Counting my change
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CYTX is on fire...up 18%
PSID NEWS...Co announces that it has achieved an important milestone in the development of its non-invasive Easy Check breath glucose detection system. The co has completed the development of a single-use capsule containing a proprietary chemical reagent that it believes will enable it to accelerate its development schedule and produce a lab-scale prototype device during 3Q10. The prototype is expected to be able to measure the levels of acetone in a patient's exhaled breath, which, in turn, will be translated into a measurement of blood glucose levels, which could eliminate a patient's need to prick his or her finger multiple times per day to get a blood sugar reading.
BNVI News..Discovery of Distinct Classes of Genes Regulated By Estrogen Receptor Beta
Results are Published In the Journal of Biological Chemistry
EMERYVILLE, Calif., June 11 /PRNewswire-FirstCall/ -- Bionovo Inc. (Nasdaq:
BNVI) today announced the publication of results from a study demonstrating the
three distinct classes of genes regulated by estrogen receptor beta (ERB). The
results are published in the Journal of Biological Chemistry. This is an
important discovery for future development of selective drugs regulating this
pathway.
"Finding ways to prevent breast cancer requires a greater understanding of
how the two estrogen receptors work. When ERa is activated by estrogens it
results in an increased risk for breast and uterine cancer. The other estrogen
receptor, ERB, counteracts the cancer promoting property of ERa in breast
cancer cells suggesting that drugs that activate ERB might prevent cancers,"
said Dr. Dale Leitman, M.D., Ph.D. from University of California, Berkeley and
Bionovo's Scientific Advisory Board Member. "This study identifies genes that
are regulated by ERB. We found these genes are regulated by a different
mechanism than ERa. These results are important step towards discovering ERB
selective compounds that may regulate genes that block the cancer promoting
effects of ERa."
Dr. Leitman continued, "Estrogens have been used extensively to treat various
indications in women's health including menopausal symptoms. Unfortunately
estrogens also result in significant increased risk for cancer, stroke and
clotting events. Estrogen's effect is mediated by interacting with both
estrogen receptors and regulating genes along both receptors' paths. Our
current study shows that the presence of estrogen is obligatory for regulating
genes with ERa but it is not required for ERB. The result is that ERB regulates
three classes of genes. The first class is genes regulated by ERB alone, the
second is genes regulated by ERB and estrogen and the third class is genes
regulated by both ERB alone and ERB and estrogen. We also show that the
mechanism involved is not singular and involves different cellular molecules
critical for this selectivity. By determining how ERB regulates genes distinct
from ERa it should become possible to target drugs that regulate only a subset
of genes, which would be more selective and likely safer than the current
estrogens used clinically that regulate both ERa and ERB similarly."
"Bionovo's mission to discover and develop unique drugs for women's health
and cancer is further enriched by the discovery of the unique classes of genes
regulated by ERB. We now know we can selectively regulate via the ERB genes
similar to estrogen as well as enhance the activity of genes regulated
independently by ERB. This opens the door for new cancer preventive drugs and
inflammatory diseases afflicting women far more than men. It also further
elucidates the potential need for multiple compounds pharmacologically causing
gene activation of various classes of genes along a single path."
The article is entitled, "Estrogen Receptor Beta Binds to and Regulates Three
Distinct Classes of Target Genes," and is available at the Journal of
Biological Chemistry website and at http://bionovo.com/investors/publications.
About Menerba
Menerba is an oral botanical drug candidate designed for the safe, effective
treatment of vasomotor symptoms (hot flashes) associated with menopause.
Menerba is an estrogen receptor beta (ERB) selective drug developed as an
alternative to the products currently on the market, which have been shown to
increase the risk for breast and uterine cancers. It has been shown that the
increased risk of breast and uterine cancers is associated with activation of
estrogen receptor alpha (ERa) and that activation of estrogen receptor beta
(ERB) blocks the growth promoting effects on breast cancer cells. Bionovo
recognized the opportunity to commercialize a product that would be as
effective as hormone therapy, without the health risks. Menerba has completed a
Phase 2 trial with positive results for efficacy and has been evaluated by an
independent Data and Safety Monitoring Board and passed through a standard
two-round examination for safety.
About Bionovo, Inc.
Bionovo, Inc. is a pharmaceutical company focused on the discovery and
development of safe and effective treatments for women's health and cancer,
markets with significant unmet needs and billions in potential annual revenue.
The company applies its expertise in the biology of menopause and cancer to
design new drugs derived from botanical sources, which have novel mechanisms of
action. Based on the results of early and mid-stage clinical trials, Bionovo
believes it has discovered new classes of drug candidates within its rich
pipeline with the potential to be leaders in their markets. Bionovo is
headquartered in Emeryville, California and its stock is traded on the NASDAQ
Capital Market under the symbol "BNVI." For more information about Bionovo and
its programs, visit http://www.bionovo.com.
Forward Looking Statements
This release contains certain forward-looking statements relating to the
business of Bionovo, Inc. that can be identified by the use of forward-looking
terminology such as "believes," "expects," or similar expressions. Such
forward-looking statements involve known and unknown risks and uncertainties,
including uncertainties relating to product development, efficacy and safety,
regulatory actions or delays, the ability to obtain or maintain patent or other
proprietary intellectual property protection, market acceptance, physician
acceptance, third party reimbursement, future capital requirements, competition
in general and other factors that may cause actual results to be materially
different from those described herein as anticipated, believed, estimated or
expected. Certain of these risks and uncertainties are or will be described in
greater detail in our filings with the Securities and Exchange Commission,
which are available at http://www.sec.gov. Bionovo, Inc. is under no obligation
(and expressly disclaims any such obligation) to update or alter its
forward-looking statements whether as a result of new information, future
events or otherwise.
SOURCE Bionovo, Inc.
/CONTACT: Tom Chesterman of Bionovo, Inc., +1-510-601-2000,
investor@bionovo.com, or Investors, Joe Diaz, Robert Blum or Joe Dorame of
Lytham Partners, LLC, +1-602-889-9700, bnvi@lythampartners.com
/Web site: http://www.bionovo.com
Market down last hour was caused on the weaker Euro. The overseas concerns have drawn attention of investors away from our steadily improving US market.Until those concerns are met we will continue to see a volatile market.
BioElectronics Corporation CEO Featured on StockGoodies.com
CEO Andrew Whelen to Discuss Expanded Worldwide Distribution
FREDERICK, MD, Jun 09, 2010 (MARKETWIRE via COMTEX) -- BioElectronics Corporation
(PINKSHEETS: BIEL), developers of innovative electromagnetic pain-relieving
medical devices, announced today that CEO Andrew Whelen will be the featured
guest interview for the fastest growing Stock Trading community,
StockGoodies.com, on Thursday, June 10th at 8:00 p.m. ET.
BioElectronics' core pulse electromagnetic technology delivers safe and effective
electromagnetic energy -- once only obtainable through the use of large,
facility-based equipment -- directly to the affected body part through
inexpensive and easy-to-wear devices. Providing clinically proven and widely
recognized anti-inflammatory and pain relief therapy, BioElectronics' unique
dermal patch delivery system is marketed under several brands to provide welcome
relief and accelerate healing from pain and discomfort due to a variety of
musculoskeletal disorders and rehabilitation.
The interview can be heard at http://www.blogtalkradio.com/stockgoodies. The
archived version can be found on the homepage of http://www.StockGoodies.com.
About StockGoodies StockGoodies is a leading publisher of news, perspective, and
marketing intelligence on all forms of equity trading: pennies, micro-cap, mid
and large cap and options. The company's vision is to empower self-directed
investors by narrowing the gap between individual traders and professionals.
About BioElectronics Corporation: BioElectronics Corporation (PINKSHEETS: BIEL)
is the maker of safe, inexpensive, drug-free medical devices and patches that
deliver pulsed electromagnetic energy to relieve pain and inflammation. The
company's wafer thin patches contain an embedded microchip and battery that
deliver pulsed electromagnetic energy, a clinically proven and widely accepted
anti-inflammatory and pain relief therapy that heretofore has only been possible
to obtain from large, facility-based equipment. BioElectronics markets and sells
its current products under the brand names ActiPatch(TM), RecoveryRx(TM),
Allay(TM) Menstrual Pain Therapy and HealFast(TM) Therapy for cats, dogs and
horses. The company is headquartered in Frederick, MD. For more information,
visit http://www.bielcorp.com.
PDMI News..CORRECTION - Paradigm to Become Current With Financial Disclosure Reporting and
Update on Retimax(TM) FDA Application
SALT LAKE CITY, UT, Jun 09, 2010 (MARKETWIRE via COMTEX) -- In the news release,
"Paradigm to Become Current With Financial Disclosure Reporting and Update on
Retimax(TM) FDA Application," issued earlier today by Paradigm Medical
Industries, Inc. (PINKSHEETS: PDMI), we are advised by the company that the
second sentence of the second paragraph should read "On June 8, 2010, Paradigm
posted a Quarterly Report for the period ended September 30, 2009 on the Pink OTC
Markets." rather than "On June 8, 2010, Paradigm posted a Quarterly Report for
the period ended September 30, 2010 on the Pink OTC Markets." as originally
issued. Complete corrected text follows.
Paradigm to Become Current With Financial Disclosure Reporting and Update on
Retimax(TM) FDA Application
SALT LAKE CITY, UT -- June 8, 2010 -- Paradigm Medical Industries, Inc.
(PINKSHEETS: PDMI) announced today that it has begun the process of becoming and
remaining current with its financial and disclosure obligations on the Pink OTC
Markets. During most of 2009, due to limited working capital, Paradigm was unable
to remain current with its quarterly and annual reports. Paradigm recently
obtained some additional funding and, as a result, has begun to correct this
critical step concerning its responsibility to provide financial information to
its shareholders and the investment community.
On June 4, 2010, Paradigm posted a Quarterly Report for the period ended June 30,
2009 on the Pink OTC Markets. On June 8, 2010, Paradigm posted a Quarterly Report
for the period ended September 30, 2009 on the Pink OTC Markets. Paradigm is in
the process of completing a financial audit and preparing an Annual Report for
the fiscal year ended December 31, 2009.
