An analysis from Adam Feuerstein at TheStreetis skeptic on Oxigene’s positive Phase II ovarian cancer data (External Source FierceBiotech, OXiGENE, NOV 12, 2014, View Source;utm_source=internal [SID:1234500966]). A decision on using Avastin for ovarian cancer is looming, but hasn’t arrived yet, complicating any analysis of a combination drug study like this. Avastin, by the way, achieved a solid PFS but not a statistically significant overall survival benefit for ovarian cancer patients, which may not prevent its approval. If Avastin plus chemo becomes the standard of care in this area, then Oxigene will face some big challenges in designing a Phase III trial, notes Feuerstein. If the biotech decides to run a non-inferiority study, it will need a big and expensive patient population to examine. If it tries to beat Avastin/chemo, it faces a very tall order. And if Avastin is rejected, that makes Oxigene’s task even more difficult. Perhaps, suggests Feuerstein, the company should go a different route and try a combination with Votrient.

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Oncoethix, the Swiss-based specialist in oncology drug development, reported that the first patient has been enrolled in an international, open-label, non-randomized, multicenter Phase 1b trial of OTX015 in advanced solid tumors (Press release OncoEthix, NOV 12, 2014, View Source [SID:1234501220]). The trial will be coordinated by Dr Lillian Siu, MD, of the Princess Margaret Hospital, Toronto, Canada, who is Professor of Medicine at the University of Toronto, and Director of the Phase 1 program.

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The trial seeks to enrol up to 98 patients across seven centers in five countries (Belgium, Canada, France, Spain and Switzerland), including the Institut Gustave-Roussy in Paris, where Professor Jean-Charles Soria is the Principal investigator. Three patients have already been enrolled. The trial aims to determine, in a first step, the suitability of five solid tumor indications under investigation (BRD-NUT Midline Carcinoma, Triple Negative Breast Cancer, Non-Small Cell Lung Cancer harbouring a rearrangement ALK gene/fusion protein or KRAS mutation, and Castrate-Resistant Prostate Cancer and Pancreatic Ductal Carcinoma) to be progressed into the Phase 2a part of the trial.

Dr Esteban Cvitkovic, MD, Founder and Chief Scientific Officer, Oncoethix, commented: "This multicenter Phase 1b trial is an important step for OTX015, as it will provide key safety and efficacy data in several solid tumor types, after having characterized its single agent safety and activity profile in the Acute Leukemias and Lymphomas in Phase 1 trial (OTX015_104). The solid tumor indications approach selected for OXT015 is based on compelling data from our own preclinical pharmacology program. We have also initiated a multicentric (France, Switzerland) Phase 2a trial in recurrent glioma."

OTX015 is a novel first-in-class synthetic small molecule inhibitor of BET bromodomain proteins 2/3/4. These proteins are considered potential cancer targets, as they play a pivotal role in regulating the transcription of growth-promoting and cell cycle regulators.

Coordinating investigator Dr Lillian Siu commented: "OTX015 is a promising drug that has shown outstanding early results in hematologic cancer studies and we are delighted to have commenced the solid tumor trial at the Princess Margaret Cancer Centre in Canada."

Bertrand Damour, Chief Executive Officer at Oncoethix, added "We believe that OTX015 has the potential to be an important new drug across a number of advanced solid tumors and the start of the Phase 1b is a key milestone for the Company. We are also ahead of schedule in our hematologic cancer program and will be releasing further data from this program at NCI/EORTC/AACR in November and the American Society of Hematology (ASH) (Free ASH Whitepaper) in December."

