�Curis, Inc. (NASDAQ: CRIS), a drug development party focused on developing following generation proprietorship targeted medicines for cancer treatment, announced that the first patient role has been treated in a Phase I clinical trial of CUDC-101, a first-in-class low molecule drug candidate that has been designed as an inhibitor of epidermic growth factor receptor (EGFR), epidermal growth factor receptor 2 (Her2) and histone deacetylase (HDAC). CUDC-101 has been intentional to simultaneously inhibit kinase activity of EGFR and Her2 patch also meddlesome with other key drivers of the cancer cell signaling network involved in tumor electric cell growth and survival through its HDAC inhibitory body process.
"We are very pleased to be participating in a trial with this promising new drug campaigner," commented Dr. Anthony W. Tolcher, Director of Clinical Research at South Texas Accelerated Research Therapeutics (START), and lead investigator of the CUDC-101 Phase I trial. "This trial aims to build on presymptomatic data suggesting that CUDC-101 may have activity across a all-embracing range of cancer types, particularly those that ar resistant to currently marketed drugs. We look forward to exploring the potency of CUDC-101 in the clinic."
"This is an important milepost for the company as we focus on advancing our targeted small corpuscle drug candidates for malignant neoplastic disease treatment into the clinic," said Curis President and CEO Dan Passeri. "We believe that CUDC-101's compounding of clinically-validated cancer targets in a single agent may present an significant advance in targeted malignant neoplastic disease therapy with respect to efficacy and safety. Moreover, single multi-targeted agents may have potentially significant monetary value advantages over multiple drugs with the same butt profile."
The Phase I trial is designed as an open-label dose escalation study of CUDC-101 in patients with advanced, refractory solid tumors. CUDC-101 will be administered on days one to five of a xIV day bike. The outset patient enrolled in the Phase I study has completed five days of dosing. The primary objectives of the Phase I trial are to appraise the safety and tolerability of escalating doses of the Phase I molecule and to establish the maximum tolerated dose and dose limiting toxicities. Secondary objectives testament be to assess the pharmacokinetics, efficacy and power of CUDC-101 to inhibit HDAC, EGFR and Her2 in this patient population. The study is expected to be conducted at two sites within the United States and to enroll betwixt 18 and 40 patients across various dose-escalating cohorts. Further trial details ar posted at ClinicalTrials.gov.
About Curis' Targeted Cancer Drug Development Programs
The end of Curis' targeted crab drug development programs is to rationally design and develop novel, proprietary little molecules that target one or more than clinically validated targets or pathways known to wreak key roles in the development or maintenance of cancer. By focusing on these validated targets, Curis hopes to reduce risk, time and costs associated with the drug development process. Using its targeted cancer dose development platform, Curis has generated single agent, multi-target small molecules that are being intentional to aggregate HDAC inhibition with crushing of targets that include EGFR, Her2, VEGFR, BCR-Abl/Src, MET, CDK, Aurora, RAF and MEK, with a goal of potentially providing enhanced efficacy over existing drugs. The first developmental candidate selected from this multi-target program is CUDC-101, a first-in-class small molecule designed to inhibit EGFR, Her2 and HDAC. Curis is also using its targeted cancer drug development platform to design single agent, single-targeted drug candidates that it believes give the voltage to reach best-in-class condition among existing single object drugs. The first candidate to be selected from Curis' undivided targeted inhibitors is CUDC-305, an by word of mouth available, synthetic small molecule inhibitor of heat cushion protein 90 (Hsp 90).
About Curis, Inc.
Curis is a drug development company that is committed to leverage its innovative signaling pathway drug technologies to seek to make new targeted small molecule drug candidates for cancer. In expanding its dose development efforts in the field of cancer through its targeted cancer drug development chopine, Curis is building upon its old experiences in targeting signaling pathways for the maturation of next generation targeted cancer therapies. For more information, see Curis' internet site at hypertext transfer protocol://www.curis.com.
