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Archived
News, 2003-2001
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2003
Cyberkinetics Inc.,
November 10, 2003, Cyberkinetics
Presents Innovative Direct Brain-computer Interface for Clinical Use in
Motor-Impaired Human Patients
Cyberkinetics Inc., July
9, 2003, Cyberkinetics,
Inc. Raises $4.3 Million to Develop its BrainGate™
Neural Interface Device
Scion Pharmaceuticals,
April 13, 2003, Scion
Pharmaceuticals Expands Patent Estate
Concentric Medical,
January 23, 2003, Concentric Medical Receives
CE Mark for MERCI™ System to Treat Acute Ischemic Stroke
Scion Pharmaceuticals,
July 18, 2003, Scion
Pharmaceuticals Completes $17.5 Million Private Financing Round To
Advance Its Ion Channel Drug Discovery Programs
2001
Forbes, February 19, 2001, Darwin Redux, By
Cynthia Robbins-Roth
Venture Capital & Healthcare, February 2001, New Firm
Seeks $20M to Invest in Neurology
VentureWire, July 02, 2001, Memory Drug Maker David Pharmaceuticals Gets
$10.5M Series A
VentureWire, July 02, 2001, Proxima Therapeutics Gets $18 Million
in Series D
VentureWire, July 02, 2001, NeuroVentures Raising First Fund,
Has Goal of $20 Million
Fortune, November 12, 2001, A Pill to
Help You Remember, By David Stipp
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Cyberkinetics Presents Innovative
Direct Brain-computer Interface for Clinical Use in Motor-Impaired Human
Patients
Company
Press Release
11.10.03
Cyberkinetics,
Incorporated will debut its development plan for BrainGate™,
an innovative multielectrode implantable
brain-computer interface device for proposed clinical use in human
patients, at the Society for Neuroscience 33rd Annual Meeting in New
Orleans, Louisiana. Cyberkinetics believes that the BrainGate
technology platform may provide paralyzed or motor-impaired patients with
a novel mode of communication through the translation of thought into
direct control of a computer.
“The
goal of the BrainGate program is to develop a
fast, reliable and unobtrusive connection between the brain of a severely
disabled person and a personal computer” stated Tim Surgenor, President and CEO of Cyberkinetics.
“If we are successful in this effort we may be able to provide
paralyzed individuals with a gateway through which they can access the
broad capabilities of computers, control devices in the surrounding
environment, and even move their own limbs. The presentation later this
week describes our initial efforts to build a system for pilot trials of
the initial safety and performance of the BrainGate
system.”
The
poster presentation will be made on Tuesday, November 11, 2003 at 9:00 AM
by John Donoghue, Ph.D., Cyberkinetics Chief
Scientific Officer and Henry Merritt Wriston
Professor, Chairman of the Department of Neuroscience, and Executive
Director of the Brain Science Program at Brown University.
Dr. Donoghue co-authored the abstract titled,
BRAINGATE™: DEVELOPING A DEVICE TO PROVIDE MOTOR IMPAIRED PATIENTS
WITH A NOVEL NEURAL OUTPUT, with researchers from Brown University and
Cyberkinetics: M.D. Serruya, R.A. Van Wagenen, S. Guillory, A.H. Caplan,
M. Saleh, B.W. Hatt.
John Donoghue, Ph.D. commented, “The development of
the BrainGate program is the culmination of 10
years of research in my academic laboratory at Brown University.
We have not only demonstrated in preclinical studies that BrainGate can remain safely implanted in the macaque
brain for at least two years, but we have shown that it can safely be
removed as well. .”
BrainGate™: Pilot Clinical Trial
Proposed for 2004
Cyberkinetics
plans to file an Investigational Device Exemption (IDE) with the Food and
Drug Administration (FDA) for a pilot clinical trial to begin in 2004
with approximately five quadriplegic participants. In the proposed study,
patients who meet Cyberkinetics' rigorous selection criteria would
receive the implant and their ability to achieve direct neural output
control over an attached computer explored. There are two proposed
primary goals of the pilot clinical trial: the first is to characterize
the safety profile of the device in humans and the second is to evaluate
the amount, type, and usefulness of neural output control that patients
can achieve.
About the BrainGate™
Device:
Cyberkinetics’
BrainGate technology platform was designed to
take advantage of the fact that many patients with motor impairment have
an intact brain that can produce movement commands. This may allow the BrainGate system to create an output signal directly
from the brain, bypassing the route through the nerves to the muscles
that can not be used in paralyzed people. Cyberkinetics’ BrainGate Neural Interface Device is a proprietary
brain-computer interface that consists of an internal neural signal sensor
and external processors that convert neural signals into an output signal
under the person’s own control. The sensor consists of a tiny chip
smaller than a baby aspirin, with one hundred electrode sensors each
thinner than a hair that detect brain cell electrical activity. The chip
is intended to be implanted on the surface of the brain in the area that
controls movement. In the pilot version of the device, a cable connects
the sensor to an external signal processor in a cart that contains
computers. The computers translate brain activity and create the
communication output using custom decoding software.
Importantly,
the entire BrainGate system was specifically
designed for clinical use in humans and thus, its manufacture,
assembly and testing are intended to meet human safety requirements. BrainGate will be the first human device that has
been designed to record, filter and amplify multiple channels of
simultaneously recorded neural activity at a very high spatial and
temporal resolution. While one day such translated instructions might be
used to stimulate muscles or move robotic limbs, Cyberkinetics is focused
on achieving the critical first step in this process, which is to enable
patients to master accurate, rapid control over a computer desktop. This
achievement alone will help to restore many activities of daily living
that are now difficult for many paralyzed humans and will provide a
platform for the development of a wide range of other assistive devices
and potentially to control paralyzed muscles.
