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China’s Canbridge nabs Puma’s Nerlynx for HER2+ breast cancer in $70M deal
BioWorld
The news source of record covering the development of innovative human therapies
Actionable Intelligence • Incisive Analysis
February 7, 2018 Volume 29, No. 26
http://www.bioworld.com/content/chinas-canbridge-nabs-pumas-nerlynx-her2-breast-cancer-70m-deal-0
or click here for a PDF version BioWorld 2
China’s Canbridge nabs Puma’s Nerlynx for HER2+ breast cancer in $70M deal
By Shannon Ellis, Staff Writer
SHANGHAI – Beijing’s Canbridge Life Sciences Inc. has acquired the greater China rights to Puma Biotechnology Inc.’s Nerlynx (neratinib) as an adjuvant for early stage HER2-positive breast cancer and other HER2 tumors, such as gastric cancer, which is highly prevalent in China.
The deal will provide Puma with an up-front payment of $30 million, with the possibility of another $40 million upon regulatory milestones. Royalties and sales milestones could also provide Puma with further payments.
Nerlynx, an irreversible tyrosine kinase inhibitor, was approved by the U.S. FDA in July. But the Los Angeles-based company encountered pushback from Europe’s regulators, with the Committee for Medicinal Products for Human Use (CHMP) indicating a negative trend vote last month. (See BioWorld, July 19, 2017, and Jan. 25, 2018.)
With poor prospects in Europe, Canbridge remains steadfast about Nerlynx’s chances in greater China. “We assessed the opportunity and even with the recent news from Europe, we will not waver in terms of our position to get this product to patients in China,” James Xue, Canbridge chairman, CEO and president, told BioWorld. “I want to emphasize this is a brand new drug that received U.S. FDA approval in an area that has very little treatment options and has a strong case for us to present to the authorities in our geographies, including mainland China, Taiwan, Hong Kong and Macau.”
Nerlynx is approved in the U.S. as an adjuvant for patients using Herceptin (trastuzumab, Roche Holding AG)-based therapy with HER2-positive breast cancer. About 20 percent to 25 percent of breast cancer patients overexpress the HER2 protein.
After a course of Herceptin, patients often have no additional treatment options, explained Xue. Depending on the individual, within about five years a significant number of patients – up to 25 percent – will find the cancer recurs in a very vicious form. Many patients lacking treatment options will die within six months; Xue called it “a very dire situation.” In China, that is especially so. “In terms of Chinese patients, the Chinese breast cancers are more aggressive compared to the western form and occur in a younger age group relative to the western patient population,” said Xue.
Assessing the global phase III MRCT data from Puma, Xue said a significant number of patients taking Nerlynx had reduced rates of recurring cancer vs. the comparator (according to Puma’s release it can be 34 percent). “This is a major accomplishment and clinical benefit for patients who do not have recurring cancer; they will live over five years,” Xue said. “And for those with recurring cancer, it allows those patients to have a chance at extended disease-free survival.”
Accelerated approval in China possible
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The large amount of data that Puma collected in its global pivotal study may help Canbridge seek accelerated approval in China. Post-ICH (International Council for Harmonisation) admittance, China’s regulators have said they will accept global data. Since a portion of the data collected by Puma also included Chinese patients and those of Asian ethnicity, there is a chance that Canbridge may be able to seek approval without a clinical study in China, or only a limited one.
“We believe that we will be able to leverage the existing data to a maximum extent for a shortened market approval pathway,” said Xue. “We will leverage the data that Puma has already built on a global scale, including Asian patients with their pivotal study. Over 2,000 patients enrolled in the pivotal study over five years – it is one of the most sophisticated studies ever done in breast cancer.”
But in Europe, regulators have raised concerns over the clinical relevance and risk-worthiness of Nerlynx in extended adjuvant use for women with early stage, HER2-positive breast cancer and asked for Puma to take “additional steps.”
Puma said the CHMP found a benefit-risk assessment for Nerlynx to be negative since it was based solely on evidence from a single pivotal trial and because “two- and five-year invasive disease-free survival benefits observed to date may lack sufficient clinical relevance.”
