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“Before the end of the year there will be a black silicon machine on someone’s line,”
I haven't seen this posted here...
Black silicon gets attention at IEEE
June 07, 2012 | Written by Amanda H. Miller | Hits: 426
Natcore Technology and the National Renewable Energy Laboratory presented a paper on their cutting-edge black silicon solar at the Institute of Electrical and Electronics Engineers June 4.Natcore and NREL have partnered to develop a special antireflective property in silicon solar cells without covering them in a toxic coating. Reducing reflectivity of a solar cell increases its efficiency and energy output.
Being selected for the presentation was an honor, said Chuck Provini, Natcore CEO. “It’s a very, very prestigious organization,” he said. The paper also helped to unite Natcore further with NREL, which Provini said is good for both organizations and the solar industry in general.
Scientists from both organizations spoke about how NREL invented the technology and how Natcore found a way to make it work. But the paper did more than present black silicon. “It’s illuminating in some ways how we’re going to need to change the way solar cells are made,” Provini said.
Solar panels need an anti-reflective coating that is currently applied with heat from furnaces. Those furnaces are expensive, difficult to mange and produce toxins. “Our process eliminates the need for that reflective coating and gets rid of those toxins,” Provini said.
Solar is a young and immature industry, Provini said. In order for it to mature to the point where it can compete in the United States, where fuel prices are low, a few things will have to happen. It will have to become more efficient and affordable, which everyone says. But the world will also have to find a way to make solar cells without so many toxins.
It’s not such an issue now when solar makes up such a small sliver of energy production, but it will be. “If we start making solar panels in quantum numbers, we have to deal with that,” Provini said.
Natcore’s wet bench in Rochester, New York has a hazmat rating of 0, Provini said. And Natcore is working on developing the technology so it can be used to build solar cells from the bottom up.
For now, though, the company is en route to commercializing its first black silicon machine. Provini said Natcore is deciding between four companies to partner with. “Before the end of the year there will be a black silicon machine on someone’s line,” he said.
It was published Feb 3, 2012.
Harvard Business School's case study on Natcore - good read.
Link...
https://docs.google.com/document/d/16NI21SQwvTz4gaW9la2IR_iYCNKkYK87cYT-A0HykQY/edit?pli=1
JMP Securities Healthcare Conference live webcast Thursday July 12, 2012.
TORONTO, ONTARIO--(Marketwire -06/28/12)- Novadaq® Technologies Inc. ("Novadaq" or the "Company") (NDQ.TO)(NVDQ), a developer of real-time medical imaging systems for use in the operating room, today announced that Dr. Rick Mangat, the company's Senior Vice President and General Manager, will present Novadaq's corporate overview at the Seventh Annual JMP Securities Healthcare Conference at 2:00 PM ET on Thursday, July 12, 2012, at The Peninsula New York Hotel in New York, NY.
A webcast of the presentation can be accessed live on the Company's website at http://www.novadaq.com under the "Events" tab in the "Investors" section, and will be archived for 90 days.
New investor presentation... July 2012
http://novadaq.com/sites/default/files/Novadaq-July-2012.pdf
New Solar Panel Designs Make Installation Cheaper
Companies in Germany and China have made simpler designs that make it easier and quicker to mount panels to roofs.
KEVIN BULLIS
Friday, July 6, 2012
With solar panel prices falling more than 80 percent in the last few years, many solar companies are turning their attention to reducing the cost of installing them. Two leading solar companies, Solon Energy, based in Berlin, and Trina Solar, based in Changzhou, China, have announced new designs for mounting solar panels to roofs—the companies say these designs can reduce the installation time by more than half, greatly reducing labor costs. The new designs reduce or eliminate the tools and hardware needed to install solar panels, and standardize solar installations, which have largely been ad hoc, reducing the time needed to design them.
While solar panels themselves used to account for most of the cost of large solar installations on commercial rooftops, the modules now account for about 40 percent of the cost. The rest comes from things like the necessary hardware, power electronics, and labor—which alone accounts for about 30 percent of the total.
Mounting solar panels on the flat rooftops of commercial installations typically involves anchoring long metal racks to the roof to create a framework that will angle the panels toward the sun and hold them together. Installers bolt the panels to this frame, wire the panels together, and electrically ground the racks.
Trina's design gets rid of most of this metal framework. It starts with some simple changes to the solar panels themselves. Solar panels resemble framed pictures—they consist of solar cells sealed behind a piece of glass and held in place and protected by a metal frame. This frame is typically bolted to the metal rack framework that angles the panel toward the roof. Trina uses the frame of the solar panel itself to provide the framework. Special hardware locks into grooves cut into the frame, propping the panel at the correct angle without the need of any tools.
The company says this reduces installation time by two-thirds, and reduces the chance that stray bolts and screws might get caught under the framework and damage the roof. Savings in materials and labor costs can add up to a 10-cent-per-watt reduction in costs for solar power, a significant drop considering that solar panels now sell for less than $1 per watt.
While Trina modifies the solar panel's metal frame, Solon eliminates it altogether. It takes an array of solar cells that have been sealed behind a layer of glass and then glues that to a plastic form that angles the cells toward the sun. This complete module is assembled in a factory, reducing the amount of work that needs to be done on site. Installers set the modules on the roof, link them together with plastic connectors (they also add some ballast), and plug wires together to establish electrical connections. Because the modules have no exposed metal, it isn't necessary to ground them, which helps reduce costs. Solon says the design reduces the time needed for mechanically mounting the panels by 75 percent, and the time needed for making the electrical connections by half. (Solon says that the impact on costs varies widely, depending on factors like labor costs.)
Both designs come with some trade-offs—for example, to achieve economies of scale, the systems provide only one standard angle for pointing the panels at the sun. At some latitudes, the panels would generate more power if they were tilted more or less than that angle.
http://www.technologyreview.com/news/428423/new-solar-panel-designs-make-installation-cheaper/?nlid=nldly&nld=2012-07-06
10 small companies with intriguing technology in an emerging market.
http://www.onemedplace.com/blog/wp-content/uploads/2012/04/OMR-Research-Issue-4-March.April_.pdf
FireFly mentioned in ISRG's conference call several times:
http://seekingalpha.com/article/505201-intuitive-surgical-s-ceo-discusses-q1-2012-results-earnings-call-transcript?source=feed
ISRG reports earnings today... will be interesting to see how many DaVinci's were sold.
New video demonstrates Prelude and Symphony...
http://www.echotx.com/
PHILADELPHIA , Aug. 9, 2011 /PRNewswire/ -- Echo Therapeutics, Inc. (Nasdaq: ECTE), a company developing the Symphony™ tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring (tCGM) system and the Prelude™ SkinPrep System for transdermal drug delivery, today announced the unveiling of a much anticipated demonstration video on the Company's website at www.echotx.com. The new video showcases the features and ease of use of the Symphony continuous glucose monitoring system in a home setting. The Company has released this demonstration video as a result of increasing demands from patients and investors for information regarding how the Symphony tCGM System works.
The launch of the video coincides with the final steps in the planning and preparation of the upcoming clinical study testing the next generation Symphony tCGM System design, which will commence in the near-term.
