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agreed! it's tanking... -47% so far... as we supposed
some got burned and riped off big time...
I just cant see this staying up with out any credible info.
GLTA
dead cat bounce here guys ?
exploded in power hour...
Why?
I guess someone is pumping this one big time to unload his packet of worthless shares?... maybe because he needs the money
this is a bankrupt company with huge Debts. (50M) ? management is warning against crooks, let their worthless shares rotate with high volume? in a PR?? holy crap... take profits in time and get the hell out of it before led around by the nose and then mangled (imo)
good luck everyone!
The Phase I results regarding this Triapine 'new news' were out last year. The manuscript which was published online on Feb-9/2010 was submitted FIVE months back -in Sept-2009. So all this NEWS was already out last year, nothing new to celebrate.
o Received September 10, 2009.
o Revision received December 4, 2009.
o Accepted December 8, 2009.
If it has anything to do with some major findings/accomplishments of the Phase-1 study of VIONQ's drug then why didn't the company PR the results in the last five months? In my experiences with biotech sector, usually the company announce the results first then submit it for publication. Because the time they submit it for publication the results are technically out. If this was so major accomplishment of Phase-1 Triapine study then the company would have announced it on or around December 8, 2009 when the manuscript was accepted for the publication by the journal, because technically the manuscript was out to public since Dec. 8 2009 with 'corrected proof' level and citation details.
When the management of a company makes this kind of announcement:
""NEW HAVEN, Conn., Jan. 25 /PRNewswire-FirstCall/ -- VION PHARMACEUTICALS, INC. issued a management statement related to the continuing trading volume in the Company's common stock.
Management informed investors that it had noticed continuing high trading volume in the Company's common stock after the Company's filing for bankruptcy and of its belief that there will be no value for the common stockholders in the Company's bankruptcy liquidation process, even under the most optimistic of scenarios. Stockholders of a company in Chapter 11 generally receive value only if all claims of the company's creditors are fully satisfied. In this case, Company management believes all such claims will not be fully satisfied, leading to its conclusion that Vion common stock will have no value."
This means the company is going to Liquidate and Shut Down.
From Yahoo board: "It's strange enough that just "Ireland Cancer Center of University Hospitals (UH) Case Medical Center " tested in their phase 1 study shows some positive result ?
It's just like a convenient store employee tells one cake tastes good. So, it's good ?
Unbelievable and Un-supported.
Just think it over WHY VION did NOT release this 'good' news, itself!
This so-called news more looks like a Fake one.
Be very careful, Man!
Some people are trying to make Great Escapes."
WHO has made this 'news" ???
All things considered it's debt is not much if it holds a promising drug and that Triapine sure seems like one. Also, I'm a little suspect of a company in BK that is paying so much attention to its supposedly worthless stock. JMO.
Hopefully we can "really" talk about this one in few years or so, if company stays afloat. Otherwise this is a dead cat bounce.
GLTA
It appears all the commotion was over Triapine and promising Phase I results and has nothing to do with Onrigin:
http://www.eurekalert.org/pub_releases/2010-02/uhcm-ucm020810.php
Still no where near an FDA app although Phase II studies are well underway. No VRMLQ at this time but well worth watching.
these people buy the close and sell the open, or the 2nd days close. usually these things fail after the 2nd day.
I'm gonna throw $1k at it in the morning just as an experiment!! we will see!
Unless there is any substantial news behind this run up, this will drop back like a rock. Company did mention that it will be looking for partnerships or become a possible buyout candidate if available.
This is not VRMLQ, not even close. Totally different situation here. BUT.....is SPA gets accepted and possible injection of cash comes into the company from outside, then we will have a pulse again.
Just because company is in BK, it doesnt mean that they cant operate at a loss. Shares will get diluted and become almost worthless or even cancel all common stock.
I am interested to see what is gonna happen tomorrow, but I have a feeling it will tank, since there is no real news
GLTA
these things can be tricks to get your money before shares are delisted or something.
Agreed, but VRMLQ was waiting for the FDA decision that time, not like VIONQ. If those peeps were there in VRMLQ, the buying pressure would have taken it to $50+, imo. So fun to watch and ride.