Another factor Canbridge will need to work through when discussing Nerlynx with Asian regulators are the side effects of Nerlynx, including grade III diarrhea. “Puma did a good job to educate us about how they developed effective patient management protocol for the side effects,” Xue said. “We looked at the data for the prevalence and seriousness of the diarrhea … the protocol developed by Puma should be very straightforward for us to adopt in China.”
Meanwhile, in the U.S., Puma is seeking to widen the scope of use for Nerlynx to more HER2-expressed cancers in a basket trial for patients with breast, cervical, biliary, salivary and non-small-cell lung cancers.
Canbridge will take the lead on gastric cancer, which is highly prevalent in China. The company will also seek out approval for other forms of HER2-positive cancers as well, including late-stage metastatic breast cancer in China.
Getting market ready
With many of China’s regulatory hurdles now lowered, Canbridge, like many Chinese biotech startups, is getting market ready for the first time. The firm’s plan is to see Nerlynx on the market by mid-2019. In advance of that, Canbridge’s CAN-002 for mucositis caused by radiation or high-dose chemotherapy should receive CFDA approval.
“The timing of this deal is excellent in terms of building a full-fledged commercial presence which is already underway,” said Xue. “This is transformative because it accelerates our vision to build a virtually integrated company from development to full commercialization. My team and I are very excited about Puma’s decision to choose us as a partner. We want to be
“I want to emphasize this is a brand new drug that received U.S. FDA approval in an area that has very little treatment options and has a strong case for us to present to the authorities in our geographies, including mainland China, Taiwan, Hong Kong and Macau.
James Xue
Chairman, President/CEO, Canbridge
known as the partner of choice in China and greater Asia area for such opportunities.”
The remainder of Canbridge’s pipeline is more early stage. CAN- 008 for glioblastoma multiforme is already in phase I trials in Taiwan. The biotech holds the greater China rights for CAN-008, which has been designated a MAH (marketing authorization holder) pilot project in China where it is seeking an IND. In addition, Canbridge’s CAN-017 is also seeking an IND in China for squamous cell esophageal cancer. Canbridge holds global rights for CAN-017, excluding North America.
Plaxgen Working to Expand Sales of Statin Test, Explore Lipid Morphology Data
360dx
Plaxgen Working to Expand Sales of Statin Test, Explore Lipid Morphology Data
Nov 21, 2017 | Adam Bonislawski
NEW YORK (360Dx) – Diagnostics firm Plaxgen is looking to expand sales of its StatRes test for predicting patient response to statins.
The Fremont, California-based company has been offering the test on an early-access basis through an agreement it signed last year with St. Joseph Health, a regional hospital system with five hospitals throughout Northern California and is now working to expand its reach through similar agreements with additional hospitals, said Shanmugavel Madasamy, Plaxgen’s founder and CEO.
The company is also investigating whether data on the morphology of cholesterol particles could help identify patients at risk of cardiac events and guide statin therapy. In September, company researchers and their collaborators published a study in the Journal of Visualized Experiments in which they found links between particle morphology and abnormal lipid levels, and observed changes in patient particle morphology following treatment with various statins.
Launched by Madasamy in 2007, Plaxgen uses a system that combines the capture of target biomarkers on plaque arrays with the isolation and analysis of those markers by techniques including flow cytometry and MALDI mass spectrometry.
The company’s plaque array system works essentially as an enrichment step, allowing researchers to investigate only plaque-related serum proteins, as opposed to the full serum proteome. The arrays are composed of soluble plaque-forming constituents that are then incubated with serum from test subjects. These plaque-forming constituents work as substrates for the plaque-related serum analytes, allowing for their pull-down and subsequent analysis.
Last year, the company published a paper on the StatRes test in the American Journal of Cardiology looking at 30 serum samples from patients with high cholesterol who went on to receive treatment with statins. It found that it was able to predict response in 13 of 15 patients receiving simvastatin and 12 of 15 patients on atorvastatin.
The company is now putting together a larger clinical validation trial in which it plans to follow thousands of patients over the course of four years. Madasamy said it hopes with that data to take the test through the US Food and Drug Administration regulatory process. Plaxgen currently offers the StatRes test as a laboratory-developed test through its CLIA lab.
