Read this below and you will know why this brutally underpriced stock with a market cap of $21 Million has MEGA UPSIDE POTENTIAL .My target is still $8-10 within 12 months if the Phase 3 results are positive .GL
Both Phase 3 passed successfully futility analysis this increases the probability of positive outcome in the final Phase 3 analysis....
from Adherex new Presentation :
COG ACCL0431:Randomized Phase 3 Study of STS for Prevention of Cisplatin-induced Hearing Loss
•Newly diagnosed children with hepatoblastoma, germ cell tumor,osteosarcoma, neuroblastoma, and
medulloblastoma
•Local and metastatic disease
•Study Chair: David Freyer, DO, MS
•135 randomized patients fully enrolled and study completed in 1Q 2012
•Futility analysis reviewed by COG DSMC August 2011 with recommendation to continue study
•Expect data to be presented at ASCO 2Q 2014
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SIOPEL 6: Rand. Phase 3 Study-Efficacy of STS in Reducing Ototoxicity in Hepatoblastoma Patients
•Newly diagnosed children with standard risk hepatoblastoma
•Single localized disease with very high historic survival rates after cisplatin treatment
•Study Chair: Peppy Brock, MD
•95 of 102 randomized patients
•Interim evaluations of efficacy of the chemotherapy reviewed by DMC after
20, 40, 60 and 80 patients are evaluable for response
•The first three (out of four) interim safety analysis after 20, 40 and 60
patients were conducted with DMC recommending study to continue
•Interim data on safety expected to be presented at ASCO Q2 2014
•Early stopping will be considered in case of greater than expected difference
between treatment arms in terms of hearing loss
Upcoming Milestones :
COG ACCL0431 Phase 3 Clinical Data H1 2014
SIOPEL 6 Phase 3 Interim Analysis H1 2014
FDA Clinical Meeting–Agree Data Acceptable for NDA H2 2014
FDA Pre NDA Meeting H2 2014
NDA Submission H1 2015
No approved treatment: Adherex has been developing STS since 2003
•Received Orphan Drug Designation in 2004 with 7.5 years exclusivity upon approval
•Phase 3 trial conducted by Children’s Oncology Group fully enrolled-data on 135 patients
expected to be presented at ASCO Q2 2014
•Phase 3 trial conducted by SIOPEL6 in children with liver cancer 95/102 patients enrolled
with interim safety data expected to be presented at ASCO Q2 2014
•Clinical trial costs covered by government grants
•Adherexhas exclusive rights to data from both studies
Intellectual property: Use-patent as chemo-protectant in-licensed from OHSU
•Issued European and Japanese patents expire 2021, US pending prosecution
STS Commercial opportunity requires minimal post approval investment
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Two late stage oncology clinical products: Sodium Thiosulfate (STS) and
Eniluracil (EU)
–STS:Data from two Phase 3 trials expected to be presented at ASCO in Q2 2014
»pending favorable outcome from both studies-file NDA
–EU: pending partnering discussions-advance to Phase 3
•US based-headquarters in Research Triangle Park, NC
•Ticker: ADHXF–USA, AHX–Toronto
•29.1 MM shares outstanding
•$ 1.7 MM in cash at 12/31/13 no debt
•Large insider ownership with aligned shareholder
incentives