"We are excited to feature the demonstration video on our website in order to illustrate the ease of using Symphony. We believe that Symphony will be an important and differentiated candidate for glucose monitoring that has the potential to change the paradigm of invasive, episodic glucose monitoring. We believe that the ease of use and needle-free, wireless and continuous features and benefits will improve patient compliance to frequent glucose testing and lead to better long term outcomes for patients," said Patrick T. Mooney , M.D., Chairman and CEO of Echo Therapeutics . "More than ever, we are enthusiastic about the potential of Symphony and we look forward to the commencement of the upcoming clinical study."
EZCH will be a $200 stock by 2015...
EZchip's 2Q earnings more than double, stock soars
http://finance.yahoo.com/news/EZchips-2Q-earnings-more-than-apf-3369520694.html?x=0&.v=1
New antibiotics bill adds 5 yrs protection from generics and fast track FDA review...
Gingrey to introduce antibiotics bill
By Sam Baker - 06/14/11 04:23 PM ET
Rep. Phil Gingrey (R-Ga.) will introduce a bill Wednesday that aims to combat the rise of drug-resistant diseases.
The bill would give drugmakers new incentives to develop treatments for certain pathogens that have become resistant to existing antibiotics. The “Generating Antibiotic Incentives Now” Act, or GAIN Act, drew bipartisan support last year, and Democrats are expected to sign on again when Gingrey reintroduces the measure Wednesday.
Gingrey’s bill targets a handful of drug-resistant pathogens — including the strain of bacteria known as MRSA, which often spreads through hospitals. The bill would give pharmaceutical companies extra incentives to tackle MRSA and other antibiotic-resistant pathogens, and it would give the agency the power to extend those incentives to other treatments.
Qualifying drugs would get a fast-track review from the Food and Drug Administration. The agency would have to decide whether to approve a new product within six months, compared with the standard 10-month window. Once approved, the drugs also would get an extra five years of protection from generic competition.
Drugs that are developed with a companion tool for diagnosing antibiotic-resistant conditions would get another six months of market protection.
http://thehill.com/blogs/healthwatch/medical-devices-and-prescription-drug-policy-/166397-gingrey-to-introduce-antibiotics-bill
Previous Lymphoseek vs. Sulfur Colloid study...
Sentinel lymph node accumulation of Lymphoseek and Tc-99m-sulfur colloid using a "2-day" protocol.
Wallace AM, Hoh CK, Limmer KK, Darrah DD, Schulteis G, Vera DR.
Source
Department of Surgery, University of California, San Diego, CA 92103, USA; Moores UCSD Cancer Center, University of California, La Jolla, CA 92093, USA.
Abstract
Lymphoseek is a receptor-binding radiopharmaceutical specifically designed for sentinel lymph node (SLN) mapping. We conducted a clinical trial which measured the injection site clearance and sentinel lymph node accumulation after a single intradermal injection of Lymphoseek or unfiltered [(99m)Tc]sulfur colloid (TcSC) using a "2-day" protocol for SLN mapping of breast cancer. Eleven patients with breast cancer participated in this study. Five patients received an intradermal administration of 1.0 nmol of (99m)Tc-labeled Lymphoseek; SLN mapping was performed on four subjects within 19 to 27 h. Six subjects received an intradermal administration of TcSC; SLN mapping was performed on five subjects within 18 to 26 h. Lymphoseek exhibited a significantly (P<.001) faster injection site clearance than TcSC. The mean Lymphoseek clearance half-time was 2.18+/-1.09 h compared to 57.4+/-92.8 h for TcSC. The mean sentinel lymph node uptake of Lymphoseek (1.5+/-1.7%) and TcSC (3.5+/-3.1%) was statistically equivalent (P=.213). When an intradermal injection is employed, Lymphoseek demonstrated faster injection site clearance than unfiltered [(99m)Tc]sulfur colloid and persistent SLN accumulation for at least 24 h.
PMID: 19647175 [PubMed - indexed for MEDLINE]
http://www.ncbi.nlm.nih.gov/pubmed/19647175
George Mills, MD
Director, Division of Medical Imaging and Radiopharmaceutical Drug Products, U.S. Food and Drug Administration
I am the Division Director in the Division of Medical Imaging and Radiopharmaceutical products, which report to the Office of New Drugs within CDER/FDA. My division is responsible for the review and approval of diagnostic imaging drugs and radiolabeled therapeutic oncologic drugs. In my capacity, I direct a staff of 34 professionals involved in the various disciplines of the review of INDs, BLAs, and NDAs.
In my prior 10+ years with FDA, I have served as a medical officer, Team Leader, Branch Chief, and as the Acting Deputy Division Director of the biologics oncology branch/division within CBER and CDER. In these positions, I served as the medical scientific Chief of the Oncology Branch/Division and as a CBER/CDER expert on medical diagnostic imaging and therapeutic radiopharmaceutical oncologic biologics and drugs. In addition, I served as a CBER/CDER expert on the review of radiographic imaging submissions in support of various licensure submissions throughout CBER/CDER.
During my experience in the Oncology Branch/Division, I have performed, directed, and coordinated the work of the professional staff within the Oncology Branch to complete the IND, BLA and NDA clinical, pharmtox, product, and project management reviews as required of the staff. I was responsible for recommending approval and/or rejection of Biologic License Applications (BLAs), supplements, Notices of Claimed Investigational Exception [INDs] and other regulatory actions pertaining to investigational biologic drugs.
Prior to coming to FDA, I was in the private clinical practice of diagnostic/therapeutic Nuclear Medicine and Pathology for 16 years. In the course of my private practice, I participated in various clinical trials with diagnostic and therapeutic biologic products.
http://www.biomarkers.org/staff/mills.html
Exelixis reports data from a Phase 1 clinical trial of the co's cabozantinib published in the Journal of Clinical Oncology (20.97 -0.03)
Mon May 23 2011 16:57:05 GMT-0400 (Eastern Daylight Time) ET
Co announced the results of the phase 1 clinical trial of cabozantinib in patients with advanced solid tumors or lymphoma have been published in the current issue of the Journal of Clinical Oncology. The publication includes safety data from all 85 patients enrolled in the phase 1 cabozantinib study, and also includes tumor response, genotyping, pharmacokinetic, and pharmacodynamic biomarker data for the 37 patients in the study with medullary thyroid cancer (MTC). Exelixis is currently conducting a phase 3 registration trial of cabozantinib in MTC and, assuming positive results from this registration trial, intends to file a New Drug Application with the U.S. Food and Drug Administration for this indication by the end of 2011. Thirty-five of 37 MTC patients had measurable disease. Partial responses were achieved in 10 of these patients (29%), and 5 of these patients had a partial response at the first radiologic assessment. Responses were observed in patients regardless of prior tyrosine kinase inhibitor therapy status. Seventeen patients (49%) experienced a 30% or greater decrease in the sum of tumor measurements compared with baseline. Stable disease for at least 6 months was observed in 25 of the 37 patients (41%) with MTC, ranging from 6.4 to 31.1 months. Stable disease of at least 3 months was reported in 38% of patients in the non-MTC subset.
Define “pump & dump specialist”.
What was Stephen Dunn doing besides covering “crap” biotech companies, that other biotech analysts were not doing?
Do you have any evidence of unethical activities or FINRA rule breaking by Stephen Dunn?
You make allegations and the ask me to verify them...you’re the one making the allegations... the burden of proof is on you. You make the ridiculous statement that Dawson James is disclosing FINRA rule breaking activity in the disclosure statement on their research reports, I then provided proof that you were wrong, and then your post making the accusation is mysteriously deleted.
