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Transcript of Pain Program Overview
Benitec Ltd
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Benitec’s ddRNAi Chronic Pain Opportunity
Non-Confidential Presentation
Benitec Ltd
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This presentation contains forward looking statements that involve risks and uncertainties. Although we believe that the expectations reflected in the forward looking statements are reasonable at this time, Benitec can give no assurance that these expectations will prove to be correct. Actual results could differ materially from those anticipated. Reasons may include risks associated with drug development and manufacture, risks inherent in the regulatory processes, delays in clinical trials, risks associated with patent protection, future capital needs or other general risks or factors.
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Table of Contents
ddRNAi Technology Investment Thesis 4
Benitec Corporate Overview 5
Overview of the ddRNAi Technology 7
Cancer Pain Market Overview 9
The ddRNAi Neuropathic Pain Target 13
Preclinical Cancer Pain Data 15
KOL Reaction to Cancer Pain Product 17
Additional Indications for the Lead ddRNAi Product 20
Cancer Pain Product Development Plan 22
Investment Opportunity Summary 24
Contact Information 25
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ddRNAi Technology
Investment Thesis
DNA-directed RNA interference (ddRNAi) is a novel technology platform capable of achieving long-term targeted gene silencing.
Benitec’s pain product utilizes the ddRNAi technology to treat neuropathic pain in patients suffering from cancer and to overcome morphine tolerance in chronic pain sufferers.
Currently available treatments for cancer pain are largely opioids that do not effectively treat neuropathic pain, creating significant need for a product with a novel mechanism of action.
An accelerated approval pathway is expected for the lead product given the high-risk patient population.
Interviewed Key Opinion Leaders have uniformly expressed enthusiasm for the product based on its novel mechanism of action and potential for long-term pain inhibition.
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Benitec Corporate Overview
Based in Sydney, Australia, Benitec is a biopharmaceutical company developing a novel
DNA-directed RNA interference (ddRNAi) platform for therapeutic use. The company
is listed on the Australian stock exchange (ASX: BLT) with a market cap of ~AU$25M
and AU$7M cash at hand.
The novel, proprietary ddRNAi platform is currently being developed across multiple
therapeutic areas where there is a significant unmet need including oncology,
neuropathic pain, and hepatitis.
Benitec has a strong management team with deep scientific and clinical resources
and extensive experience with the commercialization of biological intellectual property.
The lead product in development internally at Benitec is targeted to terminal patients
with cancer for the treatment of neuropathic pain and has the potential for
commercialization other painful conditions. Benitec also has in-house programs in lung
cancer and hepatitis B, and a partnered program in hepatitis C.
Business Overview
Business Strategy
Management Team
Product Strategy
Benitec has a robust patent portfolio protecting their platform technology across the
major pharmaceutical markets with patent coverage extending through 2030. Intellectual Property
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Benitec Senior Leadership Team
CEO
Peter French, PhD
Cell and molecular biologist with an MBA in
Technology Management. Founder of stem cell
storage company Cryosite Ltd, launched six
new probiotic-based products with Probiomics.
CFO, Company Secretary
Greg West
Chartered Accountant, Director and audit
committee chairman of ITC Ltd, IDP
Education Pty Ltd, Education Australia Ltd,
and Sydney International Film School Pty Ltd.
Board of Directors
Peter Francis LLB Grad Dip
(Intellectual Property) Non-
executive Chairman
Partner at Francis Abourizk
Lightowlers (FAL), a legal
specialist in the areas of
intellectual property and licensing
and provides legal advice to a
large number of corporations and
research bodies.
Mel Bridges BAppSc FAICD
Non-executive Director
More than 30 years experience
in the global biotechnology and
healthcare industry. During this
period, he founded and
managed successful
diagnostics, biotechnology and
medical device businesses.
John Chiplin PhD
Non-executive Director
His most recent accomplishment
was the corporate reengineering
of Arana Therapeutics, a world
leading Antibody developer,
which resulted in the acquisition
of the company by Cephalon for
a significant premium to market.
Iain Ross BSc ChD
Non-executive Director
Over 30 years experience in the
international life sciences sector.
Following a career with Sandoz,
Fisons, Hoffman La Roche, and
Celltech he has undertaken and
had input to a number of
company turnarounds and
start‐ups
Benitec’s management team has demonstrated experience and expertise in developing and licensing novel
therapeutic technology.
