On February 20, 2014 OncoMed announced the initiation of patient treatment for its third multi-center Phase 1b clinical trial of OMP-54F28 (Fzd8-Fc) with carboplatin and paclitaxel in patients with platinum-sensitive ovarian cancer (Press release OncoMed, FEB 20, 2014, View Source [SID:1234500100]).
With the commencement of this clinical study, all six of OncoMed’s planned Phase 1b clinical trials for its proprietary Wnt-pathway-targeting compounds, vantictumab (OMP-18R5) and OMP-54F28, are now enrolling patients. Earlier this year OncoMed initiated two separate Phase 1b clinical trials of OMP-54F28 with nab-paclitaxel (Abraxane) and gemcitabine in pancreatic cancer, and with sorafenib (Nexavar) in hepatocellular cancer. During the fourth quarter of 2013, OncoMed initiated three Phase 1b trials for its anti-Frizzled antibody, vantictumab; in combination with paclitaxel in breast cancer, with nab-paclitaxel and gemcitabine in pancreatic cancer, and with docetaxel in non-small cell lung cancer.
These Phase 1b combination studies will provide critical data for Bayer to exercise their option to license OMP-54F28 and vantictumab and for the planning and execution of Phase 2 clinical studies.”
The Phase 1b clinical trial of OMP-54F28 in combination with carboplatin and paclitaxel is a dose-escalation study in patients with recurrent platinum-sensitive ovarian cancer. Primary objectives of the trial are to evaluate safety of this combination regimen and determine a recommended Phase 2 dose for OMP-54F28 in combination with carboplatin and paclitaxel. Key secondary and exploratory objectives include evaluation of the pharmacokinetics (PK) and pharmacodynamics (PD) of OMP-54F28, as well as the efficacy of this combination. Tumor tissue from patients will be used to explore predictive biomarker hypotheses related to the efficacy of OMP-54F28.
Three additional investigators and clinical sites are participating in this trial: Gina Mantia-Smaldone, M.D., Fox Chase Cancer Center, Philadelphia, PA; Paul Sabbatini, M.D., Memorial Sloan-Kettering Cancer Center, New York, NY; and Nelson Teng, M.D., Stanford University, Palo Alto, CA.
Author: [email protected]
Cytokinetics Announces Proposed Public Offering of Common Stock
On February 19, 2014 Cytokinetics, Incorporated (Nasdaq: CYTK) reported that it intends to offer and sell shares of its common stock in an underwritten public offering (Press release, Cytokinetics, FEB 19, 2014, View Source [SID1234500105]). Cytokinetics also expects to grant the underwriters an option to purchase up to an additional 15% of the shares of common stock offered in the public offering, exercisable for 30 days. All of the shares in the proposed offering are to be sold by Cytokinetics. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.
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Cowen and Company, LLC is acting as the sole book-running manager. JMP Securities LLC is acting as a lead manager.
This offering is being made pursuant to an effective shelf registration statement previously filed with the U.S. Securities and Exchange Commission (the "SEC"). A preliminary prospectus supplement and accompanying prospectus describing the terms of the proposed offering will be filed with the SEC. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that Cytokinetics has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about Cytokinetics and such offering.
This press release does not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offer, if at all, will be made only by means of a prospectus supplement and accompanying prospectus forming a part of the effective registration statement. Copies of the preliminary prospectus supplement and accompanying prospectus relating to this offering may be obtained, when available, from Cowen and Company, LLC c/o Broadridge Financial Services., 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, Phone: 631-274-2806, Fax: 631-254-7140.