In the JoVE study, the company paired its plaque capture system with analysis by imaging flow cytometry, which allowed it to study the shape of circulating cholesterol particles.
ESPN Deportes — ESPN’s 24-hour, Spanish-language sports network http://www.devensec.com/devserv.html viagra prescription in the U.S. will carry the NASCAR Nationwide Series race telecast and the Daytona 500 with NASCAR-related programming and coverage. You need to see that you taking the medicine in proper discount levitra purchase way. Glutathione’s role in liver detoxification is devensec.com super cheap viagra paramount. The major ones are loss of vision hearing and erection longer than 4 cheapest viagra tablets hours. “In general, it’s understood that in atherosclerosis, not only the number of particles, but also the morphology and size of the particles, plays an important role [in the condition],” Madasamy said. However, he noted, the role of morphology has seen relatively little study compared to work focused on quantification of lipids involved in atherosclerosis.
The researchers used Plaxgen’s technology coupled to imaging flow cytometry to compare the morphology of cholesterol particles in 50 patients with plaque disease and age-matched healthy controls, and found that the subjects with plaque disease had higher levels of linear-shaped particles (mean of 18.3 percent) compared to healthy controls (mean of 11.1 percent).
They also used the platform to look at the changes in morphology of cholesterol particles in response to treatment with various lipid-lowering agents, incubating isolated particles with lovastatin, simvastatin, atorvastatin, rosuvastatin, fluvastatin, ezetimibe, fibrate, niacin, and omega-3 fatty acid. They analyzed drug-induced morphology changes and found that lovastatin, simvastatin, atorvastatin, and ezetimibe induced the formation of both linear and globular morphologies, while rosuvastatin, fluvastatin, fibrate, niacin, and omega-3 fatty acid induced formation of only globular particles.
The results, Madasamy said, suggest both the role of morphology in plaque disease and that different lipid-lowering drugs may have different effects on this morphology.
“We believe that in specific populations, the morphology data could be a biomarker to complement [existing] diagnostics to improve accuracy,” he said. “Because, yes, a patient’s lipid levels can look fine, but they can still have a heart attack or stroke.”
Madasamy said Plaxgen is now applying its morphology analysis to the amyloid-beta plaques characteristic of Alzheimer’s disease, another area of focus for the company.
“We are expanding to that and have data that we hope to publish next year,” he said.
PATIENTS LEAD THE WAY
Click here to read the full article…
BY EMILY CUKIER-MEISNER, SENIOR WRITER
FDA’s draft guidance on Duchenne muscular dystrophy and related
dystrophinopathies is the culmination of an extensive e6ort led by a
patient advocacy group that enlisted the support of patients, caregivers,
academia and industry.
DMD drug development has been hindered by a lack of defined outcome
measures and understanding of surrogate markers or biomarkers that
Relationship Between Uric Acid and Erectile Dysfunction Uric acid is blamed to be the main culprit when it actually comes to gout and as such, it has become an interesting factor of concern while talking about lovemaking conditions including ED. cialis discount pharmacy People due to certain work load or stress tend to a victim of some worst issues which can be controlled through diet therapy and exercise therapy, the rest all need drug treatment. lowest price for viagra Suppose there was a female libido enhancer that would be just as effective. best soft cialis The effects are not for very long and are simply for the viagra prescription purpose of intercourse. could support approval. To address this, FDA invited Parent Project
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FDA spokesperson Kristofer Baumgartner said in a statement to
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Drug Evaluation and Research’s knowledge that an advocacy group has
submitted a proposed draft guidance, and that this type of engagement is
an example of how early input from patients and caregivers can contribute
to drug development.
Plaque Array method links blood plaque components to Alzheimer’s
Click here to read full article…
Study on Plaxgen
Alzheimer’s disease blood
diagnostic published in
peer-reviewed journal
BY LLOYD DUNLAP
SUNNYVALE, Calif.—Plaxgen Inc., a developer
of flow cytometry-based blood diagnostics for
plaque-associated illnesses such as atherosclerosis
and Alzheimer’s disease, announced that a paper
validating its Plaque Array technology for the diagnosis
of Alzheimer’s disease was published in the
peer-reviewed journal Clinica Chimica Acta.