"As Paradigm continues to rebuild itself, it is vital that its shareholders be
kept aware of the important steps that management has taken to complete this
process. With the recent financial assistance from an outside source, Paradigm
will overcome this obstacle just as it has many other obstacles the past year,"
said Stephen Davis, Paradigm's President and Chief Executive Officer.
Paradigm also has been advised by Costruzione Strumenti Oftalmici (CSO), its
Italian partner, that there was a delay in the filing of the 510(k) application
for the Retimax(TM) (Paramax) with the FDA. The application was submitted in May
2010 rather than in February 2010 as first disclosed. The Retimax(TM) has been
designed to perform innovative tests for the early screening and follow-up for
glaucoma, age related macular degeneration, vascular retinal degeneration, and
other pathologies related to the optic nerve disease.
"Although this information concerning the filing of the 510(k) application comes
as somewhat of a surprise, it does not lessen the considerable anticipation for
this new technology by Paradigm and its customers. Paradigm will make the
necessary adjustments in its marketing and sales efforts to reflect this change.
Paradigm understands CSO's decision to delay filing the 510(k) application until
it was completely prepared to submit it for FDA approval," added Mr. Davis.
About Paradigm Medical Industries, Inc.
Paradigm Medical Industries, Inc. is a medical device company that develops,
manufactures and distributes ophthalmic diagnostic instruments and related
products for early detection of glaucoma and other eye disorders. The Company's
primary objective is to capture a niche market within the glaucoma and ultrasound
microscopy fields. The Company markets its products to ophthalmologists,
optometrists, universities, and clinics throughout the United States and
internationally.
This press release contains statements that, if not verifiable historic fact, may
be viewed as forward-looking statements that could predict future events and
outcomes with respect to Paradigm and its business. The predictions embodied in
these statements will involve risk and uncertainties and, accordingly, actual
results may differ significantly from the results discussed or implied in such
forward-looking statements.
Contact:
Stephen L. Davis
President and Chief Executive Officer
801-977-8970
http://www.paradigm-medical.com
SOURCE: Paradigm Medical Industries, Inc.
http://www.paradigm-medical.com
Copyright 2010 Marketwire, Inc., All rights reserved.
POSC News..Lantheus Medical Imaging, Inc. Presents Preliminary Data on Novel PET Myocardial
Perfusion Imaging Agent Protocol at SNM Annual Meeting
Flurpiridaz F 18 Data Determine Parameters for One-Day Rest-Stress Test to Detect
Coronary Artery Disease
NORTH BILLERICA, Mass., Jun 09, 2010 (BUSINESS WIRE) -- Lantheus Medical Imaging,
Inc., a worldwide leader in diagnostic medical imaging, today announced
preliminary Phase 2 data describing the methodology used to define an imaging
protocol for a one-day rest-stress myocardial perfusion imaging test using its
novel investigational PET imaging agent flurpiridaz F 18 injection (formerly
known as BMS747158). Flurpiridaz F 18 injection is in development for use with
Positron Emission Tomography (PET) for myocardial perfusion imaging (MPI) to
detect coronary artery disease. Data suggest that the uptake properties of
flurpiridaz F 18 injection make it possible to allow for a relatively low dosing
ratio and a delay of between 30 minutes and one hour between rest and stress
injections, depending on the mode of stress used.
Lantheus, together with its partner in this method development, Cardiovascular
Imaging Technologies of Kansas City, Mo., developed an innovative technique to
determine the dependence of the rest-to-stress dosing ratio in order to identify
the minimum delay between the two injections for a one-day rest-stress test. The
data were featured today in an oral presentation (# 798451) by Joel Lazewatsky,
Ph.D., Principal Research Scientist, Lantheus Medical Imaging, Inc., and in a
poster presentation (# 799099) on Tuesday, June 8 by James A. Case, Ph.D.,
Director of Physics at Cardiovascular Imaging Technologies, at the SNM 57th
Annual Meeting in Salt Lake City.
"Our team used data derived from a Phase 2 clinical study of flurpiridaz F18
injection PET MPI to define the optimal delay between rest and stress dosing as
part of an effort to determine the lowest total dose needed to obtain good
quality images," said Dr. Lazewatsky. "We are currently validating this model
with the second cohort of patients from the Phase 2 clinical study and we look
forward to the results."
To identify the appropriate amounts of rest and stress dosing for hypothetical
same-day rest and stress dosing, computer simulations of same-day rest and stress
images were developed using actual rest and stress image data obtained from 20
patients who were each imaged on a two-day basis. The actual rest and stress
images from the separate days together with the computer simulations of same-day
images were each reviewed in a blinded fashion by three experienced readers.
In evaluating the maximum residual contribution of the imaging agent initially
used in the rest study to the subsequent stress image which did not produce a
meaningful change in the reader's perception of the stress image, it was
determined for stress induced by adenosine (a pharmacological stress agent) that
a minimum dosing ratio of 2.0 (twice as much imaging agent used in stress as
compared to rest) was required with a 30 minute delay between injections. For
stress induced by exercise, a minimum dosing ration of 3.0 (three times as much
imaging agent used in stress as compared to rest) was needed with a one hour
delay between injections.
"Using this novel approach, we expect to validate a protocol that fits into
current clinical practice and that can be administered at the lowest possible
dose for patients undergoing a same-day rest-stress test with flurpiridaz F 18
injection," said Dana Washburn, M.D., Vice President, Clinical Development and
Medical Affairs, Lantheus Medical Imaging, Inc. "We developed this novel
methodology to define the rest and stress doses as well as the optimal delay
between the two doses without having to involve a large number of patients."
Drs. Lazewatsky and Case led the collaboration between Lantheus and
Cardiovascular Imaging Technologies to develop this unique approach to protocol
optimization. "This novel approach of modeling different dosages and time
intervals based on baseline image data not only enabled recognition of optimal
acquisition parameters for image quality and dosimetry, but dramatically
shortened development time that otherwise would have depended on trial and error
methodology," said Dr. Case.
About Flurpiridaz F 18 Injection
Flurpiridaz F 18 injection, a fluorine 18-labeled agent that binds to
mitochondrial complex 1 (MC-1), was designed to be a novel myocardial perfusion
PET imaging agent for the diagnosis of coronary artery disease (CAD). The agent
is currently in Phase 2 clinical development. CAD is the leading cause of death
in the United States for both men and women(1). Each year, more than half a
million Americans die from CAD(1).
In Phase 1 clinical studies, flurpiridaz F 18 injection was well-tolerated and
demonstrated radiation dosimetry that suggests that good quality images may be
obtained with patient radiation doses that are within accepted limits. The data
also showed high myocardial uptake at rest that significantly increased with
pharmacologically induced stress as well as a ratio of myocardial to background
uptake that was favorable and improved over time, suggesting encouraging
potential as a myocardial perfusion PET imaging agent for patients both at rest
and under stress.
About PET and MPI
Positron emission tomography, also called PET imaging or a PET scan, is a type of
nuclear medicine imaging procedure(2) that provides information about the
function and metabolism of the body's organs, unlike computed tomography (CT) or
magnetic resonance imaging (MRI), which primarily show anatomy and structure(3).
Myocardial perfusion imaging (MPI) is a non-invasive test that utilizes a small
amount of radioactive material (radiopharmaceutical) injected into the body to
depict the distribution of blood flow to the heart(4). MPI is used to identify
areas of reduced blood flow (perfusion) to the heart muscle(4). The test is
typically conducted under both rest and stress conditions, after which physicians
examine and compare the two scans and predict whether the patient has significant
coronary artery disease(4). Although single-photon emission computer tomography
(SPECT) is most commonly used for MPI(5),PET imaging has gained considerable
support and use in the field of cardiovascular imaging, as it offers many
advantages to SPECT, including higher spatial and contrast resolution, which
results in higher image quality and improved diagnostic accuracy, accurate
attenuation correction and risk stratification(6).
About Lantheus Medical Imaging, Inc.
Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic medicine for
more than 50 years, is dedicated to creating and providing pioneering medical
imaging solutions to improve the treatment of human disease. The company's proven
success in discovering, developing and marketing innovative medical imaging
agents provides a strong platform from which to bring forward breakthrough new
tools for the diagnosis and management of disease. Lantheus imaging products
include the echocardiography contrast agent DEFINITY(R) Vial for (Perflutren
Lipid Microsphere) Injectable Suspension, ABLAVAR(R) (gadofosveset trisodium), a
first-in-class magnetic resonance agent indicated for the evaluation of
aortoiliac occlusive disease in adults with known or suspected peripheral
vascular disease, TechneLite(R) (Technetium Tc99m Generator), Cardiolite(R) (Kit
for the Preparation of Technetium Tc99m Sestamibi for Injection), and Thallium
201 (Thallous Chloride Tl 201 Injection). Lantheus has more than 600 employees
worldwide with headquarters in North Billerica, Massachusetts, and offices in
Puerto Rico, Canada and Australia. For more information, visit
http://www.lantheus.com.
About Cardiovascular Imaging Technologies, LLC.
Cardiovascular Imaging Technologies, LLC. is based in Kansas City, Missouri.
CVIT's business interests include development of cardiac imaging software, core
imaging lab functions, new-agent consulting, technical support services, and
research support for Phases 1 through 4 investigations. Its core lab specializes
in modeling early Phase 1 and Phase 2 studies to help design more scientific and
accurate later stage clinical trials. The core lab also specializes in site
training and quality maintenance during later phase studies to insure data
consistency across a broad range of investigator instrumentation. It is a
recognized pioneer in the evolution of myocardial perfusion PET. Its processing,
quality control, and myocardial perfusion quantitation software is used by more
than 50% of PET centers that regularly perform myocardial perfusion imaging.
(1) National Institutes of Health, National Heart, Lung, and Blood Institute.
Coronary Artery Disease: Who Is At Risk.
http://www.nhlbi.nih.gov/health/dci/Diseases/Cad/CAD_WhoIsAtRisk.html
(http://www.nhlbi.nih.gov/health/dci/Diseases/Cad/CAD%5fWhoIsAtRisk.html).
Accessed on June 4, 2010.
