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ChemGenex Announces Poster Presentations at the 49th Annual Meeting of the American Society of Hematology
Tuesday December 4, 8:01 am ET
MELBOURNE, Australia & MENLO PARK, Calif.--(BUSINESS WIRE)--ChemGenex Pharmaceuticals Limited (ASX:CXS - News) (NASDAQ:CXSP - News) today announced that abstracts concerning phase 2/3 clinical data for omacetaxine mepesuccinate as a treatment for imatinib-resistant Chronic Myeloid Leukemia (CML) patients with the T315I mutation, and new preclinical mechanism of action data for omacetaxine mepesuccinate (formerly known as Ceflatonin®), are now available on the American Society of Hematology's (ASH’s) website (http://www.hematology.org/meetings/2007/index.cfm under "Annual Meeting Abstracts").
ASH's annual meeting is being held from December 8 to December 11, 2007 at the Georgia World Congress Center in Atlanta, Georgia, USA. The abstracts being presented are detailed below. More substantive information beyond what is contained in the abstract is embargoed until the start of each session.
Abstract 1050:
Safety and Efficacy Study of Subcutaneous Homoharringtonine (SC HHT) in Imatinib (IM)-Resistant Chronic Myeloid Leukemia (CML) with the T315I Mutation Initial Report of a Phase II Trial.
Session Type:
Poster Session, Board #204-I
Date/Time:
Saturday, December 8, 2007 - 5:30 PM
Session Info:
Poster Session: Chronic Myeloid Leukemia: Clinical Trials and Pre-Clinical Studies
5:30 p.m. - 7:30 p.m.
Abstract 2912:
Inhibitory Effects of Homoharringtonine on Leukemic Stem Cells and BCR-ABL Induced Chronic Myeloid Leukemia and Acute Lymphoblastic Leukemia in Mice.
Session Type:
Poster Session, Board #131-III
Date/Time:
Monday, December 10, 2007 - 5:00 PM
Session Info:
Poster Session: Chronic Myeloid Leukemia: Biology and Pathophysiology II
5:00 p.m. - 7:00 p.m.
About ChemGenex Pharmaceuticals Limited (www.chemgenex.com)
ChemGenex Pharmaceuticals is a pharmaceutical development company dedicated to improving the lives of patients by developing personalized oncology medicines. ChemGenex harnesses the power of genomics both to discover novel targets and drug compounds, and in clinical trials to develop more individualized treatment outcomes. ChemGenex’s lead compound, omacetaxine mepesuccinate (formerly known as Ceflatonin®), is currently in phase 2/3 clinical trials for chronic myeloid leukemia (CML) where it has demonstrated single-agent efficacy against drug-resistant disease, as well as synergistic activity with the leading marketed compound. ChemGenex has a second anticancer compound, amonafide dihydrochloride (formerly known as Quinamed®) which is in phase 2 clinical development for various solid cancers, and a portfolio of assets in pre-clinical development. ChemGenex currently trades on the Australian Stock Exchange under the symbol "CXS" and on NASDAQ under the symbol "CXSP".
Safe Harbor Statement
Certain statements made herein that use the words “estimate”, “project”, “intend”, “expect”, “believe” and similar expressions are intended to identify forward-looking statements within the meaning of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements involve known and unknown risks and uncertainties which could cause the actual results, performance or achievements of the company to be materially different from those which may be expressed or implied by such statements, including, among others, risks or uncertainties associated with the development of the company’s technology, the ability to successfully market products in the clinical pipeline, the ability to advance promising therapeutics through clinical trials, the ability to establish our fully integrated technologies, the ability to enter into additional collaborations and strategic alliances and expand current collaborations and obtain milestone payments, the suitability of internally discovered genes for drug development, the ability of the company to meet its financial requirements, the ability of the company to protect its proprietary technology, potential limitations on the company’s technology, the market for the company’s products, government regulation in Australia and the United States, changes in tax and other laws, changes in competition and the loss of key personnel. These statements are based on our management’s current expectations and are subject to a number of uncertainties that could change the results described in the forward-looking statements. Investors should be aware that there are no assurances that results will not differ from those projected.
