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AVN944 Biomarkers Correlate with Clinical Effects and Disease Stabilization in Adult AML Patients
Saturday December 8, 5:30 pm ET
GERMANTOWN, Md.--(BUSINESS WIRE)--Avalon Pharmaceuticals, Inc. (Nasdaq:AVRX - News), today announced preliminary results from its ongoing AVN944 Phase I trial in adult Acute Myelogenous Leukemia (AML) patients at the American Society of Hematology (ASH) Annual Meeting.
The research shows that AVN944 is well tolerated in refractory AML patients, with drug exposure increasing with higher dose levels. AVN944 biomarkers show a dose-dependent increase in activity including: binding to the target enzyme IMPDH, depletion of GTP pools in blast cells, and gene expression markers correlating to cell cycle blocks, GTP level and apoptosis, illustrating that biomarkers can be used to monitor exposure in patients as dose levels increase.
Utilizing the AvalonRx® platform, a predictive algorithm was developed and the preliminary data discriminates AVN944’s effect on patients with regard to disease stabilization or progression. This biomarker based patient stratification strategy could provide a valuable tool for enrichment of patients more likely to benefit from AVN944 therapy in future studies.
“Reducing the risk of clinical trials failures has been a very elusive goal in the development of cancer therapeutics,” stated Rebecca B. Klisovic, M.D., Assistant Professor of Hematology and Oncology at The Ohio State University. “These preliminary results are very exciting and Avalon’s comprehensive biomarker driven approach, if confirmed in a larger study, would go a long way toward achieving this goal.”
http://biz.yahoo.com/bw/071208/20071208005014.html?.v=1
AVN944 (IMPDH Inhibitor) and Beta-catenin Inhibitor Programs to be Presented at the American Society of Hematology Meeting
Thursday December 6, 8:00 am ET
GERMANTOWN, Md.--(BUSINESS WIRE)--Avalon Pharmaceuticals, Inc. (Nasdaq:AVRX - News), today announced that two posters will be presented at the American Society of Hematology (ASH) Annual Meeting, December 7-11, 2007, in Atlanta, GA.
Abstract #2523, “Clinical-biomarker Correlations in Adult AML Patients in a Phase I Trial of AVN944 Support Observations of Clinical Effect and Provide Hypotheses for Patient Selection for Further Clinical Trials” will be presented by Rebecca B. Klisovic, M.D., Assistant Professor of Hematology and Oncology at the Ohio State University, on Saturday, December 8 from 5:30pm-7:30pm.
Abstract #896, “In vitro Characterization of Wnt/Beta-catenin Pathway Inhibition in Multiple Myeloma Cell Lines Using a Novel Class of Small Molecules” will be presented by Jeffrey Strovel, Ph.D., Senior Scientist at Avalon, on Sunday, December 9 from 5:30pm-7:30pm.
About Avalon Pharmaceuticals
Avalon is a biopharmaceutical company focused on the discovery, development and commercialization of first-in-class cancer therapeutics. Avalon’s lead product candidate, AVN944, an IMPDH inhibitor, is in Phase II clinical development. Avalon also has preclinical programs to develop inhibitors of the Beta-catenin and Aurora/Centrosome pathways, discovery programs for inhibitors of the Survivin and Myc pathways and partnerships with Merck, MedImmune, ChemDiv, Medarex, and Novartis. AvalonRx® is the company’s proprietary platform which is based on large-scale biomarker identification and monitoring, used to discover and develop therapeutics for pathways that have historically been characterized as "undruggable." Avalon is headquartered in Germantown, MD.
Hopefully Merck & Co. isn't wrong on AVRX, starting to buy back into the stock.
Avalon Pharmaceuticals Reports Third Quarter 2007 Financial Results
Wednesday November 7, 4:05 pm ET
GERMANTOWN, Md.--(BUSINESS WIRE)--Avalon Pharmaceuticals, Inc. (Nasdaq:AVRX - News) today announced results for the three and nine months ended September 30, 2007. The Company reported no revenues in the third quarter of 2007 and a net loss of $5.4 million, or $0.32 per share. For the first nine months of 2007, revenues were $0.8 million and net loss was $16.6 million, or $1.13 per share. As of September 30, 2007, the Company had $33.4 million in cash, cash equivalents and marketable securities.
“We are pleased with the progress we made this quarter in our clinical, pre-clinical and collaboration programs,” stated Kenneth C. Carter, Ph.D., President and CEO of Avalon. “Our lead candidate, AVN944, continues to progress through Phase I and II clinical trials, we reported exciting progress in our pre-clinical programs at the recent AACR-NCI-EORTC Conference in San Francisco, and our collaborations continue to go well.”
Recent Highlights
* Patient enrollment continued in both the AVN944 Phase I clinical trial for hematological patients and the AVN944 Phase II (Part A) clinical trial for pancreatic patients.
* Posters presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics showed that AvalonRx®, the Company’s core technology, identified potent selective small molecule inhibitors for the Beta-catenin pathway that demonstrate significant tumor inhibition in multiple animal models.
* The Company reported in a poster presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics that the Company used AvalonRx® to identify and characterize small molecule inhibitors for the c-Myc pathway.
* Collaborations with Merck, Novartis and ChemDiv continue to progress.
* Bradley Lorimier appointed Chairman of Board of Directors in August 2007. Lorimier is a co-founder of Avalon and has served as a member of the Board of Directors since December 1999.
Financial Results
No revenues were reported for the third quarter of 2007, compared to $1.1 million in the third quarter of 2006. Revenues for the nine months ended September 30, 2007 were $0.8 million, compared with $2.1 million in the first nine months of 2006. Revenues in 2007 were from collaboration with Novartis Institutes for Biomedical Research. Revenues in 2006 were from collaborations with Novartis Institutes for Biomedical Research, MedImmune and the University of Louisville.
Total costs and expenses from operations were $5.7 million in the third quarter of 2007, an increase of $0.6 million compared with the $5.1 million reported for the third quarter of 2006. Total costs and expenses were $18.2 million for the nine months ended September 30, 2007, compared with $15.6 million in the comparable period of 2006. The increases in 2007 were principally due to clinical trial costs related to AVN944, compensation expenses, consulting costs and laboratory supplies expenses.
Net loss was $5.4 million for the three months ended September 30, 2007 compared with $3.7 million in the comparable three months of 2006. For the first nine months of 2007, net loss was $16.6 million, compared with $12.7 million in the first nine months of 2006. Lower revenues and higher costs in the 2007 periods resulted in the higher losses in 2007.
As of September 30, 2007, the company had $33.4 million in cash, cash equivalents and marketable securities. Of that amount, $4.9 million was held in a restricted account to serve as collateral for long-term debt.
Avalon Pharmaceuticals files for $50 million shelf
Thu Oct 25, 2007 5:13pm EDT
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WASHINGTON, Oct 25 (Reuters) - Avalon Pharmaceuticals Inc (AVRX.O: Quote, Profile, Research) filed with regulators on Thursday to periodically sell up to $50 million in common and preferred stock, debt securities and warrants.
The company said in a registration statement with the U.S. Securities and Exchange Commission that it will use the proceeds from the offering for clinical drug development, discovery of new drug candidates, the protection of intellectual property rights, and other purposes.
Under a shelf registration, a company may sell securities in one or more separate offerings with the size, price and terms to be determined at the time of sale.
Avalon Pharmaceuticals Announces Beta-catenin Pathway Inhibitors Demonstrate Significant Tumor Growth Inhibition
Thursday October 25, 8:00 am ET
GERMANTOWN, Md.--(BUSINESS WIRE)--Avalon Pharmaceuticals, Inc. (Nasdaq:AVRX - News), today announced that compounds from its Beta-catenin pathway inhibitor program demonstrated significant tumor growth inhibition in multiple animal models. The results will be presented today at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in San Francisco, CA, from 12:30pm-2:30pm and from 5:30pm-7:30pm (PDT) in two posters titled:
“Compounds selected and optimized from a biomarker based Beta-catenin pathway screen decrease Beta-catenin protein levels in xenograft tumors, induce a gene expression signature consistent with inhibition of Beta-catenin activity, and exhibit anti tumor growth properties”
“LC-363: Optimization and in vitro characterization of a novel series of small molecule inhibitors of the Wnt/Beta-catenin signaling pathway.”
“The Beta-catenin pathway is well validated and clinically important but historically has been very elusive,” stated Stephen Horrigan, Ph.D., Vice President of Research at Avalon Pharmaceuticals. “Using AvalonRx®, our proprietary drug discovery and development platform, we identified structurally distinct orally available compounds that inhibit the Beta-catenin pathway, and have optimized one of the identified compound families to have significant activity in preclinical colon cancer models. We anticipate nominating a lead compound in 2008 which we will advance into IND enabling studies.”
Avalon’s lead series demonstrates broad activity in cell lines from multiple cancers while displaying its greatest activity in colon and hematologic malignancies. Compound optimization was achieved in less than 12 months by utilizing AvalonRx®, a proprietary biomarker centric approach which increased the potency of the compounds (50-fold) on the pathway and led to a series of compounds that are active in tumor models.
Beta-catenin Pathway
It is estimated the Beta-catenin pathway is abnormally activated in more than 90% of colon cancers and in a large number of other solid and hematological cancers. Many of these tumor cells have been found to be dependent on the Beta-catenin pathway for survival and to be particularly sensitive to inhibition of this critical pathway. Since the activation of the pathway is dependent of the activity of the Beta-catenin protein, a classically intractable target, Avalon Rx® is particularly well suited for the identification and optimization of drugs targeting this important pathway.
AvalonRx®
AvalonRx® is a comprehensive, innovative and proprietary suite of technologies based upon large-scale gene expression analysis. This platform facilitates drug discovery by expanding the range of therapeutic targets for drug intervention, including targets and target pathways frequently considered intractable using conventional HTS approaches. It also allows more informed decisions about which compounds to advance towards clinical trials and facilitates drug development through identification of biomarkers of efficacy that can stratify patients or provide early indicators of response.
About Avalon Pharmaceuticals
Avalon is a biopharmaceutical company focused on the discovery, development and commercialization of first-in-class cancer therapeutics. Avalon’s lead product candidate, AVN944, an IMPDH inhibitor, is in Phase II clinical development. Avalon also has preclinical programs to develop inhibitors of the Beta-catenin and Aurora/Centrosome pathways, discovery programs for inhibitors of the Survivin and Myc pathways and partnerships with Merck, MedImmune, ChemDiv, Medarex, and Novartis. AvalonRx® is the company’s proprietary platform which is based on large-scale biomarker identification and monitoring, used to discover and develop therapeutics for pathways that have historically been characterized as "undruggable." Avalon is headquartered in Germantown, MD.
