CDU International Correspondent
LONDON — ReNeuron (Guildford, UK) in early December submitted the further data requested in the investigational new drug file for its stem cell treatment for stroke, keeping it on track to be the first to carry out an FDA-approved trial of neural stem cells in a major neurological disorder. The file, originally submitted a year ago, was put on hold in January.
The company was asked to complete a number of further pre-clinical studies, the most important examining the long-term safety profile of the product, ReN001 in a specialized rodent stroke model. The data showed no unusual or adverse safety effects in either control or treatment groups.
John Sinden, chief scientific officer, said the company was "very confident" that it had met all the FDA's requirements. "We have not just taken advice from our [own sources], we've spoken to key senior FDA people and FDA lawyers," he said.
Getting the go-ahead this time is critical for the company, which had cash of pounds 5.7 million at the end of September, enough to last until 3Q08. If the response is positive, and pending local ethical approval, the 10-patient trial will go ahead under Douglas Kondziolka at the University of Pittsburgh Medical Center. The treated patients will be in a stable condition four months post stroke and carefully selected to ensure they have no other underlying or pre-existing neurological pathologies. The trial will look at a number of measures of disability.
ReNeuron has been to talk to the UK Medicines and Healthcare Regulatory Agency to discuss the requirements for conducting a UK trial. "We talked to them when we were first interested in getting into the clinic over two years ago, but they were not able to regulate this type of product," said Sinden. "Talking to them a month ago, it is obvious they have moved on really well, and we got a very good reception."
To back a move into the clinic in the UK, the company has appointed Philip Bath, professor of Stroke Medicine at Nottingham University, onto its clinical advisory board. Bath is an expert in drug trials in stroke at both pre-clinical and clinical level.
Although eager to do a trial in the UK, Sinden said ReNeuron will wait to see what happens with the FDA application before proceeding further.
ReN001 is a clonal neural stem cell line generated from fetal brain tissue. The cell line is expanded at an industrial scale using the company's c-mycER gene, which is then switched off prior to transplantation, preventing further proliferation. The product improves functional recovery in rat models of stroke.
The patented c-mycER stem cell expansion technology has been used to generate stable human pancreatic cell lines for Type I diabetes also. The cell lines form islet cell clusters that secrete insulin in response to glucose concentrations, and express phenotypic markers for insulin-producing islet cells.----
F&S: cardiac IR growing fastest in sector
Cardiac interventional radiology represents the fastest-growing segment in the interventional radiology market, according to a new report from global consulting firm Frost & Sullivan (F&S; London). The report says that more than 40% of Europe's population suffers from cardiac diseases, with such patients preferring minimally invasive imaging procedures for related diagnosis and therapy.
The report, "European Interventional Radiology Markets," covers trends in interventional radiology markets in Europe and says that the sector is registering "steady growth," driven in part by more sophisticated and rapid imaging ... gradually widening the application area for interventional radiology and supporting market expansion." The interventional radiology market earned revenues of $399.5 million in 2006, according to the F&S study, and it estimates this to reach $683.3 million in 2013.
"Advances in the field of medical instrumentation and in radiological imaging technology have led to the rapid development of interventional procedures," says F&S Research Analyst Darshana De. "[So] the market in Europe is growing steadily due to the large number of cost-effective interventional procedures being performed in lieu of surgery."
Vascular interventional radiology, dedicated mainly to the detection and treatment of peripheral arterial diseases, is the second-largest segment in the market, according to De's report. Growth in this segment is "likely to be partially retarded" due to competition from other non-invasive imaging techniques.
The report says the lack of dedicated neuro centers across Europe, high prices for equipment and specific installation requirements have restricted the neuroradiology market to a very small size — it comprises the smallest segment in the market.
"However, with the technological advancements and faster imaging technologies, there will be significant market growth in the overall European interventional radiology markets," De says.
The major challenge for market participants will be to provide products that can be integrated with PACS, electronic medical records and other hospital IT systems. Another area of concern is the lack of well-trained radiologists.
The financial crisis faced by European healthcare systems presents a threat to sustained market growth, according to the report. To curb expenditures, governments across Europe have slashed healthcare budgets, F&S says, "making it difficult for hospitals and clinics to purchase new medical equipment."
To overcome this challenge, companies will need to produce cost-effective equipment to required specifications. "Producing a fully functional system and then assembling it according to the needs of the end users would make it easier for industry participants as well as end users," says De.----
OrbusNeich reports registry for Genous stent tops 5,000
OrbusNeich (Hong Kong) reported last month that 5,000 patients treated with its Genous stent at more than 120 sites in 29 countries are now enrolled in the global e-HEALING registry.
The e-HEALING clinical study is a multi-center, worldwide (outside the U.S.) prospective registry of patients treated with the Genous Bio-engineered R stent. The study protocol recommends that patients receive one month of clopidogrel treatment after the procedure. Clinical follow-up takes place at 30 days, six months and 12 months. The primary endpoint of the registry is target vessel failure at 12 months.
