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.

On May 19, 2016 Cerulean Pharma Inc. (NASDAQ:CERU), a clinical-stage company developing nanoparticle-drug conjugates (NDCs), reported that the Company will present in an oral session Phase 1b results of an ongoing clinical trial of CRLX101 in combination with weekly paclitaxel in patients with relapsed ovarian cancer at the Gynecologic Oncology 2016 Conference being held May 19-21 in San Antonio, Texas (Press release, Cerulean Pharma, MAY 19, 2016, View Source [SID:1234512613]). This trial is being conducted by Cerulean in collaboration with the GOG Foundation, Inc.

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Details of the presentation are as follows:

Title: A Phase 1b study of the nanoparticle-drug conjugate (NDC) CRLX101 in combination with weekly paclitaxel in patients with advanced neoplasms including platinum-resistant tumors
Date/Time: Thursday, May 19, 2016, 12:20-12:50 pm CDT
Location: Hilton San Antonio Airport Hotel
Summary: As previously announced, a maximum tolerated dose and a recommended Phase 2 dose of 15 mg/m2 for CRLX101 (bi-weekly) and weekly paclitaxel 80 mg/m2 (3 weeks on; 1 week off) have been declared. Three patients were treated with 12 mg/m2 of CRLX101 and six patients were treated with 15 mg/m2 of CRLX101. The combination appears to be generally well tolerated, and no dose limiting toxicities observed at either dose level. To date, the only treatment-related adverse events were one Grade 3 and one Grade 4 neutropenia. The most common adverse events ( > 30%) were fatigue, neutropenia, and nausea. Objective RECIST responses were achieved by 5 of 9 patients (56%), including one patient who experienced complete disappearance of the tumor but had detectable CA125. Importantly, 3 of the 5 patients who achieved objective RECIST responses were previously treated with Avastin (bevacizumab). Based on the antitumor effect observed in these first nine patients, the trial will be expanded.

About GOG Foundation, Inc. (GOG Foundation)

The GOG Foundation, Inc. (GOG Foundation) is an independent international non-profit organization with the purpose of promoting excellence in the quality and integrity of clinical and basic scientific research in the field of gynecologic malignancies. The GOG Foundation is committed to maintaining the highest standards in clinical trials development, execution, analysis and distribution of results. Continuous evaluation of the GOG Foundation’s processes is utilized in order to constantly improve the quality of patient care. The GOG Foundation conducts clinical trials for patients with a variety of gynecologic malignancies, including cancers that arise from the ovaries, uterus, cervix, vagina, and vulva. The GOG Foundation is a separate entity from the National Clinical Trials Network groups that are funded by the National Cancer Institute.

About CRLX101

CRLX101 is a nanoparticle-drug conjugate (NDC) designed to concentrate in tumors and slowly release its anti-cancer payload, camptothecin, inside tumor cells. CRLX101 inhibits topoisomerase 1 (topo 1), which is involved in cellular replication, and also inhibits hypoxia-inducible factor-1α (HIF-1α), which research suggests is a master regulator of cancer cell survival mechanisms. CRLX101 has shown activity in four different tumor types, both as monotherapy and in combination with other cancer treatments. CRLX101 is in Phase 2 clinical development and has been dosed in more than 350 patients. The U.S. FDA has granted CRLX101 Orphan Drug designation for the treatment of ovarian cancer and Fast Track designation in combination with Avastin in metastatic renal cell carcinoma.

On May 19, 2016 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that the results of the Japanese phase III study (J-ALEX) of Alecensa, in ALK fusion gene positive non-small cell lung cancer (NSCLC) patients, will be presented at the annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) which will be held June 3 -7 in Chicago, IL (USA) (Press release, Chugai, MAY 19, 2016, View Source [SID:1234512571]). Results from the J-ALEX study will be presented at the oral abstract sessions scheduled for June 6 (CDT).