In a study titled “Plaque Array Method and Proteomics-
based Identification of Biomarkers from
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that the Plaque Array methodology developed by
Plaxgen works well for detecting amyloid beta
(Abeta) and other particle formation in the blood
serum of subjects clinically determined to have
Alzheimer’s disease (AD).
As stated in the paper’s abstract, progressive
accumulation of amyloid plaques in the regions
of brain, carotid and cerebral arteries is the leading
cause of Alzheimer’s disease and related dementia
in affected patients. The early identification
of individuals with AD remains a challenging
task reliant on symptomatic events, and thus the
development of a biomarker-based approach will
significantly aid in the diagnosis of AD.
‘Titer’-ing on brink of BLA, Adma’s added endpoints encourage outcomes in RSV
Click here to read the full article…
Recent outbreaks of respiratory syncytial virus (RSV) in Alabama, Arizona and Colorado children put renewed attention on the disease for which there is no approved therapy in adults, just as Adma Biologics Inc. reported more data from the pivotal phase III trial with RI-002 in primary immune defi ciency (PIDD) that included encouraging results in RSV and other pathogens.
“We’re unable to draw any conclusions about efficacy [against the specific infectious agents] from these increases in antibody titers, but it’s good to note that from the patients the trial was based on, we were able to generate this type of dose response, if you will,”
Adam Grossman, Adma’s CEO, told BioWorld Today. “We think it’s encouraging, and we think that clinicians, patients and payers want to know that, by infusing IVIG products, they’re getting this bump” in protection.
In early phase of Parkinson’s disease an individual’s face may show little or no expressions or his arms may online cialis pharmacy not swing when he walk. Wait for 30 t0 45 minutes drscoinc.com order viagra online for the effects to show of erection. On the other hand, with proper therapy, many people with cerebral palsy can still lead normal lives. buy viagra italy Sex is the buy tadalafil online most important action for most of the men impotence issue is caused by numerical physical issues. Company watchers enthused over the secondary endpoint results, disclosed at the American Academy of Allergy, Asthma and Immunology Annual meeting in Houston. Although Ramsey, N.J.-based Adma’s shares closed Wednesday (NASDAQ:ADMA)
at $10.05, fl at, analysts at Ladenburg Thalman set a $17.50 price target, Maxim Group went higher to $18 and Laidlaw & Co. forecast $20.
In December, Adma made known top-line data demonstrating that RI-002, a plasma-derived, polyclonal, intravenous immune globulin (IVIG) product, achieved its primary endpoint of preventing serious bacterial infections: zero, which is even below the FDA’s requirement of less than one per patient-year. The pharmacokinetic profile of total immunoglobulin G was consistent with the FDA’s guidance, too. (See BioWorld Today, Dec. 4, 2014.) Added results made RI-002’s picture even brighter. In the multisite study of 59 patients diagnosed with PIDD, researchers reported secondary endpoints that included a total of 93 days, or 1.66 days per patient per year lost from work or school due to infection, and one hospitalization due to an infection of only fi ve days duration in the entire study, with immunoglobulin G trough levels above those required by the FDA for IVIG products.
A marked increase in all of the measured specific antipathogen antibodies turned up, with the greatest increase, 5.3-fold, seen in the level of neutralizing antibody titers to RSV, which “offers an area of potential differentiation from other IVIG products and is in line with our expectations, based on the donorscreening profile,” wrote Ladenburg analyst Kevin DeGeeter in a research report. “However, we were surprised to learn that patients also reported a statistically signifi cant increase in antibody titers against two other common respiratory pathogens,” which means the compound “may have the potential to protect against a broad range of clinically important respiratory pathogens, which could strengthen the argument for premium pricing compared to other IVIG products.” Specifically, the findings showed an increase in H. infl uenzae antibodies and in S. pneumoniae antibodies.