"We reached this significant enrollment milestone earlier than expected," said Sigmund Silber, MD, co-principal investigator of the study. "This reflects an increase in demand and use for Genous by physicians concerned with drug-eluting stents [DES]."
The company differentiates the product from drug-eluting stents, saying that Genous is coated with an antibody that captures a patient's endothelial progenitor cells (EPCs) to accelerate the healing process. EPCs circulate in the bloodstream and are involved in the repair of blood vessels. When attracted to the surface of Genous, EPCs rapidly form an endothelial layer over the stent that provides protection against thrombus and minimizes restenosis.
"Completing enrollment in this large registry is an important milestone in our clinical development," said Samuel Rasmussen, president/CEO of OrbusNeich..
OrbusNeich makes a variety of devices for the treatment of vascular diseases. In addition to Genous, those products include stents, balloons and guiding catheters marketed under the names of Blazer, R stent, Sapphire, Avita, Avita HP, SafeCut, Lumina and Saffron.
In addition to its Hong Kong headquarters, the company has operations in Fort Lauderdale, Florida; Hoevelaken, the Netherlands; and Shenzhen, China.----
CVRx receives CE mark for Rheos hypertension treatment
CVRx (Minneapolis) reported in November that it has received CE-mark approval for its Rheos Baroreflex Hypertension Therapy System, which it said is the only implantable device designed to control hypertension.
The company said the system was approved for marketing in Europe based on clinical studies conducted in both Europe and the U.S.
CVRx said the Rheos System provides a "physiological rational" method to reduce blood pressure (BP), using the body's own natural BP regulation system, baroreflex, to control blood pressure.
The Rheos System includes a small pulse generator implanted under the collarbone; two thin lead wires that are implanted at the left and right carotid arteries and connecting to the pulse generator; and the Rheos Programmer System, an external device used by doctors to non-invasively regulate the activation energy from the generator to the lead wires.
The company said the system "electronically activates the baroreflex," which sends signals to the brain suggesting a blood pressure increase. "The brain then acts to lower blood pressure by sending signals to various parts of the body to reduce blood pressure, including the blood vessels, heart and kidneys."
Abstract results published recently in the Journal of Hypertension reported a significant decrease in BP with the Rheos at 12 months. One-year results from 13 patients showed a 39 mmHg average decrease in systolic BP and a 26 mmHg average decrease in diastolic blood pressure.
Citing receipt of the CE mark as "an important milestone for our company," Nadim Yared, president/CEO of CVRx , said, "Currently, we are focused on advancing the Rheos Pivotal Trial in the U.S. Patient enrollment in the Rheos Pivotal Trial is under way, and we expect outcomes from this study to support our pre-market approval application to the FDA."
CVRx received investigational device exemption approval from the FDA to begin the Rheos Pivotal Trial evaluating the safety/effectiveness of the Rheos. The trial is enrolling 300 patients at multiple clinical sites in the U.S. and Europe.
The company noted that hypertension affects about 65 million people in the U.S. alone. It is estimated to cause one in every eight deaths worldwide.----
1st Stereotaxis procedures completed with new catheter
Stereotaxis (St. Louis) reported in November that the first atrial fibrillation (AF) procedures performed with its partnered magnetic irrigated catheter were successfully completed. The magnetic irrigated catheter has CE-mark approval for the remote ablation of arrhythmias and is being released "in phases" to physicians in Europe, the company said.
"The first uses of our partnered irrigated catheter in Europe are a double achievement," said CEO Bevil Hogg. "First, the cases were remarkable for their efficiency and efficacy, and we are extremely pleased with the results. Secondly, combined with our Stereotaxis Magnetic Navigation System and new NaviLine software, the irrigated catheter completes Stereotaxis' total solution for atrial fibrillation, a solution that we believe will significantly advance the treatment of complex arrhythmias and potentially become standard of care for a growing number of cases."
"Near-term, we believe that widespread adoption of our partnered magnetic irrigated catheter in Europe will bring even greater simplicity and safety to AF procedures performed there, and we look forward to these clinical benefits becoming available to patients and clinicians in the U.S. after appropriate regulatory approval," Hogg said.
Stereotaxis makes an advanced cardiology instrument control system for use in a hospital's interventional surgical suite to enhance the treatment of coronary artery disease and arrhythmias.
The Stereotaxis system is designed to enable physicians to complete more complex interventional procedures by providing image-guided delivery of catheters and guidewires through the blood vessels and chambers of the heart to treatment sites.
The system uses computer-controlled, externally applied magnetic fields that govern the motion of the working tip of the catheter or guidewire, resulting, the company said, in "improved navigation, shorter procedure time and reduced X-ray exposure."
The core components of the Stereotaxis system have received regulatory clearance in the U.S., Europe and Canada, but use of cardiac ablation catheters for treatment of AF still is considered investigational in the U.S., the company said.----
Datascope in distribution pact for catheters in Japan
USCI Holdings (Tokyo) and Datascope (Montvale, New Jersey) last month entered into a distribution agreement for Datascope's Intra Aortic Balloon Pumps (IABP) and Intra Aortic Balloon (IAB) catheters in Japan. The accord gives USCI exclusive rights to distribute the currently approved CS100 IABP, prior pumps and future IABP technologies. USCI also will distribute Datascope IAB catheters, including those specifically designed for the Japanese market.