Avalon Pharmaceuticals Announces Its Proprietary Drug Discovery and Development Platform AvalonRx(R) Identifies Potent Selective Inhibitors for the c-Myc and Beta-catenin Pathways
Tuesday October 23, 8:00 am ET
GERMANTOWN, Md.--(BUSINESS WIRE)--Avalon Pharmaceuticals, Inc. (Nasdaq:AVRX - News), today announced its proprietary drug discovery and development platform, AvalonRx®, identified potent selective inhibitors for the c-Myc and Beta-catenin pathways. The results will be presented today at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in San Francisco, CA from 12:30pm-2:30pm and from 5:30pm-7:30pm (PDT) in posters titled:
“A biomarker based high throughput screen identifies small molecular weight modulators of the Beta-catenin pathway;”
“Biomarker based high-throughput screening for identification of small molecule inhibitors, targeting the antiproliferative property of the c-Myc signaling pathway.”
“The unique capabilities of AvalonRx® allow us to target two of the most important, but historically “undruggable” cancer pathways, namely Myc and Beta-catenin,” stated Stephen Horrigan, Ph.D., Vice President of Research. “These programs should result in the development of true “first-in-class” therapeutics with direct relevance to human disease.”
AvalonRx®
AvalonRx® is a comprehensive, innovative and proprietary suite of technologies based upon large-scale gene expression analysis. This platform facilitates drug discovery by expanding the range of therapeutic targets for drug intervention, including targets and target pathways frequently considered intractable using conventional HTS approaches, allows more informed decisions about which compounds to advance towards clinical trials, and facilitates drug development through identification of biomarkers of efficacy that can stratify patients or provide early indicators of response.
About Avalon Pharmaceuticals
Avalon is a biopharmaceutical company focused on the discovery, development and commercialization of first-in-class cancer therapeutics. Avalon’s lead product candidate, AVN944, an IMPDH inhibitor, is in Phase II clinical development. Avalon also has preclinical programs to develop inhibitors of the Beta-catenin and Aurora/Centrosome pathways, discovery programs for inhibitors of the Survivin and Myc pathways and partnerships with Merck, MedImmune, ChemDiv, Medarex, and Novartis. AvalonRx® is the company’s proprietary platform which is based on large-scale biomarker identification and monitoring, used to discover and develop therapeutics for pathways that have historically been characterized as "undruggable." Avalon is headquartered in Germantown, MD.
Safe Harbor Statement
This announcement contains, in addition to historical information, certain forward-looking statements that involve risks and uncertainties. Such statements reflect the current views of Avalon management and are based on certain assumptions. Actual results could differ materially from those currently anticipated as a result of a number of factors, risks and uncertainties, including those specified under the “Risk Factors” section of our 2006 Annual Report on Form 10-K and updates contained in subsequent filings we make with the Securities and Exchange Commission.
Contact:
Avalon Pharmaceuticals, Inc.
David D. Muth
Executive Vice President &
Chief Business Officer
301-556-9900
Fax: 301-556-9910
info@avalonrx.com
or
Investors:
The Trout Group LLC
Chad Rubin, 646-378-2947
Source: Avalon Pharmaceuticals, Inc.
Avalon Pharmaceuticals to Present on Its Beta-catenin and c-Myc Pathway Inhibitor Programs at the AACR-NCI-EORTC 2007 International Conference
Avalon Pharmaceuticals, Inc. (Nasdaq:AVRX), today announced that it would be presenting four posters at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, October 22-26, 2007, in San Francisco, CA.
The posters to be presented by Avalon will describe program success against two of the most clinically relevant and historically “undruggable” pathways in cancer: Beta-catenin and c-Myc. The posters are titled:
“Compounds selected and optimized from a biomarker based Beta-catenin pathway screen decrease Beta-catenin protein levels in xenograft tumors, induce a gene expression signature consistent with inhibition of beta-catenin activity, and exhibit anti tumor growth properties.” Presentation time: Thursday, October 25, 2007, from 12:30pm-2:30pm and from 5:30pm-7:30pm (PST).
“LC-363: Optimization and in vitro characterization of a novel series of small molecule inhibitors of the Wnt/Beta-catenin signaling pathway.” Presentation time: Thursday, October 25, 2007, from 12:30pm-2:30pm and from 5:30pm-7:30pm (PST).
“A biomarker based high throughput screen identifies small molecular weight modulators of the Beta-catenin pathway.” Presentation time: Tuesday, October 23, 2007, from 12:30pm-2:30pm and from 5:30pm-7:30pm p.m. (PST).
“Biomarker based high-throughput screening for identification of small molecule inhibitors, targeting the antiproliferative property of the c-Myc signaling pathway.” Presentation time: Tuesday, October 23, 2007, from 12:30pm-2:30pm and from 5:30pm-7:30pm p.m. (PST).
About Avalon Pharmaceuticals
Avalon is a biopharmaceutical company focused on the discovery, development and commercialization of first-in-class cancer therapeutics. Avalon’s lead product candidate, AVN944, an IMPDH inhibitor, is in Phase II clinical development. Avalon also has preclinical programs to develop inhibitors of the Beta-catenin and Aurora/Centrosome pathways, discovery programs for inhibitors of the Survivin and Myc pathways and partnerships with Merck, MedImmune, ChemDiv, Medarex, and Novartis. AvalonRx® is the company’s proprietary platform which is based on large-scale biomarker identification and monitoring, used to discover and develop therapeutics for pathways that have historically been characterized as "undruggable." Avalon is headquartered in Germantown, Md.
Yes, I'm still in. Although I have reduced my position recently. I still believe this company has what it takes to significantly appreciate. It's just their timeline, that they publish, is not followed very well, imo. I wonder if their other significant collaboration will still be realized this year. Also, when will the MRK revenues begin? Questions that I have no idea of the answer to.
But yes, the patient optimist that I am compels me to stay long on this one for now.
Are you still in AVRX? I still see AVRX with so much potential for the next year or two. Once it clears these old highs, hopefully see $10,15 then $20. This is still a biotech stock that I want to have money in, instead of just trading it(keep a long as well as a trading position in it)
Bullish Engulfing Patterns (AVRX)
We got a double top breakout created today with the point & figure graph. The new bullish price objective is $9.50
http://stockcharts.com/def/servlet/SC.pnf?chart=AVRX,PLTADANRBO
Moved Above Upper Bollinger Band (AVRX)
Stocks in a New Uptrend (Aroon) (AVRX)
I agree, this is one of a hand full of small cap bio's that you just buy on any type of weakness(this one will be a $20 stock a couple of years)
Yeah, surf. My opinion is we pass the recent 52 week high and by leaps and bounds. This is not just any biotech play. These guys have AvalonRX, somethinbg Merck & Company is willing to pay-out over $200 million to them just to be "lab partners".
Just keep buying AVRX, it should test its old 52 week high if the market stays strong.
Avalon Pharmaceuticals Reports Second Quarter 2007 Financial Results
GERMANTOWN, Md., Aug. 8 /PRNewswire-FirstCall/ -- Avalon Pharmaceuticals, Inc. (Nasdaq: AVRX) today announced results for the three and six months ended June 30, 2007. Second quarter 2007 revenues were $0.1 million and net loss was $5.8 million, or $0.40 per share. For the first six months of 2007, revenues were $0.8 million and net loss was $11.2 million, or $0.82 per share. As of June 30, 2007, the company had $37.9 million in cash, cash equivalents and marketable securities.
'The past three months have been an exciting and productive time for Avalon,' stated Kenneth C. Carter, Ph.D., President and CEO of Avalon. 'We made significant progress in the AVN944 Phase I clinical trial for hematological cancers and initiated a Phase II clinical trial in pancreatic tumors. We also continued to make good progress on our internal pre-clinical programs and our partnerships with Novartis, ChemDiv and Merck. In addition, we strengthened our balance sheet with an equity financing and are pleased to have Eric Winzer join the company as our new CFO.'
Recent Highlights
-- The AVN944 dose-ranging Phase II (Part A) portion of the clinical trial
for pancreatic cancer was initiated and patient enrollment and dosing
began
-- The AVN944 Phase I dose escalation clinical trial continued for
hematological cancer patients as the drug demonstrated an acceptable
safety profile at the doses evaluated to date
-- Data presented on AVN944 at the American Association for Cancer
Research (AACR) 2007 Annual Meeting showed that biomarkers may be
useful for patient stratification
-- The screening phase of the Novartis collaboration was completed
-- Development of the High Throughput Screen (HTS) for the Merck
collaboration was initiated
-- Internal programs for Beta catenin and Aurora pathway inhibitors
continued to progress
-- Raised $20 million in gross proceeds from the May 2007 Private
Placement of Public Equity (PIPE) financing transaction
-- C. Eric Winzer appointed Chief Financial Officer in July 2007, bringing
over 25 years of broad business and financial experience
Financial Results
Revenues for the second quarter of 2007 were $0.1 million, compared with $0.4 million in the second quarter of 2006. Revenues for the six months ended June 30, 2007 were $0.8 million, compared with $1.0 million in the first six months of 2006. Revenues in 2007 were from a collaboration with Novartis Institutes for Biomedical Research, Inc. Revenues in 2006 were from collaborations with MedImmune and the University of Louisville.
Total costs and expenses from operations were $6.1 million in the second quarter of 2007, an increase of $1.0 million compared with the $5.1 million reported for the second quarter of 2006. Total costs and expenses were $12.4 million for the six months ended June 30, 2007, compared with $10.5 million in the comparable period of 2006. The increases in 2007 were principally due to clinical trial costs related to AVN944, research and development payroll expenses and laboratory supplies expenses.
Net loss was $5.8 million for the three months ended June 30, 2007 compared with $4.4 million in the comparable three months of 2006. For the first six months of 2007, net loss was $11.2 million, compared with $9.0 million in the first six months of 2006. Lower revenues and higher costs in the 2007 periods resulted in the higher losses in 2007.
Net loss per share applicable to common shareholders in the second quarter of 2007 was $0.40, compared with a net loss per share of $0.44 in the second quarter of 2006. For the six months ended June 30, 2007, net loss per share applicable to common shareholders was $0.82, compared with a net loss per share of $0.94 in the first six months of 2006. The per share net losses decreased in the 2007 periods despite higher net losses as the weighted average number of shares increased in the 2007 periods compared with the periods in 2006. The weighted average number of shares increased in the 2007 periods due to common stock issued by the company in financing transactions over the past year.
As of June 30, 2007, the company had $37.9 million in cash, cash equivalents and marketable securities. Of that amount, $4.9 million was held in a restricted account to serve as collateral for long-term debt.
CONFERENCE CALL & WEBCAST INFORMATION
Avalon Pharmaceuticals' senior management will host a conference call on Thursday, August 9, 2007 at 8:00 a.m. Eastern Daylight Savings Time, to discuss the quarterly results and recent business highlights. Live audio of the conference call will be available to investors, members of the news media and the general public by dialing 1-866-770-7129 (in the U.S.) and 617-213- 8067 (internationally), and providing the participant passcode, 95694420. To access the call by live webcast, please visit the Investor Relations section of our website at http://www.Avalonrx.com. An archived version of the webcast will also be available through September 30, 2007 on Avalon's website.
