|
Healthcare |
CEOCFO-Members Login
Become A Member!
|
This is a printer friendly page!
Alseres Pharmaceuticals Is In Phase III
Clinical Trials With Their Altropane Technology That Will Allow Them To
Diagnose Parkinson’s Disease And In Phase II With Their Cethrin
Recombinant-Protein-Based Drug For Nerve Repair In Spinal Cord Injury
Healthcare
Biotechnology
(ALSE-NASDAQ)
Alseres Pharmaceuticals, Inc.
85 Main Street
Hopkinton, MA 01748
Phone: 508-497-2360
Kenneth L. Rice Jr., J.D., L.L.M., M.B.A.
Chief Financial Officer
Interview conducted by:
Lynn Fosse, Senior Editor
CEOCFOinterviews.com
Published – July 25, 2008
BIO:
Kenneth L. Rice, Jr., J.D., L.L.M., M.B.A.
Executive Vice President - Finance & Administration
Chief Financial Officer and In-House Counsel
Mr. Rice brings over 25
years of experience in life sciences-related businesses to Alseres. Most
recently, Mr. Rice served as Vice President, Chief Financial Officer, and
Chief Commercial Officer of Aderis Pharmaceuticals, a privately held
biopharmaceutical company. Mr. Rice previously held executive positions with
MacroChem Corporation, Pentose Pharmaceuticals, Unisyn Technologies, Zymark
Corporation, and Millipore Corporation. Mr. Rice earned his LLM Taxation
from Boston University Law School, his Juris Doctor Cum Laude from Suffolk
University Law School, and his MBA and BS/BA from Babson College.
Company Profile:
Alseres Pharmaceuticals, Inc. (Nasdaq: ALSE) is
engaged in the development of therapeutic and diagnostic products primarily
for disorders in the central nervous system (CNS). The Company maintains a
world-class intellectual property position in the field of regenerative
therapeutics. The Company's energy and focus is reflected in several
important initiatives. Cethrin®, a recombinant-protein-based drug designed
to promote nerve repair after acute spinal cord injury, demonstrated
positive interim results in a Phase I/IIa clinical trial. The Company's
research and pre-clinical programs include, Inosine for the treatment of
spinal cord injury and stroke, Oncomodulin for the treatment of ocular
injury and disease and research programs directed at a number of
regenerative therapies including bone repair. The Company has a robust
molecular imaging development program targeting diagnosis of Parkinson's
disease and potentially dementia and ADHD. The Company's lead molecular
imaging product candidate is Altropane® which is in Phase III clinical
trials for the diagnosis of Parkinsonian Syndromes including Parkinson's
Disease. The Company has research collaborations with Harvard Medical School
and Children's Hospital Boston.
CEOCFO: Mr. Rice, you have a considerable
background in the industry; what attracted you to Alseres Pharmaceuticals?
Mr. Rice:
“What attracted me to Alseres was the potential offered by the core
technologies that we have for nerve repair especially in spinal cord injury
and the diagnosis of degenerative nerve disorders like Parkinson’s and
dementia.”
CEOCFO:
Would you tell us about the technologies that you have?
Mr. Rice:
“I will start with the nerve repair technology. Our lead clinical program in
nerve repair is Cethrin®. This product is being developed to restore feeling
and movement after a serious spinal cord injury. Fundamentally, what happens
in a traumatic injury to the central nervous system, like a spinal cord
injury or a traumatic brain injury, is that nerve fibers are broken. Nerve
fibers form the connections by which the body communicates from the brain to
the various muscles and organs. If nerve connections are broken it is like
breaking a telephone line. We believe our technology allows the nerve fibers
that communicate with each other to be reconnected and hopefully restore
motor and sensory function in those patients that have been injured. On the
diagnostic side it turns out that for many diseases, particularly Parkinson’s
disease and dementia, there are simply no objective diagnostic tools today.
This would be fine if not for incorrect diagnoses estimated at between 35
and 50%. There are some 18 million people in the US living with the effects
of tremor or dementia and they don’t have a definitive diagnosis of what
they have. In the case of tremor disorders there are 11 million people in
the States alone with tremors, about a million and a half of whom are
suspected to have Parkinson’s. Our imaging technology for the first time
provides the physician with a visualization of the brains of these patients
and through that visualization they are able to determine whether the
patient has Parkinson’s disease or a tremor from another source that should
be treated differently.”
CEOCFO: How
does your diagnostic technology work?
