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Amen to that
Gotta love it!
Come in here, Dear boy, have a cigar.
You're gonna go far,
You're gonna fly high,
You're never gonna die,
You're gonna make it, if you try;
They're gonna love you.
Well I've always had a deep respect,
And I mean that most sincerely.
This stock is just fantastic,
I recommend you horde.
Oh by the way, which one's Ford?
And did we tell you the name of the game, boy?
We call it Riding the Gravy Traaaaaaaaaaain.
I'm gonna go and fill up my tank with gas
Maybe now we'll start to see some action.
79! that's insane
It looks like somebody heard you!
Let's hope that's the case!!
XOMA's IL-1 Inhibitor Down and Out in Type II Diabetes
By Catherine Shaffer
BioWorld Today Contributing Writer
XOMA Ltd.'s stock slid nearly 30 percent Wednesday on news that its investigational interleukin-1 inhibitor, XOMA 052, missed its primary endpoint in a Phase IIb trial in Type II diabetes.
The drug did not achieve reduction of glycosylated hemoglobin (HbA1c) after six once-a-month treatments, essentially knocking it out of the running for the huge diabetes indication.
"There's a lot of data that we continue to analyze," said CEO Steven Engle in a conference call Tuesday evening. "When we embarked on this journey four years ago, medical science was only beginning to catch a glimpse of what effect targeting IL-1 beta would have on disease."
XOMA 052 still is in the game for cardiovascular disease, as it did produce a significant decrease in C-reactive protein (CRP), and XOMA will be proceeding with a planned initiation of a Phase III trial of the drug in Behcet's uveitis later this year.
The failure of XOMA 052 in Phase IIb was "predicted" according to Canaccord Genuity analyst Ritu Baral, based on an interim analysis from the ongoing Phase IIa trial. In that analysis, XOMA 052 showed only a 0.2 percent decrease in HbA1C, vs. a 0.1 percent decrease in the placebo group.
"Historically, because of red blood cell biology, if you treat diabetics for three months, you usually see some sort of HbA1c reduction with an active drug" But "because they didn't show anything at three months...showing anything at six months was unlikely," Baral said.
Shares of XOMA (NASDAQ: XOMA) closed Wednesday at $3.53, down $1.49.
The Phase IIb trial enrolled 421 patients with Type II diabetes on metformin monotherapy. Patients received one of four doses of XOMA 052 or placebo in addition to metformin over six months.
Mean baseline HbA1c was 7.8 percent for the XOMA 052 group and 7.7 percent for the placebo group. On average, study participants had been diagnosed with Type II diabetes for six years.
XOMA did not release HbA1c data at the end of the trial, citing, "competitive and intellectual property" concerns. In spite of what appears to be a complete failure in the diabetes indication, XOMA seemed unwilling to give up on XOMA 052 as a diabetes drug just yet.
Chief Medical Officer Patrick Scannon said XOMA 052 could still have some benefit in diabetes through improvement in systemic inflammation, and through reductions in CRP in diabetics with cardiovascular complications.
At the end of six months, patients in the Phase IIb study showed median reductions in CRP in a range from 33 percent to 54 percent in the four dose groups, compared with zero percent reduction for placebo. Increases in high density lipoprotein (HDL), the "good" cholesterol, also were observed, in spite of the fact that half of the study participants already were on lipid-lowering medication.
"In diabetes, cardiovascular disease is actually the major killer for that disease. Over the last two or three years, a number of publications came out that clearly demonstrate that tight control of blood sugar does not correlate with improvement with cardiovascular outcome," Scannon said.
Although the reductions of CRP show that XOMA 052 has promise as a therapy for cardiovascular disease (for patients with and without diabetes), the Phase IIa and IIb results in CRP would not provide evidence of cardiovascular efficacy. According to Baral, the FDA does not accept CRP as an approvable endpoint for cardiovascular disease.
As in previous XOMA 052 trials, the drug showed a favorable safety and tolerability profile, with no serious drug-related adverse events.
XOMA will push ahead with a Phase III trial of XOMA 052 in Behcet's uveitis near the end of 2011.
Scannon said XOMA and its partner, Les Laboratoires Servier, are working on next steps forward for XOMA 052 in cardiovascular disease, and that approval likely would require studies lasting longer than six months. "For competitive reasons, it is not appropriate at this time to go into details. Clearly, we have a parallel program ongoing in cardiovascular disease. As specific studies are started, we'll be sure to make you aware of them," Scannon said.
Servier paid $15 million up front and made a $19.9 million loan to XOMA for certain rights to the drug in diabetes, cardiovascular disease and Behcet's uveitis, with milestone payments that may range from $470 million to $800 million, as well as a significant investment in development expenses. (See BioWorld Today, Jan. 5, 2011.)
Under the agreement, XOMA and Servier will jointly develop and commercialize XOMA 052. XOMA retains commercial rights and options in the U.S. and Japan for Behcet's uveitis and other inflammatory and oncology indications.Servier has worldwide rights to XOMA 052 for diabetes and cardiovascular disease indications, and rights outside the U.S. and Japan for other indications. Servier will pay for the first $50 million of development expenses for Behcet's uveitis and 50 percent of further development expenses, and will fund development for cardiovascular disease and diabetes. XOMA takes responsibility for manufacturing XOMA 052 through clinical development and launch and expects to continue manufacturing the drug over the long term.
XOMA has received $35 million in cash payments and loans from Servier, and it is eligible for another $470 in milestone payments and tiered royalties up to the midteens. XOMA did not mention how much of those expected milestone payments were related to the diabetes indication.