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Abstract #9008
Alectinib (ALC) versus crizotinib (CRZ) in ALK-inhibitor naïve ALK-positive non-small cell lung cancer (ALK+NSCLC): primary results from the J-ALEX study

The J-ALEX study was an open-label, randomized phase III study that compares the efficacy and safety between Alecensa and crizotinib. The J-ALEX study enrolled 207 ALK-inhibitor naïve patients with ALK fusion gene positive advanced or recurrent NSCLC, who either had not undergone chemotherapy or had undergone one chemotherapy regimen. The subjects were allocated to either the Alecensa arm or the crizotinib arm of the study in a one to one ratio. The primary endpoint of the J-ALEX study was progression free survival (PFS) as assessed by a blinded independent review board. The secondary endpoints included overall survival, objective response rate and safety, and other endpoints.

The PFS hazard ratio of the Alecensa arm to the crizotinib arm was 0.34 and Alecensa demonstrated significantly prolonged PFS (99.6826% CI: 0.17-0.70, stratified log-rank p<0.0001). Median PFS was not reached (95% CI: 20.3-Not Estimated) in the Alecensa arm while it was 10.2 months (95%CI: 8.2-12.0) in the crizotinib arm. In the Alecensa arm, constipation (36%) was an adverse event (AE) with >30% frequency, while in the crizotinib arm nausea (74%), diarrhea (73%), vomiting (59%), visual disturbance (55%), dysgeusia (52%), constipation (46%), ALT elevation (32%), and AST elevation (31%) were each seen in >30% patients. Grade 3-4 AEs occurred in 27% of the Alecensa arm and in 51% of the crizotinib arm, there were no treatment-related deaths in either arm.

In February, 2016, Chugai carried out a prospectively defined interim analysis, and had an independent data monitoring committee examine the results. Since the results showed that Alecensa significantly prolonged the PFS to a higher extent than anticipated, the committee decided to recommend an early discontinuation of the J-ALEX study.

"It was found in Japan earlier than in any other country in the world that ALK fusion gene serves as a powerful carcinogenic factor for some types of lung cancer. Alecensa was created by Chugai as a drug selectively inhibiting the activity of ALK fusion gene, and it was first approved in Japan in 2014 based on the Japanese clinical study data. The J-ALEX study, comparing Alecensa therapy directly with standard therapy, demonstrated superiority of Alecensa over standard therapy for the first time in the world. This finding not only greatly encourages the patients suffering from ALK fusion gene positive NSCLC but also illustrates the high level of drug development progression from basic research to clinical studies in Japan," said Chugai’s Director and Executive Vice President, Dr. Yutaka Tanaka. "Chugai is extremely proud of having developed Alecensa which has been shown to provide benefit to patients."

As a top pharmaceutical company in the field of oncology in Japan, Chugai believes that early treatment using Alecensa in ALK fusion gene positive NSCLC is expected to prolong these patients’ PFS and enable them to face their disease with hope for the future.

About Alecensa
Alecensa is a highly selective ALK inhibitor discovered by Chugai. It has been reported that 2 to 5 percent of patients with NSCLC express a chromosomal rearrangement which leads to fusion of the ALK gene with another gene.1) ALK kinase signalling is constantly active in cells with such fusion genes, resulting in uncontrolled growth of tumor cells and transforming the cells into tumor cells.2, 3) Alecensa exerts its anti-tumor effect by selectively inhibiting ALK kinase activity to inhibit tumor cell proliferation and induce cell death.4) In addition, Alecensa is not recognized by the transporter proteins in the blood brain barrier that actively pump molecules out of the brain. Alecensa is active in the central nervous system and has proven activity against brain metastases.

In Japan, Alecensa is available to patients with "ALK fusion gene positive unresectable, recurrent/advanced NSCLC" and is marketed by Chugai. In the US, Alecensa was approved in December 2015 for the indication of "anaplastic lymphoma kinase (ALK) positive, metastatic non-small cell lung cancer (NSCLC) in patients who have progressed on or those who are intolerant to crizotinib." In September 2015, Roche filed the MAA in Europe to the European Medicines Agency for the approval of "ALK fusion gene positive unresectable, recurrent/advanced NSCLC."