VION - Vion Pharmaceuticals, Inc.

[gdinsd]

Vion Pharmaceuticals, Inc. (Vion) is a development-stage pharmaceutical company that develops therapeutics for the treatment of cancer. The Company has two small molecule anticancer agents in clinical development, which includes Onrigin (Laromustine)and Triapine. The Company also has two anticancer agents in the clinical development-stage. In February 2009, the Company filed a New Drug Application (NDA) for Onrigin with the United States Food and Drug Administration (FDA).

VION doubled in April 2009 from $1 to $2.

The following is from a 12/08 news release:

Q. What is Onrigin™ (laromustine) Injection and how does it work?
A: Onrigin™ (laromustine) Injection is a small molecule that works by damaging DNA. Onrigin™ (laromustine) releases the DNA chloroethylating agent 90CE after entering the blood stream. 90CE chloroethylates the O6 position of guanine residues, ultimately resulting in an interstrand DNA cross-link. Interstrand DNA cross-links are difficult to repair and are toxic to cells. Onrigin™ demonstrated a broad spectrum of anticancer activity in preclinical studies, including activity in selected cell lines resistant to other alkylating agents such as BCNU, cyclophosphamide and melphalan. In preclinical studies, Onrigin™ has been combined with other anticancer agents such as cytarabine (Ara-C). In addition, Onrigin™ or its metabolite, has been shown to be capable of crossing the blood brain barrier in preclinical models.

Q. What stage of development is Onrigin™ (laromustine) Injection in?

A: In February 2009, we filed a New Drug Application (NDA) for Onrigin™ (laromustine) Injection with the U.S. Food and Drug Administration for remission induction treatment in elderly patients with de novo poor-risk AML. 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.



Q. In what clinical trials is Onrigin™ (laromustine) Injection being evaluated?

A: 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.

Below is a table with a list of all completed, closed and ongoing Onrigin™ (laromustine) Injection clinical trials.


Trial
Indication
Sponsor
Commencement Date
Status

Phase III trial with standard remission-induction therapy
AML and MDS
Investigator
December 2008
Ongoing
Phase I/II trial in combination with daunorubicin and Aracytine
Previously untreated adult AML with unfavorable cytogenetics
Investigator
March 2009
Ongoing

Phase I/II trial in combination with cytarabine
Elderly AML and MDS
Investigator
May 2008
Ongoing

Phase I/II trial in combination with temozolomide
Brain tumors, adult
Investigator
September 2007
Ongoing

Phase III trial in combination with Ara-C
AML, relapsed
Vion
March 2005
Closed

Phase II single agent trial
AML, elderly poor-risk
Vion
May 2006
Closed

Phase II single agent trial
Small cell lung cancer
Vion
September 2005
Closed

Phase I trial in combination with stem cell transplantation
Hematologic malignancies
Investigator
November 2007
Closed

Phase II single agent trial
Brain tumors, adult
Investigator
June 2004
Completed

Phase II single agent trial
AML and high-risk myelodysplastic syndromes, elderly; AML, relapsed
Vion
March 2004
Completed

Phase I/II single agent trial
Chronic lymphocytic leukemia
Vion
July 2005
Completed

Phase I trial
Brain tumors, pediatric
Investigator
April 2005
Completed

Phase I trial in combination with temozolomide
Hematologic malignancies
Vion
October 2004
Completed

Phase I trial in combination with Ara-C
Hematologic malignancies
Vion
July 2003
Completed

Phase I single agent trial
Solid tumors
Vion
February 2003
Completed

Phase I single agent trial
Hematologic malignancies
Vion
August 2002
Completed

Phase I single agent trial
Solid tumors
Vion
June 2001
Completed

Does anyone have any further update on clinical trials? Both AML and glioblastoma are 99% uncurable cancers so any progress would would be fantastic for VION.

[lyme3m]

Is anyone playing the VION ODAC date of September 1st?

Charlie

[gdinsd]

Adam Feuerstein on the cramer site says the 9/1 approval is "bleak". check his rather lengthy article on thestreet.
I agree w him that vion has taken a big bump over the summer and it's a good time to sell.
the longer-term issue is the gathering consesus that ca therapy will soon look like aids/hiv therapy, w multiple drugs given concurrently to hammer the adult cells and novel drugs to wipe out the stem cells, plus other blockers and escape containers thrown in. so the vion approach is sound, it's just that they're so small and the competition for cloretizine tx is big. any thoughts? check the article above. gdinsd

[lyme3m]

Yupp, I read the AF article in reply to mail from the biomailbag. I wouldn't listen to anything AF writes because his track record is horrible. You'd of done well doing the exact opposite of all his 'recomendations'. e.g. He said Provenge would fail their phaseIII trial primary endpoints and that SVNT would not have a favorable ODAC just to name a couple.

I'm on the road right now but I'll be able to respond better about AF's response later.

[lyme3m]

OK, Instead of rewriting the counter points to Adams issues out, I am going to post some links from the finance.yahoo.com message boards primarily posted by badnorweigian. (I know just a message board poster. Well we all are really, yes you too, and I have found people like badnorweigian to be right more than AF. AS it turns out some of these yahoo!s actually work in the industry or did whereas AF didn't and doesn't)

Here is a response regarding AF's comment, "That says a lot about what the FDA thinks of Onrigin because almost all cancer drugs receive a priority, six-month review clock."

Yahoo! Message Boards - Vion Pharmaceuticals Inc. - Note about standard vs priority review

General objective comment regarding Onrigin

Yahoo! Message Boards - Vion Pharmaceuticals Inc. - Adam Feurstein Could be deadly wrong again!

Debate on AF's comment about the FDA stopping the trial being a huge issue.

Yahoo! Message Boards - Vion Pharmaceuticals Inc. - Problem with Adam is his FACTS are wrong ...

In general I would short or sell anything AF pumps and buy anything he bashes. Not that he's 100% wrong but he's been wrong more than right. He also just doesn't have the background to honestly know what hes talking about. I'm not saying I do, but I try to follow the advice of those with a better track record and surround myself with people who are in the industry.

[lyme3m]

Anyone else playing the VION run this week? High chances of an ODAC nod on September 1st...

[lyme3m]

Anyone else see this seekingalpha article on VION?

Vion Pharmaceuticals's Onrigin has a good chance of FDA approval - R. Saito -- Seeking Alpha

Wow!

[ctmoney]

whats the new FDA date here? It just dropped a lot, and I hear the date changed but can't find it.

[lyme3m]

There is no new FDA calendar date. Everyone was and still is anticipating the ODAC this coming Tuesday. I am personally still expecting more of a drop tomorrow and will buy more. We will see how the ODAC votes on safety and efficacy come Tuesday.

The expected FDA action date for Onrigin is 12/12/09.

The pps drop was because the ODAC meeting prep materials were 'unexpectedly' harsh. Although you do see this price behavior a lot when ODAC meeting prep materials are released.

[non47]

Thnx 4 the info!!