Human Stem Cells Help Acute SCI Rats; Chronic Trial Update
Human Stem Cells Help Acute SCI Rats; Chronic Trial Update
Posted by Sam Maddox
Friday, May 31, 2013
A study was published this week showing that rats improved function after receiving transplants of Neuralstem, Inc.’s human neural stem cells three days after a spinal cord contusion injury (at L3). The study, “Amelioration of Motor/Sensory Dysfunction and Spasticity in a Rat Model of Acute Lumbar Spinal Cord Injury by Human Neural Stem Cell Transplantation,” was led by Martin Marsala, M.D., of the University of California, San Diego (UCSD) School of Medicine.
The human cells in this experiment — they call them NSI-566 cells — are derived from a single, legally aborted fetus; these are the same ones used by Neuralstem in 15 patients in an ALS safety trial. They are also the same ones set for clinical trial in chronic SCI, which we will get to in a minute.
In all cases, the cells are injected into the exposed spinal cord in several locations; so far, they appear to be safe. For the ALS trial, the company reported earlier this month that the procedure “was found to be safe, well-tolerated, and promising for other spinal cord conditions.”
The company also notes that some of the patients benefited from the cell transplants. A 39-year-old man with ALS, Ted Herada, got two sets of stem cell transplants. After the first, in 2011, he was recovered a meaningful degree of function, then declined. A year later, he got more cells. Neuralstem reports that Ted recently completed 2.5 -mile fundraising ALS walk in Atlanta, “still going strong past finish line.” He is “Living a normal life: walking, climbing stairs, hands stronger again, increased dexterity.”
Says Principal Investigator Eva L. Feldman, M.D., University of Michigan, from a release, “Although this phase of the trial was not powered to demonstrate efficacy, we appear to have interrupted the progression of the disease in one subgroup of patients. We are anxious to move to future trial phases to examine therapeutic efficacy.”
Indeed, a Phase II trial with much larger cell dosage has been approved. From the company:
The Phase II trial is designed to treat up to 15 ambulatory ALS patients, in five different dosing cohorts, advancing up to a maximum of 40 direct injections and 400,000 cells per injection, based on safety. This compares to a maximum of 15 injections of 100,000 cells each, directly into the gray matter of the spinal cord, in the completed Phase I trial. The first 12 Phase II patients will receive injections in the cervical region of the spinal cord only, where the stem cells could help preserve breathing function; the final three patients will receive both cervical and lumbar injections.
And yes, as we reported in January a clinical trial is being prepped for chronic spinal cord injury – for those one to two years post. It is expected to begin enrolling patients this summer as centers and institutional approvals are lined up. The company hasn’t released any information about the trial but a look at the trial detail at clinicaltrial.gov shows that several centers have been identified:
• Crawford Research Institute at the Shepard Center in Atlanta. Former Reeve Foundation International Research Consortium on Spinal Cord Injury Associate Keith Tansey, M.D., Ph.D. is listed as principal investigator for the study. (keith_tansey@shepard.org).
• University of Miami
• Thomas Jefferson University Hospital, Philadelphia
ED can result from any kind of issues from these. pfizer viagra großbritannien While there are myths about pharmacy stores being unprofessional and unethical also there are various online pharmaceutical companies that follows a strict international and cialis 40 mg local legislation. cialis generico online Since sexual dysfunction is really a painful issue for women and hair loss, too. Generally, individuals will not face serious complications when using the order levitra online medication. 3. • Medical College of Wisconsin, Milwaukee
• Karl Johe, the chairman and chief medical officer of Neuralstem, announced this week that UCSD Medical School would also be one of the trial centers. For more about this site, contact Adrienne Rebollo, arebollo@ucsd.edu.
I spoke with Johe: “The dogma has been that human cell transplants to the spinal cord were not feasible. First, the environment is too hostile, due to necrosis and inflammation. Second, there is no way to overcome this. We have shown here [in the acute rats], however, that our human cells integrate into the animals. Most of the stem cells die. Some survive and they proliferate in the injured area; they continue to divide until they fill the cavity. At that point they begin to differentiate into neural tissue.”