Cautionary Statement
This iron release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation statements regarding the expected benefits of CUDC-101, the planned development of drug candidates pursuant to the Company's targeted cancer drug development platform and the Company's plans for its form I trial run of CUDC-101 . The Company may use words such as "believes", "expects", "anticipates", "plans", "seeks", "estimates", "testament", "may" or similar expressions to identify these modern statements. There are important factors that may cause actual results to be materially dissimilar from those indicated by such forward-looking statements including, among other things, risks relating to: the potential for untoward results, delays and/or failures in the Company's targeted cancer drug development program, including without limitation unintentional delays and/or failures in its clinical trial of CUDC-101 and its ongoing preclinical studies of CUDC-305; the success of the Company's coaction with Genentech, including the risks that Genentech whitethorn experience untoward results, delays and/or failures in the Hedgehog pathway antagonist program currently below clinical development and that the Company may take no control over, or foreknowledge of, the advancement of this program; difficulties or delays in obtaining or maintaining required regulatory approvals for products under development both internally and through the Genentech collaborationism; the Company's ability to obtain or maintain necessary intellectual property protection; inauspicious changes in the Company's ability to successfully action its business plan, including the Company's ability to obtain the substantial extra funding required for such execution; unplanned cash requirements and expenditures which, among other things, could shorten the estimated period in which the Company will have hard currency to fund its operations and which could also adversely dissemble the Company's estimated operating expenses for 2008 and beyond; risks relating to the Company's ability to enter into and maintain planned collaborations and maintain its stream collaborations with Genentech; and competitive pressures. The Company also faces other risk factors identified in the Quarterly Report on Form 10-Q for the quarter ended June 30, 2008 and former filings that it periodically makes with the Securities and Exchange Commission.
In addition, whatever forward-looking statements represent the Company's views only as of today and should not be relied upon as representing the views as of any subsequent date. Curis disclaims whatsoever intention or obligation to update whatever of the forward-looking statements after the date of this push release whether as a result of new information, future events or otherwise.
Curis, Inc.
More info
Monday 1 September 2008
Friday 22 August 2008
Noah And The Whale Announce North American Tour
Noah And The Whale are place setting their sights on the U.S. by heading out on tour there on in a months time.
The band will play xIII shows during September and October, as they promote debut album 'Peaceful The World Lays Me Down', which was released in their native UK before this week. The album will be in stores on September 16.
Noah and The Whale will play these shows below, some of which are disengage performances (marked with a *)
September Tour Dates:
Brooklyn, NY, Union Pool � 16
New York, NY, Sidewalk Cafe � 18
New York, NY, Mercury Lounge � 19
Boston, MA, TOAD � 20*
Montreal, QC, The Saints � 22*
Toronto, ON, Horseshoe Tavern � 23*
Chicago, IL, TBA � 25
Chicago, IL, Empty Bottle � 26
Seattle, WA, Chop Suey � 29*
Portland, OR, Doug Fir Lounge � 30*
October Tour Dates:
San Francisco, CA, 330 Ritch � 2
Los Angeles, CA, Detour Festival � 4
Los Angeles, CA, Spaceland � 6*
More information
Wednesday 6 August 2008
Eddy Huntington
Artist: Eddy Huntington
Genre(s):
disco
Other
Discography:
Meet My Friend (Single)
Year: 1987
Tracks: 5
U.S.S.R.
Year:
Tracks: 14
Hey Senorita (Single)
Year:
Tracks: 3
Fragrance Materials Association Assures Safety Of Fragrance Ingredients - No Contrary Evidence In Contested University Of Washington Study
�A written report was released by Anne Steinemann, a researcher at the University of Washington
claiming sweetness ingredients contained in a selection of consumer products are potentially toxic.
The fragrance materials industry has the highest concern for the base hit of its products.
We have a sound four-step safety testing process. RIFM, the Research Institute for Fragrance
Materials (an internationally recognized scientific body), examines multiple endpoints and exposure
for redolence materials bound for habit in consumer products. RIFM's findings are evaluated by the
RIFM Expert Panel (REXPAN), an independent and international group of dermatologists,
pathologists, environmental scientists and toxicologists world Health Organization have no ties to the scent industry.