Contact:
ChemGenex
Dr. Greg Collier
Cell (Australia): +61 419 897 501
Cell (USA): +1-650-200-8145
CEO and Managing Director
gcollier@chemgenex.com
or
Buchan Consulting
Daniella Goldberg, +61 2 9237 2803
Cell: +61 416 211 067
Media Relations
dgoldberg@bcg.com.au
or
Blueprint Life Science Group
Sabrina Antoniou, +61 (0) 400 788 277
Investor Relations - Australia
santoniou@bplifescience.com
Dan Klein, +1-415-375-3340 ext. 2024
Investor Relations - USA
dklein@bplifescience.com
--------------------------------------------------------------------------------
For the record, I still believe Provenge works, and will re-take a position on the smaller side before the interm look this year. Assuming it will not be less than the allocated .02 or thereabouts, I will take a significantly larger position before 9902b final look, as the risk/reward should be extremely compelling then. If DNDN had run larger trials, and not used TTP as the primary endpoint, things may have turned out different, but it is what it is.
Lumpy if you believe Provenge works it will have a better chance to show it with survival at the end of the trial than it will during the interim look, only the stock will be cheaper.
bdsi
I do not currently own the stock but it is very cheap. I am surprised this article hit as a story. There is no writer of the article. I looks more like an advertisement.
coly
you can pull out for any reason that you want, or for no reason at all
intermune buyout of Pirfenidone
It was a very good deal for Intermune. The only have to pay the larger milestone if the phase 3 results are good.
I can't understand why the other company agreed to it unless they are in desperate need of cash
kanzer and rosenwald.... the main difference
rosenwald licensed drugs from different institutions and starts new companies around them which is what kanzer has done previously.
With pipex he doesn't start new companies. He takes all the new technology into pp. That is a big difference.
what paper was the article posted in
you didn't provide a link
Stock (ticker): Chemgenex (CXS.AX)
Market Cap: A$200m
Recommendation: Buy
Share price: A$1.07
Price target: A$1.36
Up/(down) to target: 27.1%
Fair value: A$1.36 (DCF methodology)
Subject: Chemgenex (CXS) - a competitor stops its trial -
positive for CXS
Analyst: Scott Power (+61 7 3334 4884) / Tanya Solomon (+61
7 3334 4521)
Key points:
* US based pharmaceutical company Vertex (which is in collaboration with
Merck) has suspended its Phase 1 (safety) trial pending further analysis of
its compound which was treating patients with a type of leukemia. We
believe the suspension of this trial is positive news for Chemgenex as it
takes another potential competitor out of the market.
* The Vertex compound known as MK-0457 was being used in combination with
dasatinib in patients with chronic myelogenous leukemia containing a
particular type of mutation (T315i).
* The next milestone for Chemgenex is the presentation of interim Phase 3
data at a major oncology conference in US in December. The data is positive
refer our comments below.
Additional details:
As expected, the abstracts of key research (relevant to CXS) to be
released at the American Society of Haematology (ASH) Conference have been
released:
"Safety and Efficacy Study of Subcutaneous Homoharringtonine (SC HHT) in
Imatinib (IM)-Resistant Chronic Myeloid Leukemia (CML) with the T315I
Mutation Initial Report of a Phase II Trial. Session Type: Poster
Session, Board #204-I"
"Inhibitory Effects of Homoharringtonine on Leukemic Stem Cells and
BCR-ABL Induced Chronic Myeloid Leukemia and Acute Lymphoblastic
Leukemia in Mice. Session Type: Poster Session, Board #131-III"
* While we are still waiting for the release of the complete papers (due
8-10 December 07), we make the following comments:
* The data has been written up by researchers independent of CXS.
* The authors commented that Ceflatonin has an acceptable safety profile
and activity in patients with Gleevec (Imatininb) resistant CML.
* The authors commented that the subcutaneous dosing route offers a
convenient dosing format for self administration.
* At the time the paper was written, 19 patients with Ph+ CML with T315I
were enrolled in the clinical trial. All patients had completed at least
one induction course of Ceflatonin. T315I transcript levels were no
longer detectable in 5 patients, 2 of whom had achieved complete
haematological response (1 recently achieved, 1 maintained 7+ months).
This is a promising result, after only one treatment cycle.
* In pre-clinical studies, Ceflatonin has an inhibitory activity against
CML stem cells, and is highly effective in treating CML induced by
BCR-ABL in mice.
Scott Power
Senior Analyst
Authorised Representative - Rep Number 255971
ABN AMRO Morgans Ltd
Ph 61 7 3334 4884
scottp@abnamromorgans.com.au
The problem is stated as qt elongation but in the t315i mutation nothing works at all. if the drug had a benefit in that mutation a qt elongation once in a while would be a small price to pay. Once someone develops the t315i mutation they don't live long at all
pumping pp
I don't mean that literally
pumping pp
I responded to a question and pointed out that the ceo makes remarks that he shouldn't
I happen to think that the free copper is a valid target for alzheimers. It definitely works for wilson's
I also think the data from the small trial in MS for Trimester is good.
