Counting my change
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This should answer your question...And we’re confident we have sufficient manufacturing capacity to handle the expected increased order volume and begin delivery of product to distributors in May,” concluded Wilkinson.
I agree!
Not true,all of their pr's have had good information on their strategy.This company has been moving systematically thru the whole process so far perfectly. They know what they are doing.All companies of this type have to do some dilution to raise money,this is not a bad thing as long as it is controlled.as far as, the financing is concerned,it has been announced several times that they have private backing as well as,1.5 million combined of Robert and Paul's personal money in the game.SO far, I love what is going on
Notice the Plural on Distributors!!!
"We are all very eager to continuing building on recent successes – like our acceptance into Whole Foods Market. And we're confident we have sufficient manufacturing capacity to handle the expected increased order volume and begin delivery of product to distributors in May," concluded Wilkinson.
This is absolutely fantastic news!Whole foods is very difficult to get into.They must of loved the product.This is just the beginning of distribution!
If california succeeds in legalizing marijuana. Other states will follow once they see the massive income potential for their state.
This similar debate happened with river boat gambling,and look at that now.
News...California may legalize Marijuana
Calif. pot vote isn't just hippies versus cops
By LISA LEFF and MARCUS WOHLSEN (AP) – 12 hours ago
SAN FRANCISCO — Now that a proposal to legalize pot is on the ballot in California, well-organized groups are lining up on both sides of the debate. And it's not just tie-dyed hippies versus anti-drug crusaders.
So far, the most outspoken groups on the issue are those affiliated with California's legal medical marijuana industry and law enforcement officials who vehemently oppose any loosening of drug laws.
But the campaign that unfolds before the November election could yield some unusual allies: free-market libertarians joining police officers frustrated by the drug war to support the measure, and pot growers worried about falling prices pairing with Democratic politicians to oppose it.
Others believe legalizing and taxing the drug could improve the state's flagging economy.
"We spend so much time, our police do, chasing around these nonviolent drug offenders, we don't have time anymore to protect our people from murders and child molesters," said Jack Cole, president of Law Enforcement Against Prohibition, a group that plans to champion the California proposal between now and the election.
The initiative, also known as the "Tax Cannabis Act," received enough signatures this week to qualify for the November ballot. If it is approved, California would become the first state to legalize marijuana for recreational use by adults. The measure would also give local governments the authority to regulate and tax pot sales.
According to campaign finance records, nearly all of the more than $1.3 million spent on the campaign to qualify the question for the ballot came from businesses controlled by the proposal's main backer, Oakland medical marijuana entrepreneur Richard Lee.
Lee operates a medical marijuana dispensary and cafe in downtown Oakland and is the founder of Oaksterdam University, which trains people to run their own medical marijuana businesses. According to the school, more than 5,000 students have completed their programs.
The largest donations from an individual not connected to the marijuana business came from George Zimmer, founder and chief executive of the men's clothing chain Men's Wearhouse.
Television viewers know Zimmer as the Fremont-based company's longtime pitchman in commercials. But he is also known as a longtime supporter of efforts to liberalize the nation's drug laws.
Opponents contend that the legalization effort will pit a few wealthy individuals against regular Californians who will provide the groundswell needed to defeat the measure.
"You have rich dilettantes who want to legalize drugs and ordinary people who consider the ramifications of legalization on their communities and their families," said John Lovell, a lobbyist representing several law enforcement groups opposed to the initiative.
Lovell pointed to the lopsided defeat of a 2008 ballot issue that would have pushed treatment instead of prison for drug offenders as a sign of voters' leanings. Supporters of the measure heavily outspent opponents, but it was defeated 59 to 41 percent.
The anti-legalization campaign has not reported any contributions yet, but workers are reviewing what they believe are major flaws with the ballot initiative. They say the proposed law would allow pot to be grown in public parks and fail to prevent people with prior drug convictions from selling pot.
Meanwhile, some well-known liberals have come out against it, including the state's presumptive Democratic nominee for governor, Attorney General Jerry Brown.
Brown, who was seen in the 1970s as an icon of California's counterculture, told the San Francisco Chronicle earlier this month that he was "not going to jump on the legalization bandwagon."
"We're going to get a vote of the people soon on that, but I'm not going to support it," he said.
Legalized marijuana in California, the nation's most populous state, would represent a sea change in the nation's drug laws and put the state in direct conflict with the federal government because pot is still illegal in the eyes of federal officials.
On Thursday, a Department of Justice spokeswoman said it was too soon to speculate on whether federal authorities would sue to keep the measure from becoming law.
The administration relaxed its prosecution guidelines for medical marijuana last year, but President Barack Obama's drug czar has said the White House strongly opposes any efforts to legalize pot.
"Marijuana legalization, for any purpose, remains a non-starter in the Obama administration," Gil Kerlikowske, director of the Office of National Drug Control Policy, said last year. "It is not something that the president and I discuss. It isn't even on the agenda."
California in 1996 became the first of the 14 states that have legalized medicinal marijuana. Many jurisdictions around the country have also decriminalized marijuana to the point that low-level possession offenses are not prosecuted.
States such as California and Colorado have also been struggling to deal with an explosion in the number of medical marijuana dispensaries in recent years, a trend that has made pot readily available to the public.
A decision by California to legalize pot could lend momentum to the entire legalization movement, just like its historic 1996 law did for medical marijuana.
Legislators in Rhode Island are considering a plan to decriminalize pot, and a group in Nevada is pushing an initiative that marks the state's fourth attempt in a decade to legalize the drug.
Lawmakers in Washington state recently killed a plan to legalize the sale and use of marijuana, though lawmakers there did expand the pool of medical professionals who could prescribe the drug for medicinal use.
The ballot measure in California would allow people 21 years and older to possess up to one ounce of marijuana, enough for dozens of joints. Residents also could grow their own crop of the plant in gardens measuring up to 25 square feet.
The proposal would ban users from using marijuana in public or smoking it while minors are present. It also would make it illegal to possess the drug on school grounds or drive while under its influence.
Proponents of the measure say legalizing marijuana could save the state $200 million a year by reducing public safety costs. At the same time, it could generate tax revenue for local governments.
Law enforcement officials are promising a vigorous fight to ensure that marijuana never becomes legal in California. They believe legalized marijuana would increase crime and violence, deepen the nation's drug culture and lead teenagers to abuse pot.
The California Police Chiefs Association, Mothers Against Drunk Driving and groups such as the youth-oriented Drug Abuse Resistance Education also plan to oppose the idea.
Not everyone in law enforcement is opposed to the measure, however.
"We believe by voting for that initiative you can actually save lives," Cole said.
Copyright © 2010 The Associated Press. All rights reserved.
In the News...California is looking to legalize marijuana.
Calif. pot vote isn't just hippies versus cops
By LISA LEFF and MARCUS WOHLSEN (AP) – 12 hours ago
SAN FRANCISCO — Now that a proposal to legalize pot is on the ballot in California, well-organized groups are lining up on both sides of the debate. And it's not just tie-dyed hippies versus anti-drug crusaders.
So far, the most outspoken groups on the issue are those affiliated with California's legal medical marijuana industry and law enforcement officials who vehemently oppose any loosening of drug laws.
But the campaign that unfolds before the November election could yield some unusual allies: free-market libertarians joining police officers frustrated by the drug war to support the measure, and pot growers worried about falling prices pairing with Democratic politicians to oppose it.
Others believe legalizing and taxing the drug could improve the state's flagging economy.
"We spend so much time, our police do, chasing around these nonviolent drug offenders, we don't have time anymore to protect our people from murders and child molesters," said Jack Cole, president of Law Enforcement Against Prohibition, a group that plans to champion the California proposal between now and the election.
The initiative, also known as the "Tax Cannabis Act," received enough signatures this week to qualify for the November ballot. If it is approved, California would become the first state to legalize marijuana for recreational use by adults. The measure would also give local governments the authority to regulate and tax pot sales.
According to campaign finance records, nearly all of the more than $1.3 million spent on the campaign to qualify the question for the ballot came from businesses controlled by the proposal's main backer, Oakland medical marijuana entrepreneur Richard Lee.
Lee operates a medical marijuana dispensary and cafe in downtown Oakland and is the founder of Oaksterdam University, which trains people to run their own medical marijuana businesses. According to the school, more than 5,000 students have completed their programs.
The largest donations from an individual not connected to the marijuana business came from George Zimmer, founder and chief executive of the men's clothing chain Men's Wearhouse.
Television viewers know Zimmer as the Fremont-based company's longtime pitchman in commercials. But he is also known as a longtime supporter of efforts to liberalize the nation's drug laws.
Opponents contend that the legalization effort will pit a few wealthy individuals against regular Californians who will provide the groundswell needed to defeat the measure.
"You have rich dilettantes who want to legalize drugs and ordinary people who consider the ramifications of legalization on their communities and their families," said John Lovell, a lobbyist representing several law enforcement groups opposed to the initiative.
Lovell pointed to the lopsided defeat of a 2008 ballot issue that would have pushed treatment instead of prison for drug offenders as a sign of voters' leanings. Supporters of the measure heavily outspent opponents, but it was defeated 59 to 41 percent.
The anti-legalization campaign has not reported any contributions yet, but workers are reviewing what they believe are major flaws with the ballot initiative. They say the proposed law would allow pot to be grown in public parks and fail to prevent people with prior drug convictions from selling pot.
Meanwhile, some well-known liberals have come out against it, including the state's presumptive Democratic nominee for governor, Attorney General Jerry Brown.
Brown, who was seen in the 1970s as an icon of California's counterculture, told the San Francisco Chronicle earlier this month that he was "not going to jump on the legalization bandwagon."