(2) Radiology Info. What is Positron Emission Tomography -- Computed Tomography
(PET/CT) Scanning. http://www.radiologyinfo.org/en/info.cfm?pg=PET. Accessed on
June 4, 2010.
(3) National Institutes of Health. NIH Clinical Center. Positron Emission
Tomography Department Overview. http://clinicalcenter.nih.gov/pet/. Accessed on
June 4, 2010.
(4) Society of Nuclear Medicine. Procedure Guidelines for Myocardial Perfusion
Imaging. Version 3.0 June 2002. http://interactive.snm.org/docs/pg_ch02_0403.pdf
(http://interactive.snm.org/docs/pg%5fch02%5f0403.pdf).
(5) Salerno, M and Beller, GA, Noninvasive Assessment of Myocardial Perfusion.
Circ Cardiovasc Imaging. 2009; 2:412-424.
(6) Heller, G, Calnon, D and Dorbala, S. Recent Advances in Cardiac PET and
PET/CT Myocardial Perfusion Imaging. J Nucl Cardiol 2009; 16:962-9.
SOURCE: Lantheus Medical Imaging, Inc.
Lantheus Medical Imaging, Inc.
Priscilla Harlan, 978-671-8854
Cell: 781-799-7917
or
Pure Communications, Inc.
Michele Rozen, 617-730-8284
Cell: 617-953-2214
Copyright Business Wire 2010
Welcome Fidz to the assistant role,your comments and DD are well received
ThermaFreeze Blows it out on QVC – Revenue Production High
by Joe on June 8, 2010
TheramaFreeze Blows in out on QVC – Revenue Production High
ThermaFreeze Products Corp. (TZPC) – Over the weekend, ThermaFreeze Products Corporation’s ice substitute packs appeared on the popular shopping channel QVC over the weekend. The entire stock sold out and a matter of a few minutes. This accounted for approximately 1,500 units priced at approximately (including shipping and handling) $24.00 each. An additional 1,000 were logged into backorder. Typically, QVC quotes its customers four to six weeks to receive any backlogged item. In this case, however, the QVC people were highly impressed that the ThermaFreeze management team indicated the entire backlog could be filled within 48 hours. This is because all manufacturing for ThermaFreeze is done in the United States with ample inventory currently available and very fast product production lead times. Management is already in discussions with the QVC team to once again present this hot product to the QVC customer base. With an aggressive retail expansion currently under way (please notice all of the recent press releases regarding the subject), a successful run on QVC and the likelihood of an additional run that will allow for significantly more sales and more exposure, it is clear to us that ThermaFreeze has quickly moved out of developmental stage into a period of rapid revenue expansion. We believe this stock is one watch as the Company has recently completed its audit and is poised to move from the pink sheets to the OTCBB. It is really nice to see a small company hit is stride and that is what is happening here. Joe Noe
Thanks for the link Fidz!I appreciate your input....
Remember..Duanne Reed stores were bought out by Walgreens..Thermafreeze could easily be picked up nation-wide by Walgreens
This stock is a sleeping Giant...Awesome!!
ThermaFreeze(TM) Completes Very Successful Initial Run on QVC - Sells Out of
Stock With Orders Going Into Backlog
RED BANK, N.J., June 7, 2010 /PRNewswire via COMTEX/ -- ThermaFreeze(TM) Products
Corporation (Pink Sheets: TZPC), the maker of patented refrigerant products
designed for consumer and commercial use, today announced a successful debut on
QVC during the popular show about cooking products called "In The Kitchen with
David" which aired yesterday, Sunday, June 6th. During the show the Company's
reusable dry gel ice sheets sold completely out of stock in only a few minutes.
ThermaFreeze is already in discussions with QVC to return in this very popular
product to the airwaves.
The episode featured ThermaFreeze's dry gel pack alternative to ice and ice
substitutes, which has gained notoriety for its powerful flexibility, light
packaging and the ease with which it can be cut into other sizes. ThermaFreeze's
plastic-and-cloth design helps the pack stay cold 75 percent longer than
traditional gel packs. Applications for ThermaFreeze reusable dry gel packs range
from treating injuries to packaging easy-spoil food items for shipping to keeping
a packed lunch cold.
"It was very exciting to see the available inventory purchased in only a matter
of a few minutes and for backlog orders to also be realized," commented Jim
Bolton, COO of ThermaFreeze Products Corp. "This airing will clearly expose us to
a wider consumer audience as our retail store based distribution continues to
expand very rapidly. Consumers are responding very positively to our products for
one simple reason - ThermaFreeze is an excellent substitute to both ice and gel
packs for keeping food cold and fresh."
For more information about "In the Kitchen with David," visit
http://www.qvc.com/cgen/render.aspx?qp=promo|cd_itkwb_wknd
(http://www.qvc.com/cgen/render.aspx?qp=promo%7ccd%5fitkwb%5fwknd).
About ThermaFreeze(TM) Products Corporation
ThermaFreeze(TM) Products Corporation manufactures and markets a patented,
innovative refrigerant product designed for use in the commercial shipment of
perishables and for use as a consumer compress and chiller product. The
ThermaFreeze refrigerant is flat, lightweight and flexible, even when frozen,
making it more convenient and cost-effective to use than ice, gel packs, ice
bricks and dry ice. For more information, visit http://www.thermafreeze.com.
Safe Harbor for Forward-Looking Statements
Statements made in this release with the respect to the Company's current plans,
estimates, strategies and beliefs and other statements that are not historical
are forward-looking statements. Forward-looking statements include, but are not
limited to, those statements using words such as "believe," "expect," "plans,"
and words of similar meaning in connection with a discussion of future
operations, financial performance, events or conditions. Statements are based on
management's assumptions and beliefs in light of the currently available
information. The Company cautions that a number of important risks and
uncertainties could cause actual results to materially differ from those
discussed in the forward-looking statements and, therefore, undue reliance should
not be placed on them.
INVESTOR CONTACT:
ThermaFreeze Products Corporation
Joe Noel
(925) 922-2560
SOURCE ThermaFreeze
Copyright (C) 2010 PR Newswire. All rights reserved
SPPI..Insider Buyer Alert..
ISSUER: SPECTRUM PHARMACEUTICALS INC
SYMBOL: SPPI
SOURCE: Form 4
FILER: SHROTRIYA RAJESH C
TITLE: Chairman of the Board
DATE TRANSACTION SHARES PRICE VALUE
6/4/10 Purchase 10,000 $3.96 $39,603
OWNERSHIP: 1,163,486 (Direct)
The Form 4 is filed with the Securities and Exchange Commission by insiders
to report transactions in their companies' shares. Open market purchases
and sales must be reported within two business days of the transaction.
Insider Data Source: The Washington Service
(info@washingtonservice.com or 301-913-5100)
SPPI News..Still a steal at these prices...Spectrum Pharmaceuticals to Present at Two (2) Investor Conferences
* Morgan Joseph “Best Ideas” Conference on Wednesday, June 9
* Jefferies & Co. Global Life Sciences Conference on Friday, June 11
businesswire
Press Release Source: Spectrum Pharmaceuticals, Inc. On Monday June 7, 2010, 7:00 am EDT
IRVINE, Calif.--(BUSINESS WIRE)--Spectrum Pharmaceuticals, Inc. (Nasdaq:SPPI - News), a commercial-stage biotechnology company with a focus in oncology and hematology, announced today that an overview of the Company's business strategy will be given at two upcoming Investor Conferences.
Wednesday, June 9, 2010 @ 4:30 p.m. Eastern Time
Morgan Joseph “Best Ideas” Conference
Millennium Broadway Hotel in New York City.
Friday, June 11, 2010 @ 9:30 a.m. Eastern Time
Jefferies & Co. Global Life Sciences Conference
Grand Hyatt Hotel in New York City.
The live webcasts of Spectrum's corporate presentation will be available at http://www.sppirx.com.
About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals is a commercial-stage biotechnology company with a focus in oncology and hematology. The Company’s strategy is comprised of acquiring, developing and commercializing a broad and diverse pipeline of late-stage clinical and commercial products. In addition to building an efficient in-house clinical research organization with regulatory and data management capabilities, the Company has established a commercial infrastructure for its drug portfolio. The Company markets two oncology drugs, ZEVALIN® and FUSILEV® and has two drugs in late stage development, apaziquone and belinostat, along with a diverse pipeline. The Company also leverages the expertise of its worldwide partners to assist in the execution of its strategy. For more information, please visit the Company’s website at www.sppirx.com.
Forward-looking statement – This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements include but are not limited to statements that relate to our business and its future, Spectrum's ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, leveraging the expertise of partners around the world to assist us in the execution of our strategy, and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates, may not prove safe or effective, the possibility that our existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of revenues, our limited marketing experience, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Commission. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.
SPECTRUM PHARMACEUTICALS, INC. ®, ZEVALIN®, and FUSILEV® are registered trademarks of Spectrum Pharmaceuticals, Inc. TURNING INSIGHTS INTO HOPE™ and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc.
© 2010 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
Contact:
Spectrum Pharmaceuticals, Inc.
Paul Arndt
Senior Manager, Investor Relations
949-788-6700x216
HNAB NEWS -Data From Pivotal Phase 2 RALLY Trial Show Marqibo Produced Compelling Single-Agent Anti-Leukemic Efficacy in Advanced Relapsed/Refractory Adult Ph(-) Acute Lymphoblastic Leukemia
Press Release Source: Hana Biosciences, Inc. On Monday June 7, 2010, 7:00 am EDT
* Marqibo administered as third-, fourth-, fifth-, and sixth-line single-agent therapy
* 35% overall response rate with a predictable and manageable toxicity profile
* 20% complete response (CR) and CR with incomplete blood count recovery (CRi) rate
* 5.3 month median CR/CRi duration and 7.4 month median survival in responders
SOUTH SAN FRANCISCO, Calif., June 7, 2010 (GLOBE NEWSWIRE) -- Hana Biosciences Inc., (OTCBB:HNAB - News), today announced complete data from its pivotal, Phase 2 RALLY clinical trial for Marqibo(R) (vincristine sulfate liposome injection) for the treatment of relapsed/refractory adult Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL). Results from the RALLY trial demonstrated compelling evidence of single-agent, anti-leukemic activity in an advanced, heavily pre-treated, adult ALL population.
