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November 2005
(v05-n11) |
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- Main Story - YMI Biosciences (YMI)
- pgs. 1-30
- Macro Market Commentary
- pgs. 31-33
- BSR
Coverage Update - pg.
34-45
- Biotech Sector Short Interest Report
- pg. 46
- BSR
Model Portfolio - pg. 47
- (Full outline below...)
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This month's Biotech Monthly
Main Story initiates our coverage in YMI Biosciences (AMEX:YMI) a
Canadian company focused on the treatment of cancer and cancer pain.
Their lead drug, tesmilifene, demonstrated a survival advantage in one
Phase III trial and a second confirmatory trial is fully enrolled with
data pending June 2006. |
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| This Main Story exhaustively
examines tesmilifene, from the trials to the mechanism of action. It
also covers Nimotuzumab, the company's anti-EGFR antibody in which early
trials show efficacy without the rash typical of competitive drugs like
Erbitux. |
Subscriber direct access |
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| The following is an outline of this issue of
Biotech Monthly. |
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- Main Story - YMI Biosciences (AMEX:YMI)
- Introduction
- Table: Company statistics
-
Disclosures
Investment Case
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Multi-drug resistance
- MDR mechanism
- Table: MDR process
- Learned behavior
- Class effect
- Table: Chemotherapies sharing a
common MDR weakness
- Cellular efflux pumps
- P-glycoprotein Pump (PgP)
- The holy grail
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Tesmilifene mechanism of action
- To PgP or not to PgP
- Histamine pathway
- It's about the pumps
- Substrate mechanism
- Synergy, not monotherapy
- PgP or not
- Intercellular transport
- Mechanism summary
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Tesmilifene clinical trials
- Phase II prostate
- Side effects
- Comments
- Phase II breast
- Side effects
- Comments
- MA-19 - Phase III NCIC breast
cancer
- Table: MA-19 Eligibility
- Statistical considerations
- Interim analysis
- Final analysis
- Side effects
- Authors' comments
- Summary
- YMI's analyses of MA-19
- Pivotal Phase III - DEC
- Enrollment criteria
- Table: Geographic location of
enrollment
- Stratification
- Endpoints
- Chosen drugs
- Statistical design
- Table: DEC trial approval
thresholds
- SPA
- What we know so far
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Tesmilifene economics
- Side effects versus survival rate
- Partners
- Patent
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Tesmilifene bottom line
-
Nimotuzumab
- Mechanism
- All about the rash
- Nimo to the rescue
- Recent/ongoing clinical trials
- Table: Recent and ongoing clinical
trials (full page!)
- Planned clinical trials
- Table: Planned clinical trials
(full page!)
- Barriers
- Patents
- Cuba trade ban
- Partners
- Bottom line
- AeroLEF
- Current clinical data
- Phase I
- Phase IIa
- Competition
- Planned trials
- Bottom line
- Table:
Selected YMI Milestones
What can go wrong
- Macro Market Commentary - "Pharma
between a rock and a hard place"
Biotech Monthly Coverage Updates
- Adolor
- Cortex Pharma
- Table: Basic facts for Q3-2005
- Table: CX717 timelines
- Investment case
- Dendreon
- Forbes Medi-Tech
- ID Biomedical
- Indevus
- Introgen
- Medarex
- Nabi Biopharma
- Onyx Pharma
- Oncolytics Biotech
- SciClone
- Table: Data timelines
- Hepatitis C
- Table: Pivotal trials USA
- Table: Retreatment medication SVR%
- Non-responders to peg-interferon +
ribavarin
- Non-responders to peg-interferon
monotherapy
- Triple therapy
- Table: Triple therapy Europe
- What do we think?
- Table: Possible outcomes
- Advanced metastatic melanoma
- Standard therapies for melanoma
- Zadaxin perspectives
- Table: Comparison of melanoma trials
- Final thoughts on melanoma trial
- Hepatocellular carcinoma
- Investment case
- Sonus Pharma
- San Antonio breast data
- SN-2310
- Investment case
- Seattle Genetics
- Targeted Genetics
- ZymoGenetics
- IL-21
- Biotech Sector Short Interest
- Chart: NASDAQ Biotech Index (NBI)
short interest (indexed)
- Chart: NBI short interest as a
percentage of total NASDAQ short interest
- Table: Top 15 NBI short interest as a
percentage of float
BSR Model Portfolio Performance |
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