Mr. Rice:
“A patient will visit the physician’s office with a tremor and they don’t
quite know what it is. The physician will take a medical history and perform
a neurological evaluation of the patient using established scales for tremor
disorders and Parkinson’s. These clinical diagnoses are incorrect anywhere
from 35-50% of the time. To use our product, the patient will be sent to a
nuclear imaging facility much like cardiac patients today. The patient is
given an injection of our product, Altropane®. Their head is then scanned
using a specialized camera called a SPECT camera or (single photon emitting
computed tomography). The Altropane travels through the blood system to the
brain and it binds to a specific site in the brain on a neuron that produces
dopamine. In Parkinson’s the hallmark of the condition is that patients have
lost many of the dopamine-producing neurons. If there are low numbers of
dopamine producing neurons present in the patient, the scan will detect a
very weak signal indicating that the patient has Parkinson’s. If the signal
is strong, the physician can then determine that the tremor is caused by
something other than Parkinson’s. We believe, over time, that the agent will
help the physician and the patient by tracking the progression of their
disease. This also provides huge benefits down the road for the companies
with drugs in development that are intended to modify the progression of
Parkinson’s. A good way to demonstrate arresting of disease progression is
to show that the neuron level is actually not declining. We believe,
Altropane will enable this.”
CEOCFO:
Where are you in the process?
Mr. Rice:
“Altropane is in Phase III clinical trials. We are about two to three years
away from the market we believe.”
CEOCFO:
What other products are you working on?
Mr. Rice:
“The most exciting product in our nerve repair portfolio is a product called
Cethrin. It is in Phase II clinical trials for the treatment of acute spinal
cord injuries. There are about eleven thousand new spinal cord injuries a
year in the U.S. and it is probably triple that worldwide. The injuries
break down about 50/50 between upper spine or neck injuries; called cervical
spinal cord injuries and the lower spine called thoracic spinal injuries.
The cervical injury patients unfortunately generally wind up as quadra or
tetraplegics, and have no movement or sensory function below their neck. The
patients with thoracic injuries are very often paraplegic; they are
wheelchair bound and can move their upper torso and upper extremities. Our
drug, Cethrin, is administered to the patient during decompression surgery
that two-thirds of these patients undergo right after their injuries.
Cethrin is a small protein that is delivered topically one time to the
patient during the surgery so we don’t ask the patient to undergo any
additional procedures or any more invasive procedures than they are already
undergoing. The drug blocks what we have identified scientifically as a
master switch in the neurons that when activated causes nerve repair to be
stopped.
With regard to the science, when you get a cut on the tip of your fingers
new nerves are usually able to develop and make connections with other
nerves and that restores the feelings in your fingertips. That process is
generally known as nerve regeneration, however that process does not occur
that often in the case of spinal cord injuries or some of the severe CNS
injures like strokes or brain injuries. In those injuries useful function is
very often lost permanently because the damaged cells cannot re-grow the
connections. Further, the uninjured cells are generally unable to form new
connections to compensate for the connections that have been lost. For
years researchers have been trying to find ways to improve outcome following
these types of injuries. Our technology is based on facilitating
reconnections by re-growing the connecting fibers called axons to restore
sensory and motor function that is lost as a result of the injury. When I
describe the axon regeneration process I like to use an automobile analogy;
in order to cause an automobile to move forward one has to be able to step
on the accelerator, which would stimulate the axon growth pathways. At the
same time, the body has a very elaborate brake system and that brake system
manages to stop axons from growing when the body’s biology system doesn’t
believe they should grow. The brake system very often wins, and it is
activated after the type of injuries we are talking about here. In addition
to stepping on the accelerator, which the body tends to do naturally, it
also is necessary to make sure that you keep your foot off the brake. We
have spent a lot of time on a technological level developing and
understanding these two pathways and we have identified them down to the
level of two master switches. The one that Cethrin targets is a master
switch called Rho, Rho is the switch that we believe turns on the brake
system. Our goal at a fundamental level is to shut off the brake system
thereby enabling the body to re-grow these axons, reconnect the nerve fibers
as a result and restore function in these patients. That is what we believe
Cethrin does.
Cethrin is in Phase II trials. We reported earlier this year the results
from a Phase I/IIa clinical trials in initially 37 and now 48 subjects. We
have tested the drug in both cervical and thoracic patients with very
encouraging early results. As you may expect, the Phase I/IIa trial was
predominantly a safety trial. That having been said, it did have efficacy
measures in it as well. Those measures show that almost a quarter of all the
subjects enrolled in the trial showed improvement against a validated scale
used to measure severity of spinal injuries developed by the American Spinal
Injury Association or ASIA. One progresses through the scale from level A
through E, where A is the most severe and E is normal. All subjects that
entered the trial were classified as being the most severe injuries,
so-called ASIA A patients. We had a little over a quarter of the subjects in
the trial respond and improve at least one level on the ASIA scale which
compares very favorably to the published literature that says that one
should expect somewhere between 6 and 7% of the subjects to improve. Most
exciting to us, within the cervical subjects that were in our trial, almost
40% of these patients improved two levels or more, two of the thirteen
subjects in this group are walking after having been treated with Cethrin
and that simply doesn’t happen.