The partnership with Servier, and its related cash infusions, give XOMA financial stability going forward. A total failure of XOMA 052 in the diabetes indication should not have any effect on that stability, as it is receiving significant funding from Servier for further development of XOMA 052 in Behcet's uveitis.
IL-1 is a target that has generated a great deal of interest, but few viable candidates. Thousand Oaks, Calif.-based Amgen Inc. has an IL-1 blocker, Kineret, for rheumatoid arthritis, but it has not been very successful on the market.
And Tarrytown, N.Y.-based Regeneron Pharmaceuticals Inc.'s IL-1 blocker Arcalyst (rilonacept) is approved for cyropyrin-associated periodic syndromes (CAPS), but earned net sales of only $25.3 million 2010. In a recent Phase III trial in gout, Arcalyst met all of its endpoints.(See BioWorld Insight, Jan. 10, 2010.)
Novartis AG, of Basel, Switzerland, also has an IL-1 inhibitor, Ilaris (canakinumab), that is approved for CAPS and may present competition in other IL-1 indications.
Published March 24, 2011
I'll take some too - please! . . . . right?
I hope that I'm not in denial (and I don't mean the river in Egypt).
It seem that there have been hundreds this year alone. It's raining form 4's. yep, they're printing money to keep things going.
"CTIC simply shells out $5 million upfront and a milestone payment of $5 million when the AML pivotal trial is initiated, which is expected to occur in the fourth quarter of 2011. CTIC will also pick up 75% of the development costs with a $50 million funding cap for the first three years.
The bottom line is any kind of benefit that CTIC could provide shareholders is in the distant future, as it stands they will almost certainly be facing pressure from NASDAQ soon to get their share price up and if news regarding the advancement of their drugs treatments and the recent agreement with Chroma doesn’t push them higher then investors know what the next step may be."
http://www.otcequity.com/?p=886
I do believe that the brakes are off. . . .
Ohhh that's a fish! I thought he was saving a dog from drowning.
I agree with you, erratic price and volume. too easy to miss the boat.
Love it
OriginOil Announces Breakthrough Innovation to Increase Algae Yield
Algae Screen technology protects algae from microscopic predators, integrates with Live Extraction
Los Angeles, CA – March 21, 2011 – OriginOil, Inc. (OOIL), the developer of breakthrough technology to transform algae, the most promising source of renewable oil, into a true competitor to petroleum, today announced Algae Screen™, a process that keeps algae healthy and productive by selectively eliminating microscopic predators without the use of chemicals. The technology employs an electromagnetic pulse, similar to what is used to achieve Live Extraction™. OriginOil will offer Algae Screen and Live Extraction in one integrated offering for growers.
“Much of our technology is based on the same underlying science, so it makes sense to create ‘functionality hubs’ to simplify field operations and create more value for producers,” said OriginOil’s CEO, Riggs Eckelberry. “We see much more integration activity as the algae industry matures.”
The company recently filed for patent protection of the new Algae Screen technology, its twelfth patent application, entitled “Enhancing Algae Growth by Reducing Competing Microorganisms in a Growth Medium.”
“All algae are targets for invasion. Oil-rich algae are particularly attractive to rotifers and other microscopic predators,” said Paul Reep, Senior VP of Technology. “Algae Screen will protect an algae culture continuously from microscopic invaders, such as rotifers, bacteria, and ciliates. An additional unique benefit is that it integrates fully with Live Extraction, since it is based on similar technology.”
Microscopic invaders, such as rotifers, reduce the value of the algae crop by metabolizing valuable oil and biomass. Additionally, invasions can choke off algae growth and reduce the percentage of daily harvest. The problem exists in all types of growth systems, but most acutely in open ponds.
Algae Screen targets invaders with calibrated pulses of low-power electromagnetic energy that leave the algae safe. The pulsing and power levels are adjustable for different algae types and environmental conditions such as water hardness and salinity. Together with Live Extraction, Algae Screen offers a safe and easily manageable resource for algae health and continuous harvesting.
Love what I'm seeing!
Good morning!
Paul Reep Appears on MoneyTV
On Friday, the MoneyTV show featured our new Senior VP of Technology, Paul Reep.
(You can catch the broadcast here.)
On the show, Paul discussed his education in both Petroleum Engineering and Business Administration, and his twenty years in managerial positions at the Department of Energy, in both nuclear and renewable energy. It was the twenty-year DOE Aquatic Species Program that first awakened Paul's interest in commercializing algae.
Our own interest in bringing Paul into OriginOil dates back more than two years ago, and we've been waiting for him to complete his assignment at the USC Stevens Institute for Innovation, where he juggled up to two hundred technology licensing cases at a time!
Universities these days are serious about commercializing their inventions, and Paul's skill set is very much what OriginOil needs. Paul is very, very welcome aboard.
Algae and Nuclear Developments
Given Paul's background in nuclear energy, the discussion naturally turned to the ongoing nuclear emergency in Japan. In contrast to nuclear energy, algae is not only safe, it is already everywhere — absorbing more than half of the CO2 being created in the world every day!
That's very good news, because problems with nuclear energy will drive a boom in fossil fuels (and rising prices over time). Only algae can absorb all that CO2, while turning into a true alternative to petroleum and natural gas.
CO2 and Acid Rain
There's been a long debate over climate change. Meanwhile, one thing is undeniable about CO2: it is acidifying our lakes and oceans (remember acid rain?). Fisheries and coral reefs are endangered. The destruction of whole ecosystems is too high a price to pay for using fossil fuels.
We'll be covering more about this fascinating subject in coming MoneyTV shows, so stay tuned.