I don't think that is pumping.
After the longwinded, runaround answer by PP’s CEO to your question on Thursday’s CC, I find it astonishing that you would want to be long.
Then again, you thought HEB was a good company, so perhaps I shouldn’t be surprised you like PP.
Steven Kanzer has been buying stock on the open market. They did a warrant call to bring in cash from their warrants, so they didn't have to dilute the stock by doing a financing.
You are correct that I liked HEB many years ago. It was a mistake. Aren't we supposed to learn from our mistakes. I believe I was the first person on this board to warn people of Steven Quay, when you were getting enamored to the story. I have never made fun of, or threw sand in your eyes for mistakes that you have made. Why do you get jollys over the mistakes of others. I don't appreciate the crack above.
Nejm article on Leukotrienes. Zileuton figures prominently
Previous Volume 357:1841-1854 November 1, 2007 Number 18
Next
Leukotrienes
Marc Peters-Golden, M.D., and William R. Henderson, Jr., M.D.
Since this article has no abstract, we have provided an extract of the first 100 words of the full text and any section headings.
PubMed Citation
Leukotrienes ("leuko," from white blood cells; and "trienes," three conjugated double bonds) comprise a family of products of the 5-lipoxygenase pathway of arachidonic acid metabolism. The cysteinyl leukotrienes C4, D4, and E4 account for the biologic activity that was previously termed "slow-reacting substance of anaphylaxis," and the efficacy of antagonists to type 1 cysteinyl leukotriene receptor (CysLT1) in asthma validates the importance of cysteinyl leukotrienes and CysLT1 in this disease.1 This article reviews both established understanding and recent advances in our knowledge about leukotrienes.
Synthesis of Leukotrienes
The synthesis of leukotrienes from substrate arachidonic acid is initiated by 5-lipoxygenase in . . . [Full Text of this Article]
Leukotriene Receptors
Blockade of Leukotriene Synthesis and Leukotriene Receptors
Leukotrienes in Disease
Asthma
Antileukotriene Drugs as Controller Agents
Effects of Antileukotriene Agents on Airway Remodeling
Responsiveness to Antileukotriene Agents
Therapeutic Trials of Antileukotriene Agents
Cardiovascular Disease
Cancer
Leukotrienes in Antimicrobial Defense
Conclusions
Source Information
From the Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, University of Michigan Health System, Ann Arbor (M.P.-G.); and the Center for Allergy and Inflammation, Division of Allergy and Infectious Diseases, Department of Medicine, University of Washington, Seattle (W.R.H.).
Address reprint requests to Dr. Peters-Golden at the Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, University of Michigan Health System, 6301 MSRB III, 1150 W. Medical Center Dr., Ann Arbor, MI 48109-5642, or at petersm@umich.edu.
I own pp. I think there is a lot to the free copper theory and it appears that they have the best drug to bind to the free copper.
It is at least a piece of the alzhiemers puzzle.
I like the drug for MS also.
I don't like them doing all these other things though. They don't have the cash right now to pursue them and they need to focus on the short term drivers.
The CEO does make some remarks about ideas he should keep to himself for now.
I sent this video to some friends of mine and he took his Centrum Silver and threw it out
http://www.wwltv.com/video/index.html?nvid=192217
Bayer's peak sales numbers are no where near yours
This is the html version of the file http://www.investor.bayer.com/user_upload/2702/.
that doesn't mean you are wrong they may just want to be conservative.
The problem my be that although your European patient numbers may be correct the pricing there may not be anywhere near the pricing they get in the US.
Is the pricing they are getting in Europe for the Kidney indication the numbers that you are using in your analysis.
when do they expect approval in Japan and what is the royalty rate that Onxx will get there?
thanks
Label for Anemia Drugs Likely Won't Help Sales
By AVERY JOHNSON and JENNIFER CORBETT DOOREN
November 9, 2007; Page A16
The Food and Drug Administration toughened safety warnings on blockbuster anemia drugs, in a move that looked unlikely to help drug makers in their quest to liberalize Medicare payments for the medicines.
Two Amgen Inc. drugs, Aranesp and Epogen, along with Johnson & Johnson's Procrit, brought in $7.3 billion of revenue last year. But that was before safety concerns arose over their use by cancer and kidney patients to treat anemia, a shortage of red blood cells that can cause fatigue and other symptoms.