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Benitec’s Novel
RNA Interference Technology
ddRNAi Mechanism of Action Benitec technology
ddRNAi DNA construct
Sources: Zou W et al., Intrathecal Lentiviral-Mediated RNA Interference Targeting PKCγ Attenuates Chronic Constriction Injury–Induced Neuropathic Pain in Rats. Human Gene Therapy. 22:465–475 (April 2011)
Benitec’s ddRNAi technology platform utilizes a self-inactivating lentiviral vector to express shRNA molecules
which silence a targeted gene of interest.
The ddRNAi-based product consists of a third-generation
vesicular stomatitis virus G (VSV-G) pseudotyped self-
inactivating lentiviral vector containing a novel gene
construct.
The construct expresses a short hairpin RNA (shRNA)
molecule intended to silence the selected gene of
interest.
The expressed shRNA integrates into the host’s native
RNAi process where it is separated into single strands
and binds to the target mRNA.
– This results in cleavage of the target RNA and
silencing of the gene of interest.
ddRNAi Mechanism of Action
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Benitec’s novel ddRNAi technology allows for long-term
gene silencing.
The technology can be targeted to silence a specific
gene or multiple selected genes.
Unlike current treatments for pain, this product is long-
lasting and has the potential to cause only minimal side
effects.
The ddRNAi product is injected intrathecally into the
spinal canal where it transfects the PKCγ-containing
interneurons.
ddRNAi Technology For
Cancer Pain Treatment
Utilizing the ddRNAi platform, Benitec has developed their gene silencing technology for the treatment of pain
in terminal cancer patients.
Brain
Spinal Cord
Benitec Technology
ddRNAi DNA construct
+ Intrathecal injection of
ddRNAi DNA construct
Source: http://www.nlm.nih.gov/medlineplus/ency/imagepages/19621.htm
A ddRNAi Construct for Treating Cancer Pain The ddRNAi Platform Technology
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Cancer-Associated Pain Market
The global incidence of cancer is expected to experience a slow and steady rise driven by population growth
and increasing lifespan. More than half of all cancer patients experience some form of pain.
There are approximately 11.7 million people in the US
with cancer.
Among newly diagnosed cancer patients, 38%
experience pain.
About 74% of cancer patients with advanced disease
experience some form of pain, with estimates ranging as
high as 82%.
Among the cancer patient population who experience
pain, 30% suffer from breakthrough pain, an acute and
oftentimes extremely painful flair of pain that “breaks
through” chronic pain analgesia.
Global Incidence of Cancer-Associated
Pain Among Cancer Patients
Sources: Cowen Therapeutic Categories Outlook – Pain Management, March 20, 2011; Hearn J, Higginson IJ. Cancer Pain epidemiology: a systematic review. In Bruera ED, Portenoy RK, eds. Cancer Pain Assessment and Management. UK: Cambridge University Press; 2003; Vuorenin E. Pain as an early symptom in cancer. Clin J Pain 9(4):272-8, 1993; Ger LP et al., The prevalence and severity of cancer pain: a study of newly diagnosed cancer patients in Taiwan. J Pain Symptom Manage 15(5):285-93, 1998; Datamonitor. Cancer Pain. December 2009; http://www.cancer.org/cancer/cancerbasics/cancer-prevalence. US National Cancer Institute's Surveillance Epidemiology and End Results (SEER) database. 2007.
65%
Approximately 65% of all cancer
patients experience pain
Cancer Pain Incidence and Prevalence
Experience
Cancer-Related Pain
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Current Treatments for Cancer Pain
Opioids are the most commonly used therapy for pain,
but they are generally not helpful for neuropathic pain.
Commonly used opioids include:
– Morphine, hydrocodone, oxycodone, codeine, and
fentanyl
Opioids are often associated with side effects that
include:
– Constipation, confusion, insomnia, delirium, anxiety,
nausea, vomiting, sleep apnea, and interference with
gonadotropins
Even with the addition of adjuvant treatments such as
anti-convulsants, KOLs stated that the majority of
patients do not have their neuropathic pain significantly
relieved.
Opioids are the first line of therapy for cancer pain, but their efficacy is often insufficient and their side effects
can be severe.