According to Marsala, the 556 cells appear to be doing two things: stimulating host neuron regeneration and partially replacing the function of lost neurons. “Grafted spinal stem cells are a rich source of different growth factors which can have a neuroprotective effect and can promote sprouting of nerve fibers of the host neurons. We have also demonstrated that grafted neurons can develop contacts with the host neurons and, to some extent, restore the connectivity between centers, above and below the injury, which are involved in motor and sensory processing.”
Johe said his 566 cells appear to reduce the size of injury. “Our studies with MRI show that the surface area of scar is much, much less. The stem cells also appear to stabilize the injury – the cells restore the integrity of the tissue. The fact the animals showed reduced spasticity is a sign of reduced secondary damage,” said Johe.
“Rats often recover spontaneously,” said Johe, “so it is difficult to demonstrate a functional benefit; but the animals in our study have more accurate foot placement and better coordination of limb movement.”
Chronic SCI Trial
Johe wasn’t able to predict when this trial would commence – this summer, he hopes. He acknowledged that there has been great interest – the word chronic is extremely rare in SCI trials.
Johe thinks his stem cells are versatile and robust enough to make a difference in both acute and chronic SCI, stroke, even brain cancer. Stem cells, he said, are not like drugs, which might target a specific process or action. “Stem cells are more like a shotgun – they offer many possible actions and mechanisms. A plethora of effects will be required for a reconstructive treatment in the spinal cord.”
Here’s a summary of the chronic trial, from a release
This open-label, multi-site study will enroll up to eight patients with thoracic spinal cord injuries (T2-T12) who have an American Spinal Injury Association AIS-A level of impairment, between one and two years post injury. These patients exhibit no motor or sensory function in the relevant segments at and below the injury, and are considered to be in complete paralysis. Study patients will receive six injections in, or around, the injury site: the first four patients will receive 100,000 cells per injection; the second four patients, 200,000 cells per injection. All NSI-566 SCI patients will receive post-surgery physical therapy, as well as immunosuppressive therapy, which will be for three months, as tolerated. The trial study period will end six months post-surgery for each patient. The primary objective of the study is to determine the safety and toxicity of NSI-566 for the treatment of paralysis and related symptoms due to SCI. The secondary objectives are to evaluate graft survival in the transplant site by MRI, as well as the effectiveness of transient immunosuppression.
It is anticipated that each individual medical center will handle its own recruitment. We’ll pass along more information as it is available.
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Stem Cell Firms Struggle for Financing
Sep 1 2007 (Vol. 27, No. 15)
Stem Cell Firms Struggle for Financing
Lack of Proper Information, Over-regulation, and Confusion over IP Incites VC Hesitance
Gail Dutton
Venture capitalists say that they are very interested in stem cells but not enough to start funding stem cell companies. Right now, the business case for investment isn’t there. “Great science doesn’t equal great business,” points out Gregory A. Bonfiglio, managing director at Proteus Venture Partners.
Financiers, just past the stinging losses of the dot-com heyday, need a stronger business case nowadays for investments. In fact, it’s not just stem cell companies that are suffering. Venture capital in general is down from more than $100 billion in 2000 to less than $20 billion in 2006, Bonfiglio points out. Investments in all forms of regenerative medicine accounted for about $190 million, or less than 2% of total healthcare funding in 2005.
“VC’s goals beyond a minimum fivefold return are to get a company through two rounds of financing and generate human proof of concept—generally Phase IIA data—or build a broad platform with a strong intellectual property position that could create a lot of pipeline opportunities,” according to Doug Fambrough, Ph.D., partner, Oxford Bioscience Partners.
“I don’t think that exists in the stem cell world,” he says. “People don’t see the broad intellectual property protection that gives companies the freedom to operate and the ability to exclude. Therefore, I wouldn’t invest in a platform but in therapeutic opportunities.”
Stem cell based drugs, Dr. Fambrough adds, must have large potential markets, significant benefits compared to competitors, and the ability to be commercially supplied. A company needs to have its core research completed with proof of concept as well as a strong management team and a sturdy intellectual property position, Bonfiglio continues. Because so many of these ingredients are not yet apparent, Dr. Fambrough says he’s only interested in providing second-round financing.