In July, the Centers for Medicare and Medicaid Services said it wouldn't pay for the drugs in cancer patients whose hemoglobin -- a measure of red blood cells -- was above 10 grams per deciliter. Yesterday, the FDA warned that the medicines have been linked to tumor growth and shortened survival in cancer patients -- and increased rates of death and heart problems in kidney patients -- when used to boost hemoglobin above 12 grams per deciliter. Recent research shows the risks of death and heart attacks rise considerably when an anemia drug gives too big a boost to hemoglobin, which brings oxygen to the body's tissues.
In cancer patients undergoing chemotherapy, the FDA is now advising doctors not to use the drugs to boost hemoglobin above 12, while in kidney patients it set a range of 10 to 12.
Amgen and J&J seized on the new product label in their quest to get Medicare to reverse its restrictive reimbursement decision, which has cut into sales of the drugs. Both companies said they were petitioning Medicare to change its stance -- citing, in part, the new label as proof the FDA finds more-liberal use safe and gives doctors more discretion regarding the proper doses for individual patients.
But the FDA defended its new boxed warning as consistent with Medicare's payment decision. That's because the FDA instructs doctors to use the lowest dose necessary to prevent the need for a blood transfusion, which used to be the main treatment for anemia before the arrival of these drugs, known as erythropoiesis-stimulating agents. Jim Reddoch, an analyst with FBR Capital Markets, said the new label supports Medicare's decision and the drug makers will be unlikely to persuade Medicare to budge based on it.
"It's very rare, if not unheard of, for people to get transfused if their hemoglobins are 10 or higher," said John Jenkins, director of the FDA's office of new drugs. Medicare "has tried to take our advice to use the lowest possible dose to avoid transfusion and put payment parameters around it."
A spokeswoman for J&J unit Ortho Biotech points to data indicating some patients can require transfusions when hemoglobin levels are above 10.
Jeff Nelligan, a Medicare spokesman, said, "CMS will carefully review the label changes and their relevance, if any," to the centers' payment policies.
The new label broadens previous warnings involving cancer patients and states that the drugs "shortened overall survival" in patients with advanced breast, head and neck, lymphoid, and nonsmall-cell-lung cancers in clinical studies when used at generally higher-than-recommended doses. However, the warning states that the risks of "shortened survival and tumor progression" also can't be ruled out when the drugs are used to target a hemoglobin range that is less than 12.
The agency's latest moves reflect findings from two high-profile advisory panels convened on the medicines earlier this year. The stronger label is less restrictive than some feared. Still, it will likely make it harder to stem the decline of these blockbuster drugs' sales.
Write to Avery Johnson at avery.johnson@WSJ.com1 and Jennifer Corbett Dooren at jennifer.corbett-dooren@dowjones.com2
URL for this article:
http://online.wsj.com/article/SB119453613769586569.html
Hyperlinks in this Article:
(1) mailto:avery.johnson@WSJ.com
(2) mailto:jennifer.corbett-dooren@dowjones.com
medtronic ran the trial
they purposefully ran the trial in such a way as to make the test fail
It was brilliant on their part.
Now there will be no test that would limit their sales
Cambridge Heart should see if there is a way to sue them and win.
I am not an attorney so I don't know if they have a case.
I am sure if cigarette companies wanted to run a trial to show a positive effect of tobacco on health they could.
Maybe if Phillip Morris ran a trial of smokers vs. non smokers but excluded death and diseases caused by cancer heart attacks, pulmonary function and just left all other causes they could show statistical significance in that endpoint because smokers die from cancer, heart attacks and pulmonary diseases.
snmx
7:50, the perfect time to put out a press release with bad news.
after market still open but no one is expecting news so there was no dumping.
why can Amln file nda without a second phase 3 trial
They may file nda with data from the phase 2/3 trial but I don't think the fda will approve the drug base on a 300 patient trial. The fda is concerned about pancreatitis. With a once a week injection, I believe the fda will be concerned that if someone develops pancreatitis right after the injection how will they be treated with the drug on board for another week.
The EU is more inclined to look at pain endpoints and QoL. Those data for satra were very nice.
If you look at the side effects as noted in the fda documents the it all depends on how you define pain
kosan collaboration with roche bites the dust
Kosan to Reacquire Epothilone Program From Roche
Thursday October 25, 8:45 pm ET
Kosan to Commence Phase 2 Clinical Program for KOS-1584
HAYWARD, Calif., Oct. 25 /PRNewswire-FirstCall/ -- Kosan Biosciences Incorporated (Nasdaq: KOSN - News) today announced that Roche and Kosan are concluding their epothilone development and commercialization collaboration. The collaborative research, development and commercialization agreement entered into in September 2002 will terminate after a transition period, following which Kosan will reacquire worldwide rights to its epothilone program and have full control of clinical development of KOS-1584 and its other epothilone product candidates going forward.