And here's to a great week ahead!
Riggs and team
Riggs Eckelberry
President & CEO
OriginOil, Inc. (OOIL)
DOE’s Biomass Program Lead Engineer warns that, when it comes to biofuels, “it’s the economy, stupid”.
http://biofuelsdigest.com/bdigest/2011/03/17/does-duff-warns-that-asian-industrial-buildup-threatens-our-way-of-life-if-us-does-not-reduce-oil-consumption/
Riggs Eckelberry's New Energy
“Dried-Up Little Country” Creates “Teachable Moment” About Our “Insecure Position”
Posted: 17 Mar 2011 12:30 AM PDT
What’s the take-away from 2011's oil crisis? Hopefully, public realization that petroleum is past, not future. Supported by political and investment action.
Some interesting supporting quotes appeared in a story from the LA Times:
“This is a crisis that’s creating a teachable moment, showing us that we’re going in the wrong direction,” said Denise Bode, chief executive of the American Wind Energy Association. “People have been in this situation too many times, and once they see that the alternatives are the real deal, they’ll never go back.”
Concerns that the country’s addiction to foreign oil could pose national security risks and that the environment is fraying are stronger than ever, said Bode, who is also the former president of the Independent Petroleum Association of America.
“We’ve gone from a relatively secure position to a very insecure one,” Jim Boyd, vice chairman of the California Energy Commission, said in a statement. “Our exposure to the vagaries and instability of the world oil market has increased by a factor of 10 since the early 1990s.”
Since then, the renewable energy industry has compiled a stable of high-profile supporters. President Barack Obama said he wants 80 percent of the energy in the U.S. to come from “clean” sources by 2035. Former California Gov. Arnold Schwarzenegger regularly visited wind and solar energy production sites cropping up throughout California.
“Why should a dried-up little country like Libya with a crazy dictator play havoc with America’s economy and security?” he asked at a recent summit for Advanced Research Projects Agency-Energy, known as ARPA-E, the Department of Energy program that helps fund early-stage energy research.
Are we making progress? Yes. Does the crisis help? Seems to be helping. The real question: What permanent changes are being made? Renewable energy must not retreat when we’re out of the headlines.
Damn! Medical marijuana growers accused of trafficking
http://www.reuters.com/article/2011/03/16/us-montana-marijuana-odds-idUSTRE72F68H20110316?feedType=nl&feedName=usoddlyenough
Novartis, Roche’s Xolair Blunts Asthma Attacks in Children in U.S. Cities
By Nicole Ostrow - Mar 16, 2011 2:00 PM PT
Xolair, sold by Novartis AG (NOVN) and Roche Holding AG (ROG), improved treatment of asthma for inner-city children and young adults, according to a U.S.-funded study.
Those given an injection of Xolair had fewer days with symptoms, such as wheezing and shortness of breath, and fewer asthma attacks compared with those on a placebo, researchers said today in the New England Journal of Medicine. The patients who responded best were those most allergic to cockroaches.
About 7.1 million U.S. children under the age of 18 have asthma, according to the American Lung Association, based in Washington. Reducing children’s allergic reactions can help them have fewer asthma attacks, said William Busse, the study’s lead author, in a telephone interview yesterday.
“The take-home message for physicians and parents is to realize that allergies play an important role in making children more susceptible to viral respiratory infection-provoked asthma attacks, especially those that occur on a seasonal basis,” said Busse, a professor of medicine at the University of Wisconsin School of Medicine and Public Health, in Madison.
Asthma attacks are more likely in spring and autumn, the seasons when more allergens are in the air and respiratory viruses rise, according to the U.S. National Institutes of Health, based in Bethesda, Maryland. The agency backed the study.
Xolair works in the body by attaching itself to immunoglobulin E, an antibody responsible for allergic reactions, Busse said. The drug brings the molecule out of circulation or pulls it from cells to reduce allergic reactions, he said. Xolair is the only drug in its class, he said.
Age Limit
The medicine costs about $1,000 a month and is usually covered by insurance, Busse said. Novartis’s 2010 sales of Xolair were $369 million, while Genentech’s revenue from the product totaled $616 million, according to data in the companies’ annual reports.
Xolair was approved in the U.S. in 2003 for use in adults and children aged 12 or older. Novartis, which also helped support today’s study, and Roche’s Genentech unit failed to win U.S. clearance in 2009 for Xolair in children aged 6 to 11.
Christopher Vancheri, a Genentech spokesman, said yesterday that the companies have no plans to seek U.S. approval again for children under 12. Both Novartis and Roche are based in Basel, Switzerland.
“Allergic asthma is a growing problem among inner-city children,” Vancheri said in an e-mail. The study provides “new information that continues to help further the understanding of the mechanism of asthma in this population.”
National Network
The study covered 419 patients aged 6 to 20 who had moderate to severe allergic asthma for more than a year. The children came from Boston, Chicago, Cleveland, Dallas, Denver, New York, Washington and Tucson, Arizona. The patients were recruited by clinics in the Inner City Asthma Consortium, a nationwide network supported by the NIH.
The researchers sought to determine if adding Xolair, or omalizumab, to standard therapy reduced the number of days of asthma-related symptoms and the severity of attacks. U.S. guidelines call for patients to use inhaled corticosteroids, visit doctors and limit exposure to allergens.
The participants in the 60-week trial were split into two groups. One received Xolair and followed the guidelines for asthma therapy. The other group received a placebo and followed guidelines.