"We're going to get a vote of the people soon on that, but I'm not going to support it," he said.
Legalized marijuana in California, the nation's most populous state, would represent a sea change in the nation's drug laws and put the state in direct conflict with the federal government because pot is still illegal in the eyes of federal officials.
On Thursday, a Department of Justice spokeswoman said it was too soon to speculate on whether federal authorities would sue to keep the measure from becoming law.
The administration relaxed its prosecution guidelines for medical marijuana last year, but President Barack Obama's drug czar has said the White House strongly opposes any efforts to legalize pot.
"Marijuana legalization, for any purpose, remains a non-starter in the Obama administration," Gil Kerlikowske, director of the Office of National Drug Control Policy, said last year. "It is not something that the president and I discuss. It isn't even on the agenda."
California in 1996 became the first of the 14 states that have legalized medicinal marijuana. Many jurisdictions around the country have also decriminalized marijuana to the point that low-level possession offenses are not prosecuted.
States such as California and Colorado have also been struggling to deal with an explosion in the number of medical marijuana dispensaries in recent years, a trend that has made pot readily available to the public.
A decision by California to legalize pot could lend momentum to the entire legalization movement, just like its historic 1996 law did for medical marijuana.
Legislators in Rhode Island are considering a plan to decriminalize pot, and a group in Nevada is pushing an initiative that marks the state's fourth attempt in a decade to legalize the drug.
Lawmakers in Washington state recently killed a plan to legalize the sale and use of marijuana, though lawmakers there did expand the pool of medical professionals who could prescribe the drug for medicinal use.
The ballot measure in California would allow people 21 years and older to possess up to one ounce of marijuana, enough for dozens of joints. Residents also could grow their own crop of the plant in gardens measuring up to 25 square feet.
The proposal would ban users from using marijuana in public or smoking it while minors are present. It also would make it illegal to possess the drug on school grounds or drive while under its influence.
Proponents of the measure say legalizing marijuana could save the state $200 million a year by reducing public safety costs. At the same time, it could generate tax revenue for local governments.
Law enforcement officials are promising a vigorous fight to ensure that marijuana never becomes legal in California. They believe legalized marijuana would increase crime and violence, deepen the nation's drug culture and lead teenagers to abuse pot.
The California Police Chiefs Association, Mothers Against Drunk Driving and groups such as the youth-oriented Drug Abuse Resistance Education also plan to oppose the idea.
Not everyone in law enforcement is opposed to the measure, however.
"We believe by voting for that initiative you can actually save lives," Cole said.
Copyright © 2010 The Associated Press. All rights reserved.
There is no question they are super conservative about releasing information,Robert has told this to me in the past.They want solid Prs'.They are running this product thru the system in a strategic manner,which is perfect.
UPDATE 2-U.S. FDA OKs Salix drug for liver failure disorder
Wed Mar 24, 2010 7:04pm EDT
Stocks
Salix Pharmaceuticals Ltd
SLXP.O
$33.52
-0.01-0.03%
2:00pm CDT
* Drug to be launched by end of May
* Shares rise nearly 7 percent (Adds background)
LOS ANGELES, March 24 (Reuters) - U.S. regulators on Wednesday approved the use of Salix Pharmaceuticals Ltd's (SLXP.O) Xifaxan antibiotic as a treatment for reducing the risk of a debilitating liver disorder in adults.
The company's shares rose about 7 percent.
The Food and Drug Administration approved the drug for reducing the risk of recurrent hepatic encephalopathy, a disorder caused by chronic liver failure that can cause confusion, memory problems or coma.
About 50,000 people in the United States are hospitalized each year for the condition, where a poorly functioning liver allows bacteria-produced poisons such as ammonia to accumulate in the gut and affect the nervous system. It strikes up to 45 percent of people with cirrhosis.
Salix said there are an estimated 200,000 patients in the United States who suffer from episodic overt HE.
Piper Jaffray has estimated annual sales of Xifaxan for treating recurrent HE at $400 million to $500 million.
Xifaxan, known generically as rifaximin, is already approved by the FDA for so-called travelers' diarrhea caused by certain strains of E. coli bacteria. Sales of the drug last year totaled $118 million.
The company expects 550 mg tablets of the drug to be available by the end of May.
A pivotal trial of Xifaxan, published in the latest issue of the New England Journal of Medicine, showed that it cut the risk of recurrent hepatic encephalopathy by 58 percent. The article also said the drug reduced the risk of hospitalization.
The U.S. Food and Drug Administration previously granted orphan status to Xifaxan for treating HE. The designation comes with a seven-year marketing exclusivity period.
Other antibiotics used to treat HE are not recommended for prolonged treatment -- even though they can also reduce the number of ammonia-producing bacteria in the gut -- because of possible side effects. Xifaxan tends to stay in the intestine and not be absorbed by the body.
Salix shares, which closed at $33.52 on Nasdaq, were higher at $35.76 in after hours trading. (Reporting by Deena Beasley; editing by Andre Grenon, Gary Hill)
UPDATE 2-U.S. FDA OKs Salix drug for liver failure disorder
Wed Mar 24, 2010 7:04pm EDT
Stocks
Salix Pharmaceuticals Ltd
SLXP.O
$33.52
-0.01-0.03%
2:00pm CDT
* Drug to be launched by end of May
* Shares rise nearly 7 percent (Adds background)
LOS ANGELES, March 24 (Reuters) - U.S. regulators on Wednesday approved the use of Salix Pharmaceuticals Ltd's (SLXP.O) Xifaxan antibiotic as a treatment for reducing the risk of a debilitating liver disorder in adults.
The company's shares rose about 7 percent.
The Food and Drug Administration approved the drug for reducing the risk of recurrent hepatic encephalopathy, a disorder caused by chronic liver failure that can cause confusion, memory problems or coma.
About 50,000 people in the United States are hospitalized each year for the condition, where a poorly functioning liver allows bacteria-produced poisons such as ammonia to accumulate in the gut and affect the nervous system. It strikes up to 45 percent of people with cirrhosis.
Salix said there are an estimated 200,000 patients in the United States who suffer from episodic overt HE.
Piper Jaffray has estimated annual sales of Xifaxan for treating recurrent HE at $400 million to $500 million.
Xifaxan, known generically as rifaximin, is already approved by the FDA for so-called travelers' diarrhea caused by certain strains of E. coli bacteria. Sales of the drug last year totaled $118 million.
The company expects 550 mg tablets of the drug to be available by the end of May.
A pivotal trial of Xifaxan, published in the latest issue of the New England Journal of Medicine, showed that it cut the risk of recurrent hepatic encephalopathy by 58 percent. The article also said the drug reduced the risk of hospitalization.
The U.S. Food and Drug Administration previously granted orphan status to Xifaxan for treating HE. The designation comes with a seven-year marketing exclusivity period.
Other antibiotics used to treat HE are not recommended for prolonged treatment -- even though they can also reduce the number of ammonia-producing bacteria in the gut -- because of possible side effects. Xifaxan tends to stay in the intestine and not be absorbed by the body.
Salix shares, which closed at $33.52 on Nasdaq, were higher at $35.76 in after hours trading. (Reporting by Deena Beasley; editing by Andre Grenon, Gary Hill)
SLXP...has been halted!!
Aethlon Medical Regulation FD Disclosures
- Proposed Strategic Arrangement with Membrana GmbH
- Initiates New Breast Cancer and Lymphoma Research Collaborations
- Discloses First Bacterial Infection Data (Tuberculosis)
- Initiates First Compassionate Use Treatment in Cancer Care
- Completes First Hemopurifier(R) GMP Production Run
- Discloses India Commercialization Update
prnewswire
Press Release Source: Aethlon Medical On Wednesday March 24, 2010, 5:15 pm
SAN DIEGO, March 24 /PRNewswire/ -- At an investor conference held today, following the market close, Aethlon Medical (OTC Bulletin Board:AEMD.ob - News), the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, disclosed the following:
Proposed Strategic Arrangement with Membrana GmbH
The Company has signed a letter of intent with Membrana GmbH (Membrana) in an effort to establish a manufacturing arrangement to support large-scale production. Membrana is a leading independent membrane producer worldwide, and is the manufacturer of the hollow-fiber membranes currently utilized in the Aethlon Hemopurifier®. Membrana is also a leading supplier of microporous membranes for medical applications like dialysis, and plasma separation. Membrana GmbH is a subsidiary of Polypore International, Inc. The arrangement is subject to completion of a definitive agreement.
Initiates New Cancer Research Collaborations
Aethlon has also initiated two research studies aimed at determining the capability of the Hemopurifier® to capture immunosuppressive exosomes associated with breast cancer and lymphoma. The details of the studies are as follows:
* An in vitro study, under the collaboration of Douglas D. Taylor, Ph.D., Professor of Obstetrics, Gynecology, and Women's Health at the University of Louisville, has been initiated to determine the capability of the Hemopurifier® to capture immunosuppressive exosomes associated with breast cancer. Dr. Taylor previously conducted studies that validated the Hemopurifier® was effective in capturing immunosuppressive exosomes associated with ovarian cancer.
* An in vitro study, under the collaboration of Andrew Raubitschek, M.D., Chair of the Department of Cancer Immunotherapeutics & Tumor Immunology at the Beckman Research Institute of City of Hope in California, has been initiated to determine the capability of the Hemopurifier® to capture lymphoma related exosomes. Dr. Raubitschek is also Co-leader for the Cancer Immunotherapeutics Program at the Comprehensive Cancer Center and Chief of Radioimmunotherapy and Professor, Radiation Oncology also at the City of Hope.