REXPAN's findings are in turn used by IFRA, the International Fragrance Association, to develop
standards on aroma material usance. The IFRA Standards form the base of the globally accepted
and recognized risk management system for the safe use of fragrance ingredients and are part of the
comprehensive program contained in the IFRA Code of Practice. As a result the IFRA Code of
Practice contains around 150 substances which have been either banned or restricted in their use in
perfume products. All members of the Fragrance Materials Association of the United States (FMA)
ar required, as a condition of rank, to observe the IFRA Code of Practice. The fragrance
industry spends just about $8 1000000 (annually) in joint research on the safety of fragrances, and
much more at the individual company level.
The Steinemann study presents no new information or find analysis. Furthermore, while
Steinemann clearly states the study does not address golf links between exposure to chemicals and
wellness effects, she goes beforehand and makes that assertion anyway. She claims that, simply because
certain chemicals are salute in the analyzed products they pose a health risk to all consumers. This
is hardly sound science, just rather more like watch crystal ball gazing and cannot be compared to the
sound, main four-step safety testing process outlined above which is carried out by the
fragrance industry.
Steinemann says she's concerned about "potential perniciousness" of the chemicals launch in the tested
products. The conception of "potentially" hazardous is so tolerant that it may encompass any naturally
occurring material in department of Commerce. Many chemicals, including body of water, have no harmful effects at low
concentrations, just may be "potentially toxic" at high concentrations. We are sure that, when used in compliance with Standards, the materials which are listed by Steinemann and victimized as perfume
ingredients ar safe and can be used (if desired) with confidence.
The study found 58 unlike volatile organic compounds (VOCs) at levels above a concentration of
300 parts per one thousand million but did not lean the immersion of each chemical. To put this in context, 300
parts per zillion is just above the level of analytical spying for these materials. Ingredients which
sound scary when listed by their chemical names ar materials that occur naturally in everyday
items, often in a lot larger quantities than english hawthorn be used in fragranced products. Some examples
include: alpha-Pinene (pine forests); Acetone (cheddar cheese, apple juice, strawberries); 2-
Butanone (coffee tree, citrus fruit, grapes); Benzaldehyde (white staff of life - at >40,000 ppm, roasted coffee -
at 2,000 ppm, apple juice - at around ccc ppm); Ethanol (blackberries, cauliflower, cherries,
cucumbers); Ethyl acetate( honey, tomatoes, vinegar).
It would be folly to declare the numerous true pine forests liner the west and east coasts toxic or
risky just because they founder off the VOC, alpha-pinene. Even more folly to put a hazard
warning on a tomato which naturally contains 8501 parts per one thousand thousand of benzaldehye. Or fifty-fifty to
expect forests and tomatoes to be tagged with their constituent chemicals. So wherefore does
Steinemann want the fragrance manufacture to mark the very low levels of these same chemicals when
contained in our products, and why does she ascribe that these chemicals ar hazardous when
clearly that is non the guinea pig?
We recognize that a small number of individuals may have sensitivity to certain materials in the
environment, both natural and man-made. People who have such sensibility to consumer
products can choose to avoid using the products. We obedience that right to choose and only ask that
all citizenry - including those wHO choose to use fragranced products - are afforded the like privilege.
Consumers can get information through various consumer products websites such as the Consumer
Specialty Products Association, Soap and Detergent Association, Personal Care Product Council and
other consumer websites. Consumer product companies will answer specific questions about their
end use products, particularly if thither is a health concern. In rick, raw material suppliers will provide
information to their customer companies for consumer questions. Each fragrance provider has a
designated regulative contact wHO will supply dermatologists and other medical professionals with
otherwise individual information to assist in the diagnosis and handling of an individual's personal
situation.
The fragrance manufacture continues to work through a sound independent testing mechanism to ensure
its products persist safe for consumers.