Hospital Visits
The patients taking Xolair had a 75 percent reduction in hospitalizations, according to the report. Xolair reduced the number of days with asthma symptoms to 1.48 in two weeks compared with 1.96 for those given a placebo, while lowering the proportion of people who had serious attacks to 30 percent from 49 percent, the study found. Xolair also almost eliminated seasonal rises in the episodes.
“No differences of concern regarding safety were noted between the two groups,” the researchers wrote. Severe allergic reactions called anaphylactic events were reported in seven patients, including just one on Xolair. Such reactions can lead to death, according to safety information on Xolair.com, a website maintained by Genentech and Novartis.
Busse said it was too soon to recommend that doctors give Xolair to kids under 12 for asthma and that longer-term research is needed. The Inner City Asthma Consortium is planning to study whether giving children Xolair for a short period before going back to school can reduce asthma attacks, he said.
“We continue searching for therapeutic strategies to reduce the enormous burden of asthma,” said Daniel Rotrosen, director of the National Institute of Allergy and Infectious Diseases’s Division of Allergy, Immunology and Transplantation program, which oversees the asthma network, in a statement.
To contact the reporter on this story: Nicole Ostrow in New York at nostrow1@bloomberg.net.
To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net
Thermopylae Science and Technology
Thank you cptn'
http://www.t-sciences.com/
Those are some shoulders! They look like wings to me!
I guess so
Patients, Activists, and Friends-- FYI. . . .
Americans for Safe Access (ASA) needs your help right now to respond to a renewed federal attack on medical cannabis patients and providers. Drug Enforcement Administration (DEA) agents raided twenty-six medical cannabis facilities in Montana and two in West Hollywood, CA, in the last forty-eight hours alone! We must tell the Obama Administration to stop the raids and create a federal policy that protects legal patients!
Call the White House at (202) 456-1414 between 9:00 AM to 5:00 PM EST and send an email right now:
“I am outraged by the recent federal raids on medical marijuana patients and providers in Montana and California. Medical marijuana patients and providers should not be subject to harassment or arrest, especially when they are obeying state law. I demand the Administration stop the raids, allow states to regulate medical marijuana, and develop a federal policy that protects patients once and for all. Thank you.”
Speaking up today is the first step in standing up to federal aggression, but we have much more work to do. Our elected representatives need to hear from an empowered and energized base now more than ever. ASA needs your support so that we can train and mobilize the grassroots base and keep pushing to change federal law. Can you make a special contribution to ASA today, so that we are ready to respond to renewed federal threats?
Thank you for your support and participation! Together, we will stop the raids and secure safe access for every patient who needs medical cannabis!
Sincerely,
Steph Sherer
Executive Director
P.S. - After you call or send your email, forward this message to your friends and loved ones, and don’t forget to share it on Twitter, FaceBook, MySpace, etc.
http://safeaccessnow.org/
More than double the avrg volume - over 1 mil at 3:01. We're not the only ones who think this is good news
Giddy up!!! +2.93/+13.28% in after hour trading!
March 14, 2011 04:01 PM Eastern Daylight Time
IPX066 Demonstrates Efficacy and Safety in ADVANCE-PD Phase III Study in Treatment of Advanced Parkinson’s Disease
IPX066 met the primary end point, significantly reducing percentage of “off time” over IR CD-LD
Conference call and Webcast presentation scheduled for Tuesday, March 15 at 9:00 a.m. ET
HAYWARD, Calif.--(BUSINESS WIRE)--Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc. (NASDAQ: IPXL), today announced statistically significant, positive, top-line results of the ADVANCE-Parkinson’s Disease (PD) Phase III clinical study of the safety and efficacy of IPX066 versus immediate-release (IR) carbidopa-levodopa (CD-LD) in advanced PD patients experiencing motor fluctuations. IPX066 is an investigational extended release (ER) CD-LD product. The ADVANCE-PD results demonstrated that IPX066 produced significantly improved control of motor symptoms as compared to IR CD-LD in multiple clinical measures in subjects with advanced PD.
“In the ADVANCE-PD study, daily “off time”
The primary endpoint of this comparison study of IPX066 to IR CD-LD was the percentage of “off time” during waking hours. IPX066 demonstrated a 37% improvement from baseline for IPX066 vs. a 17% improvement from baseline for IR CD-LD (p<0.0001). “Off time” is the functional state when patients’ medication effect has worn off and there is a return of Parkinson’s symptoms.
The study enrolled 471 subjects on a stable regimen of IR CD-LD who were first entered into a dose-adjustment phase of their IR CD-LD, followed by a conversion to IPX066 after which they were then randomized to either IPX066 or IR CD-LD. Subjects converted to IPX066 experienced a reduction from baseline of more than 2 hours in total “off time” during waking hours, and this effect was maintained in the group then randomized to IPX066 during the blinded study portion. While the group treated with IR CD-LD achieved similar improvement during conversion to IPX066, “off time” worsened by 1.0 hours during double blind treatment with IR CD-LD (p<0.0001). In addition, during double-blind treatment, subjects experienced similar results in “on time” without troublesome dyskinesia with an increase of 1.9 hours for IPX066 compared to an increase of 0.8 hours for IR CD-LD as measured from study entry (p<0.001).
Additional clinical and patient-reported outcome measures in the study consistently demonstrate the improved IPX066 efficacy profile when compared to IR CD-LD. This includes the Unified Parkinson’s Disease Rating Scale (UPDRS), Clinician Global Impression of Change (CGI) and Patient Global Impression of Change (PGI), which also demonstrated significant improvements in treatment with IPX066 compared to IR CD-LD (p<0.0001 for all comparisons). In quality-of-life (QOL) measures, IPX066 demonstrated significant improvement over IR CD-LD as measured by PDQ-39 (p<0.035) and modified Rankin Test (p<0.006).