Disclosure of First Bacterial Infection Data
* An in vitro bacteriological study, under the collaboration of Jeffrey Schorey, Ph.D., of the Eck Institute of Global Health at the University of Notre Dame, demonstrated that the Hemopurifier®, in a 4-hour period, captured 97% of exosomes secreted by mycobacterium tuberculosis, the pathogenic bacterial agent that causes Tuberculosis. Dr. Schorey is a 2009 recipient of a Bill and Melinda Gates Foundation grant to study exosomes as a potential Tuberculosis vaccine.
Disclosure of First Compassionate Use Treatment
The Company also revealed the completion of its first compassionate use treatments of the Hemopurifier® on an end-stage lung cancer patient. The treatments were conducted at the Netcare Christiaan Barnard Memorial Hospital in Cape Town, South Africa and had clinical support from National Renal Care, a leading kidney disease management organization in South Africa. The Company is currently testing the Hemopurifier® cartridges used in the treatments to determine the capture rate of immunosuppressive exosomes secreted by lung cancer.
Completion of First GMP Production Run and India Commercialization Update
The Company has completed the first production run of approximately 100 Hemopurifier® cartridges under good manufacturing practices (GMP) required to export the technology for sale in India. Furthermore, the Company has received confirmation from the office of the Drug Controller General of India (DCGI) that under current device regulations the Hemopurifier® does not fall under the list of restricted devices for import or devices that need approval for import. As such, the Company is working with Vijay Kher, M.D. to establish HCV-treatment protocols. Dr. Kher previously served as the principal investigator of Hemopurifier® human studies to treat HCV at the Apollo and Fortis Hospital in Delhi, India. Dr. Kher is presently the chairman of the Department of Nephrology at the Medanta Kidney & Urology Institute at Medanta – The Medicity Institute, a $360 million, medical multi-specialty institute established to be a premier center for medical tourism on a 43-acre campus with over 1,600 hospital beds.
"Our disclosures today support our belief that we can establish and lead the industry for therapeutic devices to treat infectious disease and cancer," stated James A. Joyce, Chairman and Chief Executive Officer of Aethlon Medical, Inc.
About Aethlon Medical
Aethlon Medical, Inc. creates diagnostic and therapeutic device solutions for infectious disease and cancer. Our lead product, the Hemopurifier® is the first-in-class medical device to selectively capture circulating viruses and immunosuppressive proteins prior to cell and organ infection. Human studies have documented the ability of our Hemopurifier® to reduce viral load in patients infected with Hepatitis-C virus (HCV) and the Human Immunodeficiency Virus (HIV). Our primary clinical and commercialization focus is to establish the Hemopurifier® as an adjunct therapy to enhance and prolong the benefit of traditional infectious disease drug regimens.
The Hemopurifier® is also a broad-spectrum treatment candidate against drug resistant bioterror and pandemic threats. Third party research institutes have verified the capability of the device to capture Dengue Hemorrhagic Virus, Ebola Hemorrhagic Virus, Lassa Hemorrhagic Virus, West Nile Virus, H5N1 Avian Influenza Virus, 2009 H1N1 Influenza Virus, the reconstructed Spanish Flu of 1918 Virus, and Monkeypox Virus, which serves as a model for human Smallpox infection.
Our wholly owned subsidiary, Exosome Sciences, Inc. (ESI) was formed in October of 2009 to leverage attributes of the Hemopurifier® in the emerging exosome research field. ESI seeks to inhibit the immune cell destruction caused by exosomes secreted by solid tumors, lymphomas, and leukemia. At present, the capture of immunosuppressive exosomes secreted from ovarian cancer tumors has been demonstrated invitro. The preservation of anti-cancer immune cells would likely improve patient responsiveness to established treatment options, including immunotherapy and chemotherapy. ESI is also analyzing exosome-related opportunities to improve early cancer detection and post-surgery surveillance of tumor growth, as well as approaches to harvest exosomes for research purposes and potential reintroduction into patients afflicted with autoimmune conditions such as Rheumatoid Arthritis and Lupus.
Additional information regarding Aethlon Medical and Exosome Sciences can be accessed online at www.aethlonmedical.com.
Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the capability of the Hemopurifier® to reduce viral loads and other disease conditions or to identify disease conditions such as cancer, including the ability to capture exosomes and the impact that potential ability may have on disease conditions, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its products, the Company's ability to manufacture its products either internally or through outside companies and provide its services, the impact of government regulations, patent protection on the Company's proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings.
Contacts:
James A. Joyce
Chairman, CEO
858.459.7800 x301
jj@aethlonmedical.com
John P. Salvador
Director of Corporate Communications
858.459.7800 x307
jps@aethlonmedical.com
L2...1 @.0095 and 2@.0098
LACO, You always have been active on the board and have brought great DD to all of us!
Steris, Nephros ink mystery development deal
March 24, 2010 by MedCity News
Steris Corp. and Nephros Inc. sign a development deal for "filtration-based products" for medical devices, but company officials are mum on the specifics.
MedCity News logo
By Brandon Glenn
Sterilization products maker Steris Corp. (NYSE:STE) inked a development deal with a New Jersey firm that specializes in filtration products.
Steris and River Edge, N.J.-based Nephros Inc. (OTC:NEPH) “will jointly develop filtration-based products for medical device applications,” according to a statement from Nephros. The statement doesn’t get any more specific than that, and a Steris spokesman declined to elaborate.
“For competitive reasons, no additional details are available, beyond stating that the agreement involves collaboration on general research projects,” Stephen Norton wrote in an e-mail. A Nephros spokeswoman didn’t return a call.
The agreement calls for an initial payment from Steris to Nephros, which could receive additional payments if it hits unspecified product-development milestones.
“I would characterize the size of the payments as small and not material to Steris,” Norton wrote. “The investment is material to Nephros and they were required to disclose the agreement.”
Nephros specializes in the chronic renal disease market, selling products designed to filter harmful substances from the blood that often aren’t removed by existing methods of dialysis. Patients suffering from chronic kidney disease often are treated with dialysis, using a machine that removes a patient’s blood, filters out harmful substances and returns it to the patient’s body.
Nephrons are filtering units found in the kidneys. About a million are present in each kidney.
In July 2009, Nephros received federal regulatory approval to begin selling its “Dual Stage Ultrafilters,” which are used to filter out biological contaminants from water used in dialysis procedures. In August, it received a $2 million contract from the U.S. Navy to develop a dual-stage water purifying filter.
Like Nephros, Steris is no stranger to military contracts. Last year, the company won a $6 million research and development grant from the U.S. Dept. of Defense to study and develop a system that would sterilize and decontaminate military aircraft after exposure to biological weapons, and examine ways to prevent infections acquired in military hospitals.
Nephros is publicly traded on the over-the-counter stock markets and was founded in 1997 Columbia University scientists.
Steris, Nephros ink mystery development deal
March 24, 2010 by MedCity News
Steris Corp. and Nephros Inc. sign a development deal for "filtration-based products" for medical devices, but company officials are mum on the specifics.
MedCity News logo
By Brandon Glenn
Sterilization products maker Steris Corp. (NYSE:STE) inked a development deal with a New Jersey firm that specializes in filtration products.
Steris and River Edge, N.J.-based Nephros Inc. (OTC:NEPH) “will jointly develop filtration-based products for medical device applications,” according to a statement from Nephros. The statement doesn’t get any more specific than that, and a Steris spokesman declined to elaborate.
“For competitive reasons, no additional details are available, beyond stating that the agreement involves collaboration on general research projects,” Stephen Norton wrote in an e-mail. A Nephros spokeswoman didn’t return a call.
The agreement calls for an initial payment from Steris to Nephros, which could receive additional payments if it hits unspecified product-development milestones.
“I would characterize the size of the payments as small and not material to Steris,” Norton wrote. “The investment is material to Nephros and they were required to disclose the agreement.”
Nephros specializes in the chronic renal disease market, selling products designed to filter harmful substances from the blood that often aren’t removed by existing methods of dialysis. Patients suffering from chronic kidney disease often are treated with dialysis, using a machine that removes a patient’s blood, filters out harmful substances and returns it to the patient’s body.
Nephrons are filtering units found in the kidneys. About a million are present in each kidney.
In July 2009, Nephros received federal regulatory approval to begin selling its “Dual Stage Ultrafilters,” which are used to filter out biological contaminants from water used in dialysis procedures. In August, it received a $2 million contract from the U.S. Navy to develop a dual-stage water purifying filter.
Like Nephros, Steris is no stranger to military contracts. Last year, the company won a $6 million research and development grant from the U.S. Dept. of Defense to study and develop a system that would sterilize and decontaminate military aircraft after exposure to biological weapons, and examine ways to prevent infections acquired in military hospitals.
Nephros is publicly traded on the over-the-counter stock markets and was founded in 1997 Columbia University scientists.
Lets keep this board to opinions backed by good DD and opinion.
Stanford University Researcher and Hemispherx Biopharma Consultant Present New Integrative Immunotherapy Approach
Suggests That the Safety and Bioactivity of TLR3 Agonists May be Unique
globenewswire
Press Release Source: Hemispherx Biopharma, Inc. On Tuesday March 23, 2010, 8:00 am
PHILADELPHIA, March 23, 2010 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) (the "Company"), announced today the publication of an editorial entitled "TLR3 agonists as immunotherapeutic agents," published in the March 15, 2010 edition of Immunotherapy (2010) 2(2), 137-140, co-authored by Jonathan S. Berek, MD, Chairman, Stanford University School of Medicine Department of Obstetrics and Gynecology, and Christopher F. Nicodemus, MD, Chairman and Chief Scientific Officer, Advanced Immune Therapeutics, Inc., and HEB Consultant. Drs. Berek and Nicodemus have collaborated for more than a decade seeking to identify novel strategies to mobilize immunity to treat cancer and have conducted and published numerous preclinical and clinical studies, most notably in the field of ovarian cancer. Their long standing research interests form the basis for an active collaboration with the Company to evaluate the potential for Ampligen(R) (rintatolimod, Poly I : Poly C12U) and TLR3 agonists as cancer immunotherapeutics.