EU Palliative Care Perspective
Treatment Algorithm for Severe
Cancer Pain
Try other options from above groups. Also consider spinal administration of local anesthetics, alpha-2
agonists, nerve blocks, and spinal cord stimulation.
NSAID Opioid Opioid
Combination
Adjuvant:
Antidepressant
Anticonvulsant
Change to a
different drug
of the same
class
Change to a
drug of a
different class
Inadequate response
Inadequate response
Change to a
different route of
administration
“It could be argued that we shorten lives of many patients by
giving them increasing doses of strong opioids.”
—Palliative Care Specialist
Sources: Datamonitor. Cancer Pain. December 2009; Results of nine KOL interviews conducted by Campbell Alliance in July and August 2011.
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Unmet Needs in Cancer Pain
A significant need exists for a therapy capable of treating the complex neuropathic pain often experienced by
cancer patients.
Unmet Needs in Cancer Pain
Neuropathic pain was universally regarded by KOLs as
the most difficult type of pain to treat with currently
available therapies.
A reduction in the many side effects caused by opioids
was stated by many KOLs to be the greatest unmet
need.
The worsening of sleep apnea and interference with
gonadotropins are major concerns associated with the
high-dosage opioids used for cancer pain.
Source: Results of nine KOL interviews conducted by Campbell Alliance in July and August 2011.
“There’s always some issue related to their opioids. There’s
always something in terms of side effects.”
—Palliative Care Specialist
“We have a lot of drugs available, but unfortunately even
when you combine three or four drugs there is a group of
patients that you can only marginally help.”
—Palliative Care Specialist
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Patient Population Potentially Treated with ddRNAi Technology for Cancer Pain
Cancer Pain
Market Opportunity
0
10
20
30
40
50
60
70
80
Nu
mb
er
of
Ref
ract
ory
Te
rmin
al
Can
cer
Pai
n P
atie
nts
(Th
ou
san
ds)
ddRNAi Product Other Invasive Products
The cancer pain ddRNAi product may be used in up to 65% of cancer patients receiving invasive pain
therapy, and significant potential exists to expand into the larger cancer pain patient population.
Source: Results of nine KOL interviews conducted by Campbell Alliance in July and August 2011; Campbell Alliance analysis.
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ddRNAi Neuropathic Pain Target
Benitec has identified PKCγ as a unique target to address the unmet need in cancer pain. PKCγ has been
shown to play a major role in the transmission of neuropathic pain.
PKCγ in Pain Transmission
The PKC superfamily consists of a set of enzymes that phosphorylate serine and threonine amino
acids. The PKC enzymes are involved in cellular processes ranging from proliferation to memory.
PKCγ is a member of the PKC superfamily found mostly in the brain and spinal cord. PKCγ has
been implicated in the transmission of neuropathic pain.
Activation of PKCγ in the spinal cord is involved in persistent pain states, especially in
neuropathic pain after nerve injury.
The restricted spinal cord location of the PKCγ-containing interneurons allows a selective inhibitor
to inhibit nerve injury-induced neuropathic pain without the side effects of nonselective PKC
inhibitors.
Additional gene targets can be incorporated into the DNA construct to allow for
more robust pain inhibition.
– Additional identified targets include D-Amino acid oxidase (DAO) and nerve growth
factors.
Sources: Zou W et al., Intrathecal Lentiviral-Mediated RNA Interference Targeting PKCγ Attenuates Chronic Constriction Injury–Induced Neuropathic Pain in Rats. Human Gene Therapy. 22:465–475 (April 2011). Mellor H and Parker PJ, The extended protein kinase C superfamily. Biochem J. 1998 Jun 1;332 ( Pt 2):281-92. http://www.nlm.nih.gov/medlineplus/ency/imagepages/19621.htm
Brain
Spinal Cord
PKCγ Localization
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Key Opinion Leader Validation of the
Neuropathic Pain Target
KOLs reacted favorably to the mechanism of action because of the strong connection between PKCγ and
neuropathic pain.
PKCγ Target for Silencing
There was a very positive reception of PKCγ as a
target for the treatment of pain.
KOLs familiar with the role of PKCγ in neuropathic pain
expressed strong optimism regarding the potential to
alleviate neuropathic pain by silencing PKCγ
expression.