Previous
research conducted in non-human primates using an early version of the
Cyberkinetics technology was published by researchers at Brown University (Serruya
et al., 2002 Nature 416:141). The study demonstrated that neural output
signals from fewer than 30 motor cortex neurons (an area of the brain
responsible for movement) could be decoded in real-time into signals that
provided animals the ability to neurally
control cursor movements via a computer interface.
About
Cyberkinetics, Inc.
Cyberkinetics
is a leader in neurotechnology, an emerging
field driven by advances in neuroscience, computer science, and
engineering that promises to revolutionize the medical treatment of
nervous system dysfunction. Cyberkinetics’ first product, BrainGate™, is designed to give severely
paralyzed patients a long term, direct brain computer interface for the
purpose of communication and control of a computer. Cyberkinetics’
intellectual property features key technologies licensed from Brown University,
the Massachusetts Institute of Technology, Emory
University, and the University of Utah. Cyberkinetics is
headquartered in Foxborough,
Massachusetts and conducts engineering
and research in Salt Lake City,
Utah. More information is
available at www.cyberkineticsinc.com .
Back
to Top
Cyberkinetics, Inc.
Raises $4.3 Million to Develop its BrainGate™
Neural Interface Device
Company Press Release
07.09.03
Cyberkinetics,
Incorporated, a pioneer in the emerging field of neurotechnology,
announced today the closing of its Series A financing with an additional
investment of $4.3 million.
Investors include Oxford BioScience
Partners, Global Life Science Ventures and NeuroVentures Capital
LLC. Philip Morgan, Partner at
Global Life Science Ventures, will join Cyberkinetics’ Board of
Directors. This brings the total
of Cyberkinetics Series A financing to $9.3 million with earlier
investments made by Oxford Bioscience Partners and George Hatsopoulos, Founder and Chairman Emeritus of Thermo
Electron Corporation.
“Our goal is to build a leadership
position in the rapidly emerging field of neurotechnology
through the development of direct brain-computer medical device
interfaces that will assist patients in overcoming severe disabilities
and other neurological disorders,” stated Tim Surgenor,
President and CEO of Cyberkinetics. “This financing provides the
resources to build on our leading intellectual property position and
expand our clinical and regulatory expertise, as we are on track to begin
human clinical studies of our BrainGate™
Neural Interface Device early next year.”
Philip
Morgan, Partner at Global Life Science Ventures, commented, "We are
impressed by Cyberkinetics' innovative neurotechnologies. Not only do they potentially offer
patients with physical disabilities the possibility of restored
communication and movement, but they also open up potential new treatment
options for a range of debilitating diseases." Mr. Morgan added,
"Cyberkinetics is a valuable addition to our portfolio and we look
forward to working with the company to bring these projects to
fruition."
About
Cyberkinetics, Inc.
Cyberkinetics
is a leader in neurotechnology, an emerging
field driven by advances in neuroscience, computer science, and
engineering that promises to revolutionize the medical treatment of
nervous system dysfunction.
Cyberkinetics first product, BrainGate™,
is designed to give severely paralyzed patients a permanent, direct
brain-computer interface for the purpose of communication and control of
a computer. Cyberkinetics’
intellectual property features key technologies licensed from Brown University,
the Massachusetts Institute of Technology, Emory
University, and the University of Utah. Cyberkinetics is headquartered in Foxborough, Massachusetts and conducts engineering and research
in Salt Lake City, Utah
and Providence, Rhode Island. More information is available at www.cyberkineticsinc.com .
Back
to Top
Scion Pharmaceuticals
Expands Patent Estate
Company Press Release
04.17.03
Scion Pharmaceuticals, Inc.
announced today that it has received a Notice of Allowance for U.S.
Application No. 10,038,178 which covers compounds for the treatment of
neurological injury, neurodegenerative diseases, and neuronal loss in
ischemia, hypoxia and hypoglycemia. The company has also received Notices
of Allowance for foreign applications covering compounds that could be
useful in both central nervous system and cardiovascular disorders.
In
addition, Scion has obtained the rights to U.S. Patent No. 6,353,091 B1
covering a novel human N-type calcium channel target, which the Company
will use in the discovery of new treatments for acute and chronic pain.
"These
newly allowed patents strengthen the intellectual property position that
we are building in our central nervous system and cardiovascular
franchises", said Pravin Chaturvedi, President and CEO of Scion. "We are
truly excited by the possibility of developing new therapies for the
millions of people who suffer from diseases such as atrial
fibrillation, chronic pain, anxiety and neurodegenerative
disorders."
Scion
Pharmaceuticals Inc. discovers and develops small molecule drugs that
selectively regulate ion channels, a well established class of
pharmaceutical targets with potential application for a wide-range of
major diseases. Scion applies an innovative ion channel drug discovery
strategy that integrates functional biology and medicinal chemistry, and
its discovery engine is enabled by its proprietary High-Throughput
Electrophysiology assay (HTEP™). This approach allows the Company
to evaluate ion channel subtype target function and effects of molecules
on ion channels at the earliest stages of the drug discovery process.
Scion is initially utilizing this approach to discover drugs for the
treatment of cardiovascular and CNS disorders, with a focus on atrial fibrillation and pain respectively. Currently,
the Company holds over 70 issued U.S. patents as well as
foreign counterparts in many other countries.
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to Top
Concentric Medical Receives CE
Mark for MERCI™ System to Treat Acute Ischemic Stroke
Company Press Release
01.23.03
Concentric Medical, Inc. (Private), today announced that the Company
has received approval to affix the CE Mark to the components of the MERCI(TM)
(Mechanical Embolus Removal for Cerebral Ischemia) System, a minimally
invasive approach to quickly restore flow to blocked vessels during
ischemic stroke. The Company believes its device is the first ever to
receive this distinction for the mechanical removal of thrombus in the neurovasculature. The CE Mark indicates that the
MERCI System may be marketed in the European Union, and that the product
complies with applicable safety and quality standards. Permission to
affix the CE Mark to the components of the MERCI System followed an
extensive review of clinical data and procedures, including in vitro and
in vivo testing, and an on-site inspection of manufacturing and quality
systems.