The invited editorial highlights recent advances in the fundamental understanding of the toll like receptor pathways, notably TLR-3 and their potential as pharmaceutical targets to "mobilize immunity to eradicate microscopic and macroscopic malignancy," concluding that therapeutic improvements are now "within reach."
The authors propose that "overly robust immune responses" may be harmful and suggest that "TLR3 pathways have been distinguished from other, perhaps more toxic, TLR pathways...the safety and bioactivity of TLR-3 specific agonists can be anticipated to be unique amongst potential TLR stimulatory agents." In the editorial, Ampligen(R), an experimental therapeutic, is repeatedly cited for its unique profile amongst TLR3 stimulating agents and its potential to enhance immunity targeting infection and cancer.
Pre-clinical experimentation is not necessarily indicative of clinical outcomes and the clinical use of experimental therapeutics, including Ampligen(R), is subject to regulatory agency review and approval requirements.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx's flagship products include Alferon N Injection(R) (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen(R) and Alferon(R) LDO. Ampligen(R) is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system. Hemispherx's platform technology includes large and small agent components for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has an extensive number of patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection(R)). The Company wholly owns and exclusively operates a GMP certified manufacturing facility in the United States for commercial products. For more information please visit www.hemispherx.net.
Information contained in this news release, other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risk of competition, changing market conditions, change in laws and regulations affecting these industries and numerous other factors discussed in this release and in the Company's filings with the Securities and Exchange Commission. Any specifically referenced investigational drugs and associated technologies of the Company (including Ampligen(R) and Alferon(R) LDO) are experimental in nature and as such are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials with the referenced disorders. The forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements. Clinical trials for other potential indications of the approved biologic Alferon N Injection(R) do not imply that the product will ever be specifically approved commercially for these other treatment indications.
Contact:
Hemispherx Biopharma, Inc.
Company/Investor Contact:
Dianne Will
518-398-6222
ir@hemispherx.net
With all of the fantastic responses from the shows and my DD we are steps away from production!! This is setting up perfectly. Patience is a virtue.
SPPI NEWS!
Spectrum Pharmaceuticals Announces a National Cancer Institute-Sponsored Phase 1/2 Study of Belinostat in Thymic Malignancies
businesswire
Press Release Source: Spectrum Pharmaceuticals, Inc. On Monday March 22, 2010, 7:00 am
IRVINE, Calif.--(BUSINESS WIRE)--Spectrum Pharmaceuticals, Inc. (NasdaqGM:SPPI - News), a commercial-stage biotechnology company with a primary focus in oncology and hematology, and TopoTarget A/S, today announced that the first patient has been dosed in a National Cancer Institute (NCI)-sponsored Phase 1/2 trial of belinostat in combination with cisplatin, doxorubicin and cyclophosphamide in the first line treatment of advanced or recurrent thymic malignancies. The trial is designed to determine what drug doses can be safely administered together in patients, and to make dose recommendations for future clinical trials. This trial is among the first to test the feasibility of simultaneously administering a histone deacetylase (HDAC) inhibitor, such as belinostat, with common chemotherapy agents such as cisplatin, doxorubicin, and cyclophosphamide, in the first line treatment of advanced or recurrent thymic malignancies. The study is expected to recruit between 30 and 48 evaluable patients.
“We are pleased that the NCI continues to investigate the use of belinostat in the treatment of various cancers,” said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. “We believe belinostat has the potential to be an effective treatment in combination with existing chemotherapeutic agents for the treatment of thymomas, thymic malignancies, and other cancers.”
More information on this Phase 1/2 study can be found at www.clinicaltrials.gov.
About Belinostat
Belinostat (PXD 101) is a novel HDAC inhibitor that is being studied in multiple clinical trials as a single agent or in combination with chemotherapeutic agents for the treatment of various hematological and solid cancers. Its anticancer effect is thought to be mediated through multiple mechanisms of action, including the inhibition of cell proliferation, induction of apoptosis (programmed cell death), inhibition of angiogenesis, induction of differentiation, and the resensitization of cells that have overcome drug resistance to anticancer agents such as platinums, taxanes and topoisomerase II inhibitors. Belinostat is the only HDAC inhibitor in clinical development with multiple potential routes of administration, including intravenous administration, continuous intravenous infusion and oral administration.
About Thymoma and Thymic Carcinoma
Thymus cancers are uncommon cancers that start in the thymus. This small organ is located just behind the breast bone in the front part of the mediastinum, the space in the chest between the lungs. The thymus is an important part of the body's immune system. During fetal development and childhood, the thymus is involved in the production and maturation of T lymphocytes (also known as T cells), a type of white blood cell. T lymphocytes develop in the thymus and then travel to lymph nodes (bean-sized collections of immune system cells) throughout the body. There they help the immune system protect the body from viruses, fungus, and other types of infections. The thymus contains different types of cells, each of which can develop into different types of cancer: Epithelial cells give the thymus its structure and shape. They can give rise to thymomas and thymic carcinomas; Lymphocytes make up most of the rest of the thymus. Whether in the thymus or in other parts of the body, these immunes system cells can develop into cancers called Hodgkin disease and non-Hodgkin lymphomas; and Kulchitsky cells, or neuroendocrine cells, are much less common cells that normally release certain hormones. These cells can give rise to cancers called carcinoid tumors. Thymomas and thymic carcinomas are tumors that start from thymic epithelial cells.
About the Belinostat Registrational Study
Belinostat is currently in registrational trial, under a Special Protocol Assessment (SPA), as a monotherapy for Peripheral T-Cell Lymphoma (PTCL), an indication which has been granted Orphan Drug and Fast Track designation by the U.S. Food and Drug Administration (FDA). The registrational trial is in an open-label, multicenter, single arm efficacy and safety study in patients with relapsed or refractory peripheral T-cell lymphoma, who have failed at least one prior systemic therapy. The primary endpoint is objective response rate (ORR).
About the NCI
The National Cancer Institute (NCI) is part of the National Institutes of Health (NIH), which is one of 11 agencies that compose the Department of Health and Human Services (HHS). The NCI, established under the National Cancer Institute Act of 1937, is the Federal Government's principal agency for cancer research and training. The National Cancer Act of 1971 broadened the scope and responsibilities of the NCI and created the National Cancer Program. Over the years, legislative amendments have maintained the NCI authorities and responsibilities and added new information dissemination mandates as well as a requirement to assess the incorporation of state-of-the-art cancer treatments into clinical practice.
The National Cancer Institute coordinates the National Cancer Program, which conducts and supports research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and the families of cancer patients.
About TopoTarget
TopoTarget A/S is an international biotech company headquartered in Denmark, dedicated to finding ''Answers for Cancer'' and developing improved cancer therapies. The company was founded and is run by clinical cancer specialists and combines years of hands-on clinical experience with in-depth understanding of the molecular mechanisms of cancer. For more information, please refer to www.topotarget.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 (EOquin®) 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, that belinostat has the potential to be an effective treatment in combination with existing chemotherapeutic agents for the treatment of thymomas, thymic malignancies, and other cancers, that Belinostat has multiple potential routes of administration 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, EOquin® is a registered trademark of Allergan 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, 949-788-6700 x216
Senior Manager, Investor Relations
I feel BIEL has a real product line that will be in big demand.The company has been moving in the right direction...More transparency and working now heavily on revenue generation.All the reviews of their products have been positive.
Yes,we do discuss BIEL here often. I am a big fan of BIEL and an assistant on the BIEL board.
I talked with the CEO yesterday and I feel stronger than ever with this company.....Retail distribution is spreading like wildfire.With the new marketing program being launched,including a national sport celebrity spokesperson and infomercials we should see this product fly in 2010. The product is the best I've seen and the uses are endless. Also,lets not forget the equestrian market which ThermoFreeze is the best product for horses to ice down.
We should see TZPC more up in the pinks very shortly,as audits are being completed. I am loving this one!!! A real sleeper...but not for long in my opinion.
Always do your own DD.
Most likely in this case.
Because of substantial news that can have a major impact on the PPS
It looks like 11:05am Central 12:00pm Eastern
SOMX FDA Approved!!!!
Trade halt on SOMX
Trade Halt on SOMX
Not happy with the lack of volume.
I tryed the sample they sent me and I like the product a lot.
I am watching this one closely.
Absolutely nothing is wrong.Extremely positive news! They have a strong potential pipeline and plenty of money thru 1st quarter 2011.
BNVI News!!
Bionovo Announces 2009 Highlights and Year-End Financial Results
prnewswire
Press Release Source: Bionovo, Inc. On Monday March 15, 2010, 4:00 pm
EMERYVILLE, Calif., March 15 /PRNewswire-FirstCall/ -- Bionovo, Inc. (Nasdaq:BNVI - News) today announced financial results for the year ended December 31, 2009.
"2009 was a year of continued regulatory progress and scientific discovery," said Isaac Cohen, O.M.D., Bionovo's Chairman and Chief Executive Officer. "We have primarily focused on accomplishing the many tasks necessary for the progression of our menopausal hot flash drug candidate, Menerba, to the next level of clinical development. Specifically, we believe we have all the necessary manufacturing process controls and analytical methods in place for consistent production of the drug. 2010 is poised to be an eventful year for Bionovo as we expect to be able to initiate the next stage of clinical trials for Menerba by mid-year."
