prr investor conference in new york, page-16

Thank you gowie 77,-------------------------------------------Fundamental Research:
Biotechnology
February 23, 2011
Prima BioMed
Ticker:
ASX: PRR
Current Price:
$0.23
Recommendation:-
---BUY---
Time Frame:
12 Months
Jason Kolbert
(212) 417-8287
[email protected]
Source:BigCharts.com
Investment Thesis
Prima BioMed recently received Scientific Advice from European regulators, reaching an agreement between European Medicines Agency (EMA) and the Company on strategy and design of its Phase III study of CVac? as an ovarian cancer immunotherapy treatment. We are encouraged by the positive news and look forward to the Company advancing to the next step, initiating its Phase III in Q3-2013. We did hold an expert call this past Monday with CMO Dr. Neil Frazer and key opinion leader Dr. Jonathan Berek (Stanford Medical Centre, Head of Women?s Cancer Centre). We were impressed with the clinical data seen thus far and the scope and design of the current pivotal trial plans.
Highlights
Scientific Advice: Prima BioMed received Scientific Advice from European regulators reaching an agreement between the EMA and the Company outlining the clinical trial design, study size, endpoints, and other issues addressing the development strategy of CVac immunotherapy therapeutic ovarian cancer vaccine. A Scientific Advice is similar to a Special Protocols Assessment (SPA) agreement between US FDA and a company. This process should ensure that once the trial is complete, and providing it meets the pre-specified endpoints, the product is positioned to be approved. We believe receiving Scientific Advice marks a significant milestone, and lowers trial, regulatory risk. Phase III Clinical Trial is focused on evaluating the efficacy of CVac? in the treatment of Epithelial Ovarian Cancer (EOC) patients as the potential to prolong periods of remission (reduce instance of relapse) following optimal debulking surgery and first-line chemotherapy. The randomized, double-blind, placebo-controlled study is likely to enroll n=750 ovarian cancer patients across multiple sites in Europe, Australia, and the United States. Similar to its Phase 2b trial, efficacy will be assessed using immune-related progression free survival (irPFS) as a primary endpoint and overall survival (OS) as a secondary endpoint. However, it is important to note that the trial is statistically powered to see a difference between treatment and placebo arms. Additional objectives are assessing safety and tolerability as well as quality of life (QoL). We anticipate study recruitment to begin in mid-2011 and to have all patients enrolled by year end 2012. We expect interim data by year end 2012 or 1Q-2013 giving us insight on the progression of the study.
CVac immunotherapy is an autologous dendritic cell-based cancer therapy based on the same technology as Dendreon?s Provenge. The approval of Provenge for asymptomatic or minimally symptomatic metastatic, hormone-refractory prostate cancer, validates the underlying concept. Like Provenge,, CVac? utilizes activated dendritic cells to stimulate a cellular immune response rather than just an antibody response, which we believe is a key differentiating element resulting in a greater likelihood of success. As CVac? advances through its pivotal trial, the Company will likely gain greater visibility among investors. With success, the upside could be enormous: Dendreon has a market capitalization close to $5 billion following approval of Provenge, approximately 30x greater than Prima BioMed.
Value Drivers for Prima Ahead: Stay tuned for (1) recruitment of the first patient in Q3-2011, (2) full study enrollment by 2012, (3) interim data analysis between Q4-2012 to Q1-2013, (4) final data analysis between Q4-2013 and Q1-2014