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"Based on our discussions with Roche, we believe that the ending of our epothilone collaboration has been driven by a re-prioritization within Roche's research and development group rather than the value of our epothilone program," said Robert G. Johnson, Jr., M.D., Ph.D., Kosan's President and Chief Executive Officer. "Our control of the program permits us to determine the optimal strategy for advancing KOS-1584 into larger-scale clinical trials, potentially with a new collaborative partner, which we plan to actively seek. In the meantime, we intend to commence a Phase 2 clinical program. We continue to believe that KOS-1584 has best-in-class potential in the emerging epothilone market."
Roche believes that KOS-1584 is worthy to proceed into Phase 2 clinical trials, and that the Roche-Kosan collaboration has been highly productive," said Dan Zabrowski, Global Head of Roche Pharma Partnering. "We believe that Kosan is in the best position to exploit the therapeutic and commercial potential of KOS-1584. Kosan has been an excellent development partner, and we have appreciated the opportunity to be supportive of their progress."
Kosan does not expect the termination of its collaborative research, development and commercialization agreement with Roche to impact its financial guidance for 2007 due to transition period funding.
KOS-1584 Plans and Clinical Data
Kosan plans to commence a Phase 2 clinical program for KOS-1584. Kosan anticipates providing more information about the Phase 2 program at its upcoming Research & Development Day on October 31, 2007.
Recently, at the 2007 Annual Meeting of the American Association for Cancer Research/National Cancer Institute/European Organization for Research and Treatment of Cancer (AACR/NCI/EORTC) in San Francisco, Kosan presented updated data from an ongoing Phase 1 clinical trial of KOS-1584 demonstrating encouraging antitumor activity and tolerability in patients with solid tumors. KOS-1584 showed signs of activity in patients with non-small cell lung, ovarian, breast, prostate, pancreatic, head and neck and colon cancer.
Conference Call
Kosan will hold a conference call to discuss the termination of the collaborative research, development and commercialization agreement with Roche and related matters tomorrow at 5:30 a.m. Pacific / 8:30 a.m. Eastern. To access the live call, please dial 800.901.5231 (US) or 617.786.2961 (international), access code 41951713. Interested parties may listen to the webcast live at http://www.kosan.com by clicking on the "Webcasts" tab under the heading "Investors/Press." The webcast is also being distributed over Thomson's Investor Distribution Network to both institutional and individual investors. Individual investors can listen to the call through Thomson's individual investor center at http://www.earnings.com or by visiting any of the investor sites in Thomson's Individual Investor Network. Institutional investors can access the call via Thomson's password-protected event management site, StreetEvents, at http://www.streetevents.com. A telephonic replay will be available through November 2, 2007 by dialing 888.286.8010, access code: 61167995. International callers can dial 617.801.6888, access code: 61167995.
About Kosan
Kosan Biosciences is a biotechnology company advancing two new classes of anticancer agents through clinical development -- Hsp90 (heat shock protein 90) inhibitors and epothilones. Kosan is leveraging its proprietary discovery platform to generate a pipeline of potentially significant product candidates, primarily in the area of oncology.
Hsp90 inhibitors have a novel mechanism of action targeting multiple pathways involved in cancer cell growth and survival. Tanespimycin (KOS-953) is being tested in combination with bortezomib (Velcade®) in patients with multiple myeloma in a registration program called TIME. Tanespimycin is also being studied in HER2-positive metastatic breast cancer in combination with trastuzumab (Herceptin®), and as monotherapy in metastatic melanoma. Intravenous and oral formulations of Kosan's second-generation Hsp90 inhibitor, alvespimycin (KOS-1022), are being evaluated in Phase 1 clinical trials in hematological cancers and in HER2-positive metastatic breast cancer.
Epothilones inhibit cell division with a mechanism of action similar to taxanes, one of the most successful classes of anti-tumor agents. KOS-1584 is in Phase 1 clinical trials in patients with solid tumors.
Kosan's motilin agonist compound, KOS-2187, licensed to Pfizer, is in a Phase 1 safety trial, with plans to pursue development in gastroesophageal reflux disease (GERD).
For additional information on Kosan Biosciences, please visit the company's website at http://www.kosan.com.