Anyway, the case is different with VIONQ. They have submitted 'special protocol assessment' for onrigin- study just last month, and once the submitted protocol is approved, then they will conduct the due experiments/studies. Once those studies completed then they will submit it to the FDA for approval process. So a LONG way to reach that stage and FDA approval,imo.
http://www.prnewswire.com/news-releases/vion-pharmaceuticals-announces-filing-of-special-protocol-assessment-for-onrigintm-81217052.html
"NEW HAVEN, Conn., Jan. 12 /PRNewswire-FirstCall/ -- VION PHARMACEUTICALS, INC. (OTC Bulletin Board: VION) announced today that it had filed a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) related to a randomized Phase II/III trial of its oncology therapeutic Onrigin™ (laromustine) Injection in combination with low-dose Ara-C (LDAC) in elderly patients with newly diagnosed acute myeloid leukemia (AML). The primary objective for the Phase III part of this study is to determine if Onrigin™ plus LDAC improves overall survival compared with LDAC alone.
The SPA process is intended to evaluate a Phase III protocol whose data will form the primary basis for an efficacy claim. The Phase II/III randomized trial for which the Company filed the SPA has been designed in response to the FDA's complete response letter to the Company's New Drug Application for Onrigin™ that required a randomized trial be conducted to support the approval of Onrigin™ for the treatment of AML.
On December 17, 2009, Vion filed a voluntary petition for relief under Chapter 11 of the United States Bankruptcy Code in the United States Bankruptcy Court in the District of Delaware. Vion has retained the services of Roth Capital Partners, LLC to assist with the sale of the Company and/or its key assets during the Chapter 11 proceeding. Additional information about Vion's Chapter 11 case is available on the website of the court's claims agent at www.delclaims.com. "
Yep VRMLQ had 55M in debt....I'm just saying to everyone to do your own DD. A lot of peeps missed out on VRMLQ
This is from Jan 25th/2010 PR. "The Company recently filed its Schedules of Assets and Liabilities (the "Schedules") as of the petition date with the bankruptcy court, showing assets of $14.6 million and liabilities of $62.8 million not including certain unliquidated claims."
The Company ended the third quarter of 2009 with cash and cash equivalents totaling $18.9 million. The Company’s review of its strategic alternatives will determine the Company’s future operations, if any, and levels of cash expenditures and employee staffing. It is likely that, without additional financing, the cash and cash equivalents will not be adequate to fund operations for the next twelve months.
you are welcome 'scienceguy'. Like many others, I also want to see FDA approval here, but unfortunately it's long way to get there. It would be great if VION receives FDA approval in future with this share structure, but I highly doubt about it as it would need a lot of $$$ to complete these required studies. Life science research is pretty costly man. If it happens with this SS it would repeat VRMLQ show, imo.
Do your own DD go back and read the last Q...BK is a tatic used by drug startups waiting on the very slow FDA approval to keep the wolfs at bay....all the experts were wrong with VRMLQ.....seems to me this company is moving foward with the process and not closing up shop....SPA after BK..
Item 2.04 Triggering Events That Accelerate or Increase a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement.
The Chapter 11 bankruptcy filing described in Item 1.03 above constitutes an event of default under the Company’s indenture with U.S. Bank National Association, dated February 20, 2007 (the “Indenture”) relating to the Company’s $60,000,000 7.75% Convertible Senior Notes (the “Notes”). On December 17, 2009, all unpaid principal of, and accrued and unpaid interest and additional interest, if any, on the Notes then outstanding became automatically due and payable. However, the ability of the holders of the Notes to seek remedies to enforce their rights under the Indenture is automatically stayed as a result of the filing of the Chapter 11 petition.
There were $6500 dollar buys at .50 area. Someone really stupid or smart? Don't know yet. But that is not a typical day trader who plays $1K or less on a pump.
Rather unusual IMO for a BK co. to shell out the dough for a PR warning people not to buy their stock;)
$200-300K trade is not a big deal for a stock play that has something (rumor/news) related to 'FDA' and a share structure like VIONQ, imo. Traders play with rumors with all these stocks. Many might have banked a good profit today within those 30 minutes. Many might have traded it several times as it was just hovering in the range of 0.30-39 for over 14-15 minutes. And for a day trader like me that's lot of time to buy and sell it at least 2-3 times. It's not listed in NASDAQ/AMEX exchanges, else we might have seen trade volumes over 1-2 millions in just 10-15 minutes.
I have seen this stock reaching the last peak around $6 and falling from there around $2 within a day or two -very short time and from there to 0.04s in a couple of months. Not getting negative, but just be careful and ride the freebies and in the meantime don't forget the latest PR stating that the "Management informed investors that it had noticed continuing high trading volume in the Company's common stock after the Company's filing for bankruptcy and of its belief that there will be no value for the common stockholders in the Company's bankruptcy liquidation process, even under the most optimistic of scenarios."