Datascope said USCI is "one of the premier medical device distribution organizations in Japan [and] provides Datascope with exceptional sales and service coverage from the southern island of Kyushu to the northern island of Hokkaido." It said USCI has "especially strong service capabilities in the densely populated corridor that includes Tokyo, Nagoya and Osaka"
USCI Japan, a unit of USCI Holdings, has about 170 employees supporting its Japan operations. The company's USCI Ireland R&D and manufacturing center in Ballinasloe, Ireland, employs another 60.
"This is a major step toward achieving our vision of becoming a global company for the global vasculature. Our holding group is quite strong in interventional cardiology, cardiac rhythm disease management and cardiac surgery. The Datascope Cardiac Assist Division product line fits perfectly with our strategic focus and will help us service our two most important stakeholders, cardiac care physicians and their patients," said Michael Van Zandt, president/CEO of USCI Japan and COO of USCI Holdings.----
Cardiatis reports first use of FluidSmart stent for RAA
Cardiatis (Brussels, Belgium) last month issued a follow-up report on treatment of the first renal artery aneurysm (RAA) patient with its FluidSmart 3-D Multilayer Braided Stent, an investigational device in the European Union, which the company termed "a next-generation technology" for endovascular aneurysm repair.
The procedure was performed by Antonios Polydorou, MD, at the Agios Panteleimon General Hospital of Nikaia (Athens, Greece) in December of last year. The patient, a 78-year-old man, underwent a minimally invasive endovascular procedure that placed a Cardiatis hemodynamic modulating stent to treat a large renal artery saccular aneurysm with side branches.
Follow-up angiogram showed successful deployment and reduction in flow within the aneurysm, with improved flow within the main artery as well as within vital collateral circulation.
Cardiatis said a seven-month follow-up angiogram in July "confirmed reduction in aneurysm size, collapse of the aneurismal sac and preservation and improved flow in vital collateral circulation." It added that as of the end of October, the aneurysm remained excluded from circulation while branches remain open and functional.
The company said RAA is a rare condition found in less than 0.01% of the adult population. "Elective repair of renal artery aneurysms is generally undertaken to reduce risk of rupture," it said. "Open surgical repair with renal preservation is the current standard of care."
Polydorou said, "Advances in endovascular techniques are allowing investigators to attempt endovascular therapy for renal artery aneurysms and other visceral aneurysms. The Cardiatis FluidSmart 3-D multilayer stent was selected for this humanitarian case due to its low profile and its ability to exclude aneurysms from circulation while preserving vital collaterals."----
Aethlon Hemopurifier trials begin in India for renal disease
Aethlon Medical (San Diego), a developer of devices to treat infectious disease, in November reported initiating clinical testing of the Aethlon Hemopurifier in human studies at Fortis Hospital (Delhi, India) to evaluate safety of the Hemopurifier in up to 10 patients with end-stage renal disease.
The company said the Hemopurifier removes infectious viruses and immunosuppressive proteins from circulation, allowing the natural immune response to overcome viral infection. "The launch of this study is a significant milestone, as its successful completion will trigger our commercialization efforts in India," said James Joyce, CEO and chairman of Aethlon.
Aethlon said commercialization of the Hemopurifier in India "will be based on obtaining sufficient clinical data to drive practitioner confidence and acceptance in the marketplace. Pending the successful completion of the study, Aethlon will focus on medical conditions of greatest concern to the people of India, [including] Dengue hemorrhagic fever and HIV/AIDS." Joyce said the study's demonstration of safety, "combined with supporting data from our numerous research collaborations will provide the opportunity to treat India's most significant infectious disease threats."
Vijay Kher, MD, principal study investigator, is director of nephrology at Fortis. He previously acted as principal investigator of a Hemopurifier study conducted at the Apollo Hospital (Delhi). That study documented initial safety of the Hemopurifier and provided early efficacy observations during 24 treatments administered to dialysis patients co-infected with hepatitis-C.
Aethlon said that in a recent collaboration with researchers at India's National Institute of Virology documented that the Hemopurifier is "highly efficient in capturing infectious dengue virus from blood." In preliminary studies, the Aethlon Hemopurifier removed up to 90% of live dengue virus in 30 minutes. The company said it also is discussing the treatment of HIV-infected patients with India's National AIDS Research Institute. It is estimated that India had 5.7 million HIV cases last year, the largest infected population of any other country.----
Response Biomedical begins listing on TSX
Response Biomedical (Vancouver, British Columbia) said last month that the Toronto Stock Exchange (TSX) has conditionally approved the company's application for listing its common shares on the exchange. Listing will be subject to the company filing satisfactory final documentation with the TSX.
The system consists of a portable fluorescent reader and single-use disposable test cartridges. RAMP clinical tests are currently available for the early detection of heart attack and congestive heart failure.
Response manufactures rapid on-site diagnostic tests for use with its portable RAMP Platform for clinical and environmental applications.