“Impax Pharmaceuticals is excited to report these positive results for the ADVANCE-PD trial demonstrating the clinical benefits of IPX066 over IR CD-LD, which is the gold standard in treating advanced PD,” stated Dr. Suneel Gupta, Impax Pharmaceuticals’ Chief Scientific Officer. “Consistent with our Phase II findings, these data show IPX066 provides a robust level of efficacy across a range of PD clinical and QOL measures, which represents a potentially significant improvement over existing treatment options. With the successful completion of this ADVANCE-PD trial and the APEX-PD trial in patients with early PD, we have completed the two required Phase III trials for a New Drug Application (NDA) as agreed with the Food and Drug Administration. We are working diligently to file an NDA in the fourth quarter of 2011."
IPX066 was generally well tolerated, and during the double-blind portion of the trial had an adverse event (AE) rate of 43% compared to 40% for IR CD-LD. The most common AEs reported for IPX066 included: insomnia, nausea, fall, dizziness, and dyskinesia (no event was associated with a greater than 3.5% overall incidence). The rate of related serious AEs was comparable, with one subject in each treatment arm reporting serious treatment-related AEs in the double-blind treatment phase.
According to Robert A. Hauser, MD, Professor of Neurology, Molecular Pharmacology, and Physiology and Director of the Parkinson's Disease & Movement Disorders Center at the University of South Florida and an ADVANCE-PD study investigator, “There is a major unmet need in patients with advanced PD for a therapy that can consistently extend and improve motor symptom control through the day and enhance quality of life.” Dr. Hauser added, “In the ADVANCE-PD study, daily “off time” was reduced without worsening of dyskinesia, and both patients and clinicians reported overall improvement. The magnitude of benefit observed with IPX066 was clinically significant and results indicate that PD patients should be able to enjoy improved control of their motor symptoms and a better quality of life.”
Impax Pharmaceuticals plans to present complete results of the ADVANCE-PD study at an upcoming scientific meeting.
Conference Call Information
The Company will host a conference call and Webcast with a slide presentation on Tuesday, March 15 at 9:00 a.m. ET to discuss the results. The number to call from within the United States is (888) 461-2024 and (719) 325-2417 internationally. The call can also be accessed via a live Webcast through the Investor Relations section of the Company’s Web site, www.impaxlabs.com. In addition, a copy of the slide presentation is available in the Investor Relations section. A replay of the conference call will be available shortly after the call for a period of seven days. To access the replay, dial (888) 203-1112 (in the U.S.) and (719) 457-0820 (international callers). The access conference code is 8896538.
About Our Collaboration with GlaxoSmithKline (GSK)
Impax Pharmaceuticals and GSK announced an agreement for the development and commercialization of IPX066, outside the United States and Taiwan, in December 2010. Under the terms of the agreement, GSK received an exclusive license to sell IPX066 throughout the world except in the U.S. and Taiwan. Impax will complete the current Phase III program for IPX066, which includes the ADVANCE-PD study.
About the ADVANCE-PD Study and IPX066 Development Program
The ADVANCE-PD study is the second of two pivotal trials designed to support an NDA for IPX066 in PD. The study is a randomized, double-blind, active-control, parallel-group Phase III study of the safety and efficacy of IPX066 versus IR CD-LD in advanced PD patients with motor fluctuations. The trial enrolled 471 subjects in North America and Europe of which 393 subjects were randomized to participate in the 13-week comparison of IPX066 versus IR CD-LD. Prior to randomization, subjects on a stable IR CD-LD dose regimen entered a 3-week dose-adjustment or dose optimization period for IR CD-LD, followed by a 6-week dose-conversion period to IPX066. Subjects were instructed to take IPX066 three times a day.
The ADVANCE-PD trial results complement the earlier announced positive APEX-PD Phase III study in early PD. APEX-PD was a randomized, double-blind, placebo-controlled, parallel group, fixed-dose study comparing 3 doses of IPX066 to placebo in 381 patients with early PD.
The Company is also conducting the ASCEND-PD comparative study of IPX066 and carbidopa-levodopa and entacapone, which is currently enrolling subjects.
An Open Label Extension study for subjects from the ADVANCE-PD and APEX-PD studies is also ongoing.
About IPX066
IPX066 is an investigational CD-LD product with an enhanced pharmacokinetic profile. The IPX066 pharmacokinetic profile has the potential to offer reliable control of PD symptoms, such as the reduction in “off time” throughout the day, which has been observed in preliminary studies of IPX066.
About Parkinson’s Disease
Parkinson’s Disease is a chronic neurodegenerative movement disorder affecting over three million people in the US, Europe, and Japan.
About Impax Laboratories, Inc.
Impax Laboratories, Inc. is a technology-based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products. Impax markets its generic products through its Global Pharmaceuticals division and markets its branded products through the Impax Pharmaceuticals division. Additionally, where strategically appropriate, Impax has developed marketing partnerships to fully leverage its technology platform. Impax is headquartered in Hayward, California, and has a full range of capabilities in its Hayward, Philadelphia and Taiwan facilities. For more information, please visit the Company's Web site at: www.impaxlabs.com.
"Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995:
To the extent any statements made in this news release contain information that is not historical, these statements are forward-looking in nature and express the beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause the Company’s future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to, the effect of current economic conditions on the Company’s industry, business, financial position and results of operations, the ability to maintain an effective system of internal control over financial reporting, fluctuations in revenues and operating income, the ability to successfully develop and commercialize pharmaceutical products, reductions or loss of business with any significant customer, the impact of competition, the ability to sustain profitability and positive cash flows, any delays or unanticipated expenses in connection with the operation of the Taiwan facility, the effect of foreign economic, political, legal and other risks on operations abroad, the uncertainty of patent litigation, consumer acceptance and demand for new pharmaceutical products, the difficulty of predicting Food and Drug Administration filings and approvals, the inexperience of the Company in conducting clinical trials and submitting new drug applications, the ability to successfully conduct clinical trials, reliance on alliance and collaboration agreements, the availability of raw materials, the ability to comply with legal and regulatory requirements governing the healthcare industry, the regulatory environment, the ability to protect the Company’s intellectual property, exposure to product liability claims and other risks described in the Company’s periodic reports filed with the Securities and Exchange Commission. Forward-looking statements speak only as to the date on which they are made, and Impax undertakes no obligation to update publicly or revise any forward-looking statement, regardless of whether new information becomes available, future developments occur or otherwise.
Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=6646211&lang=en
Contacts
Impax Laboratories, Inc.
Mark Donohue
Sr. Director
Investor Relations and Corporate Communications
215-558-4526
www.impaxlabs.com
yup, twill indeed. I'm inclined to believe that in the near future this'll be followed by news of contracts and/or partnership with a some major players. . . Go Pablo
I lifted the following from the "University of Southern California’s Stevens Institute for Innovations'" website.
http://stevens.usc.edu/about_usc_stevens_team_paul_reep.php
http://stevens.usc.edu/index.php
OnGreen Enters into cleantech Patent Marketing Partnership with The USC Stevens Institute for Innovation to Advance Green Intellectual Property Commercialization
February 17, 2011
OnGreen partners with USC to speed up the transition from innovation to adoption, accelerating the global use of clean energy
Los Angeles, CA - February 17, 2011 - OnGreen, the leading online marketplace for clean tech investment, announced today it has entered into a marketing partnership with the University of Southern California’s Stevens Institute for Innovation (USC Stevens) to include USC’s patented technologies with potential clean tech applications and commercialization on its website. OnGreen will host USC’s patents on OGPX, its Patent Exchange platform. OnGreen received non-exclusive rights to assist in marketing USC’s cleantech-related patents worldwide.
OnGreen recently launched the Patent Exchange to serve early-stage innovators and entrepreneurs holding clean technology patents. The Patent Exchange enables patent holders to describe specific clean technology applications, highlight advantages of the technology, include video, other graphical data and online links in addition to standard patent data and specifications. “The Patent Exchange was built out of the need to provide universities, entrepreneurs and companies increased exposure to a broader global community,” said Nikhil R. Jain, OnGreen CEO.
"USC's expertise is in teaching and research. Some of the technologies and inventions we have available for licensing are ready for commercial use today," said Ed Beres, Senior Business Development and Licensing Associate at USC Stevens Institute for Innovation. “But in general, these inventions are still early stage. We are always looking to work closely with investors and entrepreneurs to put together a commercialization strategy or start-up team."
Krisztina “Z” Holly, USC Vice Provost for Innovation and Executive Director of USC Stevens adds, “USC is committed to speeding the transition of new ideas to society, where they can drive new industries and stimulate economic growth. As a result, successful and streamlined technology transfer operations continue to be one of our key priorities.”
“We’re excited to partner with the USC Stevens Institute and its rich portfolio of intellectual property,” says Jain. “We see our Patent Exchange supplementing USC Stevens’ organic technology transfer efforts by improving its patents’ online search visibility and by leveraging OnGreen’s ever expanding reach into international markets. In discussions with Chinese investors, entrepreneurs and companies, for example, we hear repeated interest in technologies that will accelerate the use of clean energy.” Ultimately, the Patent Exchange will serve as an effective bridge between untapped users of intellectual property and our academic partners such as USC.
About OnGreen
Los Angeles-based OnGreen is the world’s largest greentech marketplace driving money to the most promising cleantech ideas while growing the green economy one deal at a time. To learn more, visit: http://ongreen.com
About USC Stevens Institute for Innovation
Can your idea change the world? At the USC Stevens Institute for Innovation, we believe it can. But for a new idea to make broad impact, it must transition beyond concept into real world implementation and originate from the desire to address untapped real world opportunities. Doing so takes a unique combination of creativity and pragmatism, which we believe can be honed and developed for a lifetime of innovation. Innovation can come from the arts and social sciences as well as engineering or medicine. It can take the shape of new products or services; new ventures, ranging from venture-backed startups to non-profits; as well as new organizational models. The USC Stevens Institute for Innovation (http://stevens.usc.edu) is a university-wide institute in the office of the Provost designed to harness the creative thinking and innovative work at all of USC’s 17 professional schools, the USC College, and research centers across campus to build a multidisciplinary approach to innovation.
OnGreen Media Contact:
Chathri Munasinghe
chathri(at)ongreen(dot)com
(800) 297-0445 x 207
Twitter: @OnGreenInc
Facebook: OnGreen.inc
USC Stevens Institute Media Contact:
Ian Murphy
USC Stevens Director of Communications
ian(at)stevens(dot)usc(dot)edu
No doubt it would have been wasted. . . shine on you crazy diamond you!