I have played this several times, and fortunately I didn't hold the bag while getting down last time. GLTA
Thanks Penny
That helps out a lot.
Cheers Scienceguy
That's the last year submission, nothing new. Generally, researchers present findings in many professional meetings before they submit the manuscript for publication. In this case the manuscript was submitted on Sept 10, 2009.
o Received September 10, 2009.
o Revision received December 4, 2009.
o Accepted December 8, 2009.
I'm not smart enough to decode all of this, but it looks pretty positive to me -
From the journal Clinical Cancer Research
http://clincancerres.aacrjournals.org/content/early/2010/02/08/1078-0432.CCR-09-2469.full.pdf+html?sid=ac19f3b3-aa2a-4750-9627-c2831ab122e6
Protocol treatments. This was a dose-finding phase I
study of three times weekly i.v. 3-AP (Triapine) in combination
with once-weekly i.v. cisplatin chemotherapy and
daily pelvic radiation therapy administered for 5 weekly
cycles. 3-AP was supplied by Vion Pharmaceuticals...
Clinical activity. Ten of 11 (91%) enrolled patients were
assessed for tumor response, each with squamous cervical
cancer. All 10 (100%) patients achieved a complete clinical
response at post-treatment 1-month follow-up. Of the
10 complete responders, 6 (60%) had an early complete
clinical response (i.e., no disease detected after 5 weeks ...)
(Published Online First on February 9, 2010)
so no, the news is not general knowledge, yet.
Maybe a good chance to get ahead of the game...?
What ever it is,it worked for the run at the of the day.
Let see what happens tomorrow
GLTA
VIONQ study results pasted link
http://www.eurekalert.org/pub_releases/2010-02/uhcm-ucm020810.php
Public release date: 9-Feb-2010
[ Print | E-mail | Share ] [ Close Window ]
Contact: Alicia Reale
alicia.reale@uhhospitals.org
216-844-5158
University Hospitals Case Medical Center
UH Case Medical Center researchers publish promising findings for advanced cervical cancer
Regimen with new drug triapine provides both significant reduction in cancer disease and cancer control
Researchers at the Ireland Cancer Center of University Hospitals (UH) Case Medical Center, have published new findings that may lead to a new standard of care for patients with locally advanced cervical cancer.
Published in the February issue of Clinical Cancer Research, the phase one study found that a new chemotherapy medicine, Triapine, was well tolerated in combination with standard-of-care cisplatin chemotherapy and radiation treatment in women with cervical cancer. This regimen provided both significant reduction in cancer disease and cancer control.
"This new drug, which suppresses tumor growth, shows a great deal of promise for cervical cancer patients who are at high risk for relapse and cancer-related death," says Charles Kunos, MD, Primary Investigator of the study, Director of Gynecologic Radiation Oncology at UH Case Medical Center and Assistant Professor at Case Western Reserve University School of Medicine. "In this ten-patient study, a 100% complete response rate was observed and no disease progression was documented through 18 months of median follow-up."
In the study, patients were treated three times weekly with Triapine in combination with weekly cisplatin treatment and daily pelvic radiation therapy over five weeks. A phase two follow-up study is ongoing at the Ireland Cancer Center. UH Case Medical Center is the primary affiliate of Case Western Reserve University School of Medicine, a nationally recognized leader in medical research and education
"Cervical cancer affects half a million women worldwide each year," says Steven Waggoner, MD, Chief of Gynecologic Oncology at UH Case Medical Center and Assistant Professor at Case Western Reserve University School of Medicine. "We are pleased to have found a promising new treatment to help women fight this aggressive disease."
###
The study was funded by the National Cancer Institute through Case Western Reserve University School of Medicine.
About University Hospitals
University Hospitals serves the needs of patients through an integrated network of hospitals, outpatient centers and primary care physicians. At the core of our health system is University Hospitals Case Medical Center. The primary affiliate of Case Western Reserve University School of Medicine, University Hospitals Case Medical Center is home to some of the most prestigious clinical and research centers of excellence in the nation and the world, including cancer, pediatrics, women's health, orthopedics and spine, radiology and radiation oncology, neurosurgery and neuroscience, cardiology and cardiovascular surgery, organ transplantation and human genetics. Its main campus includes the internationally celebrated UH Rainbow Babies & Children's Hospital, ranked second in the nation for the care of critically ill newborns; UH MacDonald Women's Hospital, Ohio's only hospital for women; and UH Ireland Cancer Center, part of the NCI-designated Case Comprehensive Cancer Center. For more information, go to www.uhhospitals.org
--------------------------------------------------------------------------------
[ Print | E-mail | Share ] [ Close Window ]
Looks like Phase II started in July and runs until 2/2011:
http://clinicaltrials.gov/ct2/show/NCT00941070
Just pumped today.