Dr. Cohen continued, "In addition to our efforts to move Menerba through the approval process we completed many important scientific and clinical tasks supporting our cancer drug candidate portfolio. We can now confidently assert that we have a robust drug pipeline with multiple, validated drug candidates in both cancer treatment and women's health. Since Bionovo is engaged in its own discovery and development process, it should be noted that we own 100% of the rights on all of our drug candidates."
Mary Tagliaferri, M.D., Bionovo's President and Chief Medical Officer, added, "The accomplishments of the Bionovo team have clearly been recognized by the scientific and clinical community, as more and more key opinion leaders become educated and involved in our exciting future. We look forward to 2010 as a year for pivotal clinical progress and commercial partnering development."
Key Events and Milestones
* Publication of data in multiple articles on the active compound and mechanism of action for cancer treatment, BN108 (formerly known as AA102). BN108 selectively inhibits mTORC1 and induces endoplasmic reticulum stress in cancer cells and not in normal cells. The drug therefore has a dual killing effect, as evident by the fact that restoring one of the paths affected does not prevent the killing effect. This preferential effect of BN108 will most likely result in little collateral toxicity, which is commonly observed with current cancer chemotherapies.
* Publication of data describing gene regulation in multiple cell lines by several of our estrogen receptor beta drug candidates, demonstrating that Bionovo's plant-derived ER beta compounds are selective and regulate different genes which will result in different potential pharmacological uses. In addition, our studies have indicated that these compounds do not promote breast or endometrial cancer in animal models, unlike estrogen therapies. This suggests that these ER beta-selective compounds could lead to safer, more appealing therapies for menopausal disorders.
* Publication of final study results from our Phase 1B trial of Bezielle for metastatic breast cancer. Bezielle showed an excellent safety and tolerability profile. It also showed promising early efficacy in a difficult-to-treat population, including stable disease and tumor regression.
* International presentation of final study results from our Phase 2 trial of Menerba for menopausal vasomotor symptom treatment. These results included:
o After 12 weeks of treatment, there was a statistically significant decrease in frequency of all hot flashes in the higher dose of Menerba (p=0.04).
o There was a clear dose response trend in multiple efficacy analyses.
o Menerba reduced the number of times women were awakened from sleep due to hot flashes (night sweats). The median percent reduction in night sweats in the higher dose of Menerba was 67%, statistically superior to placebo (p=0.05).
o Compliance and study retention was excellent: 98% of participants completed the trial, with 91% of participants taking at least 75% of the assigned study medication.
o The only statistically significant adverse event was "transient loose stools" (12% on Menerba vs. 3% on placebo).
o During the trial, there was no difference in the number of uterine bleeding episodes between the treatment groups and placebo and no cases of endometrial hyperplasia or uterine cancer, further demonstrating Menerba's excellent safety profile.
o After 12 weeks of treatment, participants taking Menerba experienced lower body mass index and weight compared to those on placebo.
* Publication describing novel female-specific drug candidates that include Bionovo's novel plant-derived, tissue-selective estrogen receptor alpha (ER alpha) modulators (TSERaM) for the treatment of obesity. These TSERaMs represent an exciting new class of drugs that have the potential to protect postmenopausal women from weight gain and metabolic syndrome without increasing the risks of breast and endometrial cancer like estrogens used in hormone therapy.
* Publication of data on potential increase in breast cancer risk due to the inhibitory effect of tamoxifen treatment on estrogen receptor beta. This is an essential step in developing new strategies to prevent and treat breast cancer. The knowledge we obtained from the positive clinical effects of tamoxifen combined with recent discoveries of the different roles played by the two estrogen receptors is critical for the future generation of therapies for this important indication. Tamoxifen has been successfully used to treat and prevent breast cancer. However, some breast tumors become resistant to its effects. So, it is critical to discover new estrogens that work through a different mechanism. Bionovo has been developing methods to discover more selective drugs for breast cancer treatment and prevention and, to date, has identified numerous ER beta-selective drugs. This study provides the biological rationale for advancing ER beta drugs for the treatment of breast cancer, which potentially will be important, novel therapies for this indication.
* Publication describing the first novel dual mTOR inhibitor (mTORC1 and mTORC2), our drug candidate BN107, for the treatment of breast cancer. The mTOR pathway as a target for cancer therapies has been actively pursued by many pharmaceutical companies. To the Company's knowledge, this is the first report demonstrating effective inhibition of both mTOR complexes concomitantly through a novel mechanism. BN107 has a potentially unique way to target a specific sub-group of breast cancer cells that currently has no selective treatment.
* Successful financing for $17.4 million of net proceeds in a fully marketed public offering.
* Notable additions to our network of advisors and consultants, including leading healthcare professionals with extensive experience in the development of therapeutic treatments, including:
o Daniel Shames, M.D., former Director of the Division, Reproductive and Urologic Drug Products, U.S. Food and Drug Administration (FDA).
o David Lin, former Chemistry Reviewer for the Office of New Drug Products, including Division, Reproductive and Urologic Drug Products, U.S. Food and Drug Administration (FDA).
* During 2009, Bionovo significantly strengthened its Scientific Advisory Board (SAB) and Medical Advisory Board (MAB) with the addition of several world-renowned scientists and clinicians, including:
o Jan Ake Gustafsson, M.D., Ph.D., member, National Academy of Sciences and formerly of the Karolinska Institute
o Bert W. O'Malley, M.D., Recipient of the 2008 National Medal for Science, member, the National Academy of Sciences, and currently at the Baylor College of Medicine
o Willa Hsueh, M.D., Co-Director of the Diabetes Research Center at The Methodist Hospital Research Institute and Chief of the Division of Diabetes, Obesity and Lipids in the Department of Medicine at The Methodist Hospital (TMHRI)
o John Baxter, M.D., Senior Member and Co-Director of the Center for Diabetes Research at The Methodist Hospital Research Institute, and Head of Endocrinology at the Methodist Hospital
o Debu Tripathy, M.D., Professor of Medicine and Co-Director of the Women's Cancer Program at the University of Southern California
o Steven Goldstein, M.D., Director of Gynecologic Ultrasound at the New York Medical Center, and the author of many seminal works on uterine safety
o Marco Gambacciani, M.D., Professor of Obstetrics and Gynecology and Director of the Menopause Research Clinic at the Santa Chiara Univeristy Hospital in Pisa, Italy
Full Year Results
For the year ended December 31, 2009 total revenues were $0.3 million compared with $0.2 million for the same period in 2008. Revenues in 2009 consisted of a National Institute of Health (NIH) grant drawdown combined with approximately $55,000 in limited research services revenue, whereas revenues in 2008 included only the NIH grant.
For the year ended December 31, 2009 total operating expenses were $16.6 million compared with $17.5 million for the same period in 2008. The decrease in 2009 operating expenses are primarily due to decreases in clinical trial expenses partially offset by increases in expenses to support our Menerba manufacturing process development.
The net loss for the year ended December 31, 2009 was $16.4 million, or $0.20 per share, compared with a net loss of $16.7 million, or $0.22 per share, for the same period in 2008. The year-over-year decrease in net loss was driven primarily by the decreased activity related to our clinical trials.
As of December 31, 2009, cash, cash equivalents and short-term investments totaled approximately $15.9 million compared to $13.6 million at December 31, 2008. The increase is due to the public offering completed in October of 2009 resulting in net proceeds of $17.4 million, partially offset by cash used in operating activities. The net cash used in operating activities for 2009 was $13.3 million, compared with $15.3 million in 2008.
2010 Expense and Cash Guidance
Operating expenses in 2010 are expected to follow a run-rate of $1.0-1.5 million per month. Operating expenses will increase from the current run rate of $1.0 million per month when clinical trial activities increase.
The Company currently has enough funds to continue operating through 2010 into the first quarter of 2011. The Company will need to seek additional funding prior to that time, in order to continue operations and/or to increase the clinical testing program and other research.
Conference Call
The Company will conduct a conference call and web cast to review the financial results and the Company's plans for 2010 later today, Monday, March 15, 2010 at 5:00 p.m. ET.
Interested parties can access the call by dialing (800) 860-2442 or (412) 858-4600, or can listen via a live Internet web cast, which can be found at http://bionovo.com/investors/events. A replay of the call will be available via web cast at http://bionovo.com/investors/events or by playback at (877) 344-7529 or (412) 317-0088, conference code 438591, through March 18, 2010.
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 they have discovered new classes of drug candidates within their rich pipeline with the potential to be leaders in their markets. Bionovo is headquartered in Emeryville, California and 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.
Financial Tables on Following Pages
Bionovo, Inc.
(A Development Stage Company)
Consolidated Statements of Operations
(Unaudited)
Accumulated
from
February
1, 2002
(Date of
inception)
Three months Twelve months to
ended December ended December December
31, 31, 31,
2009 2008 2009 2008 2009
---- ---- ---- ---- ----
(in thousands, except per share data)
Revenues $126 $233 $288 $233 $1,180
---- ---- ---- ---- ------
Operating expenses:
Research and
development 3,006 2,534 12,499 11,416 39,706
General and
administrative 943 1,245 4,053 6,097 17,602
Merger cost - - - - 1,964
-- -- -- -- -----
Total operating
expenses 3,949 3,779 16,552 17,513 59,272
----- ----- ------ ------ ------
Loss from operations (3,823) (3,546) (16,264) (17,280) (58,092)
Change in fair value of
warrant liability - - - - 831
Interest income 9 91 84 730 2,074
Interest expense (18) (30) (95) (129) (460)
Other expense (5) - (88) (17) (153)
-- --- --- --- ----
Loss before income tax (3,837) (3,485) (16,363) (16,696) (55,800)
Income tax provision 1 (1) (1) (4) (14)
-- -- -- -- ---
Net loss $(3,836) $(3,486) $(16,364) $(16,700) $(55,814)
======= ======= ======== ======== ========
Basic and diluted net
loss per common share $(0.04) $(0.05) $(0.20) $(0.22) $(1.18)
====== ====== ====== ====== ======
Shares used in
computing basic and
diluted net loss
per share 105,501 76,363 83,623 76,353 47,345
======= ====== ====== ====== ======
Bionovo, Inc.