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements regarding the further development (including the planned commencement of one or more Phase 2 clinical trials and the timing thereof) and potential safety, efficacy, commercialization and other characteristics of KOS-1584, Kosan's plans to seek a new collaborative partner for its epothilone program and the anticipated financial impact of the termination of its collaborative research, development and commercialization agreement with Roche. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. There are a number of important factors that could cause the results of Kosan to differ materially from those indicated by these forward-looking statements, including, among others, risks related to Kosan's expectation that additional financing will be required, Kosan's past dependence on its collaboration with Roche for development of its epothilone product candidates, Kosan's ability to enter in to new partnering arrangements and the highly uncertain nature of the progress and results of Kosan's testing of KOS-1584, including the risk that studies may not demonstrate safety and efficacy sufficient to initiate additional clinical trials, continue clinical development, obtain the requisite regulatory approvals or result in a marketable product, competition and other risks detailed from time to time in Kosan's SEC reports, including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2007, and other periodic filings with the SEC. Kosan does not undertake any obligation to update forward-looking statements.
Velcade® (bortezomib) is a registered trademark of Millennium Pharmaceuticals, Inc. Herceptin® (trastuzumab) is a registered trademark of Genentech, Inc.
--------------------------------------------------------------------------------
Source: Kosan Biosciences Incorporated
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shorting dndn can be dangerous to your health
Tobias Aide: Hedge Fund Manager Was Murdered
By Scott CohnCNBC.com
| 18 Oct 2007 | 01:41 PM ET
An assistant to hedge fund manager Seth Tobias, who died suddenly last month at age 44, told CNBC he has evidence that Tobias was murdered.
Tobias, who founded Circle T Partners and was a frequent guest on CNBC, was found dead on Labor Day weekend in the swimming pool at his home near Palm Beach, Florida.
At the time, a family member said Tobias' death was apparently a heart attack. But six weeks later, the death is still under investigation.
A police spokesman in Jupiter, Florida, told CNBC the death is not classified as suspicious but investigators are awaiting toxicology results.
Bill Ash, who said he was Tobias' assistant, told CNBC he had taped proof that Tobias was a murder victim and said he has been working with police.
"I think I'm doing more for Seth than anyone as far as trying to right a wrong," said Ash.
Police said they interviewed Ash at his home in San Diego after he came forward with information. They noted that Ash has a checkered past. Ash acknowledged to CNBC that his record includes arrests for prostitution and writing bad che
Meantime, Tobias' wife is engaged in a legal battle with his four brothers over the estate, estimated to be worth at least $25 million
Attorneys for both sides declined to comment but Ash is scheduled to give a deposition in the estate battle on Monday.
The $87 million fund manged by Tobias is being liquidated, according to an attorney for the fund. Two other Circle-T funds run by other managers remain intact.
© 2007 CNBC.com
URL: http://www.cnbc.com/id/21350893/
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Paion jumps as vampire-bat drug comes back to life
Thu Oct 18, 2007 9:18am EDT
By Mantik Kusjanto
FRANKFURT, Oct 18 (Reuters) - Paion's (PA8G.DE: Quote, Profile, Research) experimental stroke drug based on the saliva of vampire bats got a fresh lease of life on Thursday as reasons for its recent failure in a major trial may pave the way for a new study.
The company said analysis showed a high percentage of patients in the failed trial did not have a blood clot in the main brain arteries for its compound desmoteplase to dissolve.
"Desmoteplase is not dead. We now understand what happened in the prior study," Peer Nils Schroeder, investor relations head at the German biotech company, told Reuters.
Paion shares soared 79 percent to 2.7 euros by 1308 GMT. The stock hit a year high of 10.62 euros in May when investors bet the drug could prove effective.
"The company has found a decent explanation why desmoteplase failed," said Sal. Oppenheim analyst Peter Duellman.
"This is good news for Paion although there is still a long way to market," he added.
The company, founded in 2000 and publicly listed in 2005, said in a statement the latest findings gave the rationale for it to proceed with desmoteplase trial.
"The key issue to be addressed in the near future is to secure sufficient funding and to implement the latest findings into the design of future trials," Chief Executive Wolfgang Soehngen said in a statement.
Desmoteplase aims to capitalise on bat saliva's ability to prevent the blood of the bat's prey from clotting, keeping blood flowing as it feeds.
Researchers hope to use that capability to break up clots in the brain that are blocking blood flow, resulting in what is known as an ischemic stroke.
In August, Paion said the late-stage trial had failed its primary goal of improving patient outcomes and the drug was also associated with hemorrhages and deaths.