This had at least $200-300K of money flow in less than a 1/2 half hour. Traders don't put that type of money up for a pump IMO.
No FDA approval. VION needs to do the study again in order to file application for the FDA approval. They will start that study when they will get approval for the experimental/study procedures. No comparison with VRMLQ. The story was different in the case of VRMLQ as it has pending application and eventually got FDA approval, not the rejection like VION.
Nothing like positive results. Didn't you read the CRL given by the FDA and VION's response/PRs to CRL? They need to do everything from the scratch (for phase2/3) and yet need to get FDA approval for the study procedures to get it started. Nothing like progress. Just pumped today. Wait and watch. I am watching this for over a year now .
No official News, Except: Vion Pharmaceuticals Issues Management Statement Regarding Trading Volume of Company's Common Stock
NEW HAVEN, Conn., Jan. 25 /PRNewswire-FirstCall/ -- VION PHARMACEUTICALS, INC. issued a management statement related to the continuing trading volume in the Company's common stock.
Management informed investors that it had noticed continuing high trading volume in the Company's common stock after the Company's filing for bankruptcy and of its belief that there will be no value for the common stockholders in the Company's bankruptcy liquidation process, even under the most optimistic of scenarios. Stockholders of a company in Chapter 11 generally receive value only if all claims of the company's creditors are fully satisfied. In this case, Company management believes all such claims will not be fully satisfied, leading to its conclusion that Vion common stock will have no value.
On December 17, 2009, Vion filed a voluntary petition for relief under Chapter 11 of the United States Bankruptcy Code in the United States Bankruptcy Court in the District of Delaware. The Company recently filed its Schedules of Assets and Liabilities (the "Schedules") as of the petition date with the bankruptcy court, showing assets of $14.6 million and liabilities of $62.8 million not including certain unliquidated claims. The Schedules are unaudited and do not purport to represent financial statements prepared in accordance with Generally Accepted Accounting Principles in the United States, and they are not intended to be fully reconciled to the Debtor's financial statements.
Additional information about Vion's Chapter 11 case is available at www.delclaims.com.
For additional information on Vion visit the Company's web site at www.vionpharm.com.
This news release contains forward-looking statements. Such statements are subject to certain risk factors which may cause Vion's plans to differ or results to vary from those expected, including Vion being unsuccessful in selling its assets or engaging in another transaction in bankruptcy, the FDA not approving Vion's Special Protocol Assessment for a Phase III randomized trial for Onrigin™,Vion not obtaining court approval of its motions in the Chapter 11 proceeding pursued by it from time to time, Vion's ability to develop, pursue, confirm and consummate one or more plans of reorganization with respect to the Chapter 11 case, Vion's ability to retain and compensate key executives and other key employees, Vion's ability to maintain relationships with its licensor and vendors, Vion's potential inability to obtain regulatory approval for its products, particularly Onrigin™, delays in the regulatory approval process, particularly for Onrigin™, delays or unfavorable results of drug trials, the need for additional research and testing, including the need for a randomized trial of Onrigin™ prior to regulatory approval, the inability to manufacture product, the potential inability to secure external sources of funding to continue operations, the inability to access capital and funding on favorable terms, continued operating losses and the inability to continue operations as a result, and a variety of other risks set forth from time to time in Vion's filings with the Securities and Exchange Commission, including but not limited to the risks attendant to the forward-looking statements included under Item 1A, "Risk Factors" in Vion's Form 10-K for the year ended December 31, 2008 and Vion's Form 10-Q for the quarter ended September 30, 2009. Except in special circumstances in which a duty to update arises under law when prior disclosure becomes materially misleading in light of subsequent events, Vion does not intend to update any of these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
COMPANY CONTACT:
Vion Pharmaceuticals, Inc.
Alan Kessman, Chief Executive Officer
Howard B. Johnson, President & CFO
(203) 498-4210
sounds good, but it`s not a official news!
sounds good, but it`s not a public news!
maybe positive results...?