Did you request the moderator or anyone else to delete message 18290 or did you somehow delete it yourself? And why?
I’ve been following your posts for years and you hold the drug companies and analysts that you examine to a high standard of truth and honesty and require them to back up claims with proof... apparently you hold yourself to a lower standard.
Here's the link to a Dawson James research report on Depomed by Stephen Dunn on Jul 10, 2007
http://www.dawsonjames.com/portal/DEPO_Termination_7_10_07.pdf
here's the disclosure at the bottom of the report...
DAWSON JAMES SECURITIES, INC., Member SIPC, FINRA, (the "Firm") does not make a market in these securities. The Firm may perform or seek to perform investment banking services for these companies in the future. Analysts receive no direct compensation in connection with the firm's investment banking business. All Dawson James employees, including the analyst(s) responsible for preparing this research report, may be eligible to receive non-product or service specific monetary bonus compensation that is based upon various factors, including total revenues of Dawson James and its affiliates as well as a portion of the proceeds from a broad pool of investment vehicles consisting of components of the compensation generated by investment banking activities, including but not limited to shares of stock and/or warrants, which may or may not include the securities referenced in this report. The Firm, its officers,directors, analysts or employees may effect transactions in and have long or short positions in the securities (or options or warrants with respect thereto) mentioned herein. Although the statements of fact in this report have been obtained from and are based upon recognized statistical services, issuer reports or communications, or other sources that the Firm believes to be reliable, we cannot guarantee their accuracy. All opinions and estimates included in this report constitute the analyst’s judgment as of the date of this report and are subject to change without notice. The Firm may effect transactions as principal or agent in the securities mentioned herein. The securities discussed or recommended in this report may be unsuitable for investors depending on their specific investment objectives and financial position. This report is offered for informational purposes only, and does not constitute an offer or solicitation to buy or sell any securities discussed herein in any jurisdiction where such would be prohibited. Additional information is available upon request.
Here's a link to all their discontinued research... http://www.dawsonjames.com/portal2.html
The key section is...
All Dawson James employees, including the analyst(s) responsible for preparing this research report, may be eligible to receive non-product or service specific monetary bonus compensation
In other words the analyst may be eligible for "non-product specific" (NOT shares or warrants) or "service specific monetary bonus" (NOT based on favorable recommendations or investment banking transactions)
that is based upon various factors, including total revenues of Dawson James and its affiliates as well as a portion of the proceeds from a broad pool of investment vehicles consisting of components of the compensation generated by investment banking activities, including but not limited to shares of stock and/or warrants, which may or may not include the securities referenced in this report.
The firm Dawson James is sometimes compensated for investment banking services with shares of stock and/or warrants and the proceeds from that compensation are put into a broad pool of investment vehicles from which the analyst is compensated.
Like I said, it is against FINRA rules for an analyst to be compensated for favorable research or specific investment banking services and it's ridiculous to suggest that a brokerage firm would disclose that they are breaking FINRA rules....
http://goo.gl/d8M5N
There are strict rules on the how a research analyst and the investment banking arm of a brokerage firm can interact... these rules have been in place since 2002...
Limitations on Relationships and Communications. Under the new rules, research analysts cannot be supervised or controlled by their firm?s investment banking department. Furthermore, investment banking personnel are prohibited from discussing or reviewing pending research reports with research analysts prior to distribution unless the firm?s legal/compliance department monitors their written and oral communications. Any review of a research report by investment banking personnel must be limited to verification of factual accuracy or to review the report for any potential conflict of interest. Analysts will not be allowed to share drafts of their research reports with subject companies, other than to check facts for accuracy after the approval of the legal/compliance department. Subject companies may not be provided with the research summary, rating or price target
sections of the research report.
http://goo.gl/arLmE
Again, I have found no complaints or regulatory action against Stephen Dunn. There has been nothing reported to FINRA on Stephen Dunn...
http://brokercheck.finra.org/Individual/IndividualSummary.aspx?SearchGroup=Individual&FirmKey=-1&BrokerKey=4649426&IndvlBCCtgry=1&IndvlIACtgry=1
If you know of any illegal activity please disclose it or retract your libelous allegation.
Oh believe me... I DO want to know. I'm curious why a FINRA registered analyst would disclose that they're being compensated by the company they're covering when it's against FINRA rules to receive such compensation.
Maybe you're confusing analyst compensation with investment banking fees paid to the broker which I said before.. Is not unusual.
How was he paid and who paid him? Most pumpers are paid in shares due to the poor financial condition of the pumped company - hence the need for the pump. It's against FINRA rules to receive ANY kind of compensation from the companies he covers. You still have'nt provided any specific evidence.
There have been no complaints or regulatory action involving Stephen Dunn according this FINRA report... http://goo.gl/vA33i
Receiving shares from companies is a violation of FINRA rules.
Dew - you have made a serious allegation...please back it up with something more substantial than your memory.
OK... that gives me pause. JMP Securities also has a buy on ECTE - anything on them?
I searched everywhere and couldn't find anything negative on Dawson James or Stephen Dunn. I didn't see any reports where DJ was compensated in shares for research reports. DJ does disclose that some companies in their coverage universe pay investment banking fees but that's not unusual.
Can you be more specific with your allegations?
Lifetech Capital research team...
Stephen M. Dunn
President LifeTech Capital
& Senior Managing Director of Research
SDunn@LifeTechCapital.com
Mr. Dunn was previously the Managing Director of Life Sciences Research at Jesup & Lamont, as well as Director of Research for Dawson James Securities and Director of Life Sciences at Cabot Adams venture capital group. He has also held management positions in Business Development, Finance and Operations having worked in over 25 countries in North America, Europe and the Far East with biomedical companies including Beckman Coulter, Coulter, Cordis (Johnson & Johnson), Telectronics (St. Jude Medical) as well as several smaller companies. With over 25 years within the global biomedical industry, Mr. Dunn has negotiated numerous intellectual property licenses, product development agreements, venture funding, M&A and joint ventures with companies such as GlaxoSmithKline, Pharmacia, Novartis, Bayer, Schering AG, Wyeth, Eli Lilly, Pfizer, Genzyme, Martek Biosciences, Fisher Life Sciences, Becton Dickinson, Idec Pharmaceuticals, Ortho Diagnostics, DakoCytomation, Los Alamos and Sandia National Laboratories, the Mayo Clinic Foundation and the Dana-Farber Institute along with dozens of smaller public and private companies throughout the world.
Mr. Dunn is a 5-star biotechnology analyst on StarMine and has appeared in both the financial and scientific media such as The Wall Street Journal, CNN, Newsweek, Forbes, Nightly Business Report, Nature Biotechnology, The Scientist, BioWorld and many other media outlets. He is also a frequent speaker and panel member for many financial, medical and venture capital events.
William D. Dawson
Senior Vice President of Research
WDawson@LifeTechCapital.com
William “Bill” Dawson was previously Senior Vice President of Life Sciences Research at Jesup & Lamont and a biotechnology analyst at Dawson James Securities where he assisted in the preparation of institutional research reports covering the small cap life sciences industry. Prior becoming a research analyst, Mr. Dawson was a capital markets representative with Dawson James where he assisted in the successful marketing of numerous banking transactions including private placements, registered secondary’s, and initial public offerings and conducted deal and non-deal road shows for biotechnology companies in the U.S.