The disappointing results sent its shares plunging, and led Forest Laboratories Inc (FRX.N: Quote, Profile, Research) to quit its partnership and return all rights for North America. Danish pharmaceuticals group Lundbeck (LUN.CO: Quote, Profile, Research), its European partner, is evaluating the findings from the analysis.
"We expect a decision from Lundbeck at least until the year end. We have no timeline," Schroeder said, adding that the firm had started to find a partner to replace Forest.
Strokes are the second leading cause of death worldwide, according to the American Stroke Association.
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Reuters journalists are subject to the Reuters Editorial Handbook which requires fair presentation and disclosure of relevant interests.
Prochymal and non-myelo
I believe that the osiris study was open label, non-myeloablative patients had a death sentence if not on orbec. If prochymal wasn't used in non myeloablative patients comparing the data is like comparing apples to oranges
does prochymal work in non myeloablatives
PAION sees continued development rationale for Desmoteplase based on findings from Phase III analysis
I know people may believe this is another case of Zebra's law but the Desmoteplase method of action should make it the perfect drug for stroke. If a drug is going to work for stroke, this is the one.
Reasons identified for high placebo response rate in Phase III stroke study DIAS-2
Aachen (Germany), 18 October 2007
Dear Mr. Benison,
PAION AG (Frankfurt Stock Exchange, Prime Standard: PA8) today reported that it has reviewed findings from the analysis of the DIAS-2 (Desmoteplase in Acute ischemic Stroke) study results. In contrast to previous Phase II studies, the DIAS-2 study did not meet its primary efficacy endpoint due to a lack of improvement in the Desmoteplase groups over placebo. Therefore, the clinical efficacy of Desmoteplase as demonstrated in two smaller Phase II studies (DIAS and DEDAS) could not be confirmed. However, the analysis of the patient subgroups has generated new findings regarding the unexpectedly high placebo rate observed in the DIAS-2 study and provides indications for the efficacy of Desmoteplase, although short of any statistical significance due to the small patient numbers of the subgroups.
From the study's top-line results, it was already known that patients in the DIAS-2 study showed on average relatively mild symptoms of stroke. Now angiographs have been evaluated as part of the analysis. The data reveal that in contrast to DIAS and DEDAS, a high percentage of DIAS-2 patients did not have a blood clot in the main brain arteries at the start of treatment, despite the detection of salvageable brain tissue (penumbra) surrounding the infarct core according to the DIAS-2 study protocol. So far, stroke experts have assumed the presence of a penumbra to be a key indication of both visible (in the larger brain arteries) and non-visible blood clots (in smaller arteries). The new findings are crucial since Desmoteplase's main mechanism of action is to dissolve blood clots in occluded arteries.
Consequently, the high percentage of DIAS-2 patients lacking a blood clot in their main brain arteries seems to be a major reason for the similar clinical outcome across the different dose groups including placebo.
In addition, findings from patient subgroups with a detectable blood clot in their main brain arteries indicate that Desmoteplase could potentially show efficacy compared to placebo. In particular, the efficacy of the drug seemed to increase with the severity of the vessel occlusion. However, these findings have to be confirmed in a larger patient group in order to achieve statistical significance.
The latest findings from DIAS-2 are currently being discussed with leading stroke experts in order to optimize the design of potential new trials.
"We have identified probable reasons for the unexpectedly good outcome in the placebo arm as well as variables that will help optimize patient selection" state Prof Dr Werner Hacke and Anthony J. Furlan, MD, chairmen of the DIAS-2 Steering Committee. "Therefore, we see a scientific rationale to move on to the next study."
PAION's Chief Executive Officer Dr Wolfgang Söhngen comments: "We believe that these findings provide a sound development rationale for Desmoteplase. Following positive feedback from our investigators, the key issue to be addressed in the near future is to secure sufficient funding and to implement the latest findings into the design of future trials. This has to be based on an assessment of potential patient benefit and the commercial opportunity from a revised program with Desmoteplase."
The analysis was carried out under the lead of PAION. In August 2007, PAION's former partner Forest Laboratories, Inc. has decided to return all rights to Desmoteplase under its sub-license agreement for North America. PAION's partner H. Lundbeck A/S is currently evaluating the findings from the analysis.