Now we know why. . . . unlock those doors and windows and let the ctic on in
Cell Therapeutics Acquires Exclusive Marketing and Co-Development Rights in the Americas to Chroma Therapeutics' Tosedostat, a First in Class Tumor Selective Oral Therapy for Treatment of Blood Related and Other Cancers
14 minutes agoPR Newswire
SEATTLE and OXFORD, England, March 14, 2011 /PRNewswire/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) and Chroma Therapeutics Ltd. ("Chroma") announced today that the companies have entered into a co-development and license agreement providing CTI with exclusive marketing and co-development rights to Chroma's drug candidate tosedostat in North, Central and South America. Tosedostat is an oral, aminopeptidase inhibitor that has demonstrated significant anti-tumor responses in blood related cancers and solid tumors in phase I-II clinical trials. CTI, in collaboration with Chroma, expects to commence a phase III clinical study in the United States and Europe in elderly patients with relapsed or refractory acute myeloid leukemia ("AML") for potential approval by the U.S. Food and Drug Administration ("FDA") and the European Medicines Agency ("EMA"). The FDA and the EMA have granted tosedostat orphan drug status for AML.
Pursuant to the terms of the agreement, CTI will make an upfront payment of $5 million and a milestone payment of $5 million when the AML pivotal trial is initiated, which is expected to occur in the fourth quarter of 2011. The agreement also includes customary development-based milestone payments related to AML, myelodysplastic syndrome ("MDS") and certain other indications, as well as royalties on net sales in CTI's territories. CTI will oversee development operations and commercialization activities in its territories and Chroma will oversee development operations and commercialization activities in the rest of the world. Subject to a funding cap of $50 million for the first three years, CTI will be responsible for 75% of development costs and Chroma will be responsible for 25% of development costs.
"Tosedostat, similar to drugs like bortezomib and lenalidomide, represents a departure from conventional cytotoxic chemotherapy toward more tumor selective targeted therapy that interferes with cellular pathways necessary for tumor survival," commented James A. Bianco, M.D., CEO of CTI. "In initial clinical studies, tosedostat was well-tolerated, given orally once a day and produced encouraging response rates in difficult to treat patients with acute leukemia and a variety of blood related cancers. We are excited to add tosedostat to our late-stage product pipeline alongside pixantrone as we continue with our strategy of building a pipeline of novel drugs for treating blood-related cancers."
Chroma is an Oxford, UK based private company led by a management team with extensive public biotechnology and large pharmaceutical company experience, including former executives of Celltech, British Biotech, AstraZeneca and Roche, and backed by leading specialist investors. Chroma is focused on harnessing chromatin biology and its novel cell accumulation (ESM) technology to develop new targeted therapies for cancer and inflammatory disorders.
"We believe that this is a collaboration that should enable the rapid progression of tosedostat toward seeking regulatory approval, given CTI's development and commercialization capabilities and experience in the blood-related cancer space," said Ian Nicholson, CEO of Chroma. "In working with clinicians in developing tosedostat we have clearly identified significant unmet medical needs where tosedostat could provide an important therapeutic advance for patients if approved."
AML is a hematologic cancer that is an aggressive, fast-growing cancer that starts inside the bone marrow with the production of abnormal blood cells. The American Cancer Society estimates that 12,330 new cases of AML will be diagnosed and approximately 8,950 deaths from AML will occur in the U.S. in 2010. AML is generally a disease affecting older people with the average patient age at onset of approximately 67 years. There remain a substantial proportion of elderly patients who do not receive intensive chemotherapy due to their inability to tolerate such regimens, and other risk factors. Therefore, there is a significant unmet medical need in developing a well-tolerated and effective treatment for these patients.
Tosedostat is an orally dosed aminopeptidase inhibitor which blocks the M1/17 family of aminopeptidases. Disrupting aminopeptidases deprives sensitive tumor cells of amino acids by blocking protein recycling resulting in tumor cell death. Tosedostat has been studied in Chroma's phase I-II clinical trials both as a single agent and in combination with other chemotherapeutic agents. Such studies have demonstrated significant anti-tumor responses without the typical side effects of conventional, non-targeted cytotoxic therapies. Initial target indications include AML, MDS and multiple myeloma.
Conference Call Information
On Monday, March 14, 2011, at 8:30 a.m. Eastern time/1:30 p.m. Central European time/5:30 a.m. Pacific time, members of CTI's and Chroma's management teams will host a conference call to discuss the co-development and licensing agreement.
Conference Call Numbers
Monday, March 14, 20118:30 a.m. Eastern/1:30 p.m. Central European/5:30 a.m. Pacific Time
1-877-941-0843 (US Participants – Toll-Free)
1-480-629-9643 (US Participants)
800-149-038 (Italy Participants – Toll-Free)
39-06-45-210-8364 (Italy Participants)
0800 358 0857 (UK Participants – Toll-Free)
44-20-8515-2302 (UK Participants)
Call-back numbers for post-listening available at 11:30 a.m. Eastern Time:
1-800-406-7325 (US Participants)
1-303-590-3030 (International)
Passcode: 4423141#
Live audio webcast at www.celltherapeutics.com will be archived for post-call listening approximately two hours after call ends.
About Cell Therapeutics, Inc.
Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit www.CellTherapeutics.com.
Sign up for email alerts and get RSS feeds at our Web site, http://www.CellTherapeutics.com/investors_alert
About Chroma Therapeutics
Chroma Therapeutics, based in Oxford (UK), is a drug discovery and development company focused in the fields of oncology and inflammatory disorders. Chroma is building a broad pipeline of first- or best-in-class treatments utilizing its expertise in chromatin biology and its novel intracellular accumulation technologies, which include the ability to selectively target drugs' tomacrophages. Chroma is backed by a number of leading specialist investors, including Abingworth, Essex Woodlands, Gilde, Phase4 and The Wellcome Trust. More information about Chroma can be found at www.chromatherapeutics.com.