Ischemic Stroke
In the United
States, ischemic stroke is the third leading
cause of death but the first leading cause of adult disability. The
Company estimates that there are more than 700,000 patients per year in
the European Union who are potential candidates for this procedure. An
ischemic stroke occurs when a blood clot or piece of plaque is lodged in
a blood vessel in the brain. This prevents blood from reaching and
providing nourishment to part of the brain and it begins to die. The
concept of Time=Brain(TM) becomes critical. Patients must reach a care
centre, be evaluated and treated quickly, or the damage can become
permanent.
Available drug therapies used to dissolve or "lyse"
blood clots in the brain must be administered within the first three
hours after the onset of the stroke. Although these therapies can be effective
they do carry a substantial risk of additional complications(1).
The MERCI System extends the time window for treating ischemic stroke
from three, all the way to eight hours, allowing many more patients to
receive treatment.
"Ischemic stroke is one of the largest unmet challenges in
healthcare today. Receipt of the CE Mark from our Notified Body is an
important accomplishment and a validation of the strength of our clinical
data, and we look forward to bringing the many benefits of MERCI to
people throughout the European Union," said Gary Curtis, President
and Chief Executive Officer of Concentric Medical, Inc.
About Concentric Medical
Concentric is developing the MERCI System to treat ischemic stroke by
removing the thrombus blocking the artery. Our objective with this novel
system is to make the treatment of ischemic stroke simple, fast and
effective. The heart of the MERCI System employs a specialised
wire that relies on super elastic linear technology(TM) to deliver the
retrieval device through a micro catheter into the arteries of the brain.
Upon exiting the catheter, the MERCI Retriever device forms the complex
shape used to ensnare and retrieve the clot. A specialised
balloon guide catheter is also used as part of the system to provide
blood flow occlusion during the retrieval process. Concentric Medical is
currently evaluating the MERCI Retriever device for ischemic stroke under
an Investigational Device Exemption trial governed by the U.S. Food and
Drug Administration. For additional information on how the MERCI System
works please visit our website at http://www.concentric-medical.com
(1) The National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. Tissue Plasminogen
activator for acute ischemic stroke. New Eng J Med 1995; 333:1581-1587
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Scion Pharmaceuticals
Completes $17.5 Million Private Financing Round To
Advance Its Ion Channel Drug Discovery Programs
Company Press Release
07.18.02
Scion Pharmaceuticals, Inc., a privately held pharmaceutical company
engaged in the discovery of novel ion channel modulators, announced today
that it has raised $17.5 million in a Series B private equity financing,
bringing the total amount raised since its inception in September 2001 to
$21.5 million. The round was led by Lehman Brothers and Lancet Capital.
Also investing were GeneChem Therapeutics
Venture Fund, Gray Ghost, Life Sciences Partners (LSP), NeuroVentures,
S.R. One, Limited, and Scion's existing
institutional investor, Oxford Bioscience Partners. Concurrent with the
financing, Scion has appointed to its Board of Directors Hingge Hsu, M.D., Managing Director of Lehman
Brothers Private Equity Group; William Golden, Managing Director of Lancet
Capital; and Joachim 'JR' Rothe, Ph.D., Partner
of LSP.
Dr. Pravin Chaturvedi,
Ph.D., President and Chief Executive Officer of Scion stated, "The
success of this financing and our ability to attract such distinguished
investors underscores the rapid progress we have made in establishing our
innovative drug discovery platform and initiating our programs in
cardiovascular and central nervous system disorders."
"Ion channels represent exciting targets for the discovery of
novel drugs to treat a broad range of human diseases," remarked Dr.
Hsu. "Until recently, the area has remained largely untapped due to
the limitations of existing drug discovery methodologies."
Dr. Chaturvedi added, "Scion's patented
High-Throughput ElectroPhysiology (HTEP™)
technology, together with our focused ion channel libraries, enable us to
discover novel drug candidates faster and more efficiently than
traditional approaches."
William Golden from Lancet Capital also commented, "We believe
Scion is the leader in ion channel drug discovery. Since Scion began
operations nine months ago, it has assembled a seasoned management and
drug discovery team with a proven track record for discovering,
developing and commercializing novel pharmaceutical products.
Additionally, Scion has a strong patent portfolio covering its
proprietary compounds and technologies. We are pleased that Lancet will
participate in Scion's continued success."
Scion uses an innovative drug discovery paradigm, which integrates the
evaluation of ion channel chemical libraries against validated targets
with HTEP. Electrophysiology is the definitive assay for ion channel drug
discovery. Scion's HTEP technology provides physiologically relevant data
to chemists in an accelerated timeframe, enabling the rapid optimization
of lead compounds. This approach eliminates the need for costly and time
consuming surrogate assays and allows Scion to arrive at preclinical
leads faster than conventional drug discovery efforts. Scion plans to
further advance and commercialize its discovery pipeline through
collaborations with leading pharmaceutical and biotechnology companies.
Scion Pharmaceuticals' (www.scionpharma.com) mission is to discover
and develop novel small molecule drugs that are specific and selective
for ion channels and receptors. The Company's initial programs are
focused on new treatments for arrhythmias, myocardial ischemia, anxiety,
pain and epilepsy. To date, Scion has over 65 issued US patents and continues to
build and expand its intellectual property estate. The Company is based
in the Boston
area and currently occupies 12,000 square feet of state-of-the-art
laboratories, including facilities for medicinal chemistry, biology and
pharmacology.
