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"In recent months, we have secured additional funding of Cdn $23.1million, finalized our drug formulation and held a key meeting with the FDA todiscuss our proposed multi-center Phase III trial for Neuradiab as a therapyfor primary glioblastoma multiforme," said Dr. Alan M. Ezrin, President andChief Executive Officer of Bradmer. "The trial design that we submitted to theU.S. Food and Drug Administration (FDA) will provide the definitive answer onthe therapeutic potential of Neuradiab for the treatment of glioblastomamultiforme and the reproducibility of the proof of concept data stemming fromprevious studies in approximately 200 patients conducted at Duke University.Our next step in the preparation for the trial is to present Bradmer'schemistry, manufacturing and controls (CMC) update to the FDA for their reviewand to meet with them for further guidance later this quarter. Following thecompletion of this meeting and subsequent update of the regulatory documentsto the FDA we look forward to receiving the necessary regulatory approvals andto initiating the Phase III trial early in 2008."
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Operational Highlights and Outlook
During the three-month period ended September 30, 2007, the Companycompleted and submitted to the FDA the trial protocol for the proposedmulti-center Phase III trial of its lead drug, Neuradiab. Based upon thissubmission and a subsequent meeting the Company held with the FDA, the FDAconcurred with Bradmer's proposed design of the Phase III trial for Neuradiab.The proposed trial is a randomized two arm multi-center study targeting 380patients in each arm comparing the current standard of care for primaryglioblastoma multiforme (GBM) with a group receiving Neuradiab as an adjunctto the current standard of care. Bradmer has received indications of interestfrom more than 30 GBM treatment centers in the U.S., which historically havetreated the majority of the annual GBM cases in the U.S., for participation inthe proposed trial.
The Company has completed formulation development work for Neuradiab andhas initiated the final validation phase of the manufacturing process for thedrug. The data produced from this final manufacturing phase will comprise thelast component of Bradmer's manufacturing data submission to the FDA and willbe the subject of a guidance meeting scheduled during the fourth quarter of2007. Prior to initiating the trial, the Company must submit a complete updateto the existing investigational new drug (IND) application. Approval of thePhase III Neuradiab protocol in newly diagnosed GBM patients has been receivedfrom a centralized institutional review board (IRB). With the concurrence ofthe FDA and a central IRB regarding trial design, clinical trial sitecontracting has been initiated.
Financial Highlights
Amounts in US Dollars, unless specified otherwise, and results expressedin accordance with Canadian Generally Accepted Accounting Principles (CanadianGAAP).
For the three-month period ended September 30, 2007, Bradmer recorded anet loss of $2,284,000, or $0.17 per common share, compared with a net loss of$457,000 or $0.06 per common share for the three-month period ended September30, 2006. For the nine-month period ended September 30, 2007, Bradmer recordeda net loss of $5,919,000, or $0.60 per common share compared with a net lossof $1,746,000 or $0.22 per common share for the nine-month period endedSeptember 30, 2006. The increased losses during the 2007 periods wereprimarily related to higher planned research and development spending on theCompany's lead clinical program, Neuradiab.
Research and development expenses for the three-m