This press release includes forward-looking statements that involve a number of risks and uncertainties the outcome of which could materially and/or adversely affect actual future results and the market price of the Company's securities. Specifically, the risks and uncertainties that could affect the development and commercialization of tosedostat include risks associated with preclinical, clinical and sales and marketing developments in the biopharmaceutical industry in general and in particular, including, without limitation, the potential failure of tosedostat to prove safe and effective (including complete and overall response rates) for the treatment of blood related and other cancers as determined by the FDA and/or the EMA, that the FDA may not accept the proposed clinical trial design of tosedostat and/or may request additional clinical trials, that clinical trials may not demonstrate the safety and effectiveness of tosedostat, that the Company cannot predict or guarantee the pace or geography of enrollment of clinical trials of tosedostat, including whether or not the majority of the patients will be enrolled in the U.S., that the phase III pivotal trial for tosedostat for AML may not start during the fourth quarter of 2011, that the Company cannot predict or guarantee the outcome or results of clinical trials of tosedostat, that the Company cannot predict or guarantee whether the co-development and license agreement will strengthen the Company's business, financial condition, operating results and prospects or the trading price of the Company's securities, that the Company cannot predict or guarantee whether milestones will be achieved pursuant to the Agreement, the Company's ability to continue to raise capital as needed to fund its operations and make milestone payments, as applicable, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing and selling the Company's products under development and co-development, and other economic, business, competitive, and/or regulatory factors affecting the Company's business generally, including those set forth in the Company's filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for its most recent fiscal year and its most recent Quarterly Report on Form 10-Q, especially in the "Factors Affecting Our Operating Results" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections, and its Current Reports on Form 8-K. Except as may be required by law, the Company does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.
SOURCE Cell Therapeutics, Inc.
CCME: Waking Up The Sales Staff
Here is some video of the visit to China MediaExpress taken on an iPhone. There
should be additional clips posted in the coming days.
The woman speaking is Vinne Ye, the assistant to the Chairman. In several clips
I am the fellow wearing the tan raincoat. The American voice heard most often is
my colleague the [...]
You may view the entire story at
http://www.thefinancialinvestigator.com/?p=336
http://vimeo.com/20999561
PetroSun Announces Settlement Agreement
SCOTTSDALE, AZ – March 11, 2011 (MarketWire)
PetroSun, Inc. (Other OTC: PSUD.PK) announced today that a Settlement Agreement and Covenant Not to Execute has been entered into by the Independence Bowl Foundation, Inc. and the Company. . This agreement, subject to its terms and conditions, will allow PetroSun to move forward with its planned exploration and other energy related operations.
http://www.petrosuninc.com/company_announcements.php
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Title sponsor
In 1990, the contest became one of the earliest college bowl games to use a title sponsor, becoming the Poulan Weed-Eater Independence Bowl. (The name gave rise to the term Weedwhacker Bowl, which is sometimes used to refer to a second-rank bowl game, especially by fans of top-ranked teams who expect their squads to compete in BCS contests.) Although it has been many years since Poulan Weed-Eater has been a sponsor, many still use their name when referring to this bowl.
Poulan (then a division of AB Electrolux Home Products, now Husqvarna AB) sponsored the game until 1996. Newell Rubbermaid's Sanford brand of writing products took over sponsorship from 1998 until 2000, while MainStay Investments sponsored from 2001 to 2003. In January 2005, in what was widely perceived as a publicity stunt, the Deja Vu chain of "gentlemen's clubs" offered to become the title sponsor. The offer was rejected.
The Independence Bowl's three-year search for a title sponsor ended on August 21, 2006 when PetroSun Inc., a Phoenix, Arizona-based company that provides services and products to suppliers of oil and gas, agreed to become the bowl's sponsor. The deal, changing the game's full name to the PetroSun Independence Bowl, was to have run through 2008 with an option for 2009; however the deal was discontinued prior to the 2008 game.
I agree with EMTPstock. The stage is just being set, we got a ways to go, this show isn't going to start for a while. So grab a good seat now before they're all gone. If your waiting to get in on a dip, I got a feeling it just might happen this week.
Which brings up the point and I almost hate to say it, I know this sounds callus, but: if there's anything that'll help turn the spotlight and bring attention to OOIL and other company like it will be events such as this awful earthquake in Japan and the very real potential of a disastrous nuclear meltdown. 10x Chernobyl so I'm told. You know that this is going to set off a wave of nuclear-phobia here in the States
http://gigaom.com/cleantech/here-comes-the-backlash-to-japans-nuclear-disaster/
Algae is safe, although I guess someone could slip into a pond and drown, grows just about anywhere, doesn't compete with food crops, has bioremediation agents, and the list goes on and on. . . so? let's get going!
By the way who in the hells idea was it to put a nuclear power plant on a fault line in the first place?
My take is that the whole purpose of this merger is to expand and enhance the product line, reduce cost / pricing, and in their own words "dramatically enhance their ability to close larger orders". Now they're in a position to do all three. Otherwise, Promark would have kept their name and the recognition it has attained over the past 20 years, cut-up IceWEB and sold off or dissolved the parts that didn't suit them. Promark knows what the market wants and needs & IceWeb knows how to make it.
I'm thinking that the tip of this new arrow will come from the custom built appliances.
Kept in mind indeed. The possible applications of this technology are as endless as they are intriguing.
Your concerns are justified, so maybe it should be made mandatory for all elected officials, and political candidates to wear those same helmets. We may even finally achieve true transparency within the operations of our government. . . then again, there may not be enough brain activity to get a reading.