On November 11, 2013 Patrys reported that it is initiating an investigator-sponsored trial (IST) evaluating the effectiveness of Patrys’ lead anti-cancer drug PAT-SM6 in combination with carfilzomib, in patients with relapsed and refractory multiple myeloma (MM) (Press release Patrys, NOV 11, 2014, View Source [SID:1234500543]). The trial will be headed by Professor Dr. Hermann Einsele, Director of the Department of Medicine II, University of Würzburg, Germany, and is being funded by Onyx Pharmaceuticals, Inc., an Amgen subsidiary.
Both clinical and preclinical studies of PAT-SM6 conducted to date have shown evidence of activity in patients with relapsed and refractory MM. One of the notable features of PAT-SM6, being demonstrated in the currently-ongoing Phase I/IIa clinical trial, is the lack of serious side-effects in treated patients. This feature of PAT-SM6 may allow it to be safely administered in combination with carfilzomib and may have the potential to improve current treatments for MM. Carfilzomib is a proteasome inhibitor owned by Onyx, and is marketed in the United States (U.S.) under the brand name Kyprolis (carfilzomib) for Injection. Onyx will provide carfilzomib study drug for the trial.

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On November 10, 2014 Eagle Pharmaceuticals reported positive results from a recently-conducted clinical trial of its bendamustine hydrochloride ("HCl") product, in which the dose was delivered in a 50mL admixture in ten minutes (the "rapidly infused product") versus a 500mL admixture in the 60-minute infusion required for Treanda (bendamustine HCl) (Press release Eagle Pharmaceuticals, NOV 10, 2014, View Source [SID:1234500946]).

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In this study, Eagle’s rapidly infused product was found to be bioequivalent to Treanda, which was the primary endpoint of the study. The incidence and profile of adverse events, both infusion-related and general, for the rapidly infused product was comparable to Treanda. This is particularly important because the rapidly infused product delivers the same amount of active ingredient as Treanda but with a lower admixture volume, which enables the Eagle product to be administered more quickly.

Eagle received tentative approval for this formulation in July 2014. The positive data supports that the product can be delivered in this new low-volume infusion.

Eagle received orphan drug designation for its rapidly infused product for chronic lymphocytic leukemia ("CLL") and indolent B-cell non-Hodgkin’s lymphoma ("NHL") on July 2, 2014.

"We are very excited about these results, and intend to file these data with the FDA as soon as possible," said Scott Tarriff, President and Chief Executive Officer. "We look forward to our pre-NDA meeting with the FDA in mid-December.

"We believe the shorter infusion time afforded by the 50mL admixture will greatly benefit cancer patients and healthcare providers alike, and our goal is to bring our rapidly infused product to market as soon as possible," Tarriff concluded.

This open-label, randomized, crossover, Phase I clinical trial was designed to compare bioequivalence of Eagle’s rapidly infused product and Treanda, and to assess the safety and tolerability of the rapidly infused product. The study evaluated 81 patients with a histologically-confirmed diagnosis of solid tumors and hematologic malignancies for which no curative or standard therapy is appropriate.

The treatment phase, pharmacokinetic assessments, infusion-related safety assessments and bioequivalence evaluation are complete in all 81 patients. The overall safety assessment is complete in over 80% of subjects and will conclude on November 17th.

On September 16, 2014, Cephalon, Inc., a wholly-owned subsidiary of Teva Pharmaceutical Industries, Ltd., filed a motion to dismiss all claims against Eagle concerning alleged infringement of U.S. Patent No. 8,445,524. Cephalon recently filed a second lawsuit in the District of Delaware alleging that Eagle’s bendamustine product infringes Cephalon’s newly-issued U.S. Patent No. 8,791,270. That case remains pending.

Eagle also confirmed that the U.S. Patent and Trademark Office ("USPTO") has allowed a patent covering administration of its bendamustine HCl product candidate in a low volume admixture with a shorter infusion time. This is the second patent allowed for this product. Eagle continues to execute its strategy to further strengthen its intellectual property surrounding this and its other products and product candidates.

miRagen’s lead program in hematological malignancy targets miR-155, a microRNA that has key roles in the differentiation, function and proliferation of blood and lymph cells (Company Pipeline miRagen Therapeutics, NOV 10, 2014, View Source [SID:1234500949]).

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