Mr. Dawson has appeared as a correspondent for OneMedTV where he interviews senior management of emerging biotechnology, healthcare and medical device companies. Mr. Dawson holds Bachelor Degrees in Biochemistry and Business Management from Eckerd College in St. Petersburg FL where he acted as Treasurer of the American Chemical Society for the Eckerd College chapter.
1- LifeTech is not a reputable firm.
Do you have some dirt on them? Lifetech Capital is the research arm of Aurora Capital...
Aurora Capital is both a boutique investment banking firm specializing in the life sciences sector and a full service brokerage firm. Our LifeTech Capital Research Division writes unique and proprietary equity research covering biotechnology and other life science companies. Our Hedge Fund and Direct Participation Program Group raises funds for hedge funds, funds of funds and direct participation programs.
The partners @ Aurora...
DAVID A. ALPERN
Mr. Alpern is a Partner of Aurora Capital Group. Mr. Alpern joined Aurora in 2006, following the completion of a Master's in Business Administration from the Harvard Business School. Previously, Mr. Alpern served as an Associate with GTCR Golder Rauner, a Chicago-based leverage buyout firm, and prior thereto as an investment banking analyst within Credit Suisse First Boston's Global Industrial & Services practice. Most recently, Mr. Alpern served as a Manager in the Corporate Development/Merger & Acquisition Group at Microsoft Corporation. Mr. Alpern currently serves on the Boards of RecoverCare and NuCO2.
Mr. Alpern completed a BA in History from the University of Michigan and an MBA from the Harvard Business School.
WILLIAM J. COUGHLIN
Mr. Coughlin is a Partner of Aurora Capital Group. Prior to joining Aurora, Mr. Coughlin was on fellowship at the Harvard Business School developing a course on international finance. Mr. Coughlin was associated with Merrill Lynch for several years, most recently as a member of their internal private equity fund. Prior to that, he worked in London as a part of the European Corporate Finance team and in Los Angeles in the Industrials Group.
Mr. Coughlin received a master's in business administration from Harvard University and a bachelor of arts degree in political philosophy and economics from Claremont McKenna College in California.
JOSH R. KLINEFELTER
Mr. Klinefelter is a Partner of Aurora Capital Group. He joined Aurora Capital Group in 1999 and then rejoined the firm after earning a master's degree in business administration from Harvard Business School. Previously, Mr. Klinefelter was an investment banking analyst in the New York and Los Angeles offices of Bear, Stearns & Co. Inc. Mr. Klinefelter currently serves on the Board of Directors of Porex and Mitchell International.
Mr. Klinefelter graduated with a bachelor of arts in Spanish and Latin American studies from Tulane University in 1997.
GERALD L. PARSKY
Mr. Parsky is a Partner of Aurora Capital Group. Previously, Mr. Parsky served as a Treasury Department and Federal Energy Office official from 1971-74, and as Assistant Secretary of the Treasury for International Affairs from 1974-77. For the next 13 years, Mr. Parsky was affiliated with the law firm of Gibson, Dunn & Crutcher, where he was a Senior Partner and member of the Executive and Management Committees. Present activities include: Regent, University of California; Trustee Emeritus, Princeton University; Trustee, George Bush Presidential Library Foundation; Trustee, Ronald Reagan Presidential Foundation; Board of Directors, The Irvine Company. Mr. Parsky serves on the Board of Directors of several of Aurora's investments.
Mr. Parsky is a graduate of Princeton University and the University of Virginia Law School.
MARK D. ROSENBAUM
Mr. Rosenbaum is a Partner of Aurora Capital Group. Previously, Mr. Rosenbaum was an Associate at Summit Partners, where he focused on investments in middle market growth companies. Prior to that he was an analyst at Montgomery Securities.
Mr. Rosenbaum graduated with a Bachelor of Science in Economics from The Wharton School at the University of Pennsylvania. He earned a master's in business administration from the John E. Anderson Graduate School of Management at UCLA where he was a Carter Fellow.
Harvard, Princeton, Wharton, Assistant Sec of the Treasury... Yep... they look like a bunch of pumpers and scam artists.
BTW - I didn't see anything questionable or implausible in their report. If you dispute their analysis why don't you refute their analysis point by point instead of besmirching their reputation.
pcrutch: "I really dont see how $ECTE will be able to compete."
Really?
LifeTech Capital report on ECTE and DXCM...
We believe the transdermal biosensor is a significant advantage
over the existing biosensors on the market. All existing FDAapproved continuous glucose monitoring (CGM) systems are
needle-based, requiring insertion of a glucose sensor into the
patient’s skin, which gives rise to risks of infection,
inflammation or bleeding at the insertion site. Symphony™ is a
non-invasive tCGM system that does not require insertion of its
glucose sensor and thus does not give rise to the risks associated
with needle-based CGM systems.
We also believe Echo Therapeutics clinical trials in the critical care setting provides a major marketing advantage over the
competition in the hospital market. The Symphony™ system would represent an answer to the new FDA demands for more accurate glucose monitors in the hospital. (see FDA to Require Hospitals to Use More Accurate Glucose Monitors)We further believe that the comparatively short 1-2 day biosensor life is not a drawback, but rather an advantage. In the at-home market, the weekly biosensors begin to lose adhesion after several showers, swimming and other physical activity and rubbing against clothing. It can cost a person $60 if they accidently dislodge or damage the biosensor whereas a cheaper 1-2 day biosensor reduces the economic risk of biosensor damage through daily activity.
Additionally, skin irritation from being in contact with the adhesive as well as the possibility of infection raises hygiene issues. The risk of infection becomes a significant issue in the critical care/ICU market. We believe a 1 or 2 day biosensor makes more sense in the same way daily disposable contact lenses are safer than extended wear contact lenses.
Finally, there are risks involving the competitor’s need for sensor wires resulting in sensor wire fractures underneath the
patients’ skin. The FDA issued a warning letter to DexCom concerning these sensor wire fractures in May 2010 and also
noted that the DexCom SEVEN and SEVEN PLUS Systems are not approved for use in children or adolescents, pregnant women or persons on dialysis and can only be used in the abdomen. (see FDA Warning Letter to DexCom on Sensor Wire Factures).
On May 21, 2010, Echo Therapeutics competitor DexCom (Nasdaq:DXCM) received an FDA Warning Letter for their Seven PLUS Continuous Glucose Monitoring System due to complaints involving sensor wire fractures underneath patient's skin as reported to the FDA. In addition, their sensors are not approved for use in children or adolescents, pregnant women or persons on dialysis and can only be used in the abdomen. Investors should note that Echo Therapeutics Symphony Transdermal Continuous Glucose Monitoring (tCGM) system eliminates the need for sensor wires and could be considered safer, especially for children and adolescents.
http://www.lifetechcapital.com/reports/ECTE%20Update%2004-01-11.pdf
Good article on RIGScan...
Biological Retrofits
Posted on May 18, 2011 by meddevice| Leave a comment
A MAb Resurrected!
