(Filing, 10-Q, Epizyme, OCT 23, 2013, View Source [SID:1234503840])

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On October 23, 2013 Australian drug development and pharmaceutical company Imugene (ASX:IMU) was pleased to advise that, consistent with its strategy to diversify through acquisition, it has executed a Sale and Purchase Agreement to acquire 100% of Biolife Science Qld Limited (Biolife), a company incorporated in Australia (Press release, Imugene, OCT 23, 2013, View Source [SID:1234509845]).

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Biolife has the rights to a novel cancer immunotherapy platform that has been developed by scientists at the University Medical School in Austria. The scientists have developed a peptide-based immunotherapy that induces a polyclonal antibody response against HER-2/neu associated tumours, including breast cancer and gastric cancer ("HER-Vaxx").

HER-2/neu is a known and validated receptor that is over-expressed on various cancerous tumours, including gastric, breast, ovarian and pancreatic cancers. Having already successfully completed a Phase I human study in breast cancer, a Phase II study in gastric cancer is planned to potentially commence in calendar 2015, subject to FDA approval.

Forrest Capital coordinated the acquisition and will be lead manager for the capital raise.

Key information on the Biolife technology, intellectual property, market potential and previous studies are included in a presentation and Q&A placed on the ASX website at:
View Source

Imugene will, subject to Shareholder approval:

Issue 300 million shares to purchase 100% of Biolife Science Qld Ltd.
Raise an additional A$2.5 million via the placement of 250 million shares at $0.01. The placement will be managed by Forrest Capital, 85 million shares issued within current capacity with the balance subject to shareholder approval.
Dr Axel Hoos current vice president, Oncology R&D at GlaxoSmithKline is expected to join the board as Non-Executive Director.

(Press release, Cleveland BioLabs, OCT 23, 2013, View Source [SID:1234503972])

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The US Food and Drug Administration (FDA) is withdrawing approval of the indication for treatment of patients with relapsed or refractory, low grade, follicular, or transformed CD20 positive non-Hodgkin’s lymphoma who have not received prior rituximab, for BEXXAR (tositumomab and iodine I 131 tositumomab) Injection held by GlaxoSmithKline (Glaxo). Glaxo has voluntarily requested that approval of this indication be withdrawn and has waived its opportunity for a hearing (US FDA, OCT 23, 2013, View Source).

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On October 21, 2013 OXiGENE reported the presentation of data from a preclinical study of ZYBRESTAT (fosbretabulin tromethamine/combretastatin A-4 phosphate or CA4P) demonstrating statistically significant differences between the treatment arm and the control arm in a model of pancreatic neuroendocrine tumors (PNETs). The data were presented at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), Boston, MA, in a poster session on October 20, 2013 (Press release OXiGENE, OCT 21, 2013, View Source [SID:1234500303]).

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The poster, titled "Combretastatin A-4 Phosphate (CA4P) is effective for the treatment of functional pancreatic neuroendocrine tumors (PNETs) in a transgenic mouse model," was presented by ZiQiang Yuan, MD, Research Assistant Professor, Department of Surgery, Albert Einstein College of Medicine. Steven K. Libutti, MD, FACS, Professor of Surgery and Genetics, Albert Einstein College of Medicine, and Montefiore Medical Center, is the senior author.

This preclinical study was designed to evaluate the efficacy of systemic administration of ZYBRESTAT or CA4P for the treatment of functional insulinomas in a transgenic mouse model of PNETs. PNETs are highly vascularized tumors which originate in the pancreas. Functional PNETs make hormones that can cause a cascade of disease symptoms, resulting in significant morbidity for the patient. An insulinoma is a PNET that causes the over-secretion of the hormone insulin.

The treatment group received ZYBRESTAT three times per week for four weeks, and the control group received a placebo. After four weeks, tumor size, serum insulin levels and other efficacy parameters, including apoptosis (cell death), cell proliferation and effects on tumor vasculature, were assessed. Key results were as follows.

Treatment with ZYBRESTAT resulted in a significant and sustained decrease in circulating insulin, with maximum effect seen by day 17 (p < 0.0001).
The reduction in insulin was accompanied by a significantly reduced tumor size in the treated group compared to the placebo group (p=0.0128).
Treatment with ZYBRESTAT was shown to disrupt tumor vasculature, induce apoptosis (cell death) and inhibit tumor cell proliferation.
ZYBRESTAT was shown to be well tolerated, with no obvious toxicity.