An analysis of the 65 evaluable subjects demonstrated an overall response in 35 percent of the subjects and a complete response (CR) or CR with incomplete blood count recovery (CRi) in 20 percent of the subjects. The estimated median overall survival in complete responders was 7.4 months, with five patients having an overall survival greater than one year. The estimated median duration of CR/CRi was 5.3 months. Ten patients treated with Marqibo went on to receive a potentially life-saving stem cell transplant. There were no unexpected toxicities.
"We believe these data position Marqibo as an effective treatment for relapsed/refractory adult ALL patients with limited to no current options, as efficacy was demonstrated in second and third salvage settings, as third- through fifth-line therapy, and in both B- and T-lineage ALL," said Anne Hagey, M.D., Chief Medical Officer of Hana Biosciences. "Based upon these data, we are moving forward with our plan to initiate a rolling NDA submission with the hopes of bringing a much needed therapy to patients with no standard treatment options. In addition, the complete RALLY results reinforce our belief that Marqibo has the potential to be an important and useful stand-alone therapy in relapsed adult leukemia. We look forward to additional and continued development in combination therapy in leukemia and lymphomas."
"The results of the RALLY trial demonstrate a clinically meaningful benefit for patients who have relapsed multiple times or who have progressed following two or more prior lines of therapy," said Susan O'Brien, M.D., Professor of Medicine in the Leukemia Department at the University of Texas, MD Anderson Cancer Center and RALLY study lead investigator. "Based on historical data with single-agent therapy, one would have expected no more than a 4 percent CR/CRi rate in such an advanced leukemia population. Marqibo's CR/CRi rate of 20 percent would be an extremely important step forward in the treatment of adult ALL"
Phase 2 RALLY Clinical Trial Design and Results
The pivotal Phase 2 RALLY clinical trial enrolled a total of 65 evaluable patients at 22 sites in the United States, Canada, Germany, and Israel. The primary objective of the RALLY clinical trial was to assess the efficacy of single-agent, weekly Marqibo (2.25 mg/m2 with no dose cap) as assessed by achievement of CR or CRi. Secondary objectives included assessments of duration of CR/CRi, overall survival (OS), safety and pharmacokinetics. Independent response assessment remains ongoing at the present time. Marqibo was dosed weekly based on actual body surface area without the dose capping applied to standard vincristine sulfate. The study population is defined as Philadelphia chromosome-negative adult patients in second or greater relapse, or those patients who relapsed following two lines of anti-leukemia chemotherapy, including those who have previously undergone stem cell transplantation.
An overall response rate (ORR) as determined by CR, CRi, partial remission, and bone marrow blast count normalization without blood count recovery was reported by investigators in 23 of 65 subjects for an ORR of 35 percent, with 13 of 65 subjects (20 percent) experiencing a CR or CRi. Marqibo enabled successful stem cell transplantation in 10 patients after dosing. The median OS in the 65 subjects is estimated to be 4.6 months (range 0.1-21.6) using Kaplan-Meier methodology. The safety profile of Marqibo is predictable, manageable, and similar to standard vincristine sulfate. The early death rate, defined as death occurring within the first 14 days on study, was 4.6 percent (3 of 56 subjects) and occurred due to progressive ALL.
The Company anticipates locking the data base and commencing a rolling NDA submission in the near future.
ASCO Presentation
The complete data from the pivotal Phase 2 RALLY trial will be presented in an oral podium presentation by Susan O'Brien M.D. (Abstract #6507) at 11:45 am on Monday, June 7 at the American Society of Clinical Oncology (ASCO) Annual Meeting being held in Chicago, Illinois, June 4-8, 2010.
About Marqibo(R) (vincristine sulfate liposome injection)
Marqibo is a novel, targeted, Optisome(TM) encapsulated formulation of vincristine sulfate, a widely-used chemotherapy, which has shown promising anti-cancer activity in patients with ALL, non-Hodgkin's lymphoma, Hodgkin's disease, and melanoma in several clinical trials. Marqibo is designed to enhance the penetration and concentration of vincristine sulfate at sites of active cancer and facilitate dose-intensification compared to standard vincristine formulations. Unlike standard vincristine, Marqibo is dosed based on actual patient body surface area without the need for dose capping.
Hana Biosciences has received orphan drug and fast track designations for Marqibo for the treatment of adult ALL from the U.S. Food and Drug Administration. Marqibo has also received orphan drug designation in adult ALL from the European Medicines Evaluation Agency.
About Hana Biosciences, Inc.
Hana Biosciences, Inc. is a biopharmaceutical company dedicated to developing and commercializing new, differentiated cancer therapies designed to improve and enable current standards of care. The company's lead product candidate, Marqibo(R), potentially treats acute lymphoblastic leukemia and lymphomas. The Company has additional pipeline opportunities some of which, like Marqibo, improve delivery and enhance the therapeutic benefits of well characterized, proven chemotherapies and enable high potency dosing without increased toxicity. Additional information on Hana Biosciences can be found at www.hanabiosciences.com.
The Hana Biosciences, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3290
Forward-Looking Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are often, but not always, made through the use of words or phrases such as "anticipates," "expects," "plans," "believes," "intends," and similar words or phrases. These forward-looking statements include without limitation, statements regarding, the timing, progress and anticipated results of Hana's planned development and regulatory activities relating to Marqibo, including its proposed NDA filing and whether such filing will be accepted for review or approved by the FDA; statements regarding the potential of Marqibo to replace existing therapies and the expected benefits Marqibo may have for patients with relapsed ALL compared to existing therapies. Such statements involve risks and uncertainties that could cause Hana's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements. Among other things, there can be no assurances that any of Hana's clinical and regulatory development efforts relating to Marqibo will be successful; that even if an NDA for Marqibo is accepted by the FDA, that it will be approved; that the data of the clinical trials of Marqibo will be sufficient to support approval by the FDA of an NDA for Marqibo; that Hana will have completed all other activities necessary for the filing of an NDA or other submission with the FDA; that the results of the clinical trials of Marqibo will support Hana's claims or beliefs concerning Marqibo's safety and effectiveness; that its existing patent and other intellectual property rights will be adequate; and that Hana will be able to secure the additional capital necessary to fund the activities required to complete the proposed NDA submission and other clinical and regulatory activities relating to Marqibo. Additional risks that may affect such forward-looking statements include Hana's need to raise additional capital to fund its product development programs, including Marqibo, to completion, Hana's reliance on third-party researchers to develop its product candidates, and its lack of experience in developing and commercializing pharmaceutical products. Additional risks are described in the company's Annual Report on Form 10-K for the year ended December 31, 2009 and in the Company's Form 10-Q for the three month period ended March 31, 2010. Hana assumes no obligation to update these statements, except as required by law.
Contact:
Hana Biosciences, Inc.
Investor & Media Contacts:
Investor Relations Team
(650) 588-6641
investor.relations@hanabiosciences.com
HNAB NEWS -Data From Pivotal Phase 2 RALLY Trial Show Marqibo Produced Compelling Single-Agent Anti-Leukemic Efficacy in Advanced Relapsed/Refractory Adult Ph(-) Acute Lymphoblastic Leukemia
Press Release Source: Hana Biosciences, Inc. On Monday June 7, 2010, 7:00 am EDT
* Marqibo administered as third-, fourth-, fifth-, and sixth-line single-agent therapy
* 35% overall response rate with a predictable and manageable toxicity profile
* 20% complete response (CR) and CR with incomplete blood count recovery (CRi) rate
* 5.3 month median CR/CRi duration and 7.4 month median survival in responders
SOUTH SAN FRANCISCO, Calif., June 7, 2010 (GLOBE NEWSWIRE) -- Hana Biosciences Inc., (OTCBB:HNAB - News), today announced complete data from its pivotal, Phase 2 RALLY clinical trial for Marqibo(R) (vincristine sulfate liposome injection) for the treatment of relapsed/refractory adult Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL). Results from the RALLY trial demonstrated compelling evidence of single-agent, anti-leukemic activity in an advanced, heavily pre-treated, adult ALL population.
An analysis of the 65 evaluable subjects demonstrated an overall response in 35 percent of the subjects and a complete response (CR) or CR with incomplete blood count recovery (CRi) in 20 percent of the subjects. The estimated median overall survival in complete responders was 7.4 months, with five patients having an overall survival greater than one year. The estimated median duration of CR/CRi was 5.3 months. Ten patients treated with Marqibo went on to receive a potentially life-saving stem cell transplant. There were no unexpected toxicities.
"We believe these data position Marqibo as an effective treatment for relapsed/refractory adult ALL patients with limited to no current options, as efficacy was demonstrated in second and third salvage settings, as third- through fifth-line therapy, and in both B- and T-lineage ALL," said Anne Hagey, M.D., Chief Medical Officer of Hana Biosciences. "Based upon these data, we are moving forward with our plan to initiate a rolling NDA submission with the hopes of bringing a much needed therapy to patients with no standard treatment options. In addition, the complete RALLY results reinforce our belief that Marqibo has the potential to be an important and useful stand-alone therapy in relapsed adult leukemia. We look forward to additional and continued development in combination therapy in leukemia and lymphomas."
"The results of the RALLY trial demonstrate a clinically meaningful benefit for patients who have relapsed multiple times or who have progressed following two or more prior lines of therapy," said Susan O'Brien, M.D., Professor of Medicine in the Leukemia Department at the University of Texas, MD Anderson Cancer Center and RALLY study lead investigator. "Based on historical data with single-agent therapy, one would have expected no more than a 4 percent CR/CRi rate in such an advanced leukemia population. Marqibo's CR/CRi rate of 20 percent would be an extremely important step forward in the treatment of adult ALL"
Phase 2 RALLY Clinical Trial Design and Results
The pivotal Phase 2 RALLY clinical trial enrolled a total of 65 evaluable patients at 22 sites in the United States, Canada, Germany, and Israel. The primary objective of the RALLY clinical trial was to assess the efficacy of single-agent, weekly Marqibo (2.25 mg/m2 with no dose cap) as assessed by achievement of CR or CRi. Secondary objectives included assessments of duration of CR/CRi, overall survival (OS), safety and pharmacokinetics. Independent response assessment remains ongoing at the present time. Marqibo was dosed weekly based on actual body surface area without the dose capping applied to standard vincristine sulfate. The study population is defined as Philadelphia chromosome-negative adult patients in second or greater relapse, or those patients who relapsed following two lines of anti-leukemia chemotherapy, including those who have previously undergone stem cell transplantation.