After more than a decade since the FDA rejected Ohio-based Neoprobe Corp.’s RIGScanTM CR, a monoclonal antibody (MAb) for the detection of colorectal cancer, the company has announced that in Pre-IND talks with the agency, the two have concluded that a new clinical trial can begin in 2012. I recall reporting on the progress of this technology about 15 years ago, but the “radiopharmaceutical” hit a major setback in 1998 when the FDA rejected it because it did not show a clear benefit for patients. Now, 12 years later, that same data that prevented its approval may have been what helped Neoprobe resurrect RIGScan. It appears that Neoprobe has some convincing data from those patients treated well over a decade ago. Treated patients had significantly higher survival rates over the ensuing years compared to patients who did not have RIGScan-tagged tissue surgically removed.
RIGScan CR is a MAb that targets a telltale colorectal cancer marker called TAG-72, which is also common in many epithethelial cell-derived tumors, including some breast tumors, invasive ductal tumors, non-small cell lung tumors, epithelial ovarian tumors, and the majority of gastric, pancreatic and esophageal cancers. So, the treatment holds great promise beyond colorectal cancers. The “radiopharmaceutical” is tagged with a radioisotope that is used for detection only, not direct therapy. Once bound to the tumor cells that may have lingered following surgery, a hand-held radiation detection device made by Neoprobe helps surgeons hone in on the cells and remove them before they repopulate.
You may be asking why you’re reading about a radiopharmaceutical in a MedTech blog, which I’m happy to explain after a brief review of MAb technology: Antibodies are the immune systems sentinel soldiers. When a pathogen enters the body, antibodies are generated to bind unique surface features on the foreign tissue. Once bound, a signal is sent to other components of the immune arsenal, including neutrophils, lymphocytes (killer T cells) and many others to mount the attack on the pathogen flagged by the antibody. Despite their nanoscale, viruses and bacteria have many unique surface features, called antigens, often consisting of different sugar and lipid molecules. (Think of facial features: more than 6 billion people and everyone unique.) The same is true for tumor cells. They have surface features that differ from healthy non-malignant cells, as well as surface features that vary among malignant tissue types.
When it encounters a virus or bacteria, the immune system will generate antibodies that recognize many of these unique surface features, not just one. Antibodies are shaped like the letter “Y.” The clef of the “Y” contains the Antigen Binding Site (ABS), which is very much like a lock that can only be engaged by the specific “key” or antigen on the pathogen.
Monoclonal antibodies are highly engineered molecules that bind to only one antigen. This is no small achievement. The process involves fusing myeloma cells with mouse spleen cells. The resulting is an immortal cell line (myeloma) that produces antibodies (spleen cells). By immunizing this little antibody factory with a single target antigen, the cell line produces antibodies that identify one very specific antigen. Of course, the process is not this clean. Different hybrid cells produce slight variants of the ideal antibody. A filtering and selection process helps find the ideal hybrid clone or “hybridoma,” which is cultured and used to pump out millions of identical antibodies of near-perfect specificity for the target antigen.
Since these molecules are of mice but for men (and women), another step in the process is required to make the molecules more human. Remember, the human immune system is designed to recognize and destroy all non-human invaders, so MAbs that are mostly murine (mouse), will themselves be targeted by the immune system. This is called HAMA for human anti-mouse antibodies, which are generated and target the MAbs and render them therapeutically useless. So, another recombination step is required to replace the large murine structural regions of the MAb with human components.
So (if I haven’t lost you yet), I write about these tiny cancer-seeking, radiolabled clones because they are more engineered than any artificial joint or pacemaker that I can think of. In fact, it’s hard to imagine a more machined medical device than these macromolecules.
However, to be fair, when mice spontaneously generate half-man-half-mouse-human-cancer-detecting antibodies that serendipitously happen to be flagged with isotopes that make them easy to spot for surgeons in the process of removing hidden colorectal tumor cells, I’ll stop writing about these molecules.
According to Rodger Brown, vice president, Regulatory Affairs and Quality Assurance of Neoprobe, “We have clarified the path to reinitiate RIGScan development and the requirements for resuming development activities and moving toward clinical trials. FDA’s guidance has provided direction to enhance our manufacturing platform, including process improvements to increase manufacturing efficiency and the quality of the underlying biologic antibody. We can now begin to implement our manufacturing plans through 2011 as a first step to recommencing clinical study of the technology in 2012 and beyond.”
In one small trial, including five patients with recurrent colorectal cancer, traditional exploration for remaining tumor cells turned up 17 sites determined to be suggestive of recurrence. These sites included the colon and rectum, as well as the abdominal wall, Iliac lymph nodes and inferior vena cava. In the same patient population, 14 positive sites were identified, and six additional positive sites, which were missed by traditional detection, were uncovered. The traditional method had a specificity of 64 % and positive predictive value of 90%, while RIGScan provided 92% sensitivity and 100% positive predictive value. None of the patients had a HAMA reaction to RIGScan CR.
Of course, much larger studies are required, but this is a very positive development for cancer patients and a Dublin Ohio biotech company that wouldn’t take no for an answer.
http://medtechintel.com/
Question - Studies show statins alone lower TG's of 10% to 20% in subjects with baseline of < 250 mg/dL. If AMR101 + statins show only 20% reduction... how is that statistically significant?
Although the most prominent effects attributable to statin therapy are its potent low-density lipoprotein cholesterol (LDL-C) lowering properties, it is also well established that statins significantly reduce non-high-density lipoprotein cholesterol (non-HDL-C), triglycerides (TG), and biomarkers of inflammation, most notably C-reactive protein (CRP). Overall, statins reduce TG levels in the range of 10% to 20% ( Table ), although it has been acknowledged that the higher the baseline TG level, the greater the TG-lowering effect. For example, baseline TG levels exceeding 250 mg/dL have been associated with reductions in the range of 22% to 45%, whereas more modest reductions have been observed with lower baseline levels.[1] This can be best identified in randomized, placebo-controlled trials ( Table ). In these outcome studies, the TG cutpoint for study exclusion has generally been 350 mg/dL to 400 mg/dL because higher levels have been viewed as a basis for pharmacologic (eg, nonstatin) treatment. Therefore, it is not surprising that, with few exceptions, the baseline TG in clinical outcome trials that evaluate statin therapy is customarily in the 100 to 200 mg/dL range, with a corresponding TG-lowering effect between 10% and 20%.[2-11] Although no relationship was observed between major coronary heart disease (CHD) events and on-treatment TG in one clinical trial of patients with CHD and high LDL-C,[12] another trial in patients with acute coronary syndrome demonstrated that lower on-treatment TG correlated with reduced CHD events.[13] Therefore, ongoing and future clinical trials will provide additional insight into the relationship between statin (monotherapy and/or combination) therapy, TG lowering, and CHD risk.
http://www.medscape.org/viewarticle/589010
FWIW... from the MARINE study...
In addition, the subgroup of patients on background statin therapy had much greater median reductions in TG, which were also statistically significant, than those not on statin therapy.
Importantly, AMR101 did not result in an increase in median LDL-C compared to placebo at either dose (-2.3% for the 4 gram group and +5.2% for the 2 gram group [p=NS]). This is the first and only triglyceride-lowering therapy studied in this population with very high triglyceride levels to show a lack of elevation in LDL-C. Furthermore, there was a statistically significant decrease in median non-HDL-C (total cholesterol less "good cholesterol") compared to placebo with both of the AMR101 treated groups (-18% for the 4 gram group [p < 0.001] and -8% for the 2 gram group [p < 0.05]).