It was noted that PKCγ makes a lot of sense for
preventing allodynia, defined as pain due to a stimulus
which does not normally provoke pain, which is a
common problem in patients with sever cancer pain.
KOLs also saw potential for the target to help with
opioid tolerance due to the relevant biochemical
cascade being similar to that of neuropathic pain.
Source: Results of nine KOL interviews conducted by Campbell Alliance in July and August 2011.
“Noting the mechanism of neuropathic pain and the cascade
of evidence associated with the activation of kinases, this
product seems to be good, especially in neuropathic pain
but also in opioid tolerance.”
—Palliative Care Specialist
“The type of cancer pain with nerve compression is the
hardest to treat, I would guess PKCγ would be
better…PKCγ is involved in the development of allodynia,
so blocking it makes sense”
—KOL in Pain Research
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ddRNAi Cancer Pain Product
Preclinical Studies
Sources: Zou W et al., Intrathecal Lentiviral-Mediated RNA Interference Targeting PKCγ Attenuates Chronic Constriction Injury–Induced Neuropathic Pain in Rats. Human Gene Therapy. 22:465–475 (April 2011). http://charliewilliamssustainability.blogspot.com/2010/10/blog-post.html. Accessed October 2011.
Preclinical studies have been conducted to determine the efficacy of PKCγ-targeted ddRNAi on pain
inhibition.
Study Design
Lentiviral vectors encoding a specially designed shRNA against the PKCγ gene (shPKCγ)
were introduced into neurons and spinal cord of rats via intrathecal catheter.
Pain threshold testing was performed using tests for mechanical and thermal pain.
– Mechanical pain was assessed by measuring paw mechanical withdrawal thresholds
(PMWT) in response to pressure from an electronic von Frey anesthesiometer (N=8).
– Thermal pain was assessed by measuring the paw withdrawal thermal latency (PWTL)
upon application of a heat source aimed at the mid-plantar area (N=8).
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ddRNAi Cancer Pain Product
Preclinical Studies—Results
PKCγ-Mediated Pain Inhibition in Rats
Sources: Zou W et al., Intrathecal Lentiviral-Mediated RNA Interference Targeting PKCγ Attenuates Chronic Constriction Injury–Induced Neuropathic Pain in Rats. Human Gene Therapy. 22:465–475 (April 2011)
Time after intrathecal delivery (days)
Time after intrathecal delivery (days)
Mec
han
ical
Wit
hd
raw
al T
hre
sho
ld (
g)
Paw
Wit
hd
raw
al L
aten
cy (
sec)
Sham Saline
Control Vector shPKCγ1 (10μl)
shPKCγ2 (10μl) shPKCγ1 (5μl) shPKCγ2 (5μl)
Sham Saline Control Vector shPKCγ1 (10μl)
shPKCγ2 (10μl)
shPKCγ1 (5μl) shPKCγ2 (5μl)
*p<0.05 vs. sham or saline group
A
B
These preliminary animal studies demonstrate the ability of PKCγ-targeted ddRNAi to achieve pain inhibition
for at least six weeks post injection.
Results
Animals showed a significant increase in pain
threshold to mechanical (A) and thermal (B)
stimulation.
The increase in pain threshold was dose-dependent
and lasted for the duration of monitoring.
No toxicity was observed in any animals for six
weeks following injection of vectors.
– Rats had normal appearance, levels of activity,
and feeding patterns.
Effi
cacy
To
xici
ty
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Key Opinion Leader Assessment of
the ddRNAi Cancer Pain Product
0
1
2
3
4
5
6
7
Overall Opinion of the ddRNAi Product
US KOL EU KOL
KOLs consistently viewed the product favorably due to its
unique mechanism of action and potential for minimal
toxicity.
No other current pipeline products were viewed with
consistent optimism and a product with a new mechanism
of action was said to be sorely needed.
The potential for the product to treat neuropathic pain
was seen as especially beneficial, as current treatments
are severely lacking for this type of pain.
The product may be particularly useful for patients with
significant opioid tolerance for whom adjuvants are
ineffective.
Question: On a scale of 1 to 7 (1=Very low, 7=Very high) how would you rate this product based on the product profile?