An overall response rate (ORR) as determined by CR, CRi, partial remission, and bone marrow blast count normalization without blood count recovery was reported by investigators in 23 of 65 subjects for an ORR of 35 percent, with 13 of 65 subjects (20 percent) experiencing a CR or CRi. Marqibo enabled successful stem cell transplantation in 10 patients after dosing. The median OS in the 65 subjects is estimated to be 4.6 months (range 0.1-21.6) using Kaplan-Meier methodology. The safety profile of Marqibo is predictable, manageable, and similar to standard vincristine sulfate. The early death rate, defined as death occurring within the first 14 days on study, was 4.6 percent (3 of 56 subjects) and occurred due to progressive ALL.
The Company anticipates locking the data base and commencing a rolling NDA submission in the near future.
ASCO Presentation
The complete data from the pivotal Phase 2 RALLY trial will be presented in an oral podium presentation by Susan O'Brien M.D. (Abstract #6507) at 11:45 am on Monday, June 7 at the American Society of Clinical Oncology (ASCO) Annual Meeting being held in Chicago, Illinois, June 4-8, 2010.
About Marqibo(R) (vincristine sulfate liposome injection)
Marqibo is a novel, targeted, Optisome(TM) encapsulated formulation of vincristine sulfate, a widely-used chemotherapy, which has shown promising anti-cancer activity in patients with ALL, non-Hodgkin's lymphoma, Hodgkin's disease, and melanoma in several clinical trials. Marqibo is designed to enhance the penetration and concentration of vincristine sulfate at sites of active cancer and facilitate dose-intensification compared to standard vincristine formulations. Unlike standard vincristine, Marqibo is dosed based on actual patient body surface area without the need for dose capping.
Hana Biosciences has received orphan drug and fast track designations for Marqibo for the treatment of adult ALL from the U.S. Food and Drug Administration. Marqibo has also received orphan drug designation in adult ALL from the European Medicines Evaluation Agency.
About Hana Biosciences, Inc.
Hana Biosciences, Inc. is a biopharmaceutical company dedicated to developing and commercializing new, differentiated cancer therapies designed to improve and enable current standards of care. The company's lead product candidate, Marqibo(R), potentially treats acute lymphoblastic leukemia and lymphomas. The Company has additional pipeline opportunities some of which, like Marqibo, improve delivery and enhance the therapeutic benefits of well characterized, proven chemotherapies and enable high potency dosing without increased toxicity. Additional information on Hana Biosciences can be found at www.hanabiosciences.com.
The Hana Biosciences, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3290
Forward-Looking Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are often, but not always, made through the use of words or phrases such as "anticipates," "expects," "plans," "believes," "intends," and similar words or phrases. These forward-looking statements include without limitation, statements regarding, the timing, progress and anticipated results of Hana's planned development and regulatory activities relating to Marqibo, including its proposed NDA filing and whether such filing will be accepted for review or approved by the FDA; statements regarding the potential of Marqibo to replace existing therapies and the expected benefits Marqibo may have for patients with relapsed ALL compared to existing therapies. Such statements involve risks and uncertainties that could cause Hana's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements. Among other things, there can be no assurances that any of Hana's clinical and regulatory development efforts relating to Marqibo will be successful; that even if an NDA for Marqibo is accepted by the FDA, that it will be approved; that the data of the clinical trials of Marqibo will be sufficient to support approval by the FDA of an NDA for Marqibo; that Hana will have completed all other activities necessary for the filing of an NDA or other submission with the FDA; that the results of the clinical trials of Marqibo will support Hana's claims or beliefs concerning Marqibo's safety and effectiveness; that its existing patent and other intellectual property rights will be adequate; and that Hana will be able to secure the additional capital necessary to fund the activities required to complete the proposed NDA submission and other clinical and regulatory activities relating to Marqibo. Additional risks that may affect such forward-looking statements include Hana's need to raise additional capital to fund its product development programs, including Marqibo, to completion, Hana's reliance on third-party researchers to develop its product candidates, and its lack of experience in developing and commercializing pharmaceutical products. Additional risks are described in the company's Annual Report on Form 10-K for the year ended December 31, 2009 and in the Company's Form 10-Q for the three month period ended March 31, 2010. Hana assumes no obligation to update these statements, except as required by law.
Contact:
Hana Biosciences, Inc.
Investor & Media Contacts:
Investor Relations Team
(650) 588-6641
investor.relations@hanabiosciences.com
The order was a definitely bigger as it is being shipped to the entire Atlantic Region stores.
ThermaFreeze(TM) Scheduled to Debut on QVC's 'In the Kitchen with David
RED BANK, N.J., June 4 /PRNewswire/ -- ThermaFreeze™ Products Corporation (Pink Sheets:TZPC.pk - News), the maker of patented refrigerant products designed for consumer and commercial use, is scheduled to debut its reusable dry gel ice sheets on QVC. The 15-piece ThermaFreeze Reusable Ice Sheets is scheduled to appear on "In the Kitchen with David," a popular show about cooking products, on Sunday, June 6 between 12PM-3PM ET (11AM-2PM CT, 9AM-12PM PT).
The episode will feature ThermaFreeze's dry gel pack alternative to ice and ice substitutes, which has gained notoriety for its powerful flexibility, light packaging and the ease with which it can be cut into other sizes. ThermaFreeze's plastic-and-cloth design helps the pack stay cold 75 percent longer than traditional gel packs. Applications for ThermaFreeze reusable dry gel packs range from treating injuries to packaging easy-spoil food items for shipping to keeping a packed lunch cold.
"QVC is a great sales outlet to help us expose a wider consumer audience to our product," said Jim Bolton, Chief Operating Officer of ThermaFreeze Products Corporation. "The show gives us the opportunity to focus on one of the many applications for ThermaFreeze—or, more specifically, how our dry gel packs work for keeping food fresh."
For more information about "In the Kitchen with David," visit http://www.qvc.com/cgen/render.aspx?qp=promo|cd_itkwb_wknd.
About ThermaFreeze™ Products Corporation
ThermaFreeze™ Products Corporation manufactures and markets a patented, innovative refrigerant product designed for use in the commercial shipment of perishables and for use as a consumer compress and chiller product. The ThermaFreeze refrigerant is flat, lightweight and flexible, even when frozen, making it more convenient and cost-effective to use than ice, gel packs, ice bricks and dry ice. For more information, visit www.thermafreeze.com.
Safe Harbor for Forward-Looking Statements
Statements made in this release with the respect to the Company's current plans, estimates, strategies and beliefs and other statements that are not historical are forward-looking statements. Forward-looking statements include, but are not limited to, those statements using words such as "believe," "expect," "plans," and words of similar meaning in connection with a discussion of future operations, financial performance, events or conditions. Statements are based on management's assumptions and beliefs in light of the currently available information. The Company cautions that a number of important risks and uncertainties could cause actual results to materially differ from those discussed in the forward-looking statements and, therefore, undue reliance should not be placed on them.
INVESTOR CONTACT:
ThermaFreeze Products Corporation
Joe Noel
(925) 922-2560
Alert..Per management,Whole Foods order has been shipped.
Just spelling it out, as it may have confused some people on how it will work.
Nature's Peak to Form Joint Venture With National Retail Marketing Network and Source One Principals to Create Multi-Brand Channel Marketing Company
Nature's Peak will join forces with the founders of National Retail Marketing Network and Source One Sales and Marketing to create a joint venture sales and marketing company with the goal to expand our product portfolio and distribution, reduce costs and boost revenues
http://ih.advfn.com/p.php?pid=nmona&article=43024536&symbol=NO%5EEVRN
PR Newswire
SANTA CRUZ, Calif., May 28 /PRNewswire-FirstCall/ --
Nature's Peak / Everock, Inc. (Pink Sheets: EVRN) announced today that it has negotiated principal terms of a joint venture with Thomas Leib and Robert O'Connell, the founders of National Retail Marketing Network / Source One Sales and Marketing.
"Source One Sales and Marketing has been with us from the very beginning," said Paul Wilkinson, CEO of Nature's Peak / Everock, Inc. "So it is only natural that anything we do to increase our product offerings, marketing and sales should include Tom Leib and Bob O'Connell."
"This joint venture makes sense on many levels. Most immediately though, Nature's Peak will benefit through better cost efficiencies now that our new partners have a bigger stake in our success."
Source One will remain independent of Nature's Peak and continue to service all of its existing clients. The new company will leverage the 60 years of combined marketing and sales experience as well as the many Industry relationships that Tom and Bob bring to the relationship.
Robert Oppenheimer of Core Business One and Nature's Peak said, "Essentially, the new company and structure will allow Nature's Peak to utilize and leverage its common stock along with cash to acquire equity positions in a portfolio of compatible product lines. Already, several companies have expressed interest in our collaborative approach to increase sales, marketing and distribution."
All the partners believe that this joint venture has the potential to accelerate the sales and distribution of several product lines – including Nature's Peak products – beyond what each product or company would accomplish independently.
"This is an exciting milestone for the future of Nature's Peak," continued Robert Oppenheimer "The new company will further support a faster distribution of Nature's Peak VeggieDip and VeggieSpread by partnering with other companies in a common channel distribution of compatible product lines."
About Everock / Nature's Peak:
Nature's Peak produces a line of all-natural gourmet vegetable dips and sandwich spreads marketed under the Nature's Peak brand.
Both VeggieDip and VeggieSpread are 100% all-natural, vegetarian, Kosher and gluten-free, and contain no preservatives, artificial ingredients, trans-fats, or sugars. There are six flavors in each product line, including novel delicious flavor combinations.
Nature's Peak products are marketed through its Master Broker to natural food stores, specialty groceries as well as regional and national grocery chains. Our products will also be available to restaurants, delis and other food service providers across America.
Visit our website at www.NaturesPeak.com to learn more about our products and to discover new and delicious recipe ideas.
