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Eleison Announces Successful Completion of Stage 1 of its Phase II Trial of ILC (Inhaled Lipid-complexed Cisplatin) for Pediatric Bone Cancer

On May 1, 2015 Eleison Pharmaceuticals LLC, a specialty pharmaceutical company developing life-saving therapeutics for rare cancers reported that it has successfully completed the first stage of its Phase II study of ILC (Inhaled Lipid-complexed Cisplatin), for the treatment of patients with pediatric osteosarcoma (bone cancer), with all 19 patients enrolled in this stage of the study having reached the study endpoint (Press release, Eleison Pharmaceuticals, MAY 1, 2015, View Source [SID1234517397]). The study has been enrolling patients at 15 of the leading U.S. hospitals and medical centers. More information about the study may be found at the www.clinicaltrials.gov website.
"In this study, we were evaluating if ILC may delay or prevent further pulmonary relapses in osteosarcoma patients", commented Mr. Edwin Thomas, CEO of Eleison. "We are very encouraged by the data generated by the study as 13 of the 19 patients experienced a relapse-free interval longer than the predicted relapse-free interval", further commented Mr. Thomas. Eleison is continuing to evaluate the study data and is planning to commence a pivotal registrational clinical trial of ILC later this year.

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CEL-SCI REPORTS 4TH CONSECUTIVE MONTH OF RECORD PATIENT ENROLLMENT IN 2015 FOR ITS PHASE III HEAD AND NECK CANCER TRIAL

On May 1, 2015 CEL-SCI Corporation (NYSE MKT: CVM) reported that in April it enrolled 31 patients with advanced primary, not yet treated, head and neck cancer into its global pivotal Phase III head and neck cancer trial for its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) (Press release, Cel-Sci, MAY 1, 2015, View Source [SID:1234506575]). April marks the 4th consecutive month of record enrollment for CEL-SCI this year following January, February and March, 2015. Enrollment was 24 patients in January, 25 patients in February and 29 patients in March. Four hundred thirty-seven (437) patients have been enrolled in the Phase III study as of April 30, 2015.

"We are very pleased with the enrollment, particularly since there were major holidays this month that made enrollment much more difficult," stated CEL-SCI Chief Executive Officer Geert Kersten.

About Multikine Phase III Study

The Multikine Phase III study is enrolling patients with advanced primary, not yet treated, head and neck cancer. The objective of the study is to demonstrate a statistically significant improvement in the overall survival of enrolled patients who are treated with the Multikine treatment regimen plus Standard of Care (SOC) vs. subjects who are treated with SOC only.

About Multikine

Multikine (Leukocyte Interleukin, Injection) is an investigational immunotherapeutic agent that is being tested in an open-label, randomized, controlled, global pivotal Phase III clinical trial as a potential first-line treatment for advanced primary head and neck cancer. If approved for use following completion of CEL-SCI’s clinical development program for head and neck cancer, Multikine would be a different type of therapy in the fight against cancer; one that appears to have the potential to work with the body’s natural immune system in the fight against tumors. The trial is expected to expand into a total of approximately 100 clinical centers in about 25 countries.

Multikine is also being tested in a Phase I study under a CRADA (Cooperative Research and Development Agreement) with the U.S. Naval Medical Center, San Diego as a potential treatment for peri-anal warts in HIV/HPV co-infected men and women. CEL-SCI has entered into two co-development agreements with Ergomed to further the development of Multikine for cervical dysplasia/neoplasia in women who are co-infected with HIV and HPV and for peri-anal warts in men and women who are co-infected with HIV and HPV.

8-K – Current report

On May 1, 2015 Sorrento Therapeutics reported that its fully owned subsidiary, IGDRASOL, has acquired exclusive distribution rights from Samyang Biopharmaceuticals ("Samyang"), a South Korean corporation, to Cynviloq (marketed as Genexol-PM in South Korea) in South America (Filing, 8-K, Sorrento Therapeutics, MAY 1, 2015, View Source [SID:1234503560]).