About FMA
The Fragrance Materials Association is a national trade association representing companies engaged
in the issue, invention and manufacture of mixtures of fragrance ingredients for use in a wide variety
of products, including fine fragrances, shampoos, soaps and detergents. FMA's activities are closely
coordinated with those of the Research Institute for Fragrance Materials (RIFM). FMA is a member of
the International Fragrance Association (IFRA) which sets safety standards for our products. In
fulfilling its mission for the industry, FMA interacts with governmental bodies and other organizations
on all levels - state, federal and international. FMA meets the necessarily of today's challenges to the
bouquet industry.
Fragrance Materials Association
More info
claiming sweetness ingredients contained in a selection of consumer products are potentially toxic.
The fragrance materials industry has the highest concern for the base hit of its products.
We have a sound four-step safety testing process. RIFM, the Research Institute for Fragrance
Materials (an internationally recognized scientific body), examines multiple endpoints and exposure
for redolence materials bound for habit in consumer products. RIFM's findings are evaluated by the
RIFM Expert Panel (REXPAN), an independent and international group of dermatologists,
pathologists, environmental scientists and toxicologists world Health Organization have no ties to the scent industry.
REXPAN's findings are in turn used by IFRA, the International Fragrance Association, to develop
standards on aroma material usance. The IFRA Standards form the base of the globally accepted
and recognized risk management system for the safe use of fragrance ingredients and are part of the
comprehensive program contained in the IFRA Code of Practice. As a result the IFRA Code of
Practice contains around 150 substances which have been either banned or restricted in their use in
perfume products. All members of the Fragrance Materials Association of the United States (FMA)
ar required, as a condition of rank, to observe the IFRA Code of Practice. The fragrance
industry spends just about $8 1000000 (annually) in joint research on the safety of fragrances, and
much more at the individual company level.
The Steinemann study presents no new information or find analysis. Furthermore, while
Steinemann clearly states the study does not address golf links between exposure to chemicals and
wellness effects, she goes beforehand and makes that assertion anyway. She claims that, simply because
certain chemicals are salute in the analyzed products they pose a health risk to all consumers. This
is hardly sound science, just rather more like watch crystal ball gazing and cannot be compared to the
sound, main four-step safety testing process outlined above which is carried out by the
fragrance industry.
Steinemann says she's concerned about "potential perniciousness" of the chemicals launch in the tested
products. The conception of "potentially" hazardous is so tolerant that it may encompass any naturally
occurring material in department of Commerce. Many chemicals, including body of water, have no harmful effects at low
concentrations, just may be "potentially toxic" at high concentrations. We are sure that, when used in compliance with Standards, the materials which are listed by Steinemann and victimized as perfume
ingredients ar safe and can be used (if desired) with confidence.
The study found 58 unlike volatile organic compounds (VOCs) at levels above a concentration of
300 parts per one thousand million but did not lean the immersion of each chemical. To put this in context, 300
parts per zillion is just above the level of analytical spying for these materials. Ingredients which
sound scary when listed by their chemical names ar materials that occur naturally in everyday
items, often in a lot larger quantities than english hawthorn be used in fragranced products. Some examples
include: alpha-Pinene (pine forests); Acetone (cheddar cheese, apple juice, strawberries); 2-
Butanone (coffee tree, citrus fruit, grapes); Benzaldehyde (white staff of life - at >40,000 ppm, roasted coffee -
at 2,000 ppm, apple juice - at around ccc ppm); Ethanol (blackberries, cauliflower, cherries,
cucumbers); Ethyl acetate( honey, tomatoes, vinegar).
It would be folly to declare the numerous true pine forests liner the west and east coasts toxic or
risky just because they founder off the VOC, alpha-pinene. Even more folly to put a hazard
warning on a tomato which naturally contains 8501 parts per one thousand thousand of benzaldehye. Or fifty-fifty to
expect forests and tomatoes to be tagged with their constituent chemicals. So wherefore does
Steinemann want the fragrance manufacture to mark the very low levels of these same chemicals when
contained in our products, and why does she ascribe that these chemicals ar hazardous when
clearly that is non the guinea pig?
We recognize that a small number of individuals may have sensitivity to certain materials in the
environment, both natural and man-made. People who have such sensibility to consumer
products can choose to avoid using the products. We obedience that right to choose and only ask that
all citizenry - including those wHO choose to use fragranced products - are afforded the like privilege.