Forward Looking Statements:
This press release contains certain "forward-looking" statements, as defined in the United States Private Securities Litigation Reform Act of 1995 that involve a number of risks and uncertainties. Statements, which are not historical facts, are forward-looking statements. The Company, through its management, makes forward-looking public statements concerning its expected future operations, performance and other developments. Such forward-looking statements are necessarily estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that other factors will not affect the accuracy of such forward-looking statements. These statements are identified as any statement that does not relate strictly to historical or current facts. They use words such as "anticipates," "intends," "plans," "expects," "will," and other words and phrases of similar meaning. In all cases, a broad variety of assumptions can affect the realization of the expectations or forecasts in those statements. It is impossible to identify all such factors, factors that could cause actual results to differ materially from those estimated by the Company. They include, but are not limited to, the Company's ability to develop operations, the Company's ability to consummate and complete an acquisition, the Company's access to future capital, the successful integration of acquired companies, government regulation, managing and maintaining growth, the effect of adverse publicity, litigation, competition, sales and other factors that may be identified from time to time in the Company's public announcements. Consequently, no forward-looking statement can be guaranteed. Actual future results may vary materially.
This press release is for information purposes only and is not, nor is it intended to, constitute an offer to sell or a solicitation of an offer to buy securities.
SOURCE Nature's Peak / Everock, Inc.
Ok here we go...I want to explain the PR from friday. What is happening is a new company is being formed, separate from Natures Peak, this will be run by Thomas Leib and Robert O'Connell mentioned in the last PR,which EVRN will have a good size position in. What the new company will do is be a sales and marketing company used to promote Natures Peak and other single product companies who need a channel to get their products to market. They have already identified these high potential single product entrepreneurs already. This a big deal, as Natures Peak will benefit from the sales of those products too.
I have talked to management in great detail about the joint venture.
I will let you know by Monday-Tues. I am traveling and lack of time right now.You are going to like it.
This is huge!! EVRN NEWS..Nature's Peak to Form Joint Venture With National Retail Marketing Network and Source One Principals to Create Multi-Brand Channel Marketing Company
Nature's Peak will join forces with the founders of National Retail Marketing Network and Source One Sales and Marketing to create a joint venture sales and marketing company with the goal to expand our product portfolio and distribution, reduce costs and boost revenues
prnewswire
Press Release Source: Nature's Peak / Everock, Inc. On Friday May 28, 2010, 4:15 pm
SANTA CRUZ, Calif., May 28 /PRNewswire-FirstCall/ -- Nature's Peak / Everock, Inc. (Pink Sheets:EVRN.pk - News) announced today that it has negotiated principal terms of a joint venture with Thomas Leib and Robert O'Connell, the founders of National Retail Marketing Network / Source One Sales and Marketing.
"Source One Sales and Marketing has been with us from the very beginning," said Paul Wilkinson, CEO of Nature's Peak / Everock, Inc. "So it is only natural that anything we do to increase our product offerings, marketing and sales should include Tom Leib and Bob O'Connell."
"This joint venture makes sense on many levels. Most immediately though, Nature's Peak will benefit through better cost efficiencies now that our new partners have a bigger stake in our success."
Source One will remain independent of Nature's Peak and continue to service all of its existing clients. The new company will leverage the 60 years of combined marketing and sales experience as well as the many Industry relationships that Tom and Bob bring to the relationship.
Robert Oppenheimer of Core Business One and Nature's Peak said, "Essentially, the new company and structure will allow Nature's Peak to utilize and leverage its common stock along with cash to acquire equity positions in a portfolio of compatible product lines. Already, several companies have expressed interest in our collaborative approach to increase sales, marketing and distribution."
All the partners believe that this joint venture has the potential to accelerate the sales and distribution of several product lines – including Nature's Peak products – beyond what each product or company would accomplish independently.
"This is an exciting milestone for the future of Nature's Peak," continued Robert Oppenheimer "The new company will further support a faster distribution of Nature's Peak VeggieDip and VeggieSpread by partnering with other companies in a common channel distribution of compatible product lines."
About Everock / Nature's Peak:
Nature's Peak produces a line of all-natural gourmet vegetable dips and sandwich spreads marketed under the Nature's Peak brand.
Both VeggieDip and VeggieSpread are 100% all-natural, vegetarian, Kosher and gluten-free, and contain no preservatives, artificial ingredients, trans-fats, or sugars. There are six flavors in each product line, including novel delicious flavor combinations.
Nature's Peak products are marketed through its Master Broker to natural food stores, specialty groceries as well as regional and national grocery chains. Our products will also be available to restaurants, delis and other food service providers across America.
Visit our website at www.NaturesPeak.com to learn more about our products and to discover new and delicious recipe ideas.
Forward Looking Statements:
This press release contains certain "forward-looking" statements, as defined in the United States Private Securities Litigation Reform Act of 1995 that involve a number of risks and uncertainties. Statements, which are not historical facts, are forward-looking statements. The Company, through its management, makes forward-looking public statements concerning its expected future operations, performance and other developments. Such forward-looking statements are necessarily estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that other factors will not affect the accuracy of such forward-looking statements. These statements are identified as any statement that does not relate strictly to historical or current facts. They use words such as "anticipates," "intends," "plans," "expects," "will," and other words and phrases of similar meaning. In all cases, a broad variety of assumptions can affect the realization of the expectations or forecasts in those statements. It is impossible to identify all such factors, factors that could cause actual results to differ materially from those estimated by the Company. They include, but are not limited to, the Company's ability to develop operations, the Company's ability to consummate and complete an acquisition, the Company's access to future capital, the successful integration of acquired companies, government regulation, managing and maintaining growth, the effect of adverse publicity, litigation, competition, sales and other factors that may be identified from time to time in the Company's public announcements. Consequently, no forward-looking statement can be guaranteed. Actual future results may vary materially.
This press release is for information purposes only and is not, nor is it intended to, constitute an offer to sell or a solicitation of an offer to buy securities.
Update..ThermaFreeze Products Corp. (TZPC) – The retail rollout of the ThermaFreeze product line is happening at a rapid rate. They started on the East Coast several months ago and are now quickly adding store shelf space in the Midwest and Western states. Internet sales are rockin’. We believe it is clear that TZPC has moved out of developmental stage and into revenue production. We are hearing the product has now been cleared for sale on Home Shopping Network, with a likely airing date in mid-to late June. Things look good at the Company. We expect to air a set of videos (similar to those on BMGP) on TZPC over the short term – segments have been shot and are at the editor. We believe they will outline the exciting changes and sharp revenue growth ramp occurring at the Company.from Joe Noel Stocks
If you were following correctly,I was commenting on the zero volume we had earlier on. Nobody could figure out why. then came the 1,000,000 trade.Not that we should got excited about a 1,000,00 in volume..
LLBO NEWS..Lifeline Biotechnologies Comments on Depository Trust Services
businesswire
Press Release Source: Lifeline Biotechnologies, Inc. On Thursday May 27, 2010, 1:39 pm EDT
RENO, Nev.--(BUSINESS WIRE)--Lifeline Biotechnologies, Inc. (Pink Sheets: LLBO - News) announced today that it has provided information to Depository Trust supporting share issuances.
Jim Holmes, Lifeline’s CEO, said, “Due to the SEC action against Leeb Brokerage Services and several of its associates involving the trading in Lifeline’s shares, Depository Trust Company (DTC) has suspended services pending clarification on the issuance of shares by the Company. DTC is the clearing agency for many brokerage firms. The suspension of services has affected the public trading in Lifeline’s shares due to brokerage firms not being able to clear trades. We have provided DTC with information supporting our share issuances in compliance with regulatory requirements. We are hopeful DTC, after reviewing the information, will re-establish their services for Lifeline Biotechnologies and are awaiting their response. The company cannot determine when the issue will be resolved and is working diligently with DTC to provide all necessary documentation and requests for information. We believe the DTC suspension of services is the major cause of the recent decline of our stock price. We would expect with the re-establishment of DTC services, the share price and volume should be positively affected.”
Holmes went on to say, “We have no association or knowledge of Leeb, its counterparts or their activities concerning the trading of Lifeline’s shares.”
The Company remains focused and its priority is the preparation and submission of a First Warning System™ medical device 510(k) application to the FDA.
Lifeline’s website (www.lbti.com) has been comprehensively updated providing extensive information on the company, its history and current affairs.
Safe Harbor: This release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 27E of the Securities Act of 1934. Statements contained in this release that are not historical facts may be deemed to be forward-looking statements. Investors are cautioned that forward-looking statements are inherently uncertain. Actual performance and results may differ materially from that projected or suggested herein due to certain risks and uncertainties including, without limitation, the ability to obtain financing, successful development of the Company's product or market acceptance of the product and regulatory and shareholder approval for anticipated actions.
Contact:
Lifeline Biotechnologies, Inc.
Jim Holmes, 775-326-9614
jholmes@lbti.com
www.lbti.com
Johnson & Johnson learned of potential problems with its Motrin formula in 2008, but instead of issuing a recall, hired an outside contractor which began buying up the products, according to congressional investigators.
WASHINGTON (AP) -- Matthew Perrone, AP Business Writer, On Thursday May 27, 2010, 12:28 pm EDT
Colleen Goggins, J&J's president for McNeil consumer products, will testify before House lawmakers Thursday about ongoing quality problems with its over-the-counter medications.
Last month McNeil recalled more than 40 varieties of children's medicines after Food and Drug Administration inspectors discovered a slew of violations at a company plant.
Some of the medicines recalled contained tiny particles of metal, though federal health regulators say the risk of health risks is remote.
The recall is the latest in a series that threaten to tarnish J&J brands like Tylenol and Benadryl.
Lawmakers will question Goggins about the latest problems as well as its handling of a 2009 recall.
According to FDA documents cited by congressional investigators, J&J learned of problems with some of its Motrin tablets in November 2008.
The company hired an outside contractor to collect samples of the product and determine whether a recall was necessary. The key question was whether the tablets dissolved properly to deliver an appropriate dose of the pain-relieving ingredient ibuprofen.
Ibuprofen is a pain reliever and fever reducer similar to Tylenol's main ingredient acetaminophen, though it can sometimes cause upset stomach.
