Item 8.01. Other Events.
We are filing the following information with the Securities and Exchange
Commission for the purpose of updating certain aspects of our publicly disclosed
description of our business, as set forth below.
Our Product Pipeline
The chart below summarizes our current product candidates and their stages of
development.
Product Candidate Phase of Indication Estimated Upcoming
Development Milestone
HyperAcute Immunotherapy Technology
HyperAcute Phase 3 IMPRESS Adjuvant to Mid-2013: 1st
Pancreas standard?of?care in interim analysis
algenpantucel-L surgically?resected (if necessary,
pancreatic cancer followed by a 2nd
interim analysis 6
to 8 months later)
2013: Complete
enrollment
HyperAcute Phase 3 Locally Advanced Late 2014/Early
Pancreas Pancreatic Cancer 2015: Complete
algenpantucel-L (LAPC) enrollment
HyperAcute Lung Phase 2B/3 Advanced Non-Small Trial initiated in
tergenpumatucel-L Cell Lung Cancer 2012
(NSCLC)
HyperAcute Phase 2: Advanced melanoma 2nd half 2013:
Melanoma Multiple Launch Phase 2B
studies being study
planned
HyperAcute Renal IND/Regulatory Renal cell cancer 2nd half 2013:
in process Launch Phase 1
clinical trial
IDO Pathway Inhibitor Technology
Indoximod Phase 1B/2 (1) 2nd-line metastatic Mid 2013: Update
solid tumors in data
combination with p53
adenovirus
Phase 1B/2 (1) 2nd-line metastatic Mid 2013: Update
solid tumors in data
combination with
Taxotere
ProvengeŽ Phase 2 Advanced prostate 2014: Complete
Indoximod cancer enrollment
Docetaxel Phase 2 Metastatic breast 2013: Update
Indoximod cancer enrollment plans
HyperAcute Phase 2B To be determined 2nd half 2013:
immunotherapy plus Disclose plan
Indoximod details
NLG-919 IDO Phase 1 2nd line metastatic 2nd half 2013:
Pathway Inhibitor solid tumors Launch study
Candidate
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(1) Co-sponsored by the National Cancer Institute
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