subgroups above 60 years (figure 2). Smaller age groups below 60 years did not demonstrate a similar OS benefit.

Figure 2.

Median OS, months
Patent Age Vosaroxin/Cytarabine Placebo/Cytarabine Hazard Ratio (95% CI)
60-64 years (n = 124) 8.1 5.2 0.72 (0.49-1.06)
65-74 years (n = 293) 7.0 5.0 0.76 (0.60-0.97)
75-84 years (n = 34) 5.5 3.3 0.72 (0.36-1.45)
Sunesis also performed a multivariate survival analysis adjusting for baseline prognostic factors. In this analysis, the HR for OS in the ITT population was 0.80 (p=0.0114) and for patients age 60 and older the OS HR was 0.68 (p=0.0004).

"All of these data and analyses further underscore the consistency, durability and robustness of the survival benefit for patients age 60 years and older who received vosaroxin in the VALOR study," said Daniel Swisher, President and Chief Executive Officer of Sunesis. "As we work toward a European regulatory decision for vosaroxin in this patient population, we remain committed to making vosaroxin available as a new treatment option for underserved patients with relapsed refractory AML. As our regulatory efforts progress, we also continue to advance active dialogues with potential pharma collaborators toward the goal of supporting a European market launch in 2017."

About QINPREZO (vosaroxin)

QINPREZO (vosaroxin) is an anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer. Preclinical data demonstrate that vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Both the U.S. Food and Drug Administration (FDA) and European Commission have granted orphan drug designation to vosaroxin for the treatment of AML. Vosaroxin is an investigational drug that has not been approved for use in any jurisdiction.

Vosaroxin’s Marketing Authorization Application for relapsed refractory AML is currently under review by the European Medicines Agency, and a regulatory decision regarding approval is expected in 2017.

The trademark name QINPREZO is conditionally accepted by the FDA and the EMA as the proprietary name for the vosaroxin drug product candidate.

On December 5, 2016 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, reported the presentation of data from a Phase 2 clinical trial of oral rigosertib and azacitidine in higher-risk myelodysplastic syndromes (HR-MDS) at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in San Diego, California (Press release, Onconova, DEC 5, 2016, View Source [SID1234516918]).

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"The complete remission rate amongst HMA-naïve HR-MDS patients is higher and responses occur more rapidly and durably with the oral rigosertib combination compared to historic single-agent azacitidine," commented Lewis R. Silverman, M.D., lead investigator in the trial and Associate Professor of Medicine, Hematology and Medical Oncology, at the Icahn School of Medicine at Mount Sinai. "Furthermore, the addition of oral rigosertib to azacitidine does not substantially change the adverse event profile of single-agent azacitidine, and thus may overcome the limitations identified in other HMA-based combinations."

The current standard of care for higher-risk MDS patients is one of two approved hypomethylating agents (azacitidine and decitabine, approved by the FDA in 2004 and 2006). Although these drugs are currently the standard of care in HR-MDS therapy, their overall response rate and duration of benefit is limited to a subset of eligible patients and all responding patients ultimately progress. Thus, there is an urgent need for improving therapeutic options for newly diagnosed HR-MDS patients. The 09-08 trial tested oral rigosertib in combination with injectable azacitidine in a dose ranging study (Phase 1), followed by an expansion cohort (Phase 2) to evaluate the efficacy and safety of the combination. Both 1st-line and 2nd-line HR-MDS patients were included in the study.

Summary of Presented Data from the 09-08 Combination Therapy Trial

Patient Demographics:

Thirty-three of 40 MDS patients enrolled were evaluable for response at the time of this analysis.
The median age was 66, with 73% of male patients. ECOG performance status was 0 or 1 in 95% of the patients. IPSS-R distribution was: 7.5% Low, 12.5% Intermediate, 37.5% High, 32.5% Very High and 10% unknown.
Safety/Tolerability of the Combination:

Oral rigosertib (560 mg qAM, 280 mg qPM) was administered on Day 1-21 of a 28-day cycle. Azacitidine 75 mg/m2/day SC or IV was administered for 7 days starting on Day 8.
The combination of oral rigosertib and azacitidine was well tolerated.
Adverse events of Grade ≥3 experienced across all cycles with the combination included thrombocytopenia (33%), neutropenia (30%), haematuria (13%), dysuria (8%), diarrhoea (3%) and arthralgia (3%).
Notably, the side effects were similar to those previously reported for azacitidine administered alone.
Efficacy of the Combination:

Thirty-three (20 HMA naïve; 13 HMA resistant) MDS patients were evaluable for efficacy analysis per IWG 2006 criteria (Cheson et al., Blood 2006).
25 of 33 (76%) patients responded per IWG — 85% of HMA naïve patients experienced a response and 62% of HMA resistant patients experienced a response.
7 of 20 (35%) HMA naïve and 1 of 13 (8%) HMA-resistant patients achieved a complete remission (CR). The median duration of CR was 8.0 months, which compares very favorably to the historic duration of CR and PR with single-agent azacitidine of 3.2 months1.
Hematologic improvement (HI) was observed in 11 of 33 patients (33%) and the median duration of response was 7.4 months for erythroid response, 8 months for platelet response, and 6.2 months for neutrophil response. Marrow CR was observed in 16 of 33 (48%) patients and the median duration of response was 12.3 months. Marrow CR combined with HI was observed in 10 of 33 (30%) patients.
The poster entitled, "Combination of Oral Rigosertib and Injectable Azacitidine in Patients with Myelodysplastic Syndromes (MDS): Results from a Phase II Study," was presented by Dr. Shyamala Navada of Mount Sinai School of Medicine at the Myelodysplastic Syndromes Session on Sunday, December 4, 2016 at the ASH (Free ASH Whitepaper) Annual Meeting in San Diego, California. A copy of the poster is available by visiting the Scientific Presentations section under the Investors & Media tab of Onconova’s website.

"We are pleased by the positive efficacy signal observed over extended periods of treatment, and the acceptable tolerability of oral rigosertib and azacitidine in 1st-line HR-MDS," stated Ramesh Kumar, Ph.D., President and CEO of Onconova. "We presented Phase 2 data to the FDA as part of our End-of-Phase 2 meeting in September 2016, and based on these discussions, we are designing a randomized, placebo controlled Phase 3 clinical trial comparing the combination of oral rigosertib plus azacitidine to azacitidine plus placebo in 1st-line HR-MDS patients with the primary composite endpoint of CR and PR rate per 2006 IWG criteria. Based on our discussions with the FDA the primary efficacy endpoint of this trial will be composite response and not survival, permitting accelerated evaluation of outcomes."

Comprehensive Safety Assessment of Rigosertib in MDS Patients

In a second poster at the conference a safety review of 557 MDS/AML patients treated with rigosertib in clinical studies, including the randomized Phase 3 ONTIME trial was presented. The poster entitled, "Comprehensive Analysis of Safety: Rigosertib in 557 Patients with Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML)," can be accessed by visiting the Scientific Presentations section under the Investors & Media tab of Onconova’s website.