But instead of testing the product, FDA found that the contractor purchased lots of Motrin from retailers and instructed employees "not to mention a recall."
"I don't think we fully understood what was going on, but it was troubling to us," said Dr. Joshua Sharfstein, FDA's Deputy Commissioner, adding that the incident "reflected poorly on the company."
J&J recalled the lots of Motrin in July 2009, when FDA inspectors confronted the company about the contractor's activities.
"This 'phantom recall' warrants further investigation by this committee," said Rep. Edolphus Towns, D-N.Y., in his opening statement Thursday. "Who at McNeil and Johnson & Johnson knew about this scheme? How high up in the corporate suite was this scheme hatched?"
Towns chairs the House Committee on Oversight and Government Reform.
In testimony Thursday, Sharfstein laid out J&J's repeated violations of quality and manufacturing procedures, which have resulted in three recalls in the last eight months.
FDA held a meeting with J&J executives in February urging them to overhaul their manufacturing operations.
"FDA told the company's leadership that significant, immediate steps were needed to address issues of compliance and quality," said Sharfstein.
Since the April 30 recall, the FDA has received hundreds of reports of complications with J&J products, including seven deaths, according to a memo distributed to congressional staffers.
The FDA has not directly linked any medical problem to the recalled J&J products.
Alert..IBOX Updated with current news!!
We now have volume @1,000,000 shares
I checked with E*Trade who investigated HESG and found no news as to why the zero volume.
The zero volume could be a corporate action,nobody trading or BK.I hope it is a corporate action!Has anyone tried to place a trade?
ALXA NEWS...Staccato(R) Loxapine (AZ-004) Reduced Signs and Symptoms of Agitation as Early as Ten Minutes After Dosing in Patients with Schizophrenia or Bipolar Disorder
Additional Phase 3 Analyses and Phase 1 Cardiovascular Safety
Data Presented by Alexza Pharmaceuticals at the American Psychiatric Association 2010 Annual Meeting
Companies:Alexza Pharmaceuticals Inc.Biovail Corporation
Press Release Source: Alexza Pharmaceuticals, Inc.; Biovail Corporation On Wednesday May 26, 2010, 4:05 pm
NEW ORLEANS, May 26 /PRNewswire-FirstCall/ -- Results of clinical studies in patients with schizophrenia or bipolar disorder demonstrated that Staccato® loxapine (AZ-004) reduced agitation in patients, regardless of the level of agitation at baseline. Improvement in agitation levels were observed as early as 10 minutes after dosing on the standard components of agitation as measured by the Positive and Negative Syndrome Scale - Excited Component (PEC). Staccato loxapine also had no significant hemodynamic effect in subjects taking chronic antipsychotic treatment and did not significantly prolong the QT interval at therapeutic doses. These and other efficacy and safety data from clinical trials involving more than 700 patients and subjects were presented in poster presentations today at the Annual Scientific Sessions of the American Psychiatric Association meeting in New Orleans, LA.
Staccato loxapine is being developed by Alexza Pharmaceuticals, Inc. (Mountain View, CA) for the rapid treatment of agitation in patients with schizophrenia or bipolar disorder. Agitation is distressing for patients and their caregivers as well as a challenge for health-care professionals to manage. An AZ-004 New Drug Application is currently under review by the U.S. Food and Drug Administration, with a PDUFA goal date of October 11, 2010. The studies being reported were sponsored by Alexza, and the AZ-004 rights for the treatment of psychiatric and/or neurological indications and the symptoms associated with these indications have been licensed in the United States and Canada to Biovail Laboratories International, SRL, a subsidiary of Biovail Corporation of Mississauga, Canada.
"As previously reported, our Phase 3 studies showed that Staccato loxapine was effective in relieving the symptoms of agitation, with an onset of effect occurring in as little as 10 minutes. Additional analyses of our Phase 3 data show that AZ-004 rapidly treated the five individual dimensions of agitation in patients with schizophrenia or bipolar disorder," said James V. Cassella, PhD, Senior Vice President, Research and Development, Alexza Pharmaceuticals, Inc.
About the AZ-004 Efficacy Studies
The additional efficacy results from two randomized, double-blind, and placebo-controlled Phase 3 clinical trials assessing the efficacy and safety of Staccato loxapine in treating agitation in patients with schizophrenia or bipolar disorder were presented in the poster, "Treating Agitation with Inhaled Loxapine (AZ-004): Efficacy Analyses in Patients with Schizophrenia or Bipolar Disorder" (Poster Session 6).
In the Phase 3 clinical trials, loxapine was administered via inhalation using the Staccato system, which delivers thermally-generated drug aerosol to the deep lungs for rapid systemic absorption with IV-like pharmacokinetics. Adults 18 to 65 years of age who met DSM-IV criteria for schizophrenia or bipolar I disorder, and presented with a relevant degree of agitation at baseline, were included in the trials. A total of 344 patients with schizophrenia and 314 patients with bipolar I disorder were randomized to receive either 0 mg, 5 mg or 10 mg of AZ-004 in an in-patient treatment facility. Up to three doses of AZ-004 could be administered to each patient during the 24-hour study period.
The primary efficacy assessment in the studies was the change from baseline at 2 hours post-dose using the total PEC score. In each study, change from baseline for each of the five items comprising the total PEC score (hostility, uncooperativeness, excitement, poor impulse control and tension, each scored 1-7) was determined starting at 10 minutes post-dose. In addition, patients were grouped by baseline severity of agitation (median split) using the total PEC scores for each study and response rates for the higher and lower agitation populations were compared.
Each of the five items comprising the PEC scale improved with AZ-004 treatment, with differences from placebo starting at 10 minutes after dosing. On average, each item improved 1 to 2 units from baseline over the first two hours post-dose for both patient groups. Thus, the change in total PEC score observed with Staccato loxapine treatment derives from similar changes on each of the five items assessed. The median PEC score at baseline was 17 across the two studies. For the 10 mg dose groups and patients having a total PEC score of 17 or less at baseline, there was on average a total PEC score improvement of 8.3 and 8.5 units for patients with schizophrenia and bipolar disorder, respectively. For patients having a total PEC score of higher than 17 at baseline, there was on average a total PEC score improvement of 8.9 and 9.7 units for patients with schizophrenia and bipolar disorder, respectively.
About the AZ-004 Cardiovascular Safety Studies
The cardiovascular safety of Staccato loxapine was assessed in a Phase 1 study of 32 subjects taking chronic antipsychotic medication and in a thorough QT study (TQT) in 48 healthy volunteers. These results were presented in the poster presentation, "The Cardiovascular Safety of Inhaled Loxapine (AZ-004)" (Poster Session 6).
The Phase 1 study was a double-blind, placebo-controlled, parallel group investigation of the safety of repeat doses of AZ-004 (at time 0, 4 and 8 hours) in patients 18 to 65 years of age who were taking chronic antipsychotic medication. Participants were randomly assigned to receive either 5 mg x 3 doses, 10 mg x 3 doses, 10 mg followed by two doses of 5 mg, or placebo x 3 doses.
There were no clinically significant mean changes in heart rate or blood pressure (BP) with repeat dosing in subjects on chronic antipsychotic medication. In the highest dose group (10 mg x 3 doses), mean changes from baseline in systolic BP were -1.75, -3.13, and -4.38 mm Hg at 10 minutes after the first, second and third doses, respectively.
The TQT study was a double-blind, double-dummy, active- and placebo-controlled, 3 period crossover study investigating the effect on the QT interval of single doses of 10 mg AZ-004, 400 mg oral moxifloxacin (active control) and placebo. In the TQT study, AZ-004 did not increase QT intervals, as demonstrated by the upper bound of the one-sided 95% confidence intervals placed on the point estimate of the placebo-subtracted change of QTcI being less than 10 ms at all eleven post-dose time points. Moxifloxacin significantly prolonged QTcI by the same metrics, demonstrating assay sensitivity. There were no clinically significant mean changes in heart rate or BP following dosing with AZ-004.
About AZ-004
AZ-004 is an anti-agitation therapeutic that combines the proprietary Staccato system with loxapine, a drug belonging to the class of compounds known generally as antipsychotics. Loxapine is currently available in oral formulations in the U.S. for the management of the manifestations of schizophrenia. The Staccato system is a hand-held, chemically-heated, single-dose inhaler that delivers a drug aerosol to the deep lung that results in IV-like pharmacokinetics and rapid systemic effects.
About Alexza
Alexza Pharmaceuticals, Inc. (Nasdaq:ALXA - News) is a pharmaceutical company focused on the research, development and commercialization of novel, proprietary products for the acute treatment of central nervous system conditions. Alexza's technology, the Staccato system, provides speed of therapeutic onset that is comparable to intravenous administration, but with greater ease, patient comfort and convenience. For more information about Alexza, visit the company's web site at http://www.alexza.com/.
About Biovail Corporation
Biovail Corporation (NYSE:BVF - News) is a specialty pharmaceutical company engaged in the formulation, clinical testing, registration, manufacture and commercialization of pharmaceutical products. The company is focused on the development and commercialization of medicines that address unmet medical needs in niche specialty central nervous system markets. For more information about Biovail, visit the company's web site at http://www.biovail.com/.
Caution Regarding Forward-Looking Information and Safe Harbor Statement
To the extent any statements made in this release contain information that is not historical, these statements are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and may be forward-looking information under applicable Canadian provincial securities legislation (collectively, "forward-looking statements"). These forward-looking statements relate to, among other things, objectives, goals, targets, strategies, intentions, plans, beliefs, estimates and outlook, and can generally be identified by the use of words such as "believe," "anticipate," "expect," "intend," "plan," "will," "may", "potential" and other similar expressions. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements.
Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of developing and commercializing drugs. Forward-looking statements also involve assumptions that, if they prove incorrect, would cause results to differ materially from those expressed or implied by such forward-looking statements. Although Alexza and Biovail believe that the expectations reflected in such forward-looking statements are reasonable, such statements involve risks and uncertainties, and undue reliance should not be placed on such statements. Certain material factors or assumptions are applied in making forward-looking statements, including, but not limited to, factors and assumptions regarding the reliability of research findings, and actual results may differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from these expectations include, among other things: uncertainties associated with the launch of a new product and the accuracy of associated research, uncertainties with respect to the development path that will be required by regulatory authorities and uncertainties with respect to the results of future clinical trials, the regulatory environment and associated filings and approvals.