There were also statistically significant reductions in several important lipid markers, including Apo B, Lp-PLA2 (Lipoprotein-phospholipase A2), VLDL-C and Total Cholesterol. These results are particularly encouraging given that no other TG-lowering therapy studies have shown such results. For these achieved endpoints, p-values were <0.01 for most and <0.05 for all. Apo B (Apolipoprotein B) is a sensitive index of residual cardiovascular risk and is generally considered to be a better predictor than LDL-C. Lp-PLA2 is an enzyme found in blood and atherosclerotic plaque; high levels have been implicated in the development and progression of atherosclerosis.
The ANCHOR trial is a multi-center, placebo-controlled, randomized, double-blind, 12-week pivotal study to evaluate the efficacy and safety of 2 grams and 4 grams of AMR101 in patients with high triglyceride levels from 200 mg/dL to less than 500 mg/dL who are also on statin therapy.
http://investor.amarincorp.com/releasedetail.cfm?ReleaseID=533361
From the link it appears that he sold his common shares but still owns options for 680,000 shares.
Nice article on PYMX in Forbes Magazine...
Antibiotic Artisan
Robert Langreth, 01.26.11, 06:00 PM EST
Forbes Magazine dated February 14, 2011
Using supercomputer simulations, chemist William DeGrado is crafting potent new drugs that mimic nature's own defenses.
http://goo.gl/FKSrY
There are lots of followers - just not here.
They're at Gilder Tech & Domino Analytics.
I found Mesoblast a few weeks ago when I came across it while researching ACTC. I bought the ADR a few days later. I'm VERY excited about their prospects.
Interim Results From Mesoblast's Phase 2 Heart Failure Trial Shows 'Off-The-Shelf' Proprietary Adult Stem Cell Product Revascor Reduces Cardiac Events, Mortality, and Hospitalization
>Analyses of time-dependent hard efficacy endpoints showed that a single injection of Revascor™ significantly reduced the number of patients who developed any severe adverse cardiac events over the follow-up period from 93.3% in the control group to 44.4% in the treated patients (p=0.001). Revascor™ also significantly reduced the number of patients who developed any major adverse cardiac events (MACE, defined as the composite of cardiac death, heart attack, or coronary revascularization procedures) from 40% to 6.7% (p=0.005). A single injection of Revascor™ reduced the overall monthly event rate of a MACE by 84% compared with controls (p=0.01), and every dose tested demonstrated a similar protective effect. Death from cardiac causes was reduced from 13.3% to 0% over this period (p=0.059) and the overall monthly rate of cardiac-related hospitalizations was reduced by 48% (p=0.07). <
http://finance.yahoo.com/news/Interim-Results-From-prnews-3122195240.html?x=0&.v=1
Wow - a single injection reduced monthly MACE rate by 84%. Zero deaths in the treated group vs. 13.3% in the control group. This will become the gold standard treatment for heart failure.
Cantor Fitzgerald report:
This morning, before the open, Compugen announced an agreement with Pfizer
(NYSE: PFE, NC) for paid access to its Predictive Peptide Discovery Platform
— Discovery on Demand — for three drug targets. Compugen anticipates
delivery of product candidates within a few months and Pfizer has the option to
exercise worldwide exclusive royalty-bearing licenses with milestone
payments.
Recall, Compugen recently entered into a similar collaboration with Bayer
Schering Pharma for an oncology target and splice variants discovered by
Compugen using its Monoclonal Antibody (mAb) Targets Discovery Platform
— one of a portfolio of 10 in silico predictive platforms developed by
Compugen — using a biocomputational approach that has been experimentally
validated.
We think Compugen's predictive platform portfolio can streamline
identification/validation of relevant biomarkers/therapeutic targets — a
paradigm shift in discovery/development programs that can mitigate risk,
condense timelines, and exponentially increase pharmas' output of both
diagnostics and therapeutics.
This rational approach to discovery — predictive biology pioneered by
Compugen — is the source of its therapeutic pipeline of eight product
candidates. We expect Compugen to enter into additional alliances in the next
6-12 months.
We think Compugen's predictive platforms can impart selectivity and speed to
pharma/dx companies — a significant and relevant competitive advantage for
pipeline-starved companies — to condense discovery/development timelines
plus provide a vast store of improved therapeutics and diagnostics. We reiterate
our BUY rating.
https://cantor.bluematrix.com/docs/pdf/0f6ce9f5-401c-483d-8fdc-c4c6068d2111.pdf
NNVC - NanoViricides. Anyone heard of this bird-flu vaccine co.?
Found it here: http://allallan.blogspot.com/
Opinions?
-------------------------------------------
In my ongoing quest for short-term trading opportunities, I have some across some services that specialize in "reverse merger" opportunities. A reverse merger stock is a stock that becomes public by buying a "shell" public company which is essentially going or already out of business. It is a quick and dirty way for a start-up to go public.
Not surprisingly, this back-door way around traditional IPO's attracts some "substance-challenged" companies. But sometimes it attracts a gem that is just in too big a hurry to get their story out and get funding to go the traditional IPO route. At least two newsletters I've seen recommend reverse merger stocks, as a way of getting in early on unknown, very small cap stocks with potentially great upside. Coincidentally, while looking for biotech stocks that could benefit from bird flu, I found a company NANOVIRICIDES INC (NNVC.pk) which looks like a great candidate for testing out the reverse merger theory. Additionally, if this company gets some publicity, it should trend up every time there's a bird flu media-scare. (The term "nano" has probably exhausted its hype-potential, so we're not counting on any additional value from the nano-name.)
One of my trading partners, Ilene, who has a degree in Pathology, has done some preliminary research on NNVC and has found the science to have some significant potential and has been very impressed with the background of the people joining the advisory board (see links below), as they not only seem highly qualified but in some cases are among the leading scientists in the field. This does not seem to be the typical penny stock, nor the typical reverse merger company.
We are buying a little bit of this stock for long-term holding, even though it is clear that an eleven-cent pink sheet stock is highly speculative and there's no guarantee that any biotech, much less this one, is ever going to appreciate in value or become profitable.
In the spirit of "do your own due diligence," I am providing the the following information on NNVC and highly recommend a visit to their web site before jumping into the ring with this one. The bet here is risking a total loss of your investment against a return of thousands of percent. Worth a roll of the dice? You decide.
-----------------------------------
Vietnam Invites NanoViricides to Play Role in Battle against Bird Flu
Monday August 22, 11:01 am ET
NEW YORK--(BUSINESS WIRE)--Aug. 22, 2005--NanoViricides, Inc. (Pink Sheets:NNVC - News), announced today that the Government of Vietnam's National Institute of Hygiene and Epidemiology ("NIHE"), Vietnam's leading institute for the surveillance, control and prevention of infectious diseases, extended an invitation to the Company to help in the battle against bird flu.
The Company will meet with the key scientific persons in this governmental agency as part of the Country's effort to prepare adequately for potential outbreaks of this highly contagious and fatal disease. "NanoViricides has an approach that appears capable of making true viricides...you appear to have a unique technology...the potential for this approach is immense and important, as any outbreaks can be curtailed before they reach epidemic proportions," noted Dr. Nguyen Tran Hien, Director of NIHE. "We are interested in discussing further the potential of developing NanoViricides against the bird flu virus strains."
Dr. Anil Diwan, President of NanoViricides, added, "Our technology has elicited the notice of the senior science community in Vietnam, a country facing an uphill battle against this deadly epidemic. They are proactive in seeking out solutions, and have the support of the world to find ways to ensure that this does not become a pandemic issue. We are honored to join them in this fight."