About Avalon Pharmaceuticals
Avalon is a biopharmaceutical company focused on the discovery, development and commercialization of first-in-class cancer therapeutics. Our lead product candidate, AVN944, an IMPDH inhibitor, is in Phase II clinical development. We have late stage preclinical programs to develop inhibitors of the Beta-catenin and Aurora pathways, discovery programs for inhibitors of the survivin and Myc pathways and partnerships with Merck, MedImmune, ChemDiv, Medarex, and Novartis. We use AvalonRx(R), our proprietary platform which is based on large-scale biomarker identification and monitoring, to discover and develop therapeutics for pathways that have historically been characterized as 'undruggable.' We are headquartered in Germantown, Maryland.
Forward Looking Statements
This announcement contains, in addition to historical information, certain forward-looking statements that involve risks and uncertainties, in particular, related to progress in our drug discovery programs and our collaborations, and clinical progress in the development of AVN944. Such statements reflect the current views of Avalon management and are based on certain assumptions. Actual results could differ materially from those currently anticipated as a result of a number of factors, risks and uncertainties including the risk that the discovery programs and collaborations may not be successful and that AVN944 will not progress successfully in its clinical trials, and other risks described in our SEC filings. There can be no assurance that our development efforts will succeed, that AVN944 will receive required regulatory clearance or, even if such regulatory clearance is received, that any subsequent products will ultimately achieve commercial success. The information in this Release should be read in conjunction with the Risk Factors set forth in our 2006 Annual Report on Form 10-K and updates contained in subsequent filings we make with the SEC.
AVALON PHARMACEUTICALS, INC.
STATEMENTS OF OPERATIONS
(unaudited)
(in thousands, except share and per share amounts)
Three Months Ended Six Months Ended
June 30, June 30,
2007 2006 2007 2006
Revenues $78 $417 $809 $956
Costs and expenses:
Research and development 4,066 3,338 8,178 6,487
General and administrative 2,043 1,795 4,271 4,048
Total costs and expenses 6,109 5,133 12,449 10,535
Loss from operations (6,031) (4,716) (11,640) (9,579)
Total other income 222 287 486 592
Net loss $(5,809) $(4,429) $(11,154) $(8,987)
Net loss attributed to
common stockholders per
common share -
basic and diluted $(0.40) $(0.44) $(0.82) $(0.94)
Weighted average number of
common shares -
basic and diluted 14,672,577 10,100,052 13,547,779 9,557,757
AVALON PHARMACEUTICALS, INC.
BALANCE SHEETS
(in thousands)
June 30, December 31,
2007 2006
(Unaudited)
ASSETS
Cash, cash equivalents and marketable securities $32,982 $14,910
Restricted cash and securities 4,898 5,520
Property and equipment, net 8,170 8,923
Other assets, net 1,832 2,038
Total assets $47,882 $31,391
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities $5,161 $5,641
Long-term liabilities 6,658 7,876
Total stockholders' equity 36,063 17,874
Total liabilities and stockholders' equity $47,882 $31,391
Contacts:
Avalon Pharmaceuticals Russo Partners, LLC
C. Eric Winzer Wendy Lau (Media)
Executive Vice President & Tel: (212) 845-4272
Chief Financial Officer
Tel: (301) 556-9900 The Trout Group
Fax: (301) 556-9910 Chad Rubin (Investors)
Email: info@avalonrx.com Tel: (646) 378-2947
SOURCE Avalon Pharmaceuticals, Inc.
Source: PR Newswire (August 8, 2007 - 3:31 PM EST)
News by QuoteMedia
www.quotemedia.com
Stocks in a New Uptrend (Aroon) (AVRX) from nightly stockcharts.com scan
Avalon Pharmaceuticals Advances AVN944 into a Phase II Clinical Trial in Solid Tumors
GERMANTOWN, Md., July 12 /PRNewswire-FirstCall/ -- Avalon Pharmaceuticals, Inc. (Nasdaq: AVRX), today announced the initiation of a Phase II clinical trial in pancreatic cancer patients. The protocol has been activated and is now open for enrollment as patients are being evaluated to start study treatment. The first active center is Yale University -- Yale Cancer Center. The Company expects to enroll patients at approximately fifteen sites for the trial.
'The advancement of AVN944 into a Phase II trial in solid tumors represents a significant milestone for AVN944 and Avalon Pharmaceuticals,' said Kenneth C. Carter, Ph.D., President and CEO. 'We believe AVN944 has the potential to provide patient benefit in several cancer types.'
The trial will be conducted in two parts (Part A and Part B), both using an open-label, non-controlled design. Eligible patients will include adult patients with advanced newly diagnosed pancreatic cancer. Part A is a dose- escalation study with a primary objective to determine the maximum tolerated dose or effective biologic dose of AVN944 in combination with gemcitabine. Approximately 15-20 patients will be enrolled in Part A. Part B is to establish the efficacy and safety of the AVN944/gemcitabine combination and approximately 110-120 patients will be enrolled. Patients will receive an initial treatment cycle of AVN944 and gemcitabine and may receive additional cycles of treatment every 28 days at the discretion of the Investigator and with the agreement of the patient. Information on the trial is available at the National Institutes of Health clinical trial database and will be updated when additional sites initiate treatment, www.ClinicalTrials.gov (a service of the U.S. National Institutes of Health developed by the National Library of Medicine).
About AVN944
AVN944 is an oral small molecule drug candidate that inhibits inosine monosphospate dehydrogenase (IMPDH), an enzyme that is critical for cells to be able to synthesize guanosine triphosphate (GTP), a molecule required for DNA synthesis and cellular signaling. IMPDH is over expressed in some cancer cells, especially in the case of hematological malignancies. In laboratory experiments, AVN944 has been shown to inhibit IMPDH activity in cells, and suppress pools of GTP. Anticancer activities of IMPDH inhibitors correlate with sustained depletion of GTP pools both in cellular models and in human subjects. AVN944 appears to have a selective effect on cancer cells in that deprivation of GTP in normal cells results in a temporary slowing of cell growth, while GTP deprivation in cancer cells induces cell death, or apoptosis.
Results from preclinical studies of AVN944 indicate that AVN944 inhibited the proliferation of lymphoid and myeloid cells, the principal cells involved in the most common types of human leukemias. In a single-dose, dose- escalation Phase I clinical trial of AVN944 conducted in the United Kingdom in healthy volunteers, AVN944: (1) was well tolerated at all tested doses with no notable side effects; (2) demonstrated good pharmacokinetic properties; and (3) had a significant inhibitory effect on IMPDH enzyme activity. Avalon filed an IND with the FDA in August 2005 and initiated U.S. phase I clinical trials in January 2006 for the treatment of hematological cancers.
About Gemcitabine HCI (GEMZAR(TM))
Gemcitabine is a chemotherapy drug that is used to treat certain types of cancer (non-small cell lung cancer, metastatic breast cancer, ovarian cancer, and pancreatic cancer). Chemotherapy drugs act to control the growth of rapidly dividing cells, including cancer cells. (Cancer cells are abnormal cells which are growing at an uncontrolled rate.) The goal of chemotherapy is to kill as many cancer cells as possible or to stop them from dividing and making more cancer cells. Gemcitabine works by interfering with the process by which cells divide and repair themselves, thus preventing the further growth of cancer cells and leading to cell death.
About Avalon Pharmaceuticals
Avalon Pharmaceuticals is a biopharmaceutical company using its proprietary technology, AvalonRx(R), to discover and develop cancer therapeutics. Avalon has a lead product in Phase I clinical development (AVN944 -- IMPDH inhibitor), as well as preclinical programs to discover inhibitors for the beta-catenin and aurora pathways now in late stage lead candidate optimization. Avalon also has discovery programs on modulators of survivin function and a drug discovery program targeting the MYC oncoprotein, one of the most important and previously intractable cancer targets. The Company has value generating partnerships with Merck, MedImmune, Medarex, and Novartis. Avalon Pharmaceuticals was established in 1999 and is headquartered in Germantown, Maryland.
Safe Harbor Statement
This announcement contains, in addition to historical information, certain forward-looking statements that involve risks and uncertainties, in particular, related to progress in our drug discovery programs and our collaborations, and clinical progress in the development of AVN944. Such statements reflect the current views of Avalon management and are based on certain assumptions. Actual results could differ materially from those currently anticipated as a result of a number of factors, risks and uncertainties including the risk that the discovery programs and collaborations may not be successful and that AVN944 will not progress successfully in its clinical trials, and other risks described in our SEC filings. There can be no assurance that our development efforts will succeed, that AVN944 will receive required regulatory clearance or, even if such regulatory clearance is received, that any subsequent products will ultimately achieve commercial success. The information in this Release should be read in conjunction with the Risk Factors set forth in our 2006 Annual Report, on Form 10-K and updates contained in subsequent filings we make with the SEC.
Contacts:
Avalon Pharmaceuticals, Inc. Russo Partners, LLC
David D. Muth Wendy Lau (Media)
Executive Vice President & Tel: (212) 845-4272
Chief Business Officer
Tel: (301) 556-9900
Fax: (301) 556-9910 The Trout Group LLC
Email: info@avalonrx.com Chad Rubin (Investors)
Tel: (646) 378-2947
SOURCE Avalon Pharmaceuticals, Inc.
Source: PR Newswire (July 12, 2007 - 6:01 AM EST)
woops news$$$$
Avalon Pharmaceuticals Advances AVN944 Into A Phase II Clinical Trial In Solid TumorsLast update: 7/12/2007 7:00:48 AM(MORE TO FOLLOW) Dow Jones NewswiresJuly 12, 2007 07:00 ET (11:00 GMT)Copyright © 2007
im buying a block after alt gets bought out in next 7 days
I see avrx as at least $25 if not $45 within 24 months
Bought back into AVRX, want to be in it for the next move(still a thin stock)
US Hot Stocks To Watch: AVRX BW CLC CFI DRI DIGE BEC -2-Last update: 6/20/2007 7:39:04 AMAmong the companies whose shares are expected to see active trading in Wednesday's session are Circuit City Stores Inc., FedEx Corp., and Morgan Stanley. CarMax Inc. (KMX, $23.19, $0.06, 0.26%) is expected to report first-quarter earnings of 30 cents a share, according to a survey of analysts by Thomson Financial. Circuit City (CC, $16.07, -$0.46, -2.78%) is expected to post a loss of 32 cents a share for the first quarter. Commercial Metals Co. (CMC, $34.80, $0.26, 0.75%) is expected to report third-quarter earnings of 79 cents a share. FedEx (FDX, $108.06, -$1.86, -1.69%) is expected to post earnings of $1.96 a share for the fourth quarter. Morgan Stanley (MS, $87.80, -$0.70, -0.79%) is expected to report second-quarter earnings of $2.01 a share. Sonic Corp. (SONC, $23.93, -$0.37, -1.52%) is expected to post earnings of 31 cents a share for the third quarter. After Tuesday's closing bell, Home Depot Inc. (HD, $38.27, $0.31, 0.82%) said it is selling its contractor-supplies business to a consortium of private-equity companies for $10.3 billion and using a big portion of the proceeds to fund a massive $22.5 billion share buyback. ATS Medical Inc. (ATSI, $1.61, $0.06, 3.87%) said it has agreed to acquire the surgical cryoablation business of CryoCath Technologies Inc. Under the terms of the deal, ATS will pay $22 million upon closing, $2 million upon the achievement of certain milestones, $2 million two years after closing and up to $4 million in contingent payments based on future sales of Surgifrost XL. Minneapolis-based ATS expects the acquisition to add immediately to its earnings. The company forecast a net loss for the first half of 2008, but now expects to be profitable in the second half of 2008, a year ahead of its previous forecast. For the remainder of 2007, ATA expects the deal to add $3 million to $5 million in incremental revenue, and $16 million to $19 million in revenue in 2008. The deal is expected to close within 10 days. Avalon Pharmaceuticals Inc. (AVRX, $5.11, -$0.02, -0.39%) said that a Phase I trial of AVN944, its treatment for hematologic malignancies in elderly and refractory patients, has shown continued positive interim results. The interim data indicates AVN944 is well tolerated, has dose-dependent pharmacokinetics, induces biomarkers of programmed cell death in cancer cells from patients, and demonstrates stabilized disease in almost half of the patients after one month of treatment, the Germantown, Md.-based biopharmaceutical company said. Avalon also said it continues to believe the Phase I trial will provide sufficient information to begin multiple Phase II studies
Actually, $6 was last trade AH.