News!
http://www.eurekalert.org/pub_releases/2010-02/uhcm-ucm020810.php
Public release date: 9-Feb-2010
Contact: Alicia Reale
alicia.reale@uhhospitals.org
216-844-5158
University Hospitals Case Medical Center
UH Case Medical Center researchers publish promising findings for advanced cervical cancer
Regimen with new drug triapine provides both significant reduction in cancer disease and cancer control
Researchers at the Ireland Cancer Center of University Hospitals (UH) Case Medical Center, have published new findings that may lead to a new standard of care for patients with locally advanced cervical cancer.
Published in the February issue of Clinical Cancer Research, the phase one study found that a new chemotherapy medicine, Triapine, was well tolerated in combination with standard-of-care cisplatin chemotherapy and radiation treatment in women with cervical cancer. This regimen provided both significant reduction in cancer disease and cancer control.
"This new drug, which suppresses tumor growth, shows a great deal of promise for cervical cancer patients who are at high risk for relapse and cancer-related death," says Charles Kunos, MD, Primary Investigator of the study, Director of Gynecologic Radiation Oncology at UH Case Medical Center and Assistant Professor at Case Western Reserve University School of Medicine. "In this ten-patient study, a 100% complete response rate was observed and no disease progression was documented through 18 months of median follow-up."
In the study, patients were treated three times weekly with Triapine in combination with weekly cisplatin treatment and daily pelvic radiation therapy over five weeks. A phase two follow-up study is ongoing at the Ireland Cancer Center. UH Case Medical Center is the primary affiliate of Case Western Reserve University School of Medicine, a nationally recognized leader in medical research and education
"Cervical cancer affects half a million women worldwide each year," says Steven Waggoner, MD, Chief of Gynecologic Oncology at UH Case Medical Center and Assistant Professor at Case Western Reserve University School of Medicine. "We are pleased to have found a promising new treatment to help women fight this aggressive disease."
###
The study was funded by the National Cancer Institute through Case Western Reserve University School of Medicine.
That news is a month old:
Vion Pharmaceuticals Announces Filing of Special Protocol Assessment for Onrigin(TM)
NEW HAVEN, Conn., Jan 12, 2010 /PRNewswire via COMTEX/ -- VION PHARMACEUTICALS, INC. (OTC Bulletin Board: VION) announced today that it had filed a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) related to a randomized Phase II/III trial of its oncology therapeutic Onrigin(TM) (laromustine) Injection in combination with low-dose Ara-C (LDAC) in elderly patients with newly diagnosed acute myeloid leukemia (AML). The primary objective for the Phase III part of this study is to determine if Onrigin(TM) plus LDAC improves overall survival compared with LDAC alone.
The SPA process is intended to evaluate a Phase III protocol whose data will form the primary basis for an efficacy claim. The Phase II/III randomized trial for which the Company filed the SPA has been designed in response to the FDA's complete response letter to the Company's New Drug Application for Onrigin(TM) that required a randomized trial be conducted to support the approval of Onrigin(TM) for the treatment of AML.
On December 17, 2009, Vion filed a voluntary petition for relief under Chapter 11 of the United States Bankruptcy Code in the United States Bankruptcy Court in the District of Delaware. Vion has retained the services of Roth Capital Partners, LLC to assist with the sale of the Company and/or its key assets during the Chapter 11 proceeding. Additional information about Vion's Chapter 11 case is available on the website of the court's claims agent at www.delclaims.com.
For additional information on Vion and its product development programs, visit the Company's Internet web site at www.vionpharm.com.
This news release contains forward-looking statements. Such statements are subject to certain risk factors which may cause Vion's plans to differ or results to vary from those expected, including Vion being unsuccessful in selling its assets or engaging in another transaction in bankruptcy, the FDA not approving Vion's Special Protocol Assessment for a Phase III randomized trial for Onrigin(TM) , Vion not obtaining court approval of its motions in the Chapter 11 proceeding pursued by it from time to time, Vion's ability to develop, pursue, confirm and consummate one or more plans of reorganization with respect to the Chapter 11 case, Vion's ability to retain and compensate key executives and other key employees, Vion's ability to maintain relationships with its licensor and vendors, Vion's potential inability to obtain regulatory approval for its products, particularly Onrigin(TM), delays in the regulatory approval process, particularly for Onrigin(TM), delays or unfavorable results of drug trials, the need for additional research and testing, including the need for a randomized trial of Onrigin(TM) prior to regulatory approval, the inability to manufacture product, the potential inability to secure external sources of funding to continue operations, the inability to access capital and funding on favorable terms, continued operating losses and the inability to continue operations as a result, and a variety of other risks set forth from time to time in Vion's filings with the Securities and Exchange Commission, including but not limited to the risks attendant to the forward-looking statements included under Item 1A, "Risk Factors" in Vion's Form 10-K for the year ended December 31, 2008 and Vion's Form 10-Q for the quarter ended September 30, 2009. Except in special circumstances in which a duty to update arises under law when prior disclosure becomes materially misleading in light of subsequent events, Vion does not intend to update any of these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
but they had a chapter 11 on dec 17.....