"The Company is excited to field these commercial opportunities," noted Leo Ehrlich, CFO. "Joint venture work offers a potential for revenues and goal oriented research that advances the Company's core business and operational purpose against specific viral enemies. We will begin a relationship with Vietnam and the surrounding nations that will allow us to advance our technology and address specific issues facing the nations of the world."
About NanoViricides
NanoViricides, Inc. is a development stage company that is creating special purpose nanomaterials for viral therapy. NanoViricides, Inc. has exclusive license in perpetuity for technologies developed by Theracour Pharma for the five virus types: HIV, HCV, Herpes, Asian (bird) flu and Influenza. A NanoViricide(TM) is a nanoparticle that contains an encapsulated active pharmaceutical ingredient and targets it to a specific type of virus. When a NanoViricide(TM) drug particle enters the patient's blood stream, it attacks and immobilizes circulating virus particles. Once this is done, the active pharmaceutical ingredient is injected into the virus by the NanoViricide(TM) particle, destroying it. The company plans to develop novel NanoViricide(TM) drugs first against HIV, and anticipates that it will license the products to major pharmaceutical companies.
This press release contains forward-looking statements which reflect the Company's current expectation regarding future events. Forward-looking statements involve risks and uncertainties. Actual events could differ materially and substantially from those projected herein and depend on a number of factors including the success of the Company's research and development strategy, the availability of adequate financing, the successful and timely completion of clinical studies and the uncertainties related to the regulatory process.
Dr. John Rossi, Holder of 14 Key Patents, and Author of over 275 Scientific Articles, Joins NanoViricides, Inc. Scientific Advisory Board
Thursday July 14, 9:33 am ET
"Widely Regarded as a World Leader in Clinical Research for the Treatment of HIV/AIDS and in the Development of Therapeutic Applications of RNA Interference"
NEW YORK--(BUSINESS WIRE)--July 14, 2005-- NanoViricides, Inc. (Pink Sheets:NNVC - News), announced today that Dr. John Rossi, Chairman and Professor, Division of Molecular Biology, Beckman Research Institute and Dean, Graduate School of Biological Sciences, City of Hope National Medical Center, Duarte, CA - http://www.cityofhope.org/gradschool/faculty/jrossi.asp - has joined the NanoViricides, Inc. Scientific Advisory Board.
City of Hope is a Comprehensive Cancer Center dedicated to the prevention and cure of cancer, HIV/AIDS, diabetes, and other life-threatening diseases.
"Dr. Rossi is a wonderful addition to our Scientific Advisory Board. He brings almost twenty five years of basic HIV research experience to our company. He is on the editorial boards of numerous science journals including Antisense Research and Development, Gene Therapy and Molecular Biology and Molecular Therapy, and has extensive experience in many critical areas that will help us develop true HIV killing nanomachines," said Eugene Seymour, MD, Chief Executive Officer of NanoViricides, Inc.
"Dr. Rossi has great expertise in the clinical aspects as well as in the HIV genome silencing aspects which are areas of special interest to NanoViricides. His active involvement as our scientific advisor will accelerate our development programs particularly for our second generation anti-HIV drugs and other nanoviricides," said Dr. Diwan, President of NanoViricides, Inc. and inventor of the underlying technology.
In addition to his responsibilities at the City of Hope, he is also Adjunct Professor, Division of Biomedical Sciences, University of California, Riverside, CA, as well as Adjunct Professor, Department of Biochemistry and Microbiology, Loma Linda University, CA.
Dr. Rossi received his PhD in microbial genetics from the University of Connecticut. His post-doctoral fellowship was at Brown University in Providence, RI.
THE NANOTECHNOLOGY REVOLUTION IN BIOPHARMACEUTICS
A New Era in Targeted Anti-Viral Therapeutics
Imagine having a nano-scale molecularly engineered "guided missile", about the size of a few billionth of a meter, that courses through the blood-stream, seeks its target e.g. a virus particle, attaches itself to the target, and then destroys the target completely.
We believe that nanoviricides are the next great advance in medicine. It is possible that some HIV patients may be "cured" by the drugs developed at NanoViricides Inc. We hope that with further knowledge and new advancements in medicine, many viral diseases will be curable. We hope to spearhead these efforts.
--------------------------------------------------------------------------------
Our President, Dr. Anil Diwan, is a 'Business of Technology' editor to Pi-Tech, the magazine launched at the Global Indian Institute of Technology Alumni Conference in 2005 (Pan - IIT 2005).
Featured articles written and edited by Dr. Diwan
Indian Institute of Technology is one of the premier schools in the world and has been featured on CBS.
NanoViricides Retains Auditor in Preparation of Filing Form 10-SB
Thursday August 4, 11:14 am ET
NEW YORK--(BUSINESS WIRE)--Aug. 4, 2005--NanoViricides, Inc. (Pink Sheets:NNVC - News; the "Company"), announced today that it had retained Bloom & Co., LLP of Hempstead, New York as its independent auditors, in anticipation of filing Form 10-SB and being quoted on the OTC bulletin board quotation system.
Commenting upon the retention, Leo Ehrlich, NanoViricides' Chief Financial Officer stated, "this is a very exciting time for NanoViricides. Retaining PCAOB registered auditors such as Bloom & Company will enable the Company to complete its first ever audit, an important step in our goal of becoming a reporting company. Upon completion of the Company's audited financial statements, we anticipate immediately filing a Form 10-SB to commence reporting obligations with the Securities and Exchange Commission. Becoming a reporting company with the objective of having our stock quoted on the OTC Bulletin Board is a positive step for the company and for our shareholders."
Dr. Cy Stein, Renowned Inventor, Holder of key Patents, Expert in Antisense and RNA, Joins Nanoviricides, Inc.
Monday July 11, 12:11 pm ET
NEW YORK--(BUSINESS WIRE)--July 11, 2005--Nanoviricides, Inc. (Pink Sheets:NNVC - News), announced today that Professor Cy Stein, MD, Head of Medical Genitourinary Oncology and Professor of Medicine, Urology and Molecular Pharmacology at the Albert Einstein College of Medicine, New York and a recognized innovator in the development of drugs based on antisense and RNA interference, has joined NanoViricides' Scientific Advisory Board.
"We are delighted to have Dr. Stein join as a member of NanoViricides' Scientific Advisory Board. We look forward to working closely with him to fully develop the potential of our nanoviricide technology," said Dr. Diwan, President of NanoViricides.
Professor Stein is a pioneer in the anti-sense DNA field and holds a number of key patents. He was a co-developer of Genta Inc.'s Genasense antisense drug that showed efficacy but needs further work. Prof. Stein is co-editor of the journal Oligonucleotides (formerly Antisense and Nucleic Acid Drug Development) and has published over 150 papers in the field.
Prof. Stein is a medical doctor and has a PhD in chemistry. He is an oncologist and was trained at the New York Hospital/Cornell Medical Center and the National Institutes of Health. He was a professor at the College of Physicians and Surgeons at Columbia University for 13 years prior to taking up the chair at the Albert Einstein College.
Prof. Stein explained, "The possibility exists that Dr. Diwan has developed the 'elusive chemical virus' that scientists have been talking about, that is, a chemical nanomaterial, that attacks a virus specifically just like a virus attacks a cell. A virus attacks cells specifically. A nanoviricide, built strictly at the chemical level, does the same, but attacks a virus. It is inspired by how viruses work, and therefore shows a great promise."