Consumers can get information through various consumer products websites such as the Consumer
Specialty Products Association, Soap and Detergent Association, Personal Care Product Council and
other consumer websites. Consumer product companies will answer specific questions about their
end use products, particularly if thither is a health concern. In rick, raw material suppliers will provide
information to their customer companies for consumer questions. Each fragrance provider has a
designated regulative contact wHO will supply dermatologists and other medical professionals with
otherwise individual information to assist in the diagnosis and handling of an individual's personal
situation.
The fragrance manufacture continues to work through a sound independent testing mechanism to ensure
its products persist safe for consumers.
About FMA
The Fragrance Materials Association is a national trade association representing companies engaged
in the issue, invention and manufacture of mixtures of fragrance ingredients for use in a wide variety
of products, including fine fragrances, shampoos, soaps and detergents. FMA's activities are closely
coordinated with those of the Research Institute for Fragrance Materials (RIFM). FMA is a member of
the International Fragrance Association (IFRA) which sets safety standards for our products. In
fulfilling its mission for the industry, FMA interacts with governmental bodies and other organizations
on all levels - state, federal and international. FMA meets the necessarily of today's challenges to the
bouquet industry.
Fragrance Materials Association
More info
Positive Opinion From Committee For Medicinal Products For Human Use (CHMP) For Evicel� Liquid Fibrin Sealant (Human)
�OMRIX Biopharmaceuticals, Inc. ("Omrix" or the "Company") (NASDAQ: OMRI), a fully-integrated biopharmaceutical company that develops and markets biosurgical and immunotherapy products, proclaimed today that it has received a positive thought for EVICEL� Fibrin Sealant (Human) from the Committee for Medicinal Products for Human Use (CHMP). Omrix is seeking approval to market Evicel in Europe for the improvement of hemostasis in surgery.
CHMP is the scientific committee of the European Medicines Agency (EMEA) and is responsible for reviewing medicinal product applications for tone, safety and efficacy. The CHMP's electropositive opinion for Evicel will now be forwarded to the European Commission for marketing authority, which is expected by the end of the third quarter of 2008 (3Q08). The CHMP's feeling also stated that the approved indication for EVICEL would read as follows, "Evicel is used as supportive handling in operation where standard surgical techniques are deficient, for improvement of hemostasis. Evicel is also indicated as suture support for hemostasis in vascular surgery."
EVICEL is currently marketed in the US by Johnson & Johnson Wound Management, a division of ETHICON, INC., a Johnson & Johnson company, with a worldwide hemostasis in surgery reading.
Upon its anticipated approval, EVICEL will be licenced for marketing in the 27 countries of the European Union, or EU. Per the terms of Omrix and ETHICON's append and statistical distribution agreement, ETHICON has the marketing rights for the EU.
About EVICEL
EVICEL� is an all-human, plasma-derived fibrin sealer currently indicated in the US as an adjunct to haemostasis for role in patients undergoing surgery, when control of bleeding by standard surgical techniques is inefficient or airy. It does not take aprotinin, which has been associated with adverse health effects. EVICEL� is easy to use and readily available for time-sensitive needs in the operating room. The product is sold as a frozen limpid and requires less than one moment preparation time after thawing.
About Omrix Biopharmaceuticals, Inc.
Omrix is a in full integrated biopharmaceutical company that develops, manufactures and markets protein-based biosurgery and passive immunotherapy products. Omrix' biosurgery product contrast includes products and product candidates that are used for the control of bleeding, or hemostasis, and other surgical applications. The Company's inactive immunotherapy product line includes antibody-rich products and cartesian product candidates for the discourse of immune deficiencies, infectious diseases and potential biodefence applications. For more information, please visit http://www.omrix.com.