(A Development Stage Company)
Consolidated Balance Sheets
December 31,
------------
2009 2008
---- ----
(unaudited) (Note *)
(in thousands)
ASSETS
Current assets:
Cash and cash equivalents $2,799 $3,270
Short-term investments 13,135 10,292
Receivables 251 126
Prepaid expenses 214 334
Other current assets 161 471
--- ---
Total current assets 16,560 14,493
Property and equipment, net 6,197 6,938
Patent pending, net 822 575
Other assets 570 498
--- ---
Total assets $24,149 $22,504
======= =======
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities:
Accounts payable $311 $521
Accrued compensation and
benefits 367 456
Current portion of lease
obligations 476 682
Current portion of notes
payable 59 -
Other current liabilities 823 668
--- ---
Total current liabilities 2,036 2,327
Non-current portion of lease
obligations 96 545
Non-current portion of notes
payable 121 -
--- --
Total liabilities 2,253 2,872
----- -----
Commitments and contingencies
Shareholders’ equity:
Preferred stock, $0.0001 par
value; 10,000,000 shares
authorized; none issued and
outstanding - -
Common stock $0.0001 par value,
190,000,000 shares authorized,
107,518,690 and 76,363,101
shares outstanding at December
31, 2009 and 2008,
respectively 11 8
Additional paid-in capital 77,704 59,050
Accumulated other comprehensive
(loss) income (5) 24
Accumulated deficit (55,814) (39,450)
------- -------
Total shareholders’ equity 21,896 19,632
------ ------
Total liabilities and
shareholders’ equity $24,149 $22,504
======= =======
* The balance sheet at December 31, 2008 has been derived from the
audited financial statements at that date but does not include all of
the information and footnotes required by accounting principles
generally accepted in the United States for complete financial
statements.
BNVI News!
Bionovo Announces 2009 Highlights and Year-End Financial Results
prnewswire
Press Release Source: Bionovo, Inc. On Monday March 15, 2010, 4:00 pm
EMERYVILLE, Calif., March 15 /PRNewswire-FirstCall/ -- Bionovo, Inc. (Nasdaq:BNVI - News) today announced financial results for the year ended December 31, 2009.
"2009 was a year of continued regulatory progress and scientific discovery," said Isaac Cohen, O.M.D., Bionovo's Chairman and Chief Executive Officer. "We have primarily focused on accomplishing the many tasks necessary for the progression of our menopausal hot flash drug candidate, Menerba, to the next level of clinical development. Specifically, we believe we have all the necessary manufacturing process controls and analytical methods in place for consistent production of the drug. 2010 is poised to be an eventful year for Bionovo as we expect to be able to initiate the next stage of clinical trials for Menerba by mid-year."
Dr. Cohen continued, "In addition to our efforts to move Menerba through the approval process we completed many important scientific and clinical tasks supporting our cancer drug candidate portfolio. We can now confidently assert that we have a robust drug pipeline with multiple, validated drug candidates in both cancer treatment and women's health. Since Bionovo is engaged in its own discovery and development process, it should be noted that we own 100% of the rights on all of our drug candidates."
Mary Tagliaferri, M.D., Bionovo's President and Chief Medical Officer, added, "The accomplishments of the Bionovo team have clearly been recognized by the scientific and clinical community, as more and more key opinion leaders become educated and involved in our exciting future. We look forward to 2010 as a year for pivotal clinical progress and commercial partnering development."
Key Events and Milestones
* Publication of data in multiple articles on the active compound and mechanism of action for cancer treatment, BN108 (formerly known as AA102). BN108 selectively inhibits mTORC1 and induces endoplasmic reticulum stress in cancer cells and not in normal cells. The drug therefore has a dual killing effect, as evident by the fact that restoring one of the paths affected does not prevent the killing effect. This preferential effect of BN108 will most likely result in little collateral toxicity, which is commonly observed with current cancer chemotherapies.
* Publication of data describing gene regulation in multiple cell lines by several of our estrogen receptor beta drug candidates, demonstrating that Bionovo's plant-derived ER beta compounds are selective and regulate different genes which will result in different potential pharmacological uses. In addition, our studies have indicated that these compounds do not promote breast or endometrial cancer in animal models, unlike estrogen therapies. This suggests that these ER beta-selective compounds could lead to safer, more appealing therapies for menopausal disorders.
* Publication of final study results from our Phase 1B trial of Bezielle for metastatic breast cancer. Bezielle showed an excellent safety and tolerability profile. It also showed promising early efficacy in a difficult-to-treat population, including stable disease and tumor regression.
* International presentation of final study results from our Phase 2 trial of Menerba for menopausal vasomotor symptom treatment. These results included:
o After 12 weeks of treatment, there was a statistically significant decrease in frequency of all hot flashes in the higher dose of Menerba (p=0.04).
o There was a clear dose response trend in multiple efficacy analyses.
o Menerba reduced the number of times women were awakened from sleep due to hot flashes (night sweats). The median percent reduction in night sweats in the higher dose of Menerba was 67%, statistically superior to placebo (p=0.05).
o Compliance and study retention was excellent: 98% of participants completed the trial, with 91% of participants taking at least 75% of the assigned study medication.
o The only statistically significant adverse event was "transient loose stools" (12% on Menerba vs. 3% on placebo).
o During the trial, there was no difference in the number of uterine bleeding episodes between the treatment groups and placebo and no cases of endometrial hyperplasia or uterine cancer, further demonstrating Menerba's excellent safety profile.
o After 12 weeks of treatment, participants taking Menerba experienced lower body mass index and weight compared to those on placebo.
* Publication describing novel female-specific drug candidates that include Bionovo's novel plant-derived, tissue-selective estrogen receptor alpha (ER alpha) modulators (TSERaM) for the treatment of obesity. These TSERaMs represent an exciting new class of drugs that have the potential to protect postmenopausal women from weight gain and metabolic syndrome without increasing the risks of breast and endometrial cancer like estrogens used in hormone therapy.
* Publication of data on potential increase in breast cancer risk due to the inhibitory effect of tamoxifen treatment on estrogen receptor beta. This is an essential step in developing new strategies to prevent and treat breast cancer. The knowledge we obtained from the positive clinical effects of tamoxifen combined with recent discoveries of the different roles played by the two estrogen receptors is critical for the future generation of therapies for this important indication. Tamoxifen has been successfully used to treat and prevent breast cancer. However, some breast tumors become resistant to its effects. So, it is critical to discover new estrogens that work through a different mechanism. Bionovo has been developing methods to discover more selective drugs for breast cancer treatment and prevention and, to date, has identified numerous ER beta-selective drugs. This study provides the biological rationale for advancing ER beta drugs for the treatment of breast cancer, which potentially will be important, novel therapies for this indication.
* Publication describing the first novel dual mTOR inhibitor (mTORC1 and mTORC2), our drug candidate BN107, for the treatment of breast cancer. The mTOR pathway as a target for cancer therapies has been actively pursued by many pharmaceutical companies. To the Company's knowledge, this is the first report demonstrating effective inhibition of both mTOR complexes concomitantly through a novel mechanism. BN107 has a potentially unique way to target a specific sub-group of breast cancer cells that currently has no selective treatment.
* Successful financing for $17.4 million of net proceeds in a fully marketed public offering.
* Notable additions to our network of advisors and consultants, including leading healthcare professionals with extensive experience in the development of therapeutic treatments, including:
o Daniel Shames, M.D., former Director of the Division, Reproductive and Urologic Drug Products, U.S. Food and Drug Administration (FDA).
o David Lin, former Chemistry Reviewer for the Office of New Drug Products, including Division, Reproductive and Urologic Drug Products, U.S. Food and Drug Administration (FDA).
* During 2009, Bionovo significantly strengthened its Scientific Advisory Board (SAB) and Medical Advisory Board (MAB) with the addition of several world-renowned scientists and clinicians, including:
o Jan Ake Gustafsson, M.D., Ph.D., member, National Academy of Sciences and formerly of the Karolinska Institute
o Bert W. O'Malley, M.D., Recipient of the 2008 National Medal for Science, member, the National Academy of Sciences, and currently at the Baylor College of Medicine
o Willa Hsueh, M.D., Co-Director of the Diabetes Research Center at The Methodist Hospital Research Institute and Chief of the Division of Diabetes, Obesity and Lipids in the Department of Medicine at The Methodist Hospital (TMHRI)
o John Baxter, M.D., Senior Member and Co-Director of the Center for Diabetes Research at The Methodist Hospital Research Institute, and Head of Endocrinology at the Methodist Hospital
o Debu Tripathy, M.D., Professor of Medicine and Co-Director of the Women's Cancer Program at the University of Southern California
o Steven Goldstein, M.D., Director of Gynecologic Ultrasound at the New York Medical Center, and the author of many seminal works on uterine safety
o Marco Gambacciani, M.D., Professor of Obstetrics and Gynecology and Director of the Menopause Research Clinic at the Santa Chiara Univeristy Hospital in Pisa, Italy
Full Year Results
For the year ended December 31, 2009 total revenues were $0.3 million compared with $0.2 million for the same period in 2008. Revenues in 2009 consisted of a National Institute of Health (NIH) grant drawdown combined with approximately $55,000 in limited research services revenue, whereas revenues in 2008 included only the NIH grant.