These and other risks concerning Alexza's business are described in additional detail in Alexza's Annual Report on Form 10-K for the year ended December 31, 2009, and Alexza's other Periodic and Current Reports filed with the U.S. Securities and Exchange Commission including the risks under the headings: "We have a history of net losses. We expect to continue to incur substantial and increasing net losses for the foreseeable future, and we may never achieve or maintain profitability.", "We will need substantial additional capital in the future. If additional capital is not available, we will have to delay, reduce or cease operations." and "Regulatory authorities may not approve our product candidates even if they meet safety and efficacy endpoints in clinical trials."
These and other risks are detailed from time to time in Biovail's filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, as well as Biovail's ability to anticipate and manage the risks associated with the foregoing. Additional information about these factors and about the material factors or assumptions underlying such forward looking statements may be found in the body of this release, as well as under Item 1A. in Biovail's most recent Annual Report on Form 10-K for the fiscal year ended December 31 2009 and under Item 1A. in Biovail's most recent Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2010.
Forward-looking statements contained in this announcement are made as of this date, and neither Alexza or Biovail undertake any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.
Alexza and Biovail caution that the foregoing list of important factors that may affect future results is not exhaustive. When relying on forward-looking statements to make decisions with respect to Alexza or Biovail, investors and others should carefully consider the foregoing factors and other uncertainties and potential events.
Staccato® is a registered trademark of Alexza Pharmaceuticals, Inc.
POSC News..
Researchers at MD Anderson Show That Positron Emission Mammography (PEM) Helps Evaluate Early Response to Neoadjuvant Chemotherapy
9:05 AM ET 5/26/10 | PR Newswire
In a recent study presented at the American Association of Cancer Research Annual Meeting in Washington, DC, researchers at the University of Texas MD Anderson Cancer Center showed that Positron Emission Mammography (PEM) helps evaluate response to neoadjuvant chemotherapy.
PEM scanners are high-resolution breast PET systems that can show the location as well as the metabolic phase of a lesion. This information is critical in determining whether a lesion is malignant and influences the course of treatment. Other imaging systems, such as mammography and ultrasound, show only the location, not the metabolic phase. PEM scanners, which are about the size of an ultrasound system, are manufactured by Naviscan, Inc. and have been commercially available since 2007.
The prospective study, conducted by Dr. Wei Yang, Associate Professor of Radiology at the University of Texas MD Anderson Cancer Center in Houston, and her team found that PEM can help physicians at a very early stage decide if a patient is responding to neoadjuvant medical therapy, a cancer treatment in which a drug is given to a patient to reduce the size of a tumor prior to surgery.
The team enrolled 9 patients with HER2 over-expressing Inflammatory Breast Cancer (IBC) in a Phase II neoadjuvant trial of lapatinib for 14 days followed by chemotherapy. Baseline tumor measurements on mammography, sonography, PEM and PET/CT scans with serial biopsies were performed. PEM and biopsies were repeated at 14 days. Quantification of tumor activity known as PEM uptake value (PUV) were compared to standardized uptake value (SUV) for PET/CT pre- and post-lapatinib and correlated with tumor size and proliferation marker Ki67.
Results from this study showed significant early decrease in PUV as a functional response to targeted therapy suggesting that PEM can be used to evaluate early response to therapy.
"The high spatial resolution of PEM combined with functional quantification tools has the potential to assess tumor response early in the course of treatment," said Dr. Yang, lead author on the study. "The ability to perform correlative studies that may help discover early on if targeted therapy is working or not will potentially save a patient from enduring the wrong type of neoadjuvant chemotherapy and enable a timely switch to the right one."
Future peer-reviewed publication of these results will appear once surgical outcomes for these patients have been acquired.
About Naviscan, Inc.
Naviscan, Inc., founded in 1995, develops and markets compact, high-resolution PET scanners intended to provide organ-specific molecular imaging and guide radiological and surgical procedures. The Naviscan PET scanner is currently installed and available in breast and imaging centers throughout the U.S. and other parts of the world. The Company is headquartered in San Diego, California and is the first to obtain FDA clearance for a high-resolution PET scanner designed to image small body parts and for breast biopsy image guidance. For more information, call 1.858.587.3641 or visit www.naviscan.com.
SOURCE Naviscan, Inc.
BIEL NEWS..BioElectronics Corporation Expands Distribution of Electromagnetic Pain Relief Patches to Russia
Company Inks Exclusive Deal With OMEC B.V. to Distribute ActiPatch(TM), Recovery Rx(TM) and Allay(TM) Products
marketwire
Press Release Source: BioElectronics Corporation On Wednesday May 26, 2010, 9:43 am EDT
FREDERICK, MD--(Marketwire - 05/26/10) - BioElectronics Corporation (Pinksheets:BIEL - News), developers of innovative electromagnetic pain-relieving medical devices, announced today that it has expanded distribution of its clinically-proven ActiPatch, Recovery Rx and Allay dermal patch systems to Russia through an agreement with The Netherlands' OMEC B.V.
The agreement gives OMEC exclusive distribution rights for the Russian Federation, Belarus and Kazakhstan. To support the new product distribution, OMEC has launched a new entity, Med Inn, specifically for distributing the BioElectronics system. The products are now available through the Med Inn website at www.actipatch.ru.
"We are very pleased to add OMEC to our growing distributor network and eager to bring our affordable, drug-free, anti-inflammatory medical devices to the Russian market," said Arnon Horev, vice president of sales and marketing with BioElectronics. "The unique delivery system of the ActiPatch, Recovery Rx and Allay products provides a convenient and effective, drug-free way to relieve pain and inflammation that we believe will resonate well with the Russian people."
BioElectronics' core pulse electromagnetic technology delivers safe and effective electromagnetic energy -- once only obtainable through the use of large, facility-based equipment -- directly to the affected body part through inexpensive and easy-to-wear devices. Providing clinically proven and widely recognized anti-inflammatory and pain relief therapy, BioElectronics' unique dermal patch delivery system is marketed under several brands to provide welcome relief and accelerate healing from pain and discomfort due to a variety of musculoskeletal disorders and rehabilitation.
ActiPatch is an over-the-counter retail product for the self-treatment of injury, chronic pain, inflammation, strain, sprain and repetitive stress injury to the back, heel, knee, wrist or elbow. Recovery Rx is a surgical recovery kit that speeds healing related to general surgery with specific products designed for Cesarean section childbirth, breast, nose or eye surgery recovery. The Allay Menstrual Pain Therapy Patch provides drug-free treatment for the monthly pain and discomfort suffered by millions of women. HealFast Therapy is designed to provide pain relief to cats, dogs and horses.
For more information about BioElectronics' innovative pulse electromagnetic therapy devices, visit www.bielcorp.com.
For more information about OMEC B.V. and Med Inn visit www.actipatch.ru or call Mr. B. Kramer (Omec) +31614671938 or Mr. O. Moiseenkov (Med Inn) +79857609294
About BioElectronics Corporation
BioElectronics Corporation (Pinksheets:BIEL - News) is the maker of safe, inexpensive, drug-free medical devices and patches that deliver pulsed electromagnetic energy to relieve pain and inflammation. The company's wafer thin patches contain an embedded microchip and battery that deliver pulsed electromagnetic energy, a clinically proven and widely accepted anti-inflammatory and pain relief therapy that heretofore has only been possible to obtain from large, facility-based equipment. BioElectronics markets and sells its current products under the brand names ActiPatch™, RecoveryRx™, Allay™ Menstrual Pain Therapy and HealFast™ Therapy for cats, dogs and horses. The company is headquartered in Frederick, MD. For more information, visit www.bielcorp.com.
About OMEC B.V.:
OMEC B.V. was 15 years ago especially established to offer logistics and distribution services for medical products into the Russian Federation and has been expanding the business with innovative products ever since. OMEC controls an impressive network in the Russian Federation that will be used to distribute the BioElectronics products.
Contact:
MEDIA CONTACT:
Hanni Itah
SS|PR
(847) 415 - 9324
Email Contact
The good news is that all the marketing and distribution expense is paid by the distributor. Biel simply collects profits.This great, as it does not involve any financing from BIEL.
(Nasdaq: NOVA) NovaMed, Inc. , a leading operator of ambulatory surgery centers in partnership with physicians, today announced that its stockholders approved an amendment to the Company’s Certificate of Incorporation to effect a one-for-three reverse split of the Company’s outstanding shares of common stock. NovaMed expects that the reverse stock split will take effect prior to the opening of markets on June 1, 2010 and will be effective with respect to stockholders of record at the close of business on May 28, 2010. As a result of the reverse stock split, each three shares of common stock will be combined into one share of common stock and the number of shares of common stock issued and outstanding or held in treasury will be reduced proportionately based on the reverse stock split ratio of 1-for-3.
(Nasdaq: TEVA)Teva Pharmaceutical Industries Ltd. will host a live audio webcast at the 2010 Citi Investment Research Global Health Care Conference with Eyal Desheh, Chief Financial Officer, Teva Pharmaceutical Industries Ltd., presenting on Thursday, May 27, 2010 in New York.
(NASDAQ: ARIA).. ARIAD Pharmaceuticals, Inc. today announced that the independent Data Monitoring Committee (DMC) of the Phase 3 SUCCEED trial has completed the second interim efficacy analysis as specified in the study protocol and has recommended that the randomized, placebo-controlled trial of oral ridaforolimus in patients with metastatic sarcomas continue to its final analysis, without modification to the study protocol.
The DMC review comprised approximately two-thirds of the progression-free survival (PFS) events anticipated in the trial. PFS is the primary end-point of the trial. The safety and efficacy of oral ridaforolimus is being evaluated in approximately 650 patients with metastatic soft-tissue and bone sarcomas who have achieved a favorable response to chemotherapy. The DMC also stated that no new safety signals were noted. Full enrollment of the trial was reached in December 2009. The final analysis of PFS is expected in the second half of 2010.