Tomorrow we make a signifcant move up.
Avalon Pharma: Cancer Treatment Shows Promise In Phase ILast update: 6/19/2007 5:40:54 PMDOW JONES NEWSWIRES Avalon Pharmaceuticals Inc. (AVRX) late Tuesday said that a Phase I trial of AVN944, its treatment for hematologic malignancies in elderly and refractory patients, has shown continued positive interim results. The interim data indicates AVN944 is well tolerated, has dose-dependent pharmacokinetics, induces biomarkers of programmed cell death in cancer cells from patients, and demonstrates stabilized disease in almost half of the patients after one month of treatment, the Germantown, Md.-based biopharmaceutical company said. Avalon also said it continues to believe the Phase I trial will provide sufficient information to begin multiple Phase II studies. -Katherine Hunt; 415-439-6400; AskNewswires
THIS WILL NOT BE ONLY NEWS I EXPECT TO HEAR FROM MERK NOW$$$
I may sell some in PM trading in the morning if we get some nice PPS action & some volume(reason, many of these bio-spikes are at the highest price/point for the day in PM trading)
NICE UP WE GO ASK 5.76 IN AH
Avalon Pharmaceuticals Announces Positive Interim Results For AVN944 Phase I Trial
-- 46% of Evaluable Patients Show Stabilized Disease; Biomarkers Correlate with Clinical Effect and Demonstrate Potential for Patient Stratification --
-- Conference Call and Webcast on Wednesday, June 20th at 8 a.m. EDT --
GERMANTOWN, Md., June 19 /PRNewswire-FirstCall/ -- Avalon Pharmaceuticals, Inc. (Nasdaq: AVRX), today announced continued positive interim results from its Phase I study of AVN944, for the treatment of hematologic malignancies in elderly and refractory patients. Interim data indicate AVN944 is well tolerated, has dose-dependent pharmacokinetics, induces biomarkers of programmed cell death in cancer cells from patients, and demonstrates stabilized disease in almost half of the patients after one-month of treatment.
'We continue to be encouraged by the positive interim results from the AVN944 trial,' stated Michael Hamilton, M.D., Avalon Pharmaceuticals' Chief Medical Officer. 'We have observed important indications of biological drug effect and disease stabilization in a significant number of patients. We continue to believe the Phase I trial will provide sufficient information to initiate multiple Phase II studies.'
Background: AVN944 is an oral small molecule drug that inhibits inosine monosphospate dehydrogenase (IMPDH), a critical enzyme for synthesis of guanosine triphosphate (GTP), a molecule required for DNA synthesis and cellular signaling. IMPDH is over expressed in many cancer cells. Pre-clinical studies showed that AVN944 is a highly specific inhibitor of IMPDH, suppresses pools of GTP, and in cultured cells has a selective growth inhibition effect on cancer cells vs. normal cells.
An earlier single-dose, dose-escalation, healthy volunteer clinical trial conducted in the United Kingdom showed that AVN944 was well tolerated at all tested doses with no notable side effects; had good pharmacokinetic properties; and had a significant inhibitory effect on IMPDH enzyme activity.
Study Design: The current U.S. Phase I study is a repeat-dose dose escalation trial in patients with advanced hematologic malignancies. Patients are dosed for 21 days on a 28-day cycle. A minimum of three patients are treated at each dose level. The study is divided into two arms, one for treatment of leukemia patients and the other for treatment of patients with lymphoma and myeloma. For the leukemia arm of the study, patients are currently being treated at the tenth dose level, 250 mg twice daily. For the lymphoma and myeloma arm, patients are currently being treated at the sixth dose level, 150 mg twice daily.
Positive Safety and Tolerability Data: The goal of the Phase I study is to establish the safety, tolerability and pharmacokinetics of the drug. Thus far, 104 one-month cycles of AVN944 have been initiated in 46 patients and the compound is well tolerated. Pharmacokinetics measurements indicate dose proportional plasma levels of AVN944 during treatment and sustained plasma concentrations at the dose levels tested thus far.
Early Activity Indicators: This Phase I study is designed to evaluate several pharmacodynamic and efficacy-related endpoints. Upon entering the trial, all patients have refractory, progressive disease and have failed all prior therapies. Thus far, 18 of 39 evaluable patients (46%) showed stabilized disease after one cycle of treatment with AVN944. These include patients with both leukemia and multiple myeloma. Patients who have achieved stable disease following completion of a one-month treatment cycle with AVN944, as determined by the clinical investigator, may be advanced to a subsequent cycle.
In the multiple myeloma cohort 60% of the patients have achieved stabilized disease after one month. Two of these patients completed five months of treatment and two others completed one full year of treatment. One AML patient has completed 8 monthly cycles of treatment.
Positive Dose Dependent Biomarker Data: The AvalonRx(R) platform has identified selected biomarkers from patient samples which show a correlation of changes in gene expression in a dose dependent manner. Importantly, several of these markers display a durable, sustained stress response indicative of cancer cell death, particularly in cancer cells from AML patients. As dose levels increase the biomarkers reflect an even greater impact of AVN944 on the cancer cells. Direct markers of apoptosis are induced at these higher levels, including members of the Bcl2 gene family which play a critical role in programmed cell death. Additionally, the IMPDH enzyme is inhibited and GTP pools are also depleted for more sustained time periods in treated patients.
Potential Study Stratification Biomarker Data: Additionally we have identified a genetic signature, existing prior to drug exposure, which correlates strongly with disease stabilization in the first cycle of therapy. While still preliminary, based on a small patient sampling, this signature could be the foundation for future patient stratification strategies in phase II and III clinical trials.
Teleconference and Webcast: The company will host a conference call on Wednesday, June 20, 2007 at 8 a.m. Eastern Daylight Time to discuss the interim results of the AVN944 Phase I clinical trial. Interested investors, analysts, members of the media and the general public can listen to the call live over the Internet from the investor section of the company's Web site or by dialing the numbers listed below. A detailed PowerPoint presentation will accompany the webcast.
Conference Call Details:
Dial-In: (800) 291-5365 (U.S.)
(617) 614-3922 (International)
Pass code: 74005634
Webcast: Please go to www.avalonrx.com, Investor Relations,
within 15 minutes prior to the call and select the
webcast link. If listening by phone and viewing the
slides, please choose the 'listen via phone' option to
view the slides in real time as there is a 30 second
delay otherwise. The conference call replay will be
available through August 15, 2007 on Avalon's website
(www.avalonrx.com).
About Avalon Pharmaceuticals
Avalon Pharmaceuticals is a biopharmaceutical company focused on the discovery and development of potential first-in-class cancer therapeutics. Avalon has a lead product in Phase I clinical development (AVN944), preclinical programs to develop inhibitors for the Beta-catenin and Aurora pathways, discovery programs for Survivin and Myc pathway inhibitors, and value generating partnerships with Merck, MedImmune, Medarex, and Novartis. By utilizing AvalonRx(R) our platform technology, based upon the proprietary use of large-scale gene expressions, we are uniquely positioned to develop therapeutics focused on pathways that have historically been characterized as 'undruggable'. Avalon was established in 1999 and is headquartered in Germantown, Md.
About AvalonRx(R)
AvalonRx(R) is a comprehensive, innovative and proprietary suite of technologies based upon large-scale gene expression analysis. This platform facilitates drug discovery by expanding the range of therapeutic targets for drug intervention, including targets and target pathways frequently considered intractable using conventional HTS approaches, allows more informed decisions about which compounds to advance towards clinical trials, and facilitates drug development through identification of biomarkers of efficacy that can stratify patients or provide early indicators of response.
Safe Harbor Statement
This announcement contains, in addition to historical information, certain forward-looking statements that involve risks and uncertainties, in particular, related to clinical progress in the development of AVN944. Such statements reflect the current views of Avalon management and are based on certain assumptions. Actual results could differ materially from those currently anticipated as a result of a number of factors, risks and uncertainties including the risk that AVN944 will not progress successfully in its clinical trials, and other risks described in our SEC filings. There can be no assurance that our development efforts will succeed, that AVN944 will receive required regulatory clearance or, even if such regulatory clearance is received, that any subsequent products will ultimately achieve commercial success. The information in this Release should be read in conjunction with the Risk Factors set forth in our 2006 Annual Report on Form 10-K and updates contained in subsequent filings we make with the SEC.
Contacts:
Avalon Pharmaceuticals, Inc. Russo Partners, LLC
David D. Muth Wendy Lau (Media)
Executive Vice President Tel: (212) 845-4272
Chief Business Officer
Tel: (301) 556-9900 The Trout Group LLC
Fax: (301) 556-9910 Chad Rubin (Investors)
Email: info@avalonrx.com Tel: (646) 378-2947
SOURCE Avalon Pharmaceuticals, Inc.
Source: PR Newswire (June 19, 2007 - 5:30 PM EDT)
News by QuoteMedia
www.quotemedia.com
wed important update from avrx = $$$$ zoom zoom
OK, boys and girls! IMO, we are getting ready for some significant gains here.
Phase 2 on avn944 to be announced soon, imvho
AVALON PHARMACEUTICALS, INC.
(Name of Issuer)
COMMON STOCK
(Title of Class of Securities)
05246P106
(CUSIP Number)
May 31, 2007
(Date of Event Which Requires Filing of this Statement)
Check the appropriate box to designate the rule pursuant to which this Schedule
is filed:
X Rule 13d-1(b)
____ Rule 13d-1(c)
____ Rule 13d-1(d)
*The remainder of this cover page shall be filled out for a reporting person's initial filing on this form with respect to the subject class of securities, and for any subsequent amendment containing information which would alter the disclosures provided in a prior cover page.