Literature of Disinformation
There’s a certain bitterness expressed by stem cell company execs toward venture capitalists. The perception is that venture capitalists are risk averse, more so than even microcaps, institutional investors, or hedge funds, according to Richard Garr, J.D., CEO of Neuralstem (www.neuralstem.com). Another exec even went as far as to say that venture capitalists were “brain dead” for not embracing a technology that has the potential to become more important than recombinant therapy.
“Venture capitalists don’t understand the science at all, and they can’t go to their usual suspects for guidance, because they either are aligned with somebody’s technology,” Garr comments, or they are too far removed from the field to comment intelligently. “The private sector, in many areas, is way ahead of the academic sector in the stem cell world.”
Research has been conducted on embryonic stem cells for slightly more than a decade but has been sharply limited in many nations. “A lot more is known about adult stem cells,” Bonfiglio says, as they have been the object of research for the past 40 or more years. “But, they are limited in scope. Embryonic stem cells address any disease in the body. The problem is finding and isolating them.”
Tom Okarma, president and CEO of Geron (www.geron.com), points to the “literature of disinformation.” Some researchers, “are furious about the fact that original stem cell lines are officially fundable and they are not getting funded,” he elaborates. Others criticize the quality of the original lines, muddling the issue for scientists and financiers alike.
According to Okarma, research papers suggest that the original stem cell lines approved for NIH research by President Bush in 2001 were contaminated and thus unfit for clinical trials. Yet, Geron is using two of those original lines successfully. The difference, he says, is that Geron treated the cells under GMP conditions. “The scientific community generally doesn’t understand that. Most academics have no experience producing or qualifying cells for human therapy.”
There’s another fallacy, too. A big question is whether human embryonic stem cells are scalable. Dr. Fambrough thinks not, presenting a repugnant specter of harvesting cells from fetal cadavers. Geron’s Okarma bristles at the notion, dismissing it as a gross inaccuracy. “We’ve done hundreds and hundreds of population-doubling procedures for some of our lines without any changes in the cells. Our lines are 100 percent scalable, are Bush-approved, and two of them are fully qualified for human use.”
No Consensus on IP Status
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Impact of U.S. Regulation
The myriad of conflicts within the field is the direct result of the 2001 restriction on stem cell lines approved for federally funded research in the U.S., according to Okarma. “We need more science,” Okarma insists. “The field is in a state of confusion.” Since 2001, he says, the NIH has invested $2.8 billion in adult stem cell research and only $130 million on embryonic stem cell work. Consequently, individual companies have done the heavy lifting.
Firms are thus focusing on adult stem cells, effectively lessening the body of knowledge on their embryonic counterparts and the stem cell field in general. The latter will result in longer approval processes as lead candidates approach the FDA and other regulatory bodies in preparation for clinical trials.
To replace those peer-reviewed studies, companies will have to perform additional large investigations themselves. For example, big Phase III evaluations will be needed to correlate surrogate endpoints with clinical improvement. Such trials are on a scale that only big pharma can bear, if they are willing to buy in, Dr. Fambrough says. So, to attract venture capital, a lot of elements need to come together, including a clinical development path a small company can handle, he adds.
“The key to attracting funding is to be close to the clinic with a good IP position,” Garr emphasizes, “and it would be very difficult now to come up with something close to the clinic that is not already in one of the existing companys’ areas.”
Those who believe you have to make individualized therapies for each patient won’t get funded because that approach isn’t scalable, Okarma emphasizes. Yet, Tengion (www.tengion.com), a tissue engineering company founded in 2003, raised $50 million in a Series B financing in June 2006 for a total of $112 million. It began Phase II trials for a bladder construct last January using a patient’s progenitor cells that aren’t yet fully differentiated.
Financial Options
The financing plan for Neuralstem, according to Garr, has been very simple. “Avoid the VCs.” Founded in 1996, it has relied on private placements and grant work to advance its work in fetal-derived stem cells. Currently, Neuralstem is in the process of migrating from the OTC Bulletin Board to the American Stock Exchange and expects to begin its first human trial in 2008.
Garr says there’s an elitist attitude among VC firms. “If you are not hooked up with Harvard or Stanford, they don’t take you seriously.” That’s true for the NIH, too, Bonfiglio adds. “The NIH is focused more on stature within the academic community. DARPA, however, is more interested in the technology.”