Average: 6.4
n = 5 out of 9
Source: Results of nine KOL interviews conducted by Campbell Alliance in July and August 2011.
“This product sounds exciting, if you can turn off the protein
that is being produced that is turning the cell on or basically
sensitizing it, you know it has so much more potential, not only
for cancer pain but other types of neuropathic pain, even for
opioid-induced hyperalgesia.” —KOL in Pain Research
“No one med is overwhelmingly efficacious for neuropathic
pain. In studies it’s about 30% of the time that you’re going to
target that pain effectively. It’s usually polypharmacy,
which also is a challenge.” —Palliative Care Specialist
Overall Product Perception
Potential to Fulfill Unmet Needs
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Potential Lead Indication for the
ddRNAi Pain Product
KOLs saw terminal cancer patients as an ideal lead indication for the ddRNAi product due to the level of
novelty of the product and the length of trials required for an indication in this patient segment.
KOLs see strong potential for the ddRNAi cancer pain
product to be used in terminal patients suffering from all
types of cancer.
Tumor types with a high degree of neuropathic pain
were noted to include pancreatic, lung, breast, ovarian,
and head & neck.
KOLs expect the ddRNAi cancer pain product to be
used before other invasive therapies such as nerve
blocks, opioid catheters, and spinal cord stimulation.
“Terminal cancer patients are a good group to target…it’s a
group that the FDA will allow you to go after relatively
easily.” —KOL in Pain Research
“Virtually all cancer patients at some time in their disease
experience neuropathic pain. It’s more common in terminal
patients…performance and pain are intertwined, this
may make a huge impact on life expectancy.”
—Palliative Care Specialist
Terminal Cancer Patients
Source: Results of nine KOL interviews conducted by Campbell Alliance in July and August 2011.
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Potential Product Adoption in
Cancer Pain
KOLs anticipate physician adoption to be initially concentrated on patients with tumor types that either are
associated with neuropathic pain or have a high number of terminal patients.
Tumor Type Rationale Number of
Annual Deaths (US & EU)
Breast High prevalence, chronic neuropathic pain common following surgery
86,000
Lung High prevalence, likely to metastasize near neural structures
290,000
Pancreatic Severe pain with high degree of neuropathic qualities, difficult to treat
82,000
Cervical Complications with nerves, significant visceral pain
9,000
Head and Neck High degree of pain with complex pain symptoms
17,000
Lymphoma High degree of neuropathic pain common with paraspinal involvement
45,000
Colon High prevalence 108,000
Prostate High prevalence, likely to cause bone metastases that are difficult to treat
74,000
Ovarian High degree of difficult to treat pain, likely to receive intrathecal pumps
34,000
Esophageal High degree of pain 32,000
“I would use this in patients with neuropathic pain and in
patients who are receiving increasing doses of opioids, just
to minimize the escalation of opioids. So not only
neuropathic pain in my opinion.”
—Palliative Care Specialist
“Any kind of tumor may produce neuropathic pain because
of the growth of the mass.”
—Palliative Care Specialist
“I would definitely use this. It’s something I could offer easily
and for some of these patients that are so severe this would
be easier and less severe than some of the neurolytic
blocks…any tumor type with spinal metastasis would
be a good candidate.”
—Palliative Care Specialist
Source: Results of nine KOL interviews conducted by Campbell Alliance in July and August 2011. American Cancer Society. Cancer Facts and Figures 2011. Available at http://www.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-029771.pdf. Accessed August 2011.
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Potential Additional Indications for
the ddRNAi Pain Product
KOLs anticipate the ddRNAi product to have use treating pain in all types of cancer patients as well as
patients suffering from conditions such as diabetic neuropathy, postherpetic neuralgia, and HIV/AIDS.
Source: Results of nine KOL interviews conducted by Campbell Alliance in July and August 2011.
Additional Indications
Following the initial indication of terminal cancer pain,
physicians indicated the product could fill a significant
unmet need in non-terminal patients also suffering
from cancer-related pain, especially those whose pain is
opioid refractory.
Approval in non-terminal cancer patients may drive the
use of the product in the medical oncology setting.
There is also a high unmet medical need in treating
patients for post-herpetic neuralgia (shingles), and
this patient segment is often also treated by palliative
care physicians. Physicians interviewed indicated that
this indication would be a logical next step in the product
life cycle.