The information required in the remainder of this cover page shall not be deemed to be "filed" for the purpose of Section 18 of the Securities Exchange Act of 1934 ("Act") or otherwise subject to the liabilities of that section of the Act but shall be subject to all other provisions of the Act (however, see the Notes).
CUSIP No. 05246P106
----------------------------------------------------------------------------
1. Names of Reporting Persons.
I.R.S. Identification Nos. of above persons (entities only).
Federated Investors, Inc.
2. Check the Appropriate Box if a Member of a Group (See Instructions)
(a)................................................
(b)................................................
3. SEC Use Only.......................................
4. Citizenship or Place of Organization: Pennsylvania
Number of 5. Sole Voting Power 1,387,500
Shares Bene-
ficially by 6. Shared Voting Power
Owned by Each
Reporting 7. Sole Dispositive Power 1,387,500
Person With:
8. Shared Dispositive Power
9. Aggregate Amount Beneficially Owned by Each Reporting Person
1,387,500
10. Check if the Aggregate Amount in Row (9) Excludes Certain Shares
(See Instructions)
11. Percent of Class Represented by Amount in Row (9) 10.41%
12. Type of Reporting Person (See Instructions) HC
1. Names of Reporting Persons.
I.R.S. Identification Nos. of above persons (entities only).
Voting Shares Irrevocable Trust
2. Check the Appropriate Box if a Member of a Group (See Instructions)
(a).................................................
(b).................................................
3. SEC Use Only........................................
4. Citizenship or Place of Organization: Pennsylvania
Number of 5. Sole Voting Power 1,387,500
Shares Bene-
ficially by 6. Shared Voting Power
Owned by Each
Reporting 7. Sole Dispositive Power 1,387,500
Person With:
8. Shared Dispositive Power
9. Aggregate Amount Beneficially Owned by Each Reporting Person
1,387,500
10. Check if the Aggregate Amount in Row (9) Excludes Certain Shares
(See Instructions)
11. Percent of Class Represented by Amount in Row (9) 10.41%
12. Type of Reporting Person (See Instructions) OO
1. Names of Reporting Persons.
I.R.S. Identification Nos. of above persons (entities only).
John F. Donahue
2. Check the Appropriate Box if a Member of a Group (See Instructions)
(a)...................................................
(b)...................................................
3. SEC Use Only..........................................
4. Citizenship or Place of Organization: United States
Number of 5. Sole Voting Power
Shares Bene-
ficially by 6. Shared Voting Power 1,387,500
Owned by Each
Reporting 7. Sole Dispositive Power
Person With:
8. Shared Dispositive Power 1,387,500
9. Aggregate Amount Beneficially Owned by Each Reporting Person
1,387,500
10. Check if the Aggregate Amount in Row (9) Excludes Certain Shares
(See Instructions)
11. Percent of Class Represented by Amount in Row (9) 10.41%
12. Type of Reporting Person (See Instructions) IN
1. Names of Reporting Persons.
I.R.S. Identification Nos. of above persons (entities only).
Rhodora J. Donahue
2. Check the Appropriate Box if a Member of a Group (See Instructions)
(a).....................................................
(b).....................................................
3. SEC Use Only............................................
4. Citizenship or Place of Organization: United States
Number of 5. Sole Voting Power
Shares Bene-
ficially by 6. Shared Voting Power 1,387,500
Owned by Each
Reporting 7. Sole Dispositive Power
Person With:
8. Shared Dispositive Power 1,387,500
9. Aggregate Amount Beneficially Owned by Each Reporting Person
1,387,500
10. Check if the Aggregate Amount in Row (9) Excludes Certain Shares
(See Instructions)
11. Percent of Class Represented by Amount in Row (9) 10.41%
12. Type of Reporting Person (See Instructions) IN
1. Names of Reporting Persons.
I.R.S. Identification Nos. of above persons (entities only).
J. Christopher Donahue
2. Check the Appropriate Box if a Member of a Group (See Instructions)
(a).......................................................
(b).......................................................
3. SEC Use Only..............................................
4. Citizenship or Place of Organization: United States
Number of 5. Sole Voting Power
Shares Bene-
ficially by 6. Shared Voting Power 1,387,500
Owned by Each
Reporting 7. Sole Dispositive Power
Person With:
8. Shared Dispositive Power 1,387,500
9. Aggregate Amount Beneficially Owned by Each Reporting Person
1,387,500
10. Check if the Aggregate Amount in Row (9) Excludes Certain Shares
(See Instructions)
11. Percent of Class Represented by Amount in Row (9) 10.41%
12. Type of Reporting Person (See Instructions) IN
INSTRUCTIONS FOR SCHEDULE 13G
Instructions for Cover Page
(l) Names and I.R.S. Identification Numbers of Reporting Persons--Furnish the full legal name of each person for whom the report is filed--i.e., each person required to sign the schedule itself--including each member of a group. Do not include the name of a person required to be identified in the report but who is not a reporting person. Reporting persons that are entities are also requested to furnish their I.R.S. identification numbers, although disclosure of such numbers is voluntary, not mandatory (see "SPECIAL INSTRUCTIONS FOR COMPLYING WITH SCHEDULE 13G" below).
(2) If any of the shares beneficially owned by a reporting person are held as a member of a group and that membership is expressly affirmed, please check row 2(a). If the reporting person disclaims membership in a group or describes a relationship with other persons but does not affirm the existence of a group, please check row 2(b) [unless it is a joint filing pursuant to Rule 13d-1(k)(1) in which case it may not be necessary to check row 2(b)].
(3) The third row is for SEC internal use; please leave blank.
(4) Citizenship or Place of Organization--Furnish citizenship if the named reporting person is a natural person. Otherwise, furnish place of organization.
(5)-(9), (11) Aggregate Amount Beneficially Owned By Each Reporting Person, Etc.--Rows (5) through (9) inclusive, and (11) are to be completed in accordance with the provisions of Item 4 of Schedule 13G. All percentages are to be rounded off to the nearest tenth (one place after decimal point).
(10) Check if the aggregate amount reported as beneficially owned in row (9) does not include shares as to which beneficial ownership is disclaimed pursuant to Rule 13d-4 (17 CFR 240.13d-4] under the Securities Exchange Act of 1934.
(12) Type of Reporting Person--Please classify each "reporting person" according to the following breakdown (see Item 3 of Schedule 13G) and place the appropriate symbol on the form:
Category Symbol
Broker Dealer BD
Bank BK
Insurance Company IC
Investment Company IV
Investment Adviser IA
Employee Benefit Plan, Pension Fund,
or Endowment Fund EP
Parent Holding Company/Control Person HC
Savings Association SA
Church Plan CP
Corporation CO
Partnership PN
Individual IN
Other OO
Notes:
Attach as many copies of the second part of the cover page as are needed, one reporting person per page.
Filing persons may, in order to avoid unnecessary duplication, answer items on the schedules (Schedule 13D, 13G or 14D-1) by appropriate cross references to an item or items on the cover page(s). This approach may only be used where the cover page item or items provide all the disclosure required by the schedule item. Moreover, such a use of a cover page item will result in the item becoming a part of the schedule and accordingly being considered as "filed" for purposes of Section 18 of the Securities Exchange Act or otherwise subject to the liabilities of that section of the Act.
Reporting persons may comply with their cover page filing requirements by filing either completed copies of the blank forms available from the Commission, printed or typed facsimiles, or computer printed facsimiles, provided the documents filed have identical formats to the forms prescribed in the Commission's regulations and meet existing Securities Exchange Act rules as to such matters as clarity and size (Securities Exchange Act Rule 12b-12).
SPECIAL INSTRUCTIONS FOR COMPLYING WITH SCHEDULE 13G
Under Sections 13(d), 13(g), and 23 of the Securities Exchange Act of 1934 and the rules and regulations thereunder, the Commission is authorized to solicit the information required to be supplied by this schedule by certain security holders of certain issuers.
Disclosure of the information specified in this schedule is mandatory, except for I.R.S. identification numbers, disclosure of which is voluntary. The information will be used for the primary purpose of determining and disclosing the holdings of certain beneficial owners of certain equity securities. This statement will be made a matter of public record. Therefore, any information given will be available for inspection by any member of the public.
Because of the public nature of the information, the Commission can use it for a variety of purposes, including referral to other governmental authorities or securities self-regulatory organizations for investigatory purposes or in connection with litigation involving the Federal securities laws or other civil, criminal or regulatory statutes or provisions. I.R.S. identification numbers, if furnished, will assist the Commission in identifying security holders and, therefore, in promptly processing statements of beneficial ownership of securities.
Failure to disclose the information requested by this schedule, except for I.R.S. identification numbers, may result in civil or criminal action against the persons involved for violation of the Federal securities laws and rules promulgated thereunder.
GENERAL INSTRUCTIONS
A. Statements filed pursuant to Rule 13d-1(b) containing the information required by this schedule shall be filed not later than February 14 following the calendar year covered by the statement or within the time specified in Rules 13d-1(b)(2) and 13d-2(c). Statements filed pursuant to Rule 13d-1(c) shall be filed within the time specified in Rules 13d-1(c), 13d-2(b) and 13d-2(d). Statements filed pursuant to Rule 13d-1(d) shall be filed not later than February 14 following the calendar year covered by the statement pursuant to Rules 13d-1(d) and 13d-2(b).
B. Information contained in a form which is required to be filed by rules under section 13(f) (15 U.S.C. 78m(f)) for the same calendar year as that covered by a statement on this schedule may be incorporated by reference in response to any of the items of this schedule. If such information is incorporated by reference in this schedule, copies of the relevant pages of such form shall be filed as an exhibit to this schedule.
C. The item numbers and captions of the items shall be included but the text of the items is to be omitted. The answers to the items shall be so prepared as to indicate clearly the coverage of the items without referring to the text of the items. Answer every item. If an item is inapplicable or the answer is in the negative, so state.
Item 1.
(a) Name of Issuer
Avalon Pharmaceuticals, Inc.
(b) Address of Issuer's Principal Executive Offices
20358 Seneca Meadows Parkway
Germantown, MD 20876
Item 2.
(a) Name of Person Filing
(b) Address of Principal Business Office or, if none, Residence
Federated Investors Tower, Pittsburgh, PA 15222-3779
(c) Citizenship
(d) Title of Class of Securities
Common Stock
(e) CUSIP Number
05246P106
Item 3. If this statement is filed pursuant to ss.ss.240.13d-1(b) or
240.13d-2(b) or (c), check whether the person filing is a:
(a) ____ Broker or dealer registered under section 15 of the
Act (15 U.S.C. 78o).
(b) ____ Bank as defined in section 3(a)(6) of the Act
(15 U.S.C. 78c).
(c) ____ Insurance company as defined in section 3(a)(19) of
the Act (15 U.S.C. 78c).
(d) ____ Investment company registered under section 8 of the
Investment Company Act of 1940 (15 U.S.C 80a-8).