Sorry I misread the post. My apologies.
I saw FDA and got excited with the huge jump.
VION announced today that it had filed a Special Protocol Assessment (SPA) with
the U.S. Food and Drug Administration (FDA) related to a randomized Phase II/III trial of its
oncology therapeutic Onrigin™ (laromustine) Injection in combination with low-dose Ara-C
(LDAC) in elderly patients with newly diagnosed acute myeloid leukemia (AML). The primary
objective for the Phase III part of this study is to determine if Onrigin™ plus LDAC improves
overall survival compared with LDAC alone.
The SPA process is intended to evaluate a Phase III protocol whose data will form the primary
basis for an efficacy claim. The Phase II/III randomized trial for which the Company filed the
SPA has been designed in response to the FDA’s complete response letter to the Company’s
New Drug Application for Onrigin™ that required a randomized trial be conducted to support
the approval of Onrigin™ for the treatment of AML.
This used to be a $20 stock 3 years ago and traded at $4 4 months ago... not sure what is going on exactly but tons of room to run imo
was there a news today? Missed i something?
where do u see fda approval... ? it wasent approved by the fda...
Im pretty curious about this one
LAst time I saw an FDA approval(?) and it jumpled like this it continued up to $29.00 (VRMLQ)
So I really dont know much about the company. Cant really say.
Maybe someone else does.
what do you think buy? or watch it trinkle back down?
will it continue up?
Whats the story with VIONQ?? Huge run at eod??
Another Vermillion??
VION announced today that it had filed a Special Protocol Assessment (SPA) with
the U.S. Food and Drug Administration (FDA) related to a randomized Phase II/III trial of its
oncology therapeutic Onrigin™ (laromustine) Injection in combination with low-dose Ara-C
(LDAC) in elderly patients with newly diagnosed acute myeloid leukemia (AML). The primary
objective for the Phase III part of this study is to determine if Onrigin™ plus LDAC improves
overall survival compared with LDAC alone.
The SPA process is intended to evaluate a Phase III protocol whose data will form the primary
basis for an efficacy claim. The Phase II/III randomized trial for which the Company filed the
SPA has been designed in response to the FDA’s complete response letter to the Company’s
New Drug Application for Onrigin™ that required a randomized trial be conducted to support
the approval of Onrigin™ for the treatment of AML.
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About Vion:
Vion Pharmaceuticals, Inc. is developing novel agents for the treatment of cancer. We have two small molecule anticancer compounds under evaluation in human clinical trials. In February 2009, we filed a New Drug Application (NDA) with the U.S. Food and Drug Administration for our potential product, Onrigin™ (laromustine) Injection, formerly Cloretazine® (VNP40101M), for remission induction treatment of acute myeloid leukemia (AML) in elderly de novo poor-risk patients. The Company has announced that the NDA has been accepted for a standard review by the FDA and that the user fee goal date for an FDA decision is December 12, 2009. There can be no assurance that the NDA will be approved by the FDA in 2009, or at all.
In addition, four clinical trials of Onrigin™ are underway in: (i) AML and myelodysplastic syndrome (MDS) in combination with cytarabine; (ii) AML and MDS in combination with standard remission-induction therapy; (iii) AML with unfavorable cytogenetics in combination with standard remission-induction chemothrapy; and (iv) brain tumors in combination with temozolomide.
Our second potential product, Triapine®, is being evaluated in trials sponsored by the National Cancer Institute.
Due Diligence:
Vion Pharma: Outlook for Upcoming FDA Advisory Panel Meeting -- Biomedreports Article
Vion Pharmaceuticals Announces Oncologic Drugs Advisory Committee Meeting for Onrigin(TM)
Upcoming Events:
9/2/2009 -- ODAC (Oncologic Drugs Advisory Committee) Meeting
Do your own Due Diligence before investing.
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