Funding prospects may improve, although it will take some time. The prevailing sentiment is that the next U.S. presidential administration will lift the ban on stem cell research. “The political drive seems to be there,” Dr. Fambrough says. Garr predicts that the U.S. Senate has enough votes to overturn the ban, but the U.S. House of Representatives will hold firm. Yet, he says, “It’s a question of when, not if.” He also says that there is the strong possibility that a bill overturning the ban will be attached this year to must-sign legislation, like the Department of Health and Human Services funding bill.
Exit Strategies
As firms enter Phase II trials, they are beginning to consider their next financial moves. Traditionally, when Phase II is completed, venture capitalists are ready to exit. As one strategy, Bonfiglio mentions mergers as a potentially attractive option, as they provide cash upfront and stock in a liquid company. “Average merger and acquisition returns are now 2.5 times higher than IPOs. Other options include a reverse merger with a public shell company or a private investment in a public entity.”
Listing the stock on the London Stock Exchanges’ Alternative Investment Market (AIM) is another opportunity, he says. Admission to AIM takes three to six months and is less regulated than NASDAQ, as Sarbanes-Oxley and SEC regulations are not involved. AIM also has smaller costs and fees, a lower threshold for listing, and a broad international mix of companies.
When it comes to funding, a good location indirectly helps. Naturally, companies in locations with a strong pharmaceutical industry, human capital, and support infrastructure have an advantage. Beyond that, some countries like Singapore and some U.S. states like California are funding stem cell initiatives.
If the other infrastructure is lacking, however, the funding can be largely irrelevant in producing viable results. “The money hasn’t really materialized,” Fambrough concludes.
Aastrom Will Test Stem Cells in Patients With Diseased Limbs
Aastrom Will Test Stem Cells in Patients With Diseased Limbs
By Rob Waters
April 30 (Bloomberg) — Aastrom Biosciences Inc. will begin a clinical study using people’s own stem cells to improve the poor blood circulation that has damaged their legs, a condition known as critical limb ischemia.
U.S. regulators have given the company permission to begin trials, based on results from a small pilot study in Germany that suggested the treatment was safe, said Elmar Burchardt, vice president of medical affairs at the Ann Arbor, Michigan, company.
About 900,000 Americans suffer from limb ischemia, which can impair the body’s ability to heal wounds and leads to 100,000 amputations each year, according to the U.S. Centers for Disease Control and Prevention. The condition is the most serious form of peripheral artery disease, which occurs when blocked arteries impede the flow of blood to the legs. It affects about 10 million people in the U.S.
“These are critically ill patients,” said Burchardt, in a phone interview. “Their wounds are not closing and they have a very high risk of having to undergo an amputation.”
The trial will include 120 patients at 20 centers around the U.S. Doctors will take bone marrow cells from the patient’s hips and send them to Aastrom, which will process them to increase the number of stem cells while keeping them from turning into other cell types.
Bone marrow is one of the places in the body where so- called adult stem cells are found. These cells have the ability to turn into cartilage, bone and blood and are part of the body’s own system for repairing injury and disease.
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In half the patients, the amplified cells will then be injected at multiple points in their legs, above and below the knee. The other patients will go through the same procedure but won’t get real stem cells.
“The idea is you cover a large area with injections, stimulate vessel growth and improve blood flow in the limb,” Burchardt said.
Eight patients went through this procedure in the German study, Burchardt said. About half have passed the one-year mark, and all of those showed signs that their wounds were healing. None of the eight patients experienced any adverse effects, he said.
If successful, results from the larger U.S. study “may apply to all ischemic diseases,” said Anthony Comerota, director of the Jobst Vascular Center in Toledo, Ohio, in a statement e-mailed by Aastrom. He is the study’s lead investigator.
The study could thus help validate the idea of using stem cells to treat heart disease. The first results from the new study won’t be available until patients have been treated for a year.
To contact the reporter on this story: Rob Waters in San Francisco at rwaters5@bloomberg.net .
Last Updated: April 30, 2007 07:01 EDT