(e) ____ An investment adviser in accordance with
ss.240.13d-1(b)(1)(ii)(E);
(f) ____ An employee benefit plan or endowment fund in
accordance with ss.240.13d-1(b)(1)(ii)(F);
(g) __X__ A parent holding company or control person in
accordance with ss. 240.13d-1(b)(1)(ii)(G);
(h) ____ A savings associations as defined in Section 3(b) of
the Federal Deposit Insurance Act (12 U.S.C. 1813);
(i) ____ A church plan that is excluded from the
definition of an investment company under section
3(c)(14) of the Investment Company Act of 1940 (15
U.S.C. 80a-3);
(j) ____ Group, in accordance with
ss.240.13d-1(b)(1)(ii)(J).
Item 4. Ownership.
Provide the following information regarding the aggregate number and percentage of the class of securities of the issuer identified in Item 1.
A. Federated Investors, Inc. (See Footnote 1, next page)
(a) Amount beneficially owned: 1,387,500
(b) Percent of class: 10.41%
(c) Number of shares as to which the person has:
(i) Sole power to vote or to direct the vote 1,387,500
(ii) Shared power to vote or to direct the vote -0-
(iii) Sole power to dispose or to direct the disposition of 1,387,500
(iv) Shared power to dispose or to direct the disposition of -0-
B. Voting Shares Irrevocable Trust
(a) Amount beneficially owned: 1,387,500
(b) Percent of class: 10.41%
(c) Number of shares as to which the person has:
(i) Sole power to vote or to direct the vote 1,387,500
(ii) Shared power to vote or to direct the vote -0-
(iii) Sole power to dispose or to direct the disposition of 1,387,500
(iv) Shared power to dispose or to direct the disposition of -0-
C. John F. Donahue
(a) Amount beneficially owned: 1,387,500
(b) Percent of class: 10.41%
(c) Number of shares as to which the person has:
(i) Sole power to vote or to direct the vote -0-
(ii) Shared power to vote or to direct the vote 1,387,500
(iii) Sole power to dispose or to direct the disposition of -0- (iv) Shared power to dispose or to direct the disposition of 1,387,500
D. Rhodora J. Donahue
(a) Amount beneficially owned: 1,387,500
(b) Percent of class: 10.41%
(c) Number of shares as to which the person has:
(i) Sole power to vote or to direct the vote -0-
(ii) Shared power to vote or to direct the vote 1,387,500
(iii) Sole power to dispose or to direct the disposition of -0-
(iv) Shared power to dispose or to direct the disposition of 1,387,500
E. J. Christopher Donahue
(a) Amount beneficially owned: 1,387,500
(b) Percent of class: 10.41%
(c) Number of shares as to which the person has:
(i) Sole power to vote or to direct the vote -0-
(ii) Shared power to vote or to direct the vote 1,387,500
(iii) Sole power to dispose or to direct the disposition of -0-
(iv) Shared power to dispose or to direct the disposition of 1,387,500
Instruction. For computations regarding securities which represent a right to acquire an underlying security see ss.240.13d-3(d)(1).
Item 5. Ownership of Five Percent or Less of a Class
If this statement is being filed to report the fact that as of the date hereof the reporting person has ceased to be the beneficial owner of more than five percent of the class of securities, check the following ____.
Instruction: Dissolution of a group requires a response to this item.
Item 6. Ownership of More than Five Percent on Behalf of Another Person.
NOT APPLICABLE
Item 7. Identification and Classification of the Subsidiary Which Acquired the
Security Being Reported on By the Parent Holding Company See Exhibit "1" Attached
Item 8. Identification and Classification of Members of the Group
NOT APPLICABLE
Item 9. Notice of Dissolution of Group NOT APPLICABLE
Item 10. Certification
(a) The following certification shall be included if the statement is filed pursuant to ss.240.13d-1(b):
By signing below I certify that, to the best of my knowledge and belief, the securities referred to above were acquired and are held in the ordinary course of business and were not acquired and are not held for the purpose of or with the effect of changing or influencing the control of the issuer of the securities and were not acquired and are not held in connection with or as a participant in any transaction having that purpose or effect.
(b) The following certification shall be included if the statement is filed pursuant to ss.240.13d-1(c):
By signing below I certify that, to the best of my knowledge and belief, the securities referred to above were not acquired and are not held for the purpose of or with the effect of changing or influencing the control of the issuer of the securities and were not acquired and are not held in connection with or as a participant in any transaction having that purpose or effect.
SIGNATURE
After reasonable inquiry and to the best of my knowledge and belief, I certify that the information set forth in this statement is true, complete and correct.
Date: June 8, 2007
By: /s/J. Christopher Donahue
Name/Title: J. Christopher Donahue, as President of Federated Investors, Inc.
Date: June 8, 2007
By: /s/John F. Donahue, individually and as Trustee of Voting Shares
Irrevocable Trust, by J. Christopher Donahue, as attorney-in-fact
Date: June 8, 2007
By: /s/Rhodora J. Donahue, individually and as Trustee of Voting Shares
Irrevocable Trust, by J. Christopher Donahue, as attorney-in-fact
Date: June 8, 2007
By: /s/J. Christopher Donahue
Name/Title: J. Christopher Donahue, individually and as Trustee of Voting
Shares Irrevocable Trust
The original statement shall be signed by each person on whose behalf the statement is filed or his authorized representative. If the statement is signed on behalf of a person by his authorized representative other than an executive officer or general partner of the filing person, evidence of the representative's authority to sign on behalf of such person shall be filed with the statement, provided, however, that a power of attorney for this purpose which is already on file with the Commission may be incorporated by reference. The name and any title of each person who signs the statement shall be typed or printed beneath his signature.
NOTE: Schedules filed in paper format shall include a signed original and five copies of the schedule, including all exhibits. See ss.240.13d-7 for other parties for whom copies are to be sent.
Attention: Intentional misstatements or omissions of fact constitute Federal criminal violations (See 18 U.S.C. 1001)
EXHIBIT "1"
ITEM 3 CLASSIFICATION OF
REPORTING PERSONS
Identity and Classification of Each Reporting Person
IDENTITY CLASSIFICATION UNDER ITEM 3
Advance Series Trust d) Investment company registered under
section 8 of the Investment Company Act
of 1940 (15 U.S.C. 80a-8).
Federated Equity Funds d) Investment company registered under
section 8 of the Investment Company Act
of 1940 (15 U.S.C. 80a-8).
Federated Index Trust d) Investment company registered under
section 8 of the Investment Company Act
of 1940 (15 U.S.C. 80a-8).
Federated Insurance Series d) Investment company registered under
section 8 of the Investment Company Act
of 1940 (15 U.S.C. 80a-8).
Federated Equity Management Company (e) Investment Adviser registered under
of Pennsylvania section 203 of the Investment Advisers
Act of 1940
Federated Global Investment (e) Investment Adviser registered under
Management Corp. section 203 of the Investment Advisers
Act of 1940
Federated Investors, Inc. (g) Parent Holding Company, in
accordance with Section
240.13d-1(b)(ii)(G)
FII Holdings, Inc. (g) Parent Holding Company, in
accordance with Section
240.13d-1(b)(ii)(G)
Voting Shares Irrevocable Trust (g) Parent Holding Company, in
accordance with Section
240.13d-1(b)(ii)(G)
John F. Donahue (g) Parent Holding Company, in
accordance with Section
240.13d-1(b)(ii)(G)
Rhodora J. Donahue (g) Parent Holding Company, in
accordance with Section
240.13d-1(b)(ii)(G)
J. Christopher Donahue (g) Parent Holding Company, in
accordance with Section
240.13d-1(b)(ii)(G)
Federated Investors, Inc. (the "Parent") is filing this Schedule 13G because it is the parent holding company of Federated Equity Management Company of Pennsylvania and Federated Global Investment Management Corp. (the "Investment Advisers"), which act as investment advisers to registered investment companies and separate accounts that own shares of common stock in AVALON PHARMACEUTICALS, INC. (the "Reported Securities'). The Investment Advisers are wholly owned subsidiaries of FII Holdings, Inc., which is wholly owned subsidiary of Federated Investors, Inc., the Parent. All of the Parent's outstanding voting stock is held in the Voting Shares Irrevocable Trust (the "Trust") for which John F. Donahue, Rhodora J. Donahue and J. Christopher Donahue act as trustees (collectively, the "Trustees"). The Trustees have joined in filing this Schedule 13G because of the collective voting control that they exercise over the Parent. In accordance with Rule 13d-4 under the Securities Act of 1934, as amended, the Parent, the Trust, and each of the Trustees declare that this statement should not be construed as an admission that they are the beneficial owners of the Reported Securities, and the Parent, the Trust, and each of the Trustees expressly disclaim beneficial ownership of the Reported Securities
EXHIBIT "2"
AGREEMENT FOR JOINT FILING OF
SCHEDULE 13G
The following parties hereby agree to file jointly the statement on Schedule 13G to which this Agreement is attached and any amendments thereto which may be deemed necessary pursuant to Regulation 13D-G under the Securities Exchange Act of 1934:
1. Federated Investors, Inc. as parent holding company of the investment advisers to registered investment companies that beneficially own the securities.
Voting Shares Irrevocable Trust, as holder of all the voting shares of Federated Investors, Inc.
John F. Donahue, individually and as Trustee
Rhodora J. Donahue, individually and as Trustee
J. Christopher Donahue, individually and as Trustee
It is understood and agreed that each of the parties hereto is responsible for the timely filing of such statement and any amendments thereto, and for the completeness and accuracy of the information concerning such party contained therein, but such party is not responsible for the completeness or accuracy of information concerning the other parties unless such party knows or has reason to believe that such information is incomplete or inaccurate.
It is understood and agreed that the joint filing of Schedule 13G shall not be construed as an admission that the reporting persons named herein constitute a group for purposes of Regulation 13D-G of the Securities Exchange Act of 1934, nor is a joint venture for purposes of the Investment Company Act of 1940.
Date: June 8, 2007
By: /s/J. Christopher Donahue
Name/Title: J. Christopher Donahue, as President of Federated Investors, Inc.
By: /s/ John F. Donahue
Name/Title: John F. Donahue, individually and as Trustee of Voting Shares
Irrevocable Trust, by J. Christopher Donahue, as attorney-in-fact.
By: /s/ Rhodora J. Donahue
Name/Title: Rhodora J. Donahue, individually and as Trustee as Voting
Shares Irrevocable Trust, by J. Christopher Donahue, as attorney-in-fact.
By: /s/ J. Christopher Donahue
Name/Title: J. Christopher Donahue, individually and as Trustee of Voting
Shares Irrevocable Trust
1. The number of shares indicated represent shares beneficially owned by registered investment companies and separate accounts advised by subsidiaries of Federated Investors, Inc. that have been delegated the power to direct investments and power to vote the securities by the registered investment companies' board of trustees or directors and by the separate accounts' principals. All of the voting securities of Federated Investors, Inc. are held in the Voting Shares Irrevocable Trust ("Trust"), the trustees of which are John F. Donahue, Rhodora J. Donahue, and J. Christopher Donahue ("Trustees'). In accordance with Rule 13d-4 under the 1934 Act, the Trust, Trustees, and parent holding company declare that the filing of this statement should not be construed as an admission that any of the investment advisers, parent holding company, Trust, and Trustees are beneficial owners (for the purposes of Sections 13(d) and/or 13(g) of the Act) of any securities covered by this statement, and such advisers, parent holding company, Trust, and Trustees expressly disclaim that they are the beneficial owners such securities.
