On September 3, 2014 Adherex Technologies Inc. (TSX: AHX; OTC: ADHXF) (the "Company") reported that it gave effect to the consolidation of its outstanding share capital on the basis of one new security for every three outstanding securities (the "Consolidation") (Press release, Fennec Pharmaceuticals, SEP 3, 2014, View Source [SID:1234510425]). In addition, the Company filed a Notice of Alteration with the British Columbia Registrar of Companies changing the name of the Company from Adherex Technologies Inc. to Fennec Pharmaceuticals Inc. to better reflect its current business focus and activities (the "Name Change"). The Company’s Common Shares post-Consolidation will trade on the TSX Exchange under a new trading symbol: FRX.

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The Consolidation will reduce the number the Company’s outstanding common shares (the "Common Shares") from approximately 29.6 million (as last reported in the Company’s most recent Quarterly Report on Form 10-Q), to approximately 9.9 million. Furthermore, as a result of the Consolidation, Adherex’s outstanding common share purchase warrants will be exercisable as follows: (i) with respect to the warrants issued by the Company on or about April 30, 2010 and March 29, 2011 and not tendered as part of the warrant exchange completed on July 29, 2014 (the "Warrant Exchange"), each 54 warrants will entitle the holder to purchase one Common Share at an exercise price of CAD$4.32, (ii) with respect to the warrants that were exchanged in connection with the Warrant Exchange, each three warrants will entitle the holder to purchase one Common Share at an exercise price of USD$1.50, and (iii) with respect to the warrants issued on November 22, 2013, each three warrants will entitle the holder to purchase one Common Share at an exercise price of USD$1.50.

All materials necessary to effect the Consolidation and the Name Change are expected be filed with the Toronto Stock Exchange (the "TSX") today and, subject to TSX approval, it is expected that the Common Shares will commence trading on the TSX under the new name and "FRX" trading symbol, as well as on a Consolidated basis on or about September 5, 2014. Letters of transmittal providing for the exchange of certificates representing pre-Consolidation Common Shares for certificates representing post-Consolidation Common Shares were mailed to registered shareholders today. Any pre-Consolidation Common Shares owned by beneficial holders and any outstanding warrants will automatically be adjusted as a result of the Consolidation and the Name Change and no further action is required to be taken by such shareholders or warrantholders.

(Press release, Intensity Therapeutics, SEP 2, 2014, View Source [SID:1234503396])

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On September 2, 2014 VentiRx Pharmaceuticals reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the investigation of motolimod (VTX-2337) when administered in combination with pegylated liposomal doxorubicin (PLD) for the treatment of women with ovarian cancer whose disease has progressed on or recurred after platinum-based chemotherapy (Press release VentiRx Pharmaceuticals, SEP 2, 2014, View Source [SID:1234500744]).

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Motolimid is a novel TLR8 immunotherapy currently being evaluated in two randomized, placebo-controlled Phase 2 trials.
FDA Fast Track Designation is designed to facilitate frequent interactions with the FDA review team to expedite clinical development and submission of a New Drug Application (NDA) for drugs with the potential to treat serious or life-threatening conditions and address unmet medical needs.

"The Fast Track designation is an important regulatory milestone for the motolimod (VTX-2337) program and underscores the potential for this novel agent to address a significant unmet medical need for women with ovarian cancer who have progressed on or recurred after receiving platinum-based chemotherapy," said Robert Hershberg, MD, PhD, President and CEO of VentiRx. "We look forward to emerging clinical data and to the possibility of providing a meaningful treatment for women with ovarian cancer."

VentiRx has completed enrollment of over 290 patients in the GOG-3003 randomized, placebo-controlled Phase 2 trial of motolimod in combination with PLD in patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal cancer who have failed prior platinum-based chemotherapy. The study is being performed in collaboration with the Gynecologic Oncology Group (GOG) Partners Program. The primary endpoint of the study is overall survival. In April 2014, the FDA granted Orphan Drug designation to motolimod (VTX-2337) for the treatment of ovarian cancer.

1. 4-[2((1R,2R)-2-Hydroxycyclohexylamino)-benzothiazol-6-yloxyl]-pyridine-2-carboxylic acid methylamide (BLZ945) is a small molecule inhibitor of CSF-1R kinase activity within osteoclasts designed to prevent skeletal related events in metastatic disease. Key metabolites were enzymatically and structurally characterized to understand the metabolic fate of BLZ945 and pharmacological implications. The relative intrinsic clearances for metabolites were derived from in vitro studies using human hepatocytes, microsomes and phenotyped with recombinant P450 enzymes. 2. Formation of a pharmacologically active metabolite (M9) was observed in human hepatocytes. The M9 metabolite is a structural isomer (diastereomer) of BLZ945 and is about 4-fold less potent. This isomer was enzymatically formed via P450 oxidation of the BLZ945 hydroxyl group, followed by aldo-keto reduction to the alcohol (M9). 3. Two reaction phenotyping approaches based on fractional clearances were applied to BLZ945 using hepatocytes and liver microsomes. The fraction metabolized (fm) or contribution ratio was determined for each metabolic reaction type (oxidation, glucuronidation or isomerization) as well as for each metabolite. The results quantitatively illustrate contribution ratios of the involved enzymes and pathways, e.g. the isomerization to metabolite M9 accounted for 24% intrinsic clearance in human hepatocytes. In summary, contribution ratios for the Phase I and Phase II pathways can be determined in hepatocytes.

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On September 1, 2014 Ipsen reported that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review of its supplemental New Drug Application (sNDA) for Somatuline Depot 120mg injection in the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) (Press release Ipsen, SEP 1, 2014, View Source [SID:1234500724]). The FDA designates priority review status to drug candidates that have the potential to offer a significant improvement in treatment compared to currently approved options. Decision is expected in early Q1, 2015.

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In the European Union, the dossier of the national marketing authorization (MA) variations for Somatuline Autogel 120mg injection has been validated by all national 25 drug regulatory authorities. The first decisions are expected by Q2 2015.

The regulatory submissions and variations were supported by the results of the CLARINET Phase III study, which demonstrated the antitumor effect of Somatuline in the treatment of patients with GEP-NETs, and which was recently published in the July 17th issue of The New England Journal of Medicine.

Marc de Garidel, Chairman and Chief Executive Officer of Ipsen stated: "We are pleased that the US and European regulatory authorities have accepted the filing for Somatuline in the treatment of GEP-NETs and that the dossier in the US has been granted priority review. We are excited about the potential benefits Somatuline could bring to patients suffering from this debilitating disease".

The data from CLARINET is purely investigational, as Somatuline is not authorized for the indication of treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in any market. In many countries where it is marketed as Somatuline Autogel, Somatuline is approved for treatment of acromegaly and for the symptoms associated with neuroendocrine tumors, which can include the treatment of GEP-NET patients experiencing symptoms from carcinoid syndrome, and Somatuline is approved in many countries for the treatment of acromegaly. Somatuline Depot is approved in the US for the treatment of acromegaly but not for the treatment of GEP-NETs or the symptoms thereof.