"Dr. Stein has strong expertise in the anti-sense approach against the HIV genome. This is of great interest to NanoViricides. His active involvement as our scientific advisor will accelerate our development programs especially for our second generation anti-HIV drugs and other nanoviricides," said Dr. Diwan, President of NanoViricides, Inc. and inventor of the underlying technology.
ISIS - another AMD player
Isis Pharmaceuticals Licenses Antisense Drug to iCo Therapeutics for the Treatment of Eye Diseases
8/25/2005 7:00:51 AM
VANCOUVER, British Columbia and CARLSBAD, Calif., Aug 25, 2005 /PRNewswire-FirstCall via COMTEX/ -- Isis Pharmaceuticals, Inc. (ISIS) and iCo Therapeutics Inc. announced today that Isis has granted an exclusive worldwide license to iCo for the development and commercialization of ISIS 13650, a second-generation antisense drug. iCo will initially develop ISIS 13650 for the treatment of various eye diseases caused by the formation of new blood vessels (choroidal neovascularization) such as age-related macular degeneration (AMD) and diabetic retinopathy.
Ocular angiogenesis, the formation of new blood vessels in the eye, appears to be controlled by growth factors such as vascular endothelial growth factor (VEGF) and can lead to the obstruction of vision. ISIS 13650 is an antisense inhibitor of c-Raf kinase, an enzyme important in the signal transduction pathway triggered by VEGF and other important growth factors. In preclinical studies, antisense inhibition of c-Raf kinase was associated with a reduction in the formation of new blood vessels in the eye, suggesting c-Raf kinase inhibition could be valuable in the treatment of both AMD and diabetic retinopathy.
"We are excited about the potential of ISIS 13650 as a treatment for a variety of eye diseases and view this as the first step in our efforts to build a franchise in ophthalmology. Our strategy is to acquire products that can be developed for isolated biological environments and we have targeted the eye as the first one," said Andrew Rae, President and CEO of iCo Therapeutics. "Isis is a leader in antisense technology and their chemistry in this area combined with our expertise in ophthalmology has all the elements necessary for a successful partnership and product. We look forward to preparing and submitting the IND (Investigational New Drug) application to the U.S. FDA and the commencement of clinical trials in humans in 2006."
"This transaction with iCo is yet another example of our successful satellite company strategy, where we gain from a partner's knowledge in concentrated research programs and we grant our partner access to our expertise in RNA-based drug development and access to our proprietary antisense chemistries and leading patent estate," said C. Frank Bennett, Ph.D., Vice President, Antisense Research at Isis Pharmaceuticals. "In return for providing companies access to our technology, we receive an ownership interest in the resulting products. Through these relationships, we are expanding the reach and potential of antisense therapeutics and participating in the success of multiple companies and products."
As part of the agreement, iCo will pay Isis an upfront fee in exchange for the exclusive, worldwide license to ISIS 13650. The upfront fee will consist of cash and a convertible promissory note, which is convertible into iCo equity. iCo will also pay Isis milestone payments for key clinical and regulatory achievements and royalties on product sales. iCo will have sole responsibility for clinical development and commercialization of the drug.
ABOUT ANTISENSE
Antisense drugs are short, chemically-modified RNA-like and DNA-like molecules that scientists design to complement a small, specific segment of messenger RNA (mRNA). An antisense oligonucleotide hybridizes with a complementary target RNA to form a duplex. The formation of this duplex prevents the target RNA from functioning normally.
Antisense inhibitors can target specific aspects of ocular disease processes and have ideal properties as therapies for the eye. The second-generation 2'MOE (2'-O-methoxyethyl modified oligonucleotides) class of compounds has been shown to exhibit favorable kinetics and excellent tolerability. The mechanism of action of antisense drugs enables the inhibition of genes that are not easily targeted with traditional small molecule or antibody therapies.
ABOUT AMD AND DIABETIC RETINOPATHY
The wet form of AMD is the leading cause of blindness in people over the age of 50. According to research by the National Eye Institute, approximately 1.7 million Americans are affected by the disease and roughly 200,000 new cases of AMD are diagnosed every year in the United States. As a disease of the elderly, the incidence is expected to grow with the aging of the population. Existing treatments for AMD, worth over half a billion dollars (USD), have shown limited long-term success and often require frequent intervention.
Diabetic retinopathy is a complication of diabetes that leads to progressive damage to the small blood vessels of the eye. The condition affects an estimated 5.6 million Americans and is the leading cause of blindness in adults of working age (20-74) in industrialized countries (Decision Resources, Inc.). According to the American Diabetes Association, in the U.S., diabetes is responsible for 8% of legal blindness and each year, between 12,000 to 24,000 people lose their sight because of diabetes.
About iCo Therapeutics, Inc.
iCo Therapeutics Inc. is an emerging, Vancouver-based biotechnology company focused on developing pre-existing drugs for a range of new conditions affecting isolated biological environments -- areas such as the eye, spinal cord, or joints -- where locally-administered application of these therapies would have minimal systemic distribution and fewer safety issues. Additional information about iCo is available at www.icotherapeutics.com.
ABOUT ISIS PHARMACEUTICALS, INC.
Isis Pharmaceuticals, Inc. is exploiting its expertise in RNA to discover and develop novel drugs for its product pipeline and for its partners. The Company has successfully commercialized the world's first antisense drug and has 12 antisense drugs in development to treat metabolic, cardiovascular and inflammatory diseases, and cancer. In its Ibis division, Isis is developing and commercializing the TIGER biosensor system, a revolutionary system to identify infectious organisms. As an innovator in RNA-based drug discovery and development, Isis is the owner or exclusive licensee of more than 1,500 issued patents worldwide. Additional information about Isis is available at www.isispharm.com.
SOURCE Isis Pharmaceuticals, Inc.; iCo Therapeutics Inc.
Dr. John Clement, Chief Technology & Development Officer of iCo, +1-604-602-9414;
or Elayne Wandler of ABCommunications, +1-604-831-2506, for iCo; or Navjot Rai,
Investor Relations & Corporate Communications of Isis Pharmaceuticals, Inc.,
+1-760-603-2331
NVAX - positive results on avian flu vaccine.
Novavax soars on avian flu vaccine
Thursday August 25, 1:02 pm ET
Stock in Novavax jumped as much as 41 percent Thursday after the company reported positive results from an experimental vaccine for avian influenza.
Novavax, which moved its headquarters from Columbia to the Philadelphia area in September, still has a research laboratory in Rockville.
The company reported in the journal Vaccine that an avian flu vaccine developed with its proprietary technology protected animals from the virus in preclinical trials.
Virus-Like Particle technology, or VLP, is an alternative to traditional methods of producing vaccines. The technology is capable of producing large quantities of vaccine in a short period, Novavax says.
The company's stock (NASDAQ: NVAX - News) was up 25 cents to $1.21 per share in Thursday trading on volume of more than 8 million shares, 16 times its normal trading volume.
Novavax also develops hormone replacement therapies and prescription prenatal vitamins.
It lost $5.7 million last quarter, compared with a $7.7 million net loss in the same quarter a year ago.
Published August 25, 2005 by the Washington Business Journal
http://biz.yahoo.com/bizj/050825/1155907.html?.v=1