EXHIBIT 3
POWER OF ATTORNEY
Each person who signature appears below hereby constitutes and appoints J. Christopher Donahue their true and lawful attorney-in-fact and agent, with full power of substitution and resubstitution for them and in their names, place and stead, in any and all capacities, to sign any and all Schedule 13Ds and/or Schedule 13Gs, and any amendments thereto, to be filed with the Securities and Exchange commission pursuant to Regulation 13D-G of the Securities Exchange Act of 1934, as amended, by means of the Securities and Exchange Commission's electronic disclosure system known as EDGAR; and to file the same, with all exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorney-in-fact and agent, full power and authority to sign and perform each and every act and thing requisite and necessary to be done in connection therewith, as fully to all intents and purposes as each of them might or could do in person, hereby ratifying and confirming all that said attorney-in-fact and agent, or their or his substitute or substitutes, may lawfully do or cause to be done by virtue thereof.
SIGNATURES TITLE OR CAPACITY
/s/John F. Donahue Individually and as Trustee of
---------------------------
John F. Donahue the Voting Shares Irrevocable Trust
/s/Rhodora J. Donahue Individually and as Trustee of
---------------------------
Rhodora J. Donahue the Voting Shares Irrevocable Trust
Sworn to and subscribed before me this 23rd day of September, 2004.
/s/Madaline P. Kelly
Notary Public
My Commission Expires: February 22, 2008
Avalon Pharmaceuticals Closes $20 Million in Private Placement of Common Stock and Warrants to Institutional Investors
GERMANTOWN, Md., May 29 /PRNewswire-FirstCall/ -- Avalon Pharmaceuticals, Inc. (Nasdaq: AVRX), today announced that it closed the sale of common stock and common stock warrants to institutional investors that was previously announced on May 25, 2007. The Company sold 3,838,772 shares of its common stock at $5.21 per share. The investors will also receive warrants to purchase up to 959,694 shares of Avalon's common stock at an exercise price of $6.00 per share. The warrants will expire in five years. Gross proceeds of the sale were $20 million. Participants in the transaction included Passport Management LLC, Federated Kaufmann Fund, Merlin Nexus, Hunt BioVentures, Special Situations Life Sciences Fund, Biotechnology Value Fund and other select institutional investors.
Proceeds will be used to fund further development of Avalon's lead oncology drug, AVN944, and the continued advancement of its Beta catenin, Aurora pathway, Survivin and Myc inhibitor programs.
'We are pleased to have attracted such a high quality group of investors in this offering,' said Kenneth C. Carter, Ph.D., President and CEO of Avalon. 'This financing provides Avalon with the resources for the next two years, during which time we expect to reach several key milestones in the development of our pipeline. Of particular note, AVN944 should move into Phase II clinical trials for the treatment of solid and liquid tumors in the second half of 2007, our Beta catenin inhibitor program is expected to progress through pre-clinical studies and enter the clinic in 2008 and our Aurora Pathway inhibitor program should follow it by 6-8 months.'
Rodman & Renshaw, LLC served as lead placement agent for the transaction. Trout Capital LLC acted as co-placement agent for the transaction.
The shares were issued in a private placement under Regulation D of the Securities Act of 1933, as amended. The shares therefore have not been registered under the Act or any state securities law or regulation and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.
About Avalon Pharmaceuticals
Avalon Pharmaceuticals is a biopharmaceutical company using its proprietary technology, AvalonRx(R), to discover and develop cancer therapeutics. Avalon has a lead product in Phase I clinical development (AVN944 - IMPDH inhibitor), as well as preclinical programs to discover inhibitors for the beta-catenin and aurora pathways now in late stage lead candidate optimization. Avalon also has discovery programs on modulators of survivin function and a drug discovery program targeting the MYC oncoprotein, one of the most important and previously intractable cancer targets. The company has value generating partnerships with Merck, MedImmune, Medarex, and Novartis. Avalon Pharmaceuticals was established in 1999 and is headquartered in Germantown, Md.
About AVN944
AVN944 is an oral small molecule drug candidate that inhibits inosine monophospate dehydrogenase (IMPDH), an enzyme that is critical for cells to be able to synthesize guanosine triphosphate (GTP), a molecule required for DNA synthesis and cellular signaling. Avalon filed an IND with the FDA in August 2005 and initiated U.S. Phase I clinical trials in January 2006 for use of AVN944 for the treatment of hematological cancers. Interim data from the study, announced in December 2006, indicate that AVN944 is well tolerated, has dose-dependent pharmacokinetics, induces biomarkers of programmed cell death in cancer cells from patients, and has resulted in stabilized disease after a one-month treatment cycle in half of the patients that have been treated thus far. Comprehensive data on the biological and clinical activity of AVN944 from the Phase I study and the initiation of multiple Phase II studies are expected by midyear 2007.
About AvalonRx(R)
AvalonRx(R) is a comprehensive, innovative and proprietary suite of technologies based upon large-scale gene expression analysis. This platform facilitates drug discovery by expanding the range of therapeutic targets for drug intervention, including targets and target pathways frequently considered intractable using conventional HTS approaches. It allows more informed decisions about which compounds to advance towards clinical trials, and facilitates drug development through identification of biomarkers of efficacy. The analysis of the selected biomarkers can aid in the stratification of patients or provide early indicators of response.
Safe Harbor Statement
This announcement contains, in addition to historical information, certain forward-looking statements that involve risks and uncertainties. Such forward-looking statements include, among others, statements regarding (i) the use of the proceeds of the offering in the further development of AVN944 and in the continued development of additional pipeline programs), (ii) the potential to advance Avalon's preclinical programs and (iii) the potential to advance AVN944 in clinical trials, including the anticipated timing of the commencement of Phase II clinical trials. Such statements reflect the current views of Avalon management and are based on certain assumptions. Actual results could differ materially from those currently anticipated as a result of a number of factors, risks and uncertainties, including the risk that our discover programs may not be successful, the risk that AVN944 will not progress successfully in its clinical trials, and other risks described in our filings with the SEC.
Contacts:
Avalon Pharmaceuticals, Inc. Russo Partners, LLC
Gary Lessing Wendy Lau (Media)
Executive Vice President & CFO Tel: (212) 845-4272
Tel: (301) 556-9900
Fax: (301) 556-9910 The Trout Group LLC
Email: info@avalonrx.com Chad Rubin (Investors)
Tel: (212) 477-9007 ext. 47
SOURCE Avalon Pharmaceuticals, Inc.
Source: PR Newswire (May 29, 2007 - 6:16 PM EDT)
News by QuoteMedia
www.quotemedia.com
AVRX filled the gap & landed on its longterm trend line(buying some AVRX here)
AVRX still needs to fill that gap around $4.60 & I would purchase there unless the whole market is selling off.
This company is about to explode to the upside, imo.
With all the recent news and developments the company is looking like it is headed considerably higher, again imo.
1st quarter earnings due soon, so the quiet period is now in effect. Don't expect to see any new news until earnings released before May 15, but I do expect to see this stock to hold its own, and perhaps continue the appreciation.
GLTA
AVRX more good new out:
AVN944 Shows Potent Antiproliferative Activity in Human Endothelial Cells
Wednesday April 18, 6:30 am ET
GERMANTOWN, Md., April 18 /PRNewswire-FirstCall/ -- Avalon Pharmaceuticals, Inc. (Nasdaq: AVRX - News), today described the potent antiproliferative activity of AVN944 in human endothelial cells (HUVEC), and showed that the compound prevents blood vessel formation in a mouse model. The newly elucidated antiangiogenic properties of the compound were examined in a study poster entitled, "Antiangiogenic Properties of AVN944, A Potent Inhibitor of IMPDH," presented at the American Association for Cancer Research Annual Meeting held April 14-18, 2007, in Los Angeles.
"Results of this study provide new insight into the mechanism of action of AVN944," stated Zoe Weaver, Ph.D., staff scientist at Avalon and lead investigator in the study. "The suppression of blood vessel growth, without any adverse effects to the mice, gives us a strong rationale to include solid tumors, especially those that may be more sensitive to agents that inhibit tumor angiogenesis, in our Phase II trials."
AVN944 is an orally available inhibitor of inosine monophosphate dehydrogenase (IMPDH) 1 and 2. IMPDH2 is highly upregulated in many malignancies, including hematologic cancers, and is required for the de novo production of guanine nucleotides. AVN944 is a potent inhibitor of cancer cell proliferation and elicits a specific set of cellular responses directly related to depletion of cellular guanosine triphosphate (GTP) pools. Recent studies of IMPDH inhibitors suggest that they may elicit antiangiogenic effects and could provide added benefit as a cancer therapy through blockade of tumor angiogenesis. To investigate this approach, scientists at Avalon evaluated AVN944 in a series of angiogenesis assays to determine the potential utility of this drug as an antiangiogenic agent for cancer treatment.
As a result, AVN944 was found to potently inhibit proliferation of HUVECs. This antiproliferative activity was reversed by the addition of guanine, indicating that AVN944 is inhibiting IMPDH activity and depleting GTP pools in endothelial cells. Other in vitro assessments of AVN944 activity in endothelial cells included a comprehensive analysis of global gene expression changes resulting from IMPDH inhibition in these cells. The gene expression signature induced by AVN944 in endothelial cells was indicative of GTP metabolism and cell cycle inhibition, similar to gene expression profiles exhibited by cancer cell lines. Additionally, treatment of Matrigel plug- bearing mice with AVN944 inhibited the growth of new blood vessels to a similar or greater degree than mycophenolate mofetil, an FDA-approved immunosuppressant drug.
Avalon investigators next plan to expand the AVN944 preclinical program to include rodent solid tumor models. Avalon's results, detailing the potent inhibition of endothelial cells in vitro combined with inhibition of angiogenesis in an in vivo model, could position this drug for rapid development as a novel antiangiogenic agent for cancer therapy.
About AVN944
AVN944 is an oral small molecule drug candidate that inhibits inosine monosphospate dehydrogenase (IMPDH), an enzyme that is critical for cells to be able to synthesize guanosine triphosphate (GTP), a molecule required for DNA synthesis and cellular signaling. IMPDH is over expressed in some cancer cells, especially in the case of hematological malignancies. In laboratory experiments, AVN944 has been shown to inhibit IMPDH activity in cells, and suppress pools of GTP. Anticancer activities of IMPDH inhibitors correlate with sustained depletion of GTP pools both in cellular models and in human subjects. AVN944 appears to have a selective effect on cancer cells in that deprivation of GTP in normal cells results in a temporary slowing of cell growth, while GTP deprivation in cancer cells induces cell death, or apoptosis.