OncoMed Publishes Data on Tarextumab’s Anti-Cancer Stem Cell Activity in Clinical Cancer Research

On May 1, 2015 OncoMed Pharmaceuticals reported that data summarizing preclinical study results for its anti-Notch2/3 antibody, tarextumab (OMP-59R5) were published in the May 1, 2015 edition of Clinical Cancer Research (Press release, OncoMed, MAY 1, 2015, View Source [SID:1234503253]). The article details tarextumab’s anti-tumor effects alone and in combination with chemotherapy and elucidates the drug candidate’s mechanisms of activity. Additionally, data is presented describing the basis for biomarker identification of tumors with increased sensitivity to treatment with tarextumab.

"The early evidence of activity that we are seeing for tarextumab in our clinical trials is consistent with results of our preclinical studies. For instance, the Phase 1b biomarker-delineated response rates and survival data for tarextumab in pancreatic cancer is similar to the preclinical evidence that tumors with high Notch3 gene expression are more likely to respond to treatment," said Paul J. Hastings, OncoMed’s Chairman and Chief Executive Officer. "Tarextumab is currently being studied in two randomized Phase 2 clinical trials for pancreatic cancer and small cell lung cancer. We look forward to reporting additional clinical and biomarker data from our tarextumab program in the months to come."

Key findings from the paper, titled "Targeting Notch signaling with a Notch2/Notch3 antagonist (tarextumab) inhibits tumor growth and decreases tumor initiating cell frequency", include:

Tarextumab was efficacious in inhibiting the growth of preclinical patient-derived xenografts from various solid tumor types, including lung, ovarian, breast and pancreatic cancers, indicating the potential for broad utility of tarextumab.

Tarextumab demonstrated a dual mechanism of action: inhibiting signaling of Notch2 and Notch3 in tumor cells and modulating the function of tumor vasculature through its action on pericytes.

Inhibition of Notch signaling in tumor cells was associated with a reduction in cancer stem cell frequency, promotion of tumor cell differentiation and a delay in tumor recurrence following chemotherapy treatment.

Tumor sensitivity to treatment with tarextumab in combination with chemotherapy was significantly higher in pancreatic tumors that had a higher level of Notch3 gene expression.

Based on these data, Notch3 gene expression is being evaluated as a potential predictive biomarker for tarextumab in ongoing clinical trials.

"In this paper, we show that the blockade of Notch signaling with tarextumab sensitizes tumors to chemotherapy and reduces cancer stem frequency, delaying cancer recurrence as compared to chemotherapy alone," said Tim Hoey, Ph.D., Senior Vice President, Cancer Biology and a co-author of the paper. "Preclinical data for tarextumab, particularly as part of a combination regimen, provide a strong rationale for the utility of targeting Notch2 and Notch3 for cancer treatment, and suggest that this therapeutic approach may improve clinical outcomes. We are currently exploring the impact of this targeted anti-cancer stem cell agent in our Phase 2 clinical trials."

About Tarextumab (anti-Notch2/3, OMP-59R5)

Tarextumab (anti-Notch2/3, OMP-59R5) is a fully human monoclonal antibody that targets the Notch2 and Notch3 receptors. Preclinical studies have suggested that tarextumab exhibits two mechanisms of action: (1) by downregulating Notch pathway signaling, tarextumab appears to have anti-cancer stem cell effects, and (2) tarextumab affects pericytes, impacting stromal and tumor microenvironment. Tarextumab is currently being studied in two randomized Phase 2 clinical trials. The "ALPINE" study is assessing tarextumab with Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin bound) plus gemcitabine in first-line advanced pancreatic cancer patients. The "PINNACLE" study is testing tarextumab in combination with etoposide and cisplatin and etoposide and carboplatin in first-line extensive stage small cell lung cancer patients. Data from OncoMed’s Phase 1a and Phase 1b clinical trials of tarextumab indicate that the antibody is well tolerated, with on-target modulation of the Notch signaling pathway and signs of anti-tumor activity. Tarextumab is part of OncoMed’s collaboration with GlaxoSmithKline (GSK). GSK has an option to obtain an exclusive license to tarextumab during certain time periods through completion of the proof-of-concept Phase 2 trials.

10-Q – Quarterly report [Sections 13 or 15(d)]

Threshold Pharmaceuticals has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Threshold Pharmaceuticals, APR 30, 2015, View Source [SID1234503259]).