For the year ended December 31, 2009 total operating expenses were $16.6 million compared with $17.5 million for the same period in 2008. The decrease in 2009 operating expenses are primarily due to decreases in clinical trial expenses partially offset by increases in expenses to support our Menerba manufacturing process development.
The net loss for the year ended December 31, 2009 was $16.4 million, or $0.20 per share, compared with a net loss of $16.7 million, or $0.22 per share, for the same period in 2008. The year-over-year decrease in net loss was driven primarily by the decreased activity related to our clinical trials.
As of December 31, 2009, cash, cash equivalents and short-term investments totaled approximately $15.9 million compared to $13.6 million at December 31, 2008. The increase is due to the public offering completed in October of 2009 resulting in net proceeds of $17.4 million, partially offset by cash used in operating activities. The net cash used in operating activities for 2009 was $13.3 million, compared with $15.3 million in 2008.
2010 Expense and Cash Guidance
Operating expenses in 2010 are expected to follow a run-rate of $1.0-1.5 million per month. Operating expenses will increase from the current run rate of $1.0 million per month when clinical trial activities increase.
The Company currently has enough funds to continue operating through 2010 into the first quarter of 2011. The Company will need to seek additional funding prior to that time, in order to continue operations and/or to increase the clinical testing program and other research.
Conference Call
The Company will conduct a conference call and web cast to review the financial results and the Company's plans for 2010 later today, Monday, March 15, 2010 at 5:00 p.m. ET.
Interested parties can access the call by dialing (800) 860-2442 or (412) 858-4600, or can listen via a live Internet web cast, which can be found at http://bionovo.com/investors/events. A replay of the call will be available via web cast at http://bionovo.com/investors/events or by playback at (877) 344-7529 or (412) 317-0088, conference code 438591, through March 18, 2010.
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 they have discovered new classes of drug candidates within their rich pipeline with the potential to be leaders in their markets. Bionovo is headquartered in Emeryville, California and 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.
Financial Tables on Following Pages
Bionovo, Inc.
(A Development Stage Company)
Consolidated Statements of Operations
(Unaudited)
Accumulated
from
February
1, 2002
(Date of
inception)
Three months Twelve months to
ended December ended December December
31, 31, 31,
2009 2008 2009 2008 2009
---- ---- ---- ---- ----
(in thousands, except per share data)
Revenues $126 $233 $288 $233 $1,180
---- ---- ---- ---- ------
Operating expenses:
Research and
development 3,006 2,534 12,499 11,416 39,706
General and
administrative 943 1,245 4,053 6,097 17,602
Merger cost - - - - 1,964
-- -- -- -- -----
Total operating
expenses 3,949 3,779 16,552 17,513 59,272
----- ----- ------ ------ ------
Loss from operations (3,823) (3,546) (16,264) (17,280) (58,092)
Change in fair value of
warrant liability - - - - 831
Interest income 9 91 84 730 2,074
Interest expense (18) (30) (95) (129) (460)
Other expense (5) - (88) (17) (153)
-- --- --- --- ----
Loss before income tax (3,837) (3,485) (16,363) (16,696) (55,800)
Income tax provision 1 (1) (1) (4) (14)
-- -- -- -- ---
Net loss $(3,836) $(3,486) $(16,364) $(16,700) $(55,814)
======= ======= ======== ======== ========
Basic and diluted net
loss per common share $(0.04) $(0.05) $(0.20) $(0.22) $(1.18)
====== ====== ====== ====== ======
Shares used in
computing basic and
diluted net loss
per share 105,501 76,363 83,623 76,353 47,345
======= ====== ====== ====== ======
Bionovo, Inc.
(A Development Stage Company)
Consolidated Balance Sheets
December 31,
------------
2009 2008
---- ----
(unaudited) (Note *)
(in thousands)
ASSETS
Current assets:
Cash and cash equivalents $2,799 $3,270
Short-term investments 13,135 10,292
Receivables 251 126
Prepaid expenses 214 334
Other current assets 161 471
--- ---
Total current assets 16,560 14,493
Property and equipment, net 6,197 6,938
Patent pending, net 822 575
Other assets 570 498
--- ---
Total assets $24,149 $22,504
======= =======
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities:
Accounts payable $311 $521
Accrued compensation and
benefits 367 456
Current portion of lease
obligations 476 682
Current portion of notes
payable 59 -
Other current liabilities 823 668
--- ---
Total current liabilities 2,036 2,327
Non-current portion of lease
obligations 96 545
Non-current portion of notes
payable 121 -
--- --
Total liabilities 2,253 2,872
----- -----
Commitments and contingencies
Shareholders’ equity:
Preferred stock, $0.0001 par
value; 10,000,000 shares
authorized; none issued and
outstanding - -
Common stock $0.0001 par value,
190,000,000 shares authorized,
107,518,690 and 76,363,101
shares outstanding at December
31, 2009 and 2008,
respectively 11 8
Additional paid-in capital 77,704 59,050
Accumulated other comprehensive
(loss) income (5) 24
Accumulated deficit (55,814) (39,450)
------- -------
Total shareholders’ equity 21,896 19,632
------ ------
Total liabilities and
shareholders’ equity $24,149 $22,504
======= =======
* The balance sheet at December 31, 2008 has been derived from the
audited financial statements at that date but does not include all of
the information and footnotes required by accounting principles
generally accepted in the United States for complete financial
statements.
He should...he always has in the past.
ADVENTRX Receives Brand Name Acceptance for ANX-530
prnewswire
Press Release Source: ADVENTRX Pharmaceuticals, Inc. On Friday March 12, 2010, 8:00 am
SAN DIEGO, March 12 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) today announced that the U.S. Food and Drug Administration (FDA) has accepted the proposed proprietary name "Exelbine™" for the Company's product candidate ANX-530 (vinorelbine injectable emulsion).
"We are pleased with the FDA's response to our proprietary name request and look forward to continued regulatory progress on ANX-530," said Brian M. Culley, Chief Executive Officer of ADVENTRX.
Following completion of its review process, the FDA concluded that "Exelbine" is acceptable provided the information presented by ADVENTRX regarding the safety of interchanging ANX-530 with other vinorelbine injectable products is confirmed during review of an ANX-530 New Drug Application (NDA).
As previously announced, the Company submitted an NDA for ANX-530 to the FDA in December 2009. In March 2010, the Company announced that it had received a refusal-to-file letter from the FDA regarding its ANX-530 NDA submission. In the letter, the FDA indicated that the data included in the December 2009 NDA submission from the intended commercial manufacturing site was insufficient to support a commercially-viable expiration dating period. The FDA identified only this one chemistry, manufacturing and controls (CMC) reason for the refusal to file. ADVENTRX has requested a face-to-face meeting with the FDA to understand its requirements and define the path to a successful filing of an ANX-530 NDA at the earliest possible time.
About ADVENTRX Pharmaceuticals
ADVENTRX Pharmaceuticals is a specialty pharmaceutical company whose product candidates are designed to improve the performance of existing cancer treatments by addressing limitations associated principally with their safety and use. More information can be found on the Company's web site at www.adventrx.com.
Forward Looking Statements
ADVENTRX cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements that involve risks and assumptions that, if they materialize or do not prove to be accurate, could cause ADVENTRX's results to differ materially from historical results or those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that FDA determines that there is a safety concern related to interchanging ANX-530 with other vinorelbine injectable products; the risk that the FDA's requirements for an ANX-530 NDA to be accepted for review do not justify continued development of ANX-530; ADVENTRX's dependence on the success of ANX-530, and increased uncertainty as to whether ANX-530 will receive regulatory approval or be commercialized successfully; the potential that FDA may not accept a resubmitted ANX-530 NDA for review, or that the bioequivalence data and other information included in the ANX-530 NDA may not adequately support bioequivalence with Navelbine; the potential that changes made in transferring the manufacturing process for ANX-530 may result in a lack of comparability between the commercial product and the material used in clinical trials, and that FDA may require ADVENTRX to perform additional non-clinical or clinical studies; the potential for FDA to impose other requirements to be completed before or after approval of the ANX-530 NDA; the risk that ADVENTRX will have insufficient capital to support its operations during the FDA review of an ANX-530 NDA, should a resubmitted ANX-530 be accepted; the risk that ADVENTRX will pursue development activities at levels or on timelines, or will incur unexpected expenses, that shortens the period through which its operating funds will sustain it; the risk that ADVENTRX will be unable to raise sufficient additional capital to commercialize ANX-530, if an ANX-530 NDA is approved; and other risks and uncertainties more fully described in ADVENTRX's press releases and periodic filings with the Securities and Exchange Commission. ADVENTRX's public filings with the Securities and Exchange Commission are available at www.sec.gov.
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date when made. ADVENTRX does not intend to revise or update any forward-looking statement set forth in this press release to reflect events or circumstances arising after the date on which it was ma
ADVENTRX Receives Brand Name Acceptance for ANX-530
prnewswire
Press Release Source: ADVENTRX Pharmaceuticals, Inc. On Friday March 12, 2010, 8:00 am
SAN DIEGO, March 12 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) today announced that the U.S. Food and Drug Administration (FDA) has accepted the proposed proprietary name "Exelbine™" for the Company's product candidate ANX-530 (vinorelbine injectable emulsion).
"We are pleased with the FDA's response to our proprietary name request and look forward to continued regulatory progress on ANX-530," said Brian M. Culley, Chief Executive Officer of ADVENTRX.
Following completion of its review process, the FDA concluded that "Exelbine" is acceptable provided the information presented by ADVENTRX regarding the safety of interchanging ANX-530 with other vinorelbine injectable products is confirmed during review of an ANX-530 New Drug Application (NDA).