Results from preclinical studies of AVN944 indicate that AVN944 inhibited the proliferation of lymphoid and myeloid cells, the principal cells involved in the most common types of human leukemias. In a single-dose, dose- escalation Phase I clinical trial of AVN944 conducted in the United Kingdom in healthy volunteers, AVN944: (1) was well tolerated at all tested doses with no notable side effects; (2) demonstrated good pharmacokinetic properties; and (3) had a significant inhibitory effect on IMPDH enzyme activity. Avalon filed an IND with the FDA in August 2005 and initiated U.S. Phase I clinical trials in January 2006 for the treatment of hematological cancers.
About Avalon Pharmaceuticals
Avalon Pharmaceuticals is a biopharmaceutical company using its proprietary technology, AvalonRx®, to discover and develop cancer therapeutics. Avalon has a lead product in Phase I clinical development (AVN944 - IMPDH inhibitor), as well as preclinical programs to discover inhibitors for the beta-catenin and aurora pathways now in late stage lead candidate optimization. Avalon also has discovery programs on modulators of survivin function and a drug discovery program targeting the MYC oncoprotein, one of the most important and previously intractable cancer targets. The company has value generating partnerships with Merck, MedImmune, Medarex, and Novartis. Avalon Pharmaceuticals was established in 1999 and is headquartered in Germantown, Md.
Safe Harbor Statement
This announcement contains, in addition to historical information, certain forward-looking statements that involve risks and uncertainties, in particular, related to progress in our drug discovery programs and our collaborations, and clinical progress in the development of AVN944. Such statements reflect the current views of Avalon management and are based on certain assumptions. Actual results could differ materially from those currently anticipated as a result of a number of factors, risks and uncertainties including the risk that the discovery programs and collaborations may not be successful and that AVN944 will not progress successfully in its clinical trials, and other risks described in our SEC filings. There can be no assurance that our development efforts will succeed, that AVN944 will receive required regulatory clearance or, even if such regulatory clearance is received, that any subsequent products will ultimately achieve commercial success. The information in this Release should be read in conjunction with the Risk Factors set forth in our 2005 Annual Report on Form 10-K and updates contained in subsequent filings we make with the SEC.
Contacts:
Avalon Pharmaceuticals, Inc. Noonan Russo
David Muth Greg Geisman
Executive Vice President Tel: (619) 814-3510
& Chief Business Officer
Tel: (301) 556-9900
Fax: (301) 556-9910 The Trout Group LLC
Email: info@avalonrx.com Chad Rubin (Investors)
Tel: (646) 378-2947
AVRX was featured in Business Week magazine in their weekly "Inside Wall Street" column.
APRIL 23, 2007
INSIDE WALL STREET
Avalon's New Lab Partner: Merck
Avalon pharmaceuticals (AVRX ), a little-known biopharma focusing on small-molecule therapeutics for cancer, has teamed up with Big Pharma, including Merck (MRK ), for the use of its AvalonRx drug discovery system. On Mar. 6, Merck signed a pact to use AvalonRx to screen selected Merck compounds to identify inhibitors against an undisclosed target essential for the development of cancer. Avalon could receive up to $200 million in various milestone payments, plus royalties on products. Ren Benjamin of Rodman & Renshaw, who rates Avalon "outperform/speculative," says he is encouraged that the value of AvalonRx technology "is being recognized by the large pharma companies." Avalon, with 2006 sales of just $2.7 million, previously signed pacts with Novartis (NVS ), MedImmune (MEDI ), and Medarex (MEDX ). Avalon's agreement with Merck "should result in identifying first-in-class drug candidates," says Avalon ceo Kenneth Carter. He expects one more Big Pharma to sign up next year. Avalon also makes drugs and its lead product, AVN944, now in Phase 1 trials, aims to inhibit growth of tumor cells, including myeloma, colon, and lung. Patrick Flanigan of wr Hambrecht (it did banking for Avalon) says AVN944 could see peak sales of $500 million. He rates Avalon, trading at 4.67, a buy, with a year's target of 13.
Hey surf, thanks for the heads up, are you watching MGLG right now? It is rocketing.
Traders must be guessing good news for AVRX next week out of ACC meeting:
Avalon Pharmaceuticals to Present at the American Association for Cancer Research 2007 Annual Meeting
GERMANTOWN, Md., April 10 /PRNewswire-FirstCall/ -- Avalon Pharmaceuticals, Inc. (Nasdaq: AVRX) (NYSE Arca: AVRX), today announced that AVN944 will be the subject of three poster presentations at the American Association for Cancer Research 2007 Annual Meeting to be held on April 14-18, 2007 in Los Angeles, Calif.
The first poster presented by Avalon, will review the data derived from the Avalon ongoing Phase I clinical trial of AVN944 for the treatment of hematological cancers. The poster is titled, 'The Modulation of Gene Expression and Guanosine Pools by Inhibition of Inosine Monophosphate Dehydrogenase (IMPDH); correlating In Vitro Cell Resistance with Biomarker Response in Patient Samples from the Phase I Trial.' This poster will provide data from clinical samples that correlate IMPDH inhibition, GTP pool suppression, and associated changes in tumor cell gene expression. The presentation will be Monday, April 16, 2007 from 8 a.m. until noon Pacific Time.
The second Avalon poster presentation is titled, 'Antiangiogenic Properties of AVN944, A Potent Inhibitor of IMPDH.' The poster will describe in vitro and in vivo experiments that reveal the effects of AVN944 on blood vessel formation. The presentation will be on Tuesday, April 17, 2007 from 8 a.m. until noon Pacific Time.
Another poster that will discuss AVN944 will be presented by the lab of Dr. Beverly Mitchell of Stanford University. The poster is titled, 'GTP depletion induces translocation of TIF-IA and PAF53, inhibition of pre-rRNA synthesis and dislocation of nucleolar proteins.' The presentation cites AVN944 as a compound that has effects on rRNA inhibition and nucleolar protein translocation. The poster presentation will be Tuesday, April 17, 2007 from 1 p.m. until 5 p.m. Pacific Time.
All three posters are in the Experimental and Molecular Therapeutics Poster Sessions.
About AVN944
AVN944 is an oral small molecule drug candidate that inhibits inosine monosphospate dehydrogenase (IMPDH), an enzyme that is critical for cells to be able to synthesize guanosine triphosphate (GTP), a molecule required for DNA synthesis and cellular signaling. IMPDH is over expressed in some cancer cells, especially in the case of hematological malignancies. In laboratory experiments, AVN944 has been shown to inhibit IMPDH activity in cells, and suppress pools of GTP. Anticancer activities of IMPDH inhibitors correlate with sustained depletion of GTP pools both in cellular models and in human subjects. AVN944 appears to have a selective effect on cancer cells in that deprivation of GTP in normal cells results in a temporary slowing of cell growth, while GTP deprivation in cancer cells induces cell death, or apoptosis. Results from preclinical studies of AVN944 indicate that AVN944 inhibited the proliferation of lymphoid and myeloid cells, the principal cells involved in the most common types of human leukemias. In a single-dose, dose- escalation phase I clinical trial of AVN944 conducted in the United Kingdom in healthy volunteers, AVN944: (1) was well tolerated at all tested doses with no notable side effects; (2) demonstrated good pharmacokinetic properties; and (3) had a significant inhibitory effect on IMPDH enzyme activity. Avalon filed an IND with the FDA in August 2005 and initiated U.S. phase I clinical trials in January 2006 for the treatment of hematological cancers.
About Avalon Pharmaceuticals
Avalon Pharmaceuticals is a biopharmaceutical company using its proprietary technology, AvalonRx(R), to discover and develop cancer therapeutics. Avalon has a lead product in Phase I clinical development (AVN944 - IMPDH inhibitor), as well as preclinical programs to discover inhibitors for the beta-catenin and aurora pathways now in late stage lead candidate optimization. Avalon also has discovery programs on modulators of survivin function and a drug discovery program targeting the MYC oncoprotein, one of the most important and previously intractable cancer targets. The company has value generating partnerships with Merck, MedImmune, Medarex, and Novartis. Avalon Pharmaceuticals was established in 1999 and is headquartered in Germantown, Md.
Safe Harbor Statement
This announcement contains, in addition to historical information, certain forward-looking statements that involve risks and uncertainties, in particular, related to progress in our drug discovery programs and our collaborations, and clinical progress in the development of AVN944. Such statements reflect the current views of Avalon management and are based on certain assumptions. Actual results could differ materially from those currently anticipated as a result of a number of factors, risks and uncertainties including the risk that the discovery programs and collaborations may not be successful and that AVN944 will not progress successfully in its clinical trials, and other risks described in our SEC filings. There can be no assurance that our development efforts will succeed, that AVN944 will receive required regulatory clearance or, even if such regulatory clearance is received, that any subsequent products will ultimately achieve commercial success. The information in this Release should be read in conjunction with the Risk Factors set forth in our 2005 Annual Report on Form 10-K and updates contained in subsequent filings we make with the SEC.
Contacts:
Avalon Pharmaceuticals, Inc. Noonan Russo
Gary Lessing Greg Geissman (Media)
Executive Vice President & CFO Tel: (619) 814-3510
Tel: (301) 556-9900
Fax: (301) 556-9910 The Trout Group LLC
Email: info@avalonrx.com Chad Rubin (Investors)
Tel: (646) 378-2947
SOURCE Avalon Pharmaceuticals, Inc.
AVRX will be much higher in the coming months:
avrx: COLLABORATION WITH MERCK FURTHER VALIDATES AVALONRx; REITERATE BUY RATING AND $13 PRICE TARGET
We believe Avalon Pharmaceuticals is an undiscovered gem with unlimited potential. Avalon's powerful platform technology (AvalonRx) has the potential to discover drugs against 'intractable' targets. We believe the Merck collaboration further validates AvalonRx's capabilities. Near-term, we expect AVRX shares to be driven by news flow on AVN944, as incrementally new Phase I data are possible at ASCO and we expect the initiation of Phase II trials in 2007. We are reiterating our Buy rating and $13 price target. Full Report - PDF
Got in at $2.83.
Looking good on todays news. Check out this link.
http://www.wrhambrecht.com/research/biotech/avrx.html
Good luck.
AVRX is currently a Buy on any weakness in the PPS.
GERMANTOWN, Md. (AP) -- Avalon Pharmaceuticals Inc. said Tuesday it is collaborating with Merck & Co. to develop inhibitors for an undisclosed target, focusing on cancer.
Avalon will use its AvalonRx platform to screen a select set of compounds and identify possible targets. The company could receive up to $200 million in milestone, regulatory and other payments as part of the agreement.
Merck will be responsible for clinical development, regulatory approval and commercialization of any potential product candidates, the company said.
Shares of Avalon jumped $1.36, or 29.4 percent, to $5.99 in after-hours trading after falling 4 cents to close at $4.63 on the Nasdaq Stock Market.
Shares of Merck rose 42 cents to close at $44.67 on the New York Stock Exchange.
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