Back to Top
Cynthia Robbins-Roth
02.19.01
During the late 1990s, the venture capital firms that helped create
the biotech industry ditched drug discovery deals to do Internet plays.
Many of the industry's supporters, including me, have been whining and
complaining about that desertion. But it may have been just what biotech
needed to get some quality back into the startup pool of companies, by
forcing survival of the fittest.
The hot-hot-hot biotech public markets of the late 1980s and early
1990s generated huge returns for early investors, creating a rush to add
biotech to venture portfolios. Many of these newcomers missed the crucial
point that good biotech deals require strong scientific expertise. But
even more important, they need a grasp of the commercialization issues in
turning "cutting-edge" science into revenue-generating
products.
VC firms recruited biotech investors loaded with degrees in business,
law, and science without bothering to look for real-world experience.
Many of these junior VCs had never been employed, much less managed other
employees or projects. Some of them, emboldened by their firms' hefty
bank accounts, set a new benchmark for rude behavior toward
entrepreneurs.
The resulting mess gave us a batch of biotech companies that were left
twisting in the wind when their VC-loaded boards panicked at the lack of
Wall Street enthusiasm and flocked to dot-coms.
Today, there is a distinct shift occurring, with a slow but steady
flow of lucrative biotech deals coming from a new set of specialist investors.
While the big VC firms are bulking up to become "full-service"
silicon funds, complete with in-house public relations and human resource
experts, a new generation of biotech finance geeks is creating the next
crop of biotech winners.
Says Constance McKee, CEO of Xavos in Woodside, California:
"While you always want the money, you need investors who see the
opportunity to build value and understand just how time-consuming and
risky drug development and commercialization really are." Another
important trait is a willingness to fund deals outside the flavor of the
month by being savvy enough about the biopharma
business to look beyond the buzzwords.
One biotech investor who fits this description is Fred Craves,
founding partner at what's now Bay City Capital in San Francisco. He was CEO of Codon in the 1980s, sold it to Schering AG in 1990,
ran Schering's West Coast Berlex Bioscience, cofounded the Burrill &
Craves merchant bank, then founded his current
venture capital firm in 1996 to do life science investments. The
principals, including the former CEOs of Calgene
and Affymax, all have operational backgrounds.
Bay City specializes in turnarounds of biotech "fallen angels,"
combining a working board of retired big pharma
execs and an executive-in-residence program to give their portfolio
companies access to real-world acumen long before they could recruit it
internally.
All this requires a time frame longer than the typical venture
horizon. Bay City
gets that luxury by having the Pritzker family
as its only limited partner. "The family has behaved as a merchant
bank for five generations," says Craves. "We don't have to
placate lots of limited partners with a need for near-term returns. We
can work a deal for seven or eight years if we think value is there and
we can grow it."
Another knowledgeable biotech investor is Dennis Purcell, senior
managing partner at Perseus-Soros
Biopharmaceutical Fund. He started out at PaineWebber with the hot team
of Dr. Stelios Papadopoulos and Reinaldo Diaz, moved to Hambrecht & Quist in 1994 to head up Life Sciences, then joined Perseus-Soros
this year. Purcell's time in the trenches gives him a valuable
perspective of how to achieve long-term value in biotech, and his current
fund is structured to give him the time and capital to support those
firms he believes will produce. He has built an advisory board that
includes former heads of the Food and Drug Administration and Rockefeller University, along with a hefty
assortment of scientists and physicians.
Other new biotech insider favorites in the venture biz with
battle-tested business development experience and a gut-level
understanding of science include:
Skyline Ventures (Palo Alto, California): Recent addition Dr. Yasunori Kaneko trained as an M.D. and worked as a
banker for Paribas in Tokyo,
but he spent most of his career in business development at Genentech and Tularik and
as CEO of Zyomyx.
Earlybird Venture Capital (Palo Alto): Cofounded by Dr. Vera Kallmeyer,
a neurosurgeon who was part of Aviron's
founding team as vice president of business development and CFO.
HealthCare Ventures (Cambridge,
Massachusetts): This firm
has added Dr. Chris Mirabelli, SmithKline research scientist and cofounder of Isis
Pharmaceuticals and founder/CEO of LeukoSite
(acquired in 1999 by Millennium), and Gus Lawlor,
former COO at LeukoSite.
J. P. Morgan Partners (San
Francisco): Biotech deals are flowing from
Rodney Ferguson, former biochemist, lawyer, and senior director of
business and corporate development at Genentech,
and former InterWest Partners venture
capitalist.
NeuroVentures Fund (Charlottesville,
Virginia): The managing
director and general partner of this new fund, Dr. Mark
Cochran, started as a researcher turned vice president
of business development at Bayer Biotech, then worked with MDS Capital
before returning to his neuroscience roots.
International Biomedicine Management Partners (Basel, Switzerland): Dr. Jürgen Drews retired as
president of Roche's global research and development to work in venture
capital, and he continued to fund biotech through the venture drought
before moving to Bear Stearns.
Falcon Technology Partners (Devon, Pennsylvania):
This is the family fund of Dr. George Rathmann,
founding CEO of Amgen and ICOS and now chairman of Hyseq.
Three Arch Partners (Menlo
Park, California):
Jeff Bird, former senior vice president of business operations at Gilead
Sciences, joined this respected fund last summer.
Life Science Venture Fund (Tokyo): The first Japanese biotechnology
venture fund is led by Dr. Tadashi Matsumoto, former research scientist
and business development director at Kyowa Hakko and founder of ReqMed, a business development firm.
All of these VCs have been on the drug development battleground, fighting
to move a concept from the lab bench into the marketplace. They have a
fierce belief in the inherent value of biotechnology. As one biotech
insider put it, "They had the balls to invest when others were
insecure about the biotech business model, because they understood the
demand for new products from big pharma."