Cytokinetics intends to file a preliminary prospectus supplement relating to the proposed offering with the SEC, which will be available along with the prospectus filed with the SEC in connection with the shelf registration on the SEC’s website at View Source
Onconova Announces Results From Phase 3 ONTIME Trial of Rigosertib in Higher Risk Myelodysplastic Syndromes (MDS)
On February 19, 2014 Onconova announced that the Phase 3 ONTIME trial of intravenous (IV) rigosertib in patients with higher risk myelodysplastic syndromes (MDS) who had progressed on, failed or relapsed after prior therapy with hypomethylating agents (HMAs) did not meet the primary endpoint of overall survival compared to best supportive care (BSC) (Press release Onconova, FEB 19, 2014, View Source [SID:1234500101]). The ONTIME trial enrolled 299 patients including 199 patients in the IV rigosertib plus BSC arm. Median overall survival in the IV rigosertib plus BSC arm was 8.2 months compared to 5.8 months in BSC only arm. Treatment with IV rigosertib plus BSC did not demonstrate a statistically significant improvement in median overall survival when compared to BSC only (Hazard Ratio=0.86; p-value=0.27).
However, a post-hoc analysis demonstrated a statistically significant increase in median overall survival in the subset of patients who had progressed on or failed previous treatment with HMAs (i.e., had not responded to HMAs), thus demonstrating potential activity of rigosertib in these MDS patients. In this subset of patients (184 of 299 enrolled patients), the median overall survival was 8.5 months in the IV rigosertib plus BSC arm compared to 4.7 months in BSC only arm (Hazard Ratio=0.67; p-value=0.022). Among this patient population, 127 patients were in the treatment arm, and 57 patients were in the BSC arm. The other subset which was comprised of patients who had relapsed after responding to previous treatment with HMAs (115 of 299 patients enrolled), did not show a statistically significant survival benefit. Additional analysis is underway to identify potential survival benefit in other subsets of patients.
Preliminary safety analysis indicates that rigosertib was generally well tolerated in the study population. Severe adverse events were uncommon, with a similar profile of serious adverse events in both study arms. Grade 3/4 treatment-related hematologic and non-hematologic adverse events were reported in less than 7% and 3% of patients, respectively. Incidence of all grades of treatment-related nausea, diarrhea, fatigue and constipation were 22%, 17%, 17%, and 15%, respectively. All other treatment-related adverse events were reported in less than 10% of patients. Additional details, including secondary endpoints, will be presented at the 2014 ASCO (Free ASCO Whitepaper) Annual Meeting.
Onconova is working closely with its partners, Baxter and SymBio, as they evaluate the results of this study. It plans to engage with the U.S. Food and Drug Administration (FDA) and European regulatory agencies with the goal of determining the next steps in advancing development of rigosertib for this underserved patient population. It remains committed to advancing rigosertib to address important medical needs in MDS and solid tumors. Ongoing efforts include trials of oral rigosertib in transfusion-dependent lower risk MDS patients, where, after consultation with regulatory agencies, it is planning to initiate a Phase 3 trial as soon as possible.
Human medicines European public assessment report (EPAR): Velcade, bortezomib, Revision: 33, Authorised
Velcade is now also approved in the EU in combination with pegylated liposomal doxorubicin or dexamethasone for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation (External Source EMA , Johnson & Johnson, FEB 19, 2014, View Source [SID:1234500092]).
Lilly Announces Ramucirumab Phase III Lung Cancer Trial Meets Primary Endpoint of Overall Survival
A global Phase III study (REVEL) of ramucirumab in combination with chemotherapy in patients with second-line non-small cell lung cancer (NSCLC), showed a statistically significant improvement in the primary endpoint of overall survival in the ramucirumab-plus-docetaxel arm compared to the control arm of placebo plus docetaxel (Press release Eli Lilly, FEB 19, 2014, View Source [SID:1234500091]). REVEL also showed a statistically significant improvement in progression-free survival in the ramucirumab arm compared to the control arm.
The global, randomized, double-blind REVEL trial compared ramucirumab and docetaxel to placebo and docetaxel in NSCLC patients whose disease has progressed after failure of prior platinum-based chemotherapy for locally advanced or metastatic disease. The study included nonsquamous and squamous NSCLC patients. The most common ( > 5% incidence) Grade > 3 adverse events occurring at a higher rate on the ramucirumab-plus-docetaxel arm compared to the control arm were decreased white blood cell count (neutropenia/leukopenia), febrile neutropenia, fatigue/asthenia and hypertension.
Lilly plans to present data from the REVEL trial at an upcoming scientific meeting and intends to submit the first application of these data to regulatory authorities in 2014.