Cethrin is an orphan drug in the US. We will commence our Phase IIb trial a
little later this year. We have also been fortunate over the past year or so
to assemble what we consider to be a world-class group of scientific and
clinical advisors on spinal cord injuries. Our approach of targeting the Rho
pathway has indirect validation by virtue of the fact that many large
companies in the space have declared nerve repair to be strategic to them
and are working in the same pathways. Companies like Biogen-IDEC, Genentech,
Novartis, Glaxo SmithKline, Johnson & Johnson and Merck, have all declared
that these therapeutics are of strategic importance to them. We are ahead of
everyone at this point with the world’s leading clinical program in spinal
cord injury. We also have intellectual property protecting not only Cethrin,
but also for molecules in pathways adjacent to and upstream of our core
nerve repair technology. Our patent estate includes ninety issued and
pending patents worldwide that cover pretty much all of the major pathways
and targets in the space. We believe that positions us for productive
discussions and possible collaborations with many of those companies as
well.”
CEOCFO: How
are you funded for all the development?
Mr. Rice:
“In the late fall of 2004 on the heels of a major change in the management
and the board, Alseres’ long term mission was changed to focus on nerve
repair and neuroimaing. Our lead investor is a group out of New York called
Ingalls and Snyder led by Mr. Robert Gipson. It is a syndicate of very high
net-worth individuals that manages a little over $3 billion in cash right
now and they own collectively about 70% of the Company. They have been
providing most of the funding for us for the past three years and continue
to do so. That said, we are a public company and that status will provide us
with longer term access to the public capital markets as well.
CEOCFO:
What is ahead over the next few years, and would you touch on some of the
other products?
Mr. Rice:
“As I mentioned before, the Cethrin program will start a Phase IIb trial
later this year and that trial could take until the early part of 2010 to
fully enroll. We are very excited about the fact that Altropane our lead
imaging agent is so close to market. We expect that the final stage of our
POET-2 program, which is the last Phase III pivotal trial program for Altropane, will start a little later this year or early next year. We
started the first part of that program already. We are assembling what in
the imaging business is called a “training set” of images which the readers
can use to be trained on. We are about half way through that enrollment. We
will follow that with the actual patients that will constitute the pivotal
trial. We expect that in the 2010 timeframe we will be looking to submit
Altropane for approval in the US.
We are also looking at Altropane in another indication area outside of
Parkinson’s disease called dementia with Lewy bodies, which is a subset of
Alzheimer’s dementia. It is very hard to differentiate the two. In this case
if one is misdiagnosed, such as diagnosed with Alzheimer’s dementia and
treated with anti-psychotic drugs, when in fact one has dementia with Lewy
bodies, there is a very real medical risk that the side-effects of those
drugs could be fatal in some cases. This is a significant opportunity to
expand the potential for Altropane. We expect to be begin Phase II work with
Altropane in dementia with Lewy bodies later this year as well.
Our preclinical pipeline is actually quite robust. We have technology
surrounding the brake system, but we also have a great deal of technology on
the pro-regenerative side of the equation. All of our experts are telling us
that the best long term way to fully address issues of the magnitude of
spinal cord injury and stroke and traumatic brain injury and other central
nervous system traumas, is to be able to develop drugs that activate both
pathways at the same time. Our preclinical efforts are focused on our
pro-regenerative assets as well and we expect to be releasing pre-clinical
animal data over the coming year or so from those assets.”
CEOCFO: Why
should Alseres stand out for investors?
Mr.
Rice: “First,
we believe that we have the world’s leading neuroimaging program. Although
we are not on the market outside the US as GE is, we are the only Phase III
program in the U.S. GE is not here and they are not intending to come here.
We have the opportunity to own the U.S. market, which as I said is something
bordering on eighteen million patients over the next couple of years and we
believe once Altropane is approved it will garner a great deal of that
market very quickly. In addition, we know that we have the world’s leading
clinical program in acute spinal cord injuries for which you are probably
aware there are simply no choices today for the patient. There are no drugs
to help acute spinal cord injury patients gain back motor or sensory
function. We are ahead of the only other clinical program we know of that is
being run by Novartis. We believe that we are by far the world leader in
pre-clinical nerve repair technologies and behind all of that our
intellectual property protects a much broader array of regenerative
therapies, new technology and new cures in things like oncology and
cardiovascular disease and bone repair. We believe we have a great array of
assets and a strong team, with very good investors. We are actually a very
attractive valuation today, trading at about a $50M market cap. We have $35
million of convertible debt on our balance sheet as well. One could look at
us as a $75 to $80 million valuation with assets that approach over $1.5
billion of revenue opportunity.”
disclaimers
Any reproduction or further distribution of this
article without the express written consent of CEOCFOinterviews.com is prohibited.
|