Thanks to Darwinism, biotech now has toughened investors ready to
weather the storms of the next decade—and to reap the
incredible benefits.
Cynthia Robbins-Roth is the founding partner of BioVenture
Consultants and author of From Alchemy to IPO: The Business of
Biotechnology (Perseus Books). She spends
most of her time working with early-stage biotech companies and writing
cranky columns about recalcitrant venture capitalists.
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Memory Drug Maker David
Pharmaceuticals Gets $10.5M Series A
Monday, July 02, 2001
HALF MOON BAY, Calif. (VENTUREWIRE) -- David Pharmaceuticals, a
company making memory enhancement drugs, has received $10.5 million in Series
A funding, Polaris Ventures principal Christoph
Westphal told VentureWire.
Sofinnova Ventures, Sofinnova
Partners, and NeuroVentures also participated in the round. Sofinnova Ventures was the lead investor.
In addition to Mr. Westphal, John S. Patton,
co-founder of San Carlos, Calif.-based Inhale, Ed Frymoyer,
founder of Brocade, and Michael Powell, managing director with Sofinnova Ventures, have joined the company's board
of directors.
Mr. Westphal said the financing will be used to
support the company as its products enter clinical trials. The company,
based in Half Moon Bay,
Calif., has three drug
candidates that are either in trials now or will enter them soon, he
said. The company, founded about a year and a half ago, will likely seek
another round, but Mr. Westphal would not
speculate on the timing.
David Pharmaceuticals declined to comment when contacted for this story. Mark Cochran, managing partner with
NeuroVentures, said the company has a good valuation, although he would
not provide an exact figure. "It wasn't difficult for them to raise
$10.5 million," he said.
Telephone: 650-560-0210
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Proxima Therapeutics Gets
$18 Million in Series D
Monday, July 02, 2001
ALPHARETTA, Ga. (VENTUREWIRE) -- Proxima Therapeutics, an Alpharetta,
Ga.-based maker of devices that help treat cancer patients, has raised
about $18 million in Series D financing, Proxima president and CEO Tim
Patrick told VentureWire. The round was led
Domain Associates, with participation from NeuroVentures, New Enterprise
Associates, Merrill Lynch Ventures, and Hillman Medical Ventures. Robert
More, general partner at Domain, joined Proxima's
board.
NEA led the company's $11.3 million Series C round in 1998 and Hillman
led its $4 million Series B round in 1997, Mr. Patrick said. The company
received $800,000 in seed financing in 1995.
Proxima recently brought its first medical device to market and is in the
process of getting FDA clearance for a second product that will help
breast cancer patients, Mr. Patrick said. He said the company is
considering an IPO, possibly in early 2002. "We've increased our
discussions with investment banks," he said.
http://www.proxima.org
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NeuroVentures Raising
First Fund, Has Goal of $20 Million
Monday, July 02, 2001
CHARLOTTSVILLE, Va. (VENTUREWIRE) -- NeuroVentures, a venture capital
firm located in Charlottesville,
Va., is raising its first
fund, the firm's managing partner, Mark Cochran,
told VentureWire. The new fund will focus on
companies in the neurosciences space, Mr. Cochran said. He said it has
raised $5 million to date, primarily from individual investors. The firm
is shooting to close at $20 million this fall, he said.
NeuroVentures will make deals at multiple stages, but will lean towards
earlier deals, Mr. Cochran said. He said companies that receive money
would typically have valuations of $30 million or less. The firm has no
geographic preference, he said.
NeuroVentures recently invested in David Pharmaceuticals, a Half Moon
Bay, Calif.-based maker of memory-enhancing drugs, which received $10.5
million in a Series A round, led by Sofinnova
Ventures. The firm has also invested in Proxima Therapeutics, an Alpharetta,
Ga.-based maker of cancer treatment devices. Mr.
Cochran said NeuroVentures is examining five additional deals now, but
would not comment on them.
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MEMORY- A Pill to Help You Remember
Suddenly the race is on to develop the thinking person's Viagra.
Monday, November 12, 2001
By David Stipp
If you want instant rapport with someone over 40, try mentioning that
your memory is going downhill. About 70 million anxious baby-boomers will
be eager to bond with you. You'll quickly come to see that those
unnerving senior moments--the time the new CFO cornered you and you
couldn't remember her name, the day you took 20 minutes to find your
parked car, your recent blocking on the word "hammock"--are
just part of middle age.
Bring up memory lapses with your doctor, and he or she will probably say
that these minor midlife brain cramps are rarely a sign of imminent
Alzheimer's. Instead, physicians describe non-elderly people with memory
complaints as the "worried well." But that expression, while
meant to be reassuring, has an implication that isn't comforting at all:
"Well" simply means you're losing it at the usual rate.
Here's the hard truth: Average scores on memory tests decline steadily
after age 25, says Thomas H. Crook, a former National Institutes of
Health researcher who now runs Psychologix, a
firm he founded to offer computerized cognitive assessment. Midlife
memory erosion is unsurprising, given that by late middle age we're
losing, on average, about 1% of our brain volume each year. We
compensate, of course, with endless variations on tying a string around a
finger. Falling back on habits and experience to reduce the need to
absorb new information helps too.
But when it comes to total brainpower--the kind that's increasingly in
demand in the info age--well, you may as well put on sneakers and try to
literally outsprint
the hungry young lions circling your job as to out-cogitate them. Tests
that mimic practical memory tasks, such as associating names with new
faces and remembering phone numbers after a short delay, suggest that by
age 55 most of us are only about 75% as good at learning and recalling
new things as we were at 25.
