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Trading of Clovis Oncology, Inc. Common Stock Halted

On April 12, 2016 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that NASDAQ has halted trading of the Company’s common stock (Press release, Clovis Oncology, APR 12, 2016, View Source;p=RssLanding&cat=news&id=2156231 [SID:1234510704]). The U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) is meeting this morning to discuss the company’s New Drug Application (NDA) for rociletinib for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation.

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About Rociletinib
Rociletinib is the company’s novel, oral, targeted covalent (irreversible) mutant-selective inhibitor of EGFR in development for the treatment of NSCLC in patients with initial activating EGFR mutations, as well as the dominant resistance mutation T790M. Data from both the pivotal, single-arm TIGER-X and TIGER-2 clinical trials served as the basis for the U.S. and EU regulatory submissions for the treatment of advanced mutant EGFR T790M-positive lung cancer. Rociletinib was granted Breakthrough Therapy designation by the FDA in May 2014.

Celsion Announces Upcoming Presentation at AACR 2016 Highlighting Potential of GEN-1 IL-12 Immunotherapy in Ovarian Cancer

On April 12, 2016 Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, reported that data highlighting the potential of GEN-1 in ovarian cancer will be presented at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, which is being held in New Orleans from April 16-20, 2016 (Press release, Celsion, APR 12, 2016, View Source [SID:1234510703]). GEN-1 is an IL-12 DNA plasmid vector formulated into a nanoparticle with a non-viral delivery system to cause the sustained local production and secretion of the Interleukin-12 (IL-12) protein loco-regionally to the tumor site.

The poster presentation relates to data demonstrating the significant synergistic anti-cancer effects of GEN-1 in combination with Avastin and Doxil, as well as promising safety and efficacy clinical data for GEN-1 in combination with Doxil in platinum-resistant ovarian cancer patients.

Details of the presentation are as follows:

Abstract Title: Interleukin-12 Gene Therapy in Combination with Bevacizumab and PEGylated Liposomal Doxorubin for Treatment of Disseminated Ovarian Cancer

Session Title: Drug Delivery

Date and Time: April 18, 2016 from 1:00 – 5:00 pm

"GEN-1 has consistently shown improved outcomes in both pre-clinical and clinical studies when combined with standard of care therapeutics," said Michael H. Tardugno, Celsion’s chaiman, president and CEO. "The remarkable findings from this study further reinforce our development strategy for GEN-1 and accelerate our plans for clinical trials in ovarian cancer patients who have had limited success with first line treatments."

The Company is currently enrolling patients in the OVATION Study, a Phase 1b dose escalating trial combining GEN-1 with neo-adjuvant therapies in newly diagnosed ovarian cancer patients which will provide a starting dose for a follow-on Phase 1/2 study combining GEN-1 with Avastin and Doxil. The Phase 1/2 combination trial is expected to begin in the second half of 2016.

About GEN-1 Immunotherapy

GEN-1, designed using Celsion’s proprietary TheraPlas platform technology, is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anti-cancer immunity acting through the induction of T-lymphocyte and natural killer (NK) cell proliferation. The Company has previously reported positive safety and encouraging Phase I results with GEN-1 given as monotherapy in patients with peritoneally metastasized ovarian cancer, and recently completed a Phase Ib trial of GEN-1 in combination with PEGylated doxorubicin in patients with platinum-resistant ovarian cancer. GEN-1 has also demonstrated preclinical activity in glioblastoma multiforme (brain cancer) and the Company plans to initiate a Phase I study in this indication in the second half of 2015.

Type 2 diabetes-related variants influence the risk of developing multiple myeloma: results from the IMMEnSE consortium.