As previously announced, the Company submitted an NDA for ANX-530 to the FDA in December 2009. In March 2010, the Company announced that it had received a refusal-to-file letter from the FDA regarding its ANX-530 NDA submission. In the letter, the FDA indicated that the data included in the December 2009 NDA submission from the intended commercial manufacturing site was insufficient to support a commercially-viable expiration dating period. The FDA identified only this one chemistry, manufacturing and controls (CMC) reason for the refusal to file. ADVENTRX has requested a face-to-face meeting with the FDA to understand its requirements and define the path to a successful filing of an ANX-530 NDA at the earliest possible time.
About ADVENTRX Pharmaceuticals
ADVENTRX Pharmaceuticals is a specialty pharmaceutical company whose product candidates are designed to improve the performance of existing cancer treatments by addressing limitations associated principally with their safety and use. More information can be found on the Company's web site at www.adventrx.com.
Forward Looking Statements
ADVENTRX cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements that involve risks and assumptions that, if they materialize or do not prove to be accurate, could cause ADVENTRX's results to differ materially from historical results or those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that FDA determines that there is a safety concern related to interchanging ANX-530 with other vinorelbine injectable products; the risk that the FDA's requirements for an ANX-530 NDA to be accepted for review do not justify continued development of ANX-530; ADVENTRX's dependence on the success of ANX-530, and increased uncertainty as to whether ANX-530 will receive regulatory approval or be commercialized successfully; the potential that FDA may not accept a resubmitted ANX-530 NDA for review, or that the bioequivalence data and other information included in the ANX-530 NDA may not adequately support bioequivalence with Navelbine; the potential that changes made in transferring the manufacturing process for ANX-530 may result in a lack of comparability between the commercial product and the material used in clinical trials, and that FDA may require ADVENTRX to perform additional non-clinical or clinical studies; the potential for FDA to impose other requirements to be completed before or after approval of the ANX-530 NDA; the risk that ADVENTRX will have insufficient capital to support its operations during the FDA review of an ANX-530 NDA, should a resubmitted ANX-530 be accepted; the risk that ADVENTRX will pursue development activities at levels or on timelines, or will incur unexpected expenses, that shortens the period through which its operating funds will sustain it; the risk that ADVENTRX will be unable to raise sufficient additional capital to commercialize ANX-530, if an ANX-530 NDA is approved; and other risks and uncertainties more fully described in ADVENTRX's press releases and periodic filings with the Securities and Exchange Commission. ADVENTRX's public filings with the Securities and Exchange Commission are available at www.sec.gov.
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date when made. ADVENTRX does not intend to revise or update any forward-looking statement set forth in this press release to reflect events or circumstances arising after the date on which it was ma
Just received the sample, looks great,will do more DD
Neoprobe Announces Successful Meeting on Lymphoseek Phase 3 Results
Submission Plan for New Drug Application for Lymphoseek Reviewed With FDA
Conference Call Scheduled for 8:30 a.m. Tomorrow, Friday, March 12, 2010
businesswire
Press Release Source: Neoprobe Corporation On Thursday March 11, 2010, 4:05 pm
DUBLIN, OHIO--(BUSINESS WIRE)--Neoprobe Corporation (OTCBB: NEOP - News), a diversified developer of innovative oncology and surgical diagnostic and treatment products, today announced that it recently met with the United States Food and Drug Administration (FDA) to review the clinical trial results of a Phase 3 investigational new drug, Lymphoseek®. The Phase 3 clinical study (NEO3-05) was conducted in subjects diagnosed with either breast cancer or melanoma. The FDA review included the efficacy and safety results of the NEO3-05 study and Neoprobe’s plans for the submission of a New Drug Application (NDA) for Lymphoseek. The NDA submission will be based on the clinical results of NEO3-05 and other already completed clinical evaluations of Lymphoseek. FDA encouraged Neoprobe to request a series of pre-NDA meetings in the coming months to review the components of the NDA prior to its formal submission. Neoprobe indicated to FDA that the Company plans to submit the NDA following satisfactory completion of these meetings.
“We are very pleased with our recent discussions with the FDA review team regarding the NEO3-05 Phase 3 clinical results,” said David Bupp, Neoprobe’s President and CEO. “The results from this meeting have clearly confirmed our pathway for the submission of a NDA approximating our previously disclosed target timeline. The potential clearance of the NDA in 2011 would position Lymphoseek to be the first radiopharmaceutical for the preoperative or intraoperative identification of lymphatic tissue. Neoprobe will be working with FDA in the coming months to prepare for a successful review of the Lymphoseek NDA, and to determine additional information that could be provided on a post-marketing basis to extend or expand the labeling from that planned for the initial NDA.”
“The performance of Lymphoseek in the Phase 3 study was excellent,” said Dr. Fred Cope, Neoprobe’s Vice President, Pharmaceutical Research and Clinical Development. “The primary and secondary efficacy endpoints of the study were met and no significant adverse events were reported that were directly attributed to Lymphoseek. The results of the Phase 3 trial have been favorably received by the members of the medical and scientific community. We plan to continue ongoing clinical evaluations of Lymphoseek that will be supportive of the NDA and subsequent amended claims for the product.”
The NEO3-05 Phase 3 study was an open label trial of node-negative subjects with either breast cancer or melanoma. It was designed to evaluate the safety and the accuracy of Lymphoseek while identifying the lymph nodes draining from the subject’s tumor site. To demonstrate the accuracy of Lymphoseek, each subject consenting to participate in the study was injected in proximity to the tumor with Lymphoseek and one of the vital blue dyes that are commonly used in lymphatic mapping procedures. The primary efficacy objective of the study was to identify lymph nodes that contained the vital blue dye and to demonstrate a statistically acceptable concordance rate between the identification of lymph nodes with the vital blue dye and Lymphoseek. To be successful, the study needed to achieve a statistical p-value of at least 0.05.
In this review meeting with FDA, the full analysis of the NEO3-5 clinical data was discussed. The protocol compliant clinical sites that participated in the NEO3-05 study contributed 136 Intent-To-Treat (ITT) subjects who provided 215 lymph nodes that contained the vital blue dye. 210 of the vital blue dye positive lymph nodes contained Lymphoseek for an overall concordance rate of 98% achieving a statistical p-value of 0.0001. In addition to the nodes identified by vital blue dye and Lymphoseek, Lymphoseek was able to identify 85 additional lymph nodes that did not contain the vital blue dye, and 18% of these nodes were found by pathology to contain cancer. There were no significant safety events related to Lymphoseek. The FDA indicated that the clinical data would be supportive of a NDA submission for Lymphoseek.
In future pre-NDA meetings, Neoprobe will continue discussions with the FDA reviewers regarding the pre-clinical and chemistry, manufacturing and control quality data modules that will be part of the NDA submission. Neoprobe will be discussing elements of the statistical analysis plan that would support the NDA, including the design of any prospective clinical evaluations to support the primary indication, and to potentially expand the future indications for Lymphoseek.
Neoprobe’s President and CEO, David Bupp, Vice President, Pharmaceutical Research and Clinical Development, Frederick Cope, Ph.D. and Vice President, Regulatory Affairs and Quality Assurance, Rodger Brown, will discuss the NEO3-05 results and FDA meeting results during a conference call scheduled for 8:30 AM EST, Friday, March 12, 2010.
The conference call can be accessed as follows:
Conference Call Information
TO PARTICIPATE LIVE: TO LISTEN TO A REPLAY:
Date: Mar. 12, 2010 Available until: Mar. 19, 2010
Time: 8:30 AM ET Toll-free (U.S.) Dial in # : (877) 660-6853
International Dial in # : (201) 612-7415
Toll-free (U.S.) Dial in # : (877) 407-8031
International Dial in # : (201) 689-8031 Replay passcode:
Account #: 286
Conference ID #: 346813
About Neoprobe
Neoprobe is a biomedical company focused on enhancing patient care and improving patient outcome by meeting the critical intraoperative diagnostic information needs of physicians and therapeutic treatment needs of patients. Neoprobe currently markets the neoprobe® GDS line of gamma detection systems that are widely used by cancer surgeons. In addition, Neoprobe holds significant interests in the development of related biomedical systems and radiopharmaceutical agents including Lymphoseek® and RIGScan™ CR. Neoprobe’s subsidiary, Cira Biosciences, Inc., is also advancing a patient-specific cellular therapy technology platform called ACT.
Neoprobe’s strategy is to deliver superior growth and shareholder return by maximizing its strong position in gamma detection technologies and diversifying into new, synergistic biomedical markets through continued investment and selective acquisitions. www.neoprobe.com
Statements in this news release, which relate to other than strictly historical facts, such as statements about the Company’s plans and strategies, expectations for future financial performance, new and existing products and technologies, anticipated clinical and regulatory pathways, and markets for the Company’s products are forward-looking statements The words “believe,” “expect,” “anticipate,” “estimate,” “project,” and similar expressions identify forward-looking statements that speak only as of the date hereof. Investors are cautioned that such statements involve risks and uncertainties that could cause actual results to differ materially from historical or anticipated results due to many factors including, but not limited to, the Company’s continuing operating losses, uncertainty of market acceptance of its products, reliance on third party manufacturers, accumulated deficit, future capital needs, uncertainty of capital funding, dependence on limited product line and distribution channels, competition, limited marketing and manufacturing experience, risks of development of new products, regulatory risks and other risks detailed in the Company’s most recent Annual Report on Form 10-K and other Securities and Exchange Commission filings. The Company undertakes no obligation to publicly update or revise any forward-looking statements.
Contact:
Neoprobe Corporation
Brent Larson, Vice President / CFO, 614-822-2330
OR
The Shoreham Group
Tim Ryan, 212-242-7777