You'd think that by now every major drug company would have mounted a
crash effort to develop the thinking person's Viagra--memory medicines
that really work. Says Crook: "If a patient with presbyopia
[the normal loss of close-up vision in middle age] complained to his
physician, 'Doc, I'm having trouble reading the newspaper,' he wouldn't
be told, 'That's what nature intended, so just go home and read less.' " But memory pills haven't happened, and the main
reason is simple: Until last spring drugmakers
didn't have a well-accepted diagnostic target to aim at.
Now that has changed. Spurred by progress in the fight against
Alzheimer's, doctors have begun to embrace a kind of early-warning
diagnostic category called mild cognitive impairment, or MCI--a state of
fuzziness that falls between ordinary midlife memory loss and the
devastating cognitive decline of Alzheimer's. When the Food and Drug
Administration last spring effectively endorsed MCI as a diagnostic
category, it opened a "totally new landscape for developing memory
drugs," says Harry M. Tracy, publisher of NeuroInvestment,
a Rye, N.H., newsletter.
At least a half-dozen fleet-footed startups plan to push potential
medicines for MCI quickly into clinical trials. And while you shouldn't
head for the pharmacy just yet--even if the trials pan out, new memory
drugs are still several years from market--medical practice is on the
verge of a society-altering change. At least some of the drugs for MCI
are likely to ameliorate the milder memory deterioration almost all of us
experience. The "normal" cognitive slide of middle age may well
be transformed into a treatable abnormality--just as the blues were
"medicalized" by the advent of
Prozac.
The leaders include companies whose drugs have shown promise in animal
and, in some cases, human studies. Cortex Pharmaceuticals in Irvine,
Calif., plans late this year to launch an MCI trial with its CX516 drug,
which appears to strengthen neuronal connections involved in recording
memories. Memory Pharmaceuticals, a closely held Montvale, N.J.,
company, hopes to launch an MCI trial with one of its drugs by the end of
2002, says President Axel Unterbeck. And one of
the most interesting startups, David Pharmaceuticals of Half Moon Bay,
Calif., expects to begin an MCI trial this year with a compound
discovered, but neglected, by the Swiss drug giant Novartis.
Memory Fixers
Companies are aiming to develop drugs for mild cognitive impairment,
which may signal incipient Alzheimer's.
|
Company
|
Drug
|
Testing Stage
|
|
Cortex
Pharmaceuticals (COR)
Irvine, Calif.
www.cortexpharm.com
|
CX516
|
Phase I to begin soon
|
|
David Pharmaceuticals
Half Moon Bay, Calif.
www.davidpharma.com
|
DVD-742
|
Phase I to begin soon
|
|
NeoTherapeutics
(NEOT)
Irvine, Calif.
www.neotherapeutics.com
|
Neotrofin
|
Pivotal trial for Alzheimer's; MCI testing planned
|
|
Memory
Pharmaceuticals
Montvale, N.J.
www.memorypharma.com
|
Specific drugs have not been announced.
|
Research is in the lab and animal test stages.
|
|
Helicon
Therapeutics
Farmingdale, N.Y.
|
Specific drugs have not been announced.
|
Research is in the lab and animal test stages.
|
|
NeuroLogic
Rockville, Md.
www.neurologicinc.com
|
Specific drugs have not been announced.
|
Research is in the lab and animal test stages.
|
To understand why the memory-pill race is getting under way only
now--instead of 15 years ago, when boomers started turning 40--it helps
to know a little of the history of Alzheimer's. Details of its cognitive
catastrophe were first described in 1906 by German neurologist Alois Alzheimer. But doctors didn't pay much
attention to the disease for decades--infectious diseases, heart attacks,
and other killers prevented most people from living long enough to get
it, and those who did often were vaguely classed as senile rather than as
suffering from a specific disease.
Alzheimer's and its dismaying implications finally came into focus in the
1970s. Today more than four million Americans have it, costing the U.S.
an estimated $100 billion a year. As the huge baby-boom generation grows
old, Alzheimer's could sink the economy--its incidence skyrockets after
65, and nearly half of seniors over 85 have it, according to some
studies. Ironically, boomers' fixation on life-extending physical fitness
may exacerbate the trend. In a moment of black humor, Cortex CEO Vince Simmon predicts, "Before long, we'll need fleets
of vans that cruise around all day picking up elderly joggers and taking
them home--they'll be in great shape but won't remember where they
live."
By 1980, Alzheimer's research kicked into high gear. The first
therapeutic fruits of this effort are on the market in the U.S.
now: four drugs to treat Alzheimer's. They are not terribly effective--at
best, they temporarily mitigate symptoms. Far more potent remedies now
moving from the lab to the clinic may be able to keep many Alzheimer's
patients out of nursing homes. But "the real payoffs will come when
we're able to initiate treatment right at the earliest stage of the
disease," says John Morris, an Alzheimer's expert at Washington University
in St. Louis.
"That's why there's so much interest in MCI."
What exactly is MCI? Some researchers believe almost all patients with
MCI are headed down the steepening cognitive
slope to Alzheimer's. Others aren't so sure. Marilyn Albert, who studies
MCI at Boston's Massachusetts General Hospital, says only a handful of
the 165 elderly patients she has tracked since 1992 have gone on to
dementia, the terrible dreamlike confusion that sets in as Alzheimer's
progresses.
To get an idea of how MCI affects daily life, I visited one of Albert's
research subjects, a chipper 86-year-old retired pharmacist who lives
with his wife in a trim split-level near Boston. For Frank, MCI is worrisome,
inconvenient, frustrating, and embarrassing. But it's not debilitating
like Alzheimer's. "Sometimes I can't think of the names of the guys
I've been playing golf with for years," he says. "More than
once, when I've left my house to do a couple of errands, I forget to do
one of the two. I used to get in the car and head anyplace without
thinking. Now I'm scared I'll get lost" on trips more than a few
miles from home.