Safe Harbor Statement
This news vent contains modern statements. Forward-looking statements render the Company's current expectations or forecasts of succeeding events. Forward-looking statements include statements about the Company's expectations, beliefs, plans, objectives, intentions, assumptions and other statements that are non historical facts. Forward-looking statements are depicted object to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions that could cause actual results to differ materially from those expected or implied by the modern statements. The Company's actual results could differ materially from those anticipated in forward-looking statements for many reasons, including the factors described in the Company's filings with the Securities and Exchange Commission (SEC), including sections entitled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the Company's Form 10-K as filed with the SEC on March 17, 2008, and the Company's most recent quarterly reports on Form 10-Q and its current reports on Form 8-K. Unless required by law, the Company undertakes no obligation to publicly update or revise any advanced statement to reflect circumstances or events after the date of this news release.
Omrix Biopharmaceuticals, Inc.
More info
CHMP is the scientific committee of the European Medicines Agency (EMEA) and is responsible for reviewing medicinal product applications for tone, safety and efficacy. The CHMP's electropositive opinion for Evicel will now be forwarded to the European Commission for marketing authority, which is expected by the end of the third quarter of 2008 (3Q08). The CHMP's feeling also stated that the approved indication for EVICEL would read as follows, "Evicel is used as supportive handling in operation where standard surgical techniques are deficient, for improvement of hemostasis. Evicel is also indicated as suture support for hemostasis in vascular surgery."
EVICEL is currently marketed in the US by Johnson & Johnson Wound Management, a division of ETHICON, INC., a Johnson & Johnson company, with a worldwide hemostasis in surgery reading.
Upon its anticipated approval, EVICEL will be licenced for marketing in the 27 countries of the European Union, or EU. Per the terms of Omrix and ETHICON's append and statistical distribution agreement, ETHICON has the marketing rights for the EU.
About EVICEL
EVICEL� is an all-human, plasma-derived fibrin sealer currently indicated in the US as an adjunct to haemostasis for role in patients undergoing surgery, when control of bleeding by standard surgical techniques is inefficient or airy. It does not take aprotinin, which has been associated with adverse health effects. EVICEL� is easy to use and readily available for time-sensitive needs in the operating room. The product is sold as a frozen limpid and requires less than one moment preparation time after thawing.
About Omrix Biopharmaceuticals, Inc.
Omrix is a in full integrated biopharmaceutical company that develops, manufactures and markets protein-based biosurgery and passive immunotherapy products. Omrix' biosurgery product contrast includes products and product candidates that are used for the control of bleeding, or hemostasis, and other surgical applications. The Company's inactive immunotherapy product line includes antibody-rich products and cartesian product candidates for the discourse of immune deficiencies, infectious diseases and potential biodefence applications. For more information, please visit http://www.omrix.com.
Safe Harbor Statement
This news vent contains modern statements. Forward-looking statements render the Company's current expectations or forecasts of succeeding events. Forward-looking statements include statements about the Company's expectations, beliefs, plans, objectives, intentions, assumptions and other statements that are non historical facts. Forward-looking statements are depicted object to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions that could cause actual results to differ materially from those expected or implied by the modern statements. The Company's actual results could differ materially from those anticipated in forward-looking statements for many reasons, including the factors described in the Company's filings with the Securities and Exchange Commission (SEC), including sections entitled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the Company's Form 10-K as filed with the SEC on March 17, 2008, and the Company's most recent quarterly reports on Form 10-Q and its current reports on Form 8-K. Unless required by law, the Company undertakes no obligation to publicly update or revise any advanced statement to reflect circumstances or events after the date of this news release.
Omrix Biopharmaceuticals, Inc.
More info
Friday 11 July 2008
New Edition - New Edition And New Kids Team Up
Veteran boy bands NEW EDITION and NEW KIDS ON THE BLOCK are to team up to record a new track.
The reformed groups have been brought together by New Kids star Donnie Wahlberg, who initially came up with the idea and co-wrote the tune.
The new song, Full Service, will appear on NKOTB's untitled new album.
However, it won't feature former New Edition star Bobby Brown, who wasn't part of the recording process.
Producer RedOne tells People.com, "It went really smoothly. There were no egos or attitudes. It felt like they'd been friends forever."
The project ends decade-long rumours the two boy bands intensely dislike each other.
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