Type 2 diabetes (T2D) has been suggested to be a risk factor for multiple myeloma (MM), but the relationship between the two traits is still not well understood. The aims of this study were to evaluate whether 58 genome-wide-association-studies (GWAS)-identified common variants for T2D influence the risk of developing MM and to determine whether predictive models built with these variants might help to predict the disease risk. We conducted a case-control study including 1420 MM patients and 1858 controls ascertained through the International Multiple Myeloma (IMMEnSE) consortium. Subjects carrying the KCNQ1rs2237892T allele or the CDKN2A-2Brs2383208G/G, IGF1rs35767T/T and MADDrs7944584T/T genotypes had a significantly increased risk of MM (odds ratio (OR)=1.32-2.13) whereas those carrying the KCNJ11rs5215C, KCNJ11rs5219T and THADArs7578597C alleles or the FTOrs8050136A/A and LTArs1041981C/C genotypes showed a significantly decreased risk of developing the disease (OR=0.76-0.85). Interestingly, a prediction model including those T2D-related variants associated with the risk of MM showed a significantly improved discriminatory ability to predict the disease when compared to a model without genetic information (area under the curve (AUC)=0.645 vs AUC=0.629; P=4.05×10(-) (06)). A gender-stratified analysis also revealed a significant gender effect modification for ADAM30rs2641348 and NOTCH2rs10923931 variants (Pinteraction=0.001 and 0.0004, respectively). Men carrying the ADAM30rs2641348C and NOTCH2rs10923931T alleles had a significantly decreased risk of MM whereas an opposite but not significant effect was observed in women (ORM=0.71 and ORM=0.66 vs ORW=1.22 and ORW=1.15, respectively). These results suggest that TD2-related variants may influence the risk of developing MM and their genotyping might help to improve MM risk prediction models.
© 2015 Society for Endocrinology.

Influence of the HER2 Ile655Val polymorphism on trastuzumab-induced cardiotoxicity in HER2-positive breast cancer patients: a meta-analysis.

The HER2 655 A&gt;G genetic variant has recently been associated with trastuzumab-induced cardiotoxicity in HER2 breast cancer patients. Considering previous results, the aim of our study was to validate the role of this polymorphism as a predictor of the cardiac toxicity of trastuzumab in breast cancer patients.
Our study population was composed of 78 HER2 breast cancer patients receiving trastuzumab. The HER2 655 A&gt;G (rs1136201) genetic variant was genotyped using TaqMan allelic discrimination technology. Patients were classified on the basis of the occurrence of cardiotoxic events or the absence of cardiotoxic events during 1 year after the first infusion.
The HER2 655 A&gt;G polymorphism was significantly associated with cardiotoxicity: AG versus AA [P=0.012, odds ratio (OR)=5.12, 95% confidence interval (CI) 1.43-18.36], AG+GG versus AA (P=0.01, OR=5.72, 95% CI 1.50-21.76), AG versus AA+GG (P=0.005, OR=7.17, 95% CI 1.82-28.29). A meta-analysis combining these data with the results from previous studies confirmed this association.
Our results support the role of the HER2 655 A&gt;G polymorphism as a genetic marker of trastuzumab-induced cardiotoxicity in HER2-positive breast cancer patients.

Prognostic significance of Wilms tumor 1 mRNA expression levels in peripheral blood and bone marrow in patients with myelodysplastic syndromes.

This present study was designed to follow up 82 patients among 115 MDS patients registered in study ODK-0801 for 5 years, to analyze the relationship between the WT1 mRNA expression level and prognosis.
This study aimed to investigate the clinical utility of WT1 mRNA expression levels.
After study ODK-0801, we investigated the conditions of the same patients once a year, including any clinical and laboratory findings supporting the diagnosis, and treatment among the living patients.
When we assessed the survival time of 82 MDS patients by WT1 mRNA expression level, there were significant differences between the &lt; 500 and ≥ 104 copies/μ g RNA groups and between the 500-104 and ≥ 104 copies/μ g RNA groups for BM levels (p &lt; 0.01). Examination of the time of freedom from cute myeloid leukemia (AML) transformation indicated that a high WT1 mRNA expression level (&gt; 104 copies/μ g RNA) was a strong prognostic factor for a short time to AML transformation.
The results indicate that the tumorigenesis of MDS is likely to originate at the stem cell level, suggesting that the WT1 mRNA level measurement in the BM is an effective prognostic marker in patients with MDS.