Growing interest in MCI is bringing even milder memory problems to the
fore. In September the Institute for the Study of Aging in New York City
sponsored a landmark meeting on age-associated memory impairment--the
decline most people experience after 50. Attended by researchers and
pharmaceutical executives, the meeting signaled a turning point: The
worried well are finally on the medical establishment's radar screen.
The prospect of cognitive-enhancement drugs raises fascinating and
disturbing issues. Once such pills become available, will middle-aged
professionals who make life-or-death decisions--surgeons, pilots, top officials at intelligence agencies--be required to
take them? Will performance standards go up in every line of work,
leaving people who can't afford brain boosters in the dust? If we start
taking memory pills, will we end up losing our true selves? Will we grow
befuddled as endless trivia stick to our Velcro-like minds? Or obsessed
with painful memories that won't fade?
Harvard psychologist Daniel L. Schacter
explores such issues in a recent book, The Seven Sins of Memory. Most
memory glitches, such as absentmindedness, are actually byproducts of
desirable features of the mind, he argues. When we forget where we put
the keys, for example, we're typically operating on automatic pilot, a
supremely useful trick that frees up mental resources so that we can
attend to important things. Schacter doesn't
oppose trying to soup up our memories. He just shows what a tricky
business it will be.
Still, we aren't novices at it. Most of us already take memory boosters
every day--nicotine and caffeine, for instance, have both been shown to
transiently improve performance on memory tests. A 1993 British study
found that the more coffee subjects drank, up to about five cups a day,
the higher their average scores on various tests of cognition, including
on a memory quiz that involved recalling items from a list of foods.
Elderly subjects benefited the most--those who drank four to six cups
daily had scores roughly 8% higher than uncaffeinated
peers. (Tea drinking, the Brits observed, also seemed to boost memory,
though not as much as coffee.)
Sugar can give a brief memory boost too--the glucose that surges into the
blood after eating sweets serves as both fuel for neurons and a key
ingredient for making acetylcholine, a brain chemical that helps form
memories. No wonder Proust got a kick from his madeleine and tea.
Given all this, you might wonder whether iffy "smart drugs"
like ginkgo biloba can do even more for your
remembrance of things past than a trip to Starbucks. The answer may well
be no. Studies suggest that people with serious memory problems
experience modest improvements after taking ginkgo, says Harvard's Schacter, but the effect is probably due to increased
alertness much like that induced by a stiff cup of joe.
It probably won't ever be possible to develop a do-all memory pill. There
are many kinds of memory, for one thing--the motor programs we use to tie
shoes, the semantic memories underlying language, the high-level
"explicit" memories we draw on to tell our life story, to name
a few. Some kinds, such as the ability to remember faces and word
meanings, deteriorate little over the years. Others, especially the
memory systems we use to assimilate new things, seem distressingly
age-sensitive. A reason may be that the brain's processing speed declines
with age. The slowing likely impairs "working memory," a
crucial mental scratchpad that organizes new information before selected
parts are stored.
What's more, pulling levers in the black box of the brain is a very risky
business--the list of known memory enhancers includes not only addictive
drugs like nicotine but also deadly ones like strychnine. That helps
explain why big drug companies have shied from cognitive enhancement. And
why the key research in the area has been carried out by upstarts and
mavericks. Among them are the pioneers who now have MCI drugs ready for
trial.
Since the 1980s a distinguished team at the Russian
Academy of Medical Sciences in Moscow has pursued increasingly potent drugs related
to piracetam, a medicine widely used outside
the U.S.
as a cognitive enhancer. Another visionary is neuroscientist Cesare Mondadori, who led a
team at Ciba-Geigy, now part of Novartis, that discovered two of the most interesting
cognitive boosters on the horizon.
Perhaps the most remarkable member of the damn-the-torpedoes set is Glenn
"Buddy" Diamond, an entrepreneur who set out six years ago to
mitigate his son's Down syndrome. That congenital disorder causes not
only retardation but also progressive brain damage much like that of
Alzheimer's. Starting with zero funding and no drug industry experience,
Diamond managed to light a fire under the development of both the Russian
and the Novartis drugs, enlist some of
biotech's leading lights to back his cause, and inspire the formation of
David Pharmaceuticals--the startup is named after his 9-year-old son.
Known to associates as a brilliant, uncompromising polymath, Diamond was
a Minneapolis
consultant on business turnarounds when David was born. He soon became a
self-taught expert on Down syndrome. But his growing knowledge led to
frustration--no effective treatments exist for the disorder. To Diamond,
this seemed a totally unacceptable institutional failure. "The
conservative element always prevails in group settings" like large
drug companies, he says, "and risks need to be taken in areas like
this."
In 1996 he quit consulting to devote himself to what he calls pharmaco-archeology, the search for promising
experimental drugs languishing on academic and corporate shelves. He
sought out a retired Merck research manager as a mentor and began
dreaming of forming a drug company around his finds. His quest began with
piracetam, which has been tried as a remedy for
everything from Down syndrome to vertigo. Developed three decades ago in Belgium,
the drug (pronounced per-ASS-a-tam) has shown some ability in improving
memory and other cognitive functions in animal and human studies. But its
benefits have proved too limited to yield galvanizing data.
Diamond reasoned that chemical variants of piracetam
might be more potent. Working at home, he pored over the huge medical
literature on the drug. In 1996 he spotted a reference to the Russian
work in an obscure journal. As David sat on his lap, he typed an e-mail
inquiry about the work to one of the authors in Moscow, Rita Ostrovskaya.
Her reply sent father and son racing to the local patent library one
snowy afternoon.
Ostrovskaya, known for landmark studies in the
1970s on the workings of tranquilizers like Valium, had turned to
cognitive enhancement in the 1980s. She and colleagues created a series
of piracetam-like compounds. By the early 1990s
they had discovered versions that appeared to be 1,000 times more potent
than piracetam in animal and test-tube studies.