KOLs noted that the ddRNAi product also has potential
to meet significant unmet needs in patients with pain
caused by diabetic neuropathy, chemotherapy-
induced neuropathy, and HIV/AIDs.
“Patients having chemotherapy can have an activation of
herpes. It’s devastating, it changes their life more than
cancer. There is no treatment that is effective so I’m sure
the patients would be willing to try this. They have
neuropathic pain; it’s very bad.” —Palliative Care Specialist
“HIV patients often have neuropathic pain, and it can be
chronic pain. This product has the potential to reduce pain
for a long period of time, and the patient is taking drugs
day in and day out for their condition.”
—Palliative Care Specialist
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Potential Additional Indications for
the ddRNAi Pain Product
Recent research has shown that silencing of the PKCg gene also significantly reduces morphine tolerance in
a pre-clinical pain model.
Addressing Morphine Tolerance
Morphine is among the most prescribed opioid pain
relievers for severe chronic pain.
Morphine tolerance is a major clinical hurdle due to the
progressive decline of dose potency occurring after a few
weeks of treatment.
Tolerance is countered by administration of increasing
dosage, increasing the side effects of morphine therapy, or
selecting another pain suppressant in opioid rotation trails.
Research demonstrated successful reduction of morphine
tolerance using the same ddRNAi construct that is
shown to be effective in overcoming neuropathic pain.
These finding broaden the areas of application of the
technology Benitec is developing, increasing morphine
treatment efficiency in a large of chronic pain patients
besides those suffering from cancer related neuropathic
pain.
Source: Z. Song et al, THE JOURNAL OF GENE MEDICINE Vol 12, pages 873–880, 2010
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Clinical Trial Plan for the ddRNAi
Cancer Pain Product
A phase I/II study of the ddRNAi-based product is planned in terminal cancer patients with intractable pain
and a quick timeline to approval is expected.
Study Overview
Patient Population Study Design Objectives
Randomised double blind phase I/II study of ascending single doses of intrathecally administered
ddRNAi-based product in terminal cancer patients experiencing cancer-associated pain
Patients who have
intractable pain due to an
underlying malignancy (or
other terminal illness)
Life expectancy < 6 months
Determine the acute safety profile of the
ddRNAi-based product when administered
intrathecally in a single dose
Determine the efficacy (chemo-sensitizing)
effects of the ddRNAi-based product when
administered three days prior to each cycle
of standard chemotherapy (repeat single
doses)
The study will include three dosing
arms with each dose given to n = 4
patients and 1 control patient
Dose 1 (low dose)
Dose 2 (medium dose)
Dose 3 (high dose)
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ddRNAi Cancer Pain Product
Development Plan and Timeline
ddRNAi Cancer Pain Product Clinical Development Timeline
2011 2012 2013 2014 2015
Preclinical Studies (anti-human PKCγ construct)
Phase I/II Clinical Studies
Phase I/II Trial (cancer patients with intractable pain)
* Other indications include: diabetic neuropathy, postherpetic neuralgia, and HIV/AIDS
Additional Planned Studies:
Toxicology and biodistribution studies
Large Phase II and III studies in cancer patients
Other indications*
Proof of concept in pre-clinical model of pain
Toxicology studies
IND Preparation and Submission
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Investment Opportunity Summary
ddRNAi Product Asset Summary
Extensive IP Estate Patent Coverage Through 2030
Favorable KOL Response Strong Support From KOLs for the Unique MOA
Additional Indications
Potential use in Diabetic Neuropathy, Postherpetic Neuralgia,
and HIV/AIDS
Unmet Medical Need Large, Unmet Need for Treatment of Cancer Pain
Large Market Opportunity High Revenue Potential in Oncology and Additional
Indications
Potential for Accelerated Timeline Short-term Trials are Anticipated in Initial Indications
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Contact Information
To respond to this introduction to the ddRNAi opportunity, please contact:
Dr. Peter French, Ph.D., M.B.A.
CEO Benitec Ltd.
Phone: +61 (0)412 457 595 E-mail: [email protected]
or
Ben Bonifant Senior Vice President
Campbell Alliance Phone: (919) 844-7100 x7176
E-mail: [email protected]