One version, GVS-111, showed special promise: It protected brain cells
from toxins and improved cognition in animal tests.
Wondering how they might attract commercial interest in the West, the
Russians in 1995 obtained a U.S. patent covering their
work. When the effervescent entrepreneur from Minneapolis contacted them out of the
blue a few months later, says Ostrovskaya,
"It was like God was helping us."
For Diamond, who knew he needed intellectual property to raise money, the
Russian patent was electrifying news. In 1997 he arranged for Ostrovskaya and her colleague Sergei
Seredenin to visit potential investors in Minneapolis. But the
millions of dollars needed to develop GVS-111 failed to materialize when,
Diamond says, "key investors lost their nerve." In 1998 he
concluded that the Midwest wasn't the right place to start a
brain-science revolution and took his one-man show to Silicon
Valley.
One of his first stops was the biotech powerhouse Genentech,
whose co-founder, the late Robert Swanson, had been impressed by
Diamond's gumption when the two met in 1996. Swanson's connections led
Diamond to David Pharma's future chairman, John
Patton, chief scientist at Inhale Therapeutic Systems in Palo Alto, and
David's future CEO, Rodney Pearlman, an energetic Australian transplant
who had also worked at Genentech. In June 1998,
Pearlman and Diamond sat down at a Palo
Alto restaurant to sketch plans for the startup.
Meanwhile, Diamond had unearthed another promising memory enhancer by
digging through reams of patent filings--a compound discovered a decade
earlier by Mondadori's team at Ciba-Geigy.
After talking to Mondadori, who had left the
company in 1994 and now works at a French biotech startup called Neuro3D,
"I realized I'd hit another vein of gold," Diamond says.
Gritty and unorthodox, Mondadori had spearheaded
an ambitious effort to develop memory enhancers in the 1980s. One of his
first achievements was to improve animal tests used to register drugs'
effects on memory. Typically such tests involve giving rodents
experimental compounds, then observing how well they retain new
information over minutes to hours. But such tests don't get at the kind
of memory enhancement that aging humans really care about, such as
improved ability to summon up details of something that happened
yesterday or last week, argues Mondadori.
"I wanted to find compounds that facilitate retrieval in older
animals," he adds.
To do that, his team maintained a colony of elderly mice, all of which
had undergone a singular learning experience: Each animal was placed on a
raised platform near the entrance to a dark, den-like compartment, like a
cliff dweller's home. When the mouse instinctively tried to hide in the
enclosure, it was repelled by a mild foot shock--the floor was
electrified. If the mouse was removed and, a few hours later, returned to
the platform, it would remember to defy instinct and stay out of the
shelter. But Mondadori's team found that over
several weeks the memory would fade and the rodent would act as if it had
never been shocked. That is, unless it were
under the influence of a drug that boosted memory in just the way Mondadori wanted.
After screening some 400 drug candidates with the test, his team finally
hit paydirt: A compound they dubbed 006 enabled
mice to remember the shocking experience for a full two months--an
eternity to a doddering rodent. The researchers eventually found two
other compounds that passed the demanding test, though one proved too
unstable to formulate as a drug. The slim pickings didn't faze Mondadori--as his team advanced the two drugs toward
clinical trials, it became clear that they could run circles around
existing drugs like piracetam in a broad array
of animal tests. But after more than a decade of work, the company put
the project on a back burner. "Upper management decided to concentrate
on Alzheimer's disease and stroke" rather than iffy problems like
mild cognitive impairment, says Mondadori, who
resigned soon after.
Fast-forward to 1997. "One Sunday evening I got a call from a man
named Buddy Diamond," Mondadori says.
"It was very strange. Somehow he knew about our work on 006,"
which had never been published in medical journals. "He asked me if
it would be available to license from Novartis."
With Mondadori's help, Diamond contacted the
Swiss company and, after months of tricky negotiations, persuaded it to
farm out the stalled project to his startup. Following up on the coup,
David CEO Pearlman negotiated a license for the second Novartis drug.
With the Russian and Novartis drugs in its
pipeline, David was set to seek a first round of venture funding. But
Pearlman, who had taken over fundraising, faced a stiff challenge--after
high-tech stocks tanked in early 2000, VCs got very stingy. Criss-crossing the country for a year, Pearlman
finally assembled a respectable $11 million first round that closed in
April. But there was a cost: Diamond, whose role was diminished when the
VCs took seats on the board, left the company. "My vision was
abandoned," he asserts. Pearlman counters that "once we moved
the company from a vision into reality, the vision itself had to
change." The products may still ultimately help Down sufferers.
Despite losing its pharmaco-archeologist, David
Pharma has nimbly darted to the vanguard in the
race to develop drugs for mild cognitive impairment. Two of its three
medicines have already undergone early safety tests in humans, and
efficacy trials are expected to begin within months. In September, NeuroInvestment spotlighted David as one of only two
companies poised to obtain efficacy data on novel drugs for MCI over the
next two years. (The other is Cortex.)
Several companies, including Memory Pharmaceuticals, should follow soon
after with effectiveness data on other drugs for MCI, predicts NeuroInvestment. The progress at large drug
companies, which have now entered the race but for competitive reasons
rarely talk about early-stage projects, is harder to gauge. Given that
boomers and other memory-challenged pill poppers already shell out an
estimated $1 billion annually for ginkgo alone, there's little doubt that
Big Pharma is putting serious money into the
quest for cognitive Viagras. Who knows? As we
boomers jog into the sunset, maybe we won't need to be chased by roving
vans after all.
Copyright 2001 Time Inc. All rights reserved. Reproduction in whole or
in part without permission is prohibited.
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