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Please also refer to the attached PDF-version of the press release. To open the attachment, you will need the free Acrobat Reader (tm). The current version can be downloaded using the following link, for example: http://www.adobe.com/products/acrobat/readstep2.html
Conference Call
On Thursday, 18 October 2007 at 2 p.m. CEST (1 p.m. BST, 8 a.m. EDT) PAION will host a public conference call during which the latest findings in the DIAS-2 data analysis will be discussed. Participants may dial +49 69 2222 2220 (Germany), +44 20 7138 0839 (UK) or +1 718 354 1362 (USA). Please enter 2904733 as participant pass code. The conference call will be conducted in English. To allow for smooth processing we suggest that you dial in 10 minutes before the beginning of the call. The conference call will be recorded. A replay will be available starting approx. 2 hours after the call until end of day 20 October 2007. The dial-in details for the replay will be published after the conference call on our website www.paion.de/investors.
About Desmoteplase
Desmoteplase, the most fibrin-specific plasminogen activator known today, is a genetically engineered version of a clot-dissolving protein found in the saliva of the vampire bat Desmodus rotundus . It has received fast-track designation from the U.S. Food and Drug Administration for the indication of acute ischemic stroke.
About DIAS-2
The DIAS-2 (Desmoteplase in Acute Ischemic Stroke) study was designed to investigate the improvement of clinical outcome in patients with acute ischemic stroke treated with Desmoteplase within 3 to 9 hours after onset of stroke symptoms. Among other criteria, the detection of salvageable brain tissue (penumbra) of at least 20% compared to the infarct core was applied for including patients in the study. The blinded, randomized, placebo-controlled, dose-ranging Phase III study was jointly conducted by PAION and Forest and enrolled a total of 186 patients in Europe, USA, Canada, Australia, Hong Kong and Singapore.
About Stroke
Stroke is the third leading cause of death in the industrialised world and a leading cause of serious, long-term disability. In the US alone, 700,000 people suffer a stroke each year, and around 20% of them die within four weeks. For the US, the American Heart Association expects the financial burden of stroke due to in-hospital costs, long-term care programs and productivity losses to exceed 62 billion dollars in 2007 alone.
About PAION
PAION is a biopharmaceutical company based in Aachen, Germany (listed at Frankfurt Stock Exchange, Prime Standard, ISIN DE000A0B65S3). It aims to become a leader in developing and marketing innovative drugs for the treatment of stroke and other thrombotic diseases for which there is a substantial unmet medical need.
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For additional information, please contact:
Dr Peer Nils Schroeder, Investor Relations / Public Relations
PAION AG
Martinstrasse 10-12
52062 Aachen - Germany
Tel. +49 241 4453-152
E-mail pn.schroeder@paion.de
www.paion.de
___________________________________
Orbec had > 60% reduction in treatment failures at day 80. OSIR will not use TTF as the primary. And the data referenced by DrBio went out to 94 days.
sorry i think I was hillucinating. I have know idea where I got that data. I never even took drugs
a Monday approval would be fine
ixempra
do you know what the pdufa date for this was supposed to be
they are doing a webcast right now
they will have a replay
Evotec Reports Positive Top-Line Results in Phase II Study with EVT 201 in Elderly Insomniacs with Daytime Sleepiness
· Statistical significance in primary and key secondary endpoints at both doses
· Data confirm robust sleep onset and sleep maintenance effects seen in the first Phase II study in the adult population
Hamburg, Germany | Oxford, UK – Evotec AG (Frankfurt Stock Exchange: EVT) announced today positive top-line results from its second phase II trial of EVT 201 in elderly primary insomnia patients with daytime sleepiness. These top-line results are from the pre-specified intention-to-treat analysis from the 149 patients who were randomized into the study.
The study showed a highly significant improvement between both doses of EVT 201 and placebo on the primary endpoint of polysomnography (PSG) derived Total Sleep Time (TST); compared to placebo, mean TST increased by 30.9 minutes (9%) on EVT 201 1.5 mg and 56.4 minutes (17%) on EVT 201 2.5 mg; p=0.0001 and p=<0.0001 respectively.
Significant improvements were also seen across key PSG-derived secondary endpoints including Wake After Sleep Onset (WASO) and Latency to Persistent Sleep (LPS). Although the study was not powered to show this, the 2.5 mg dose also showed a significant effect on TWT (Total Wake Time) during the second half of the night, indicating that EVT 201 is highly effective in maintaining sleep throughout the night. This was further confirmed by the hour-by-hour analysis of TWT. Treatment with EVT 201 produced a statistically significant reduction in TWT for all hours of the night apart from hour 7.
A randomized, double-blind, placebo-controlled parallel group design was used to assess the hypnotic efficacy of EVT 201 1.5 mg and 2.5 mg following 7 nights dosing. The study was conducted in 20 sleep labs in the US using both objective and subjective measures. PSG data were collected on nights 1, 6 and 7 and results are based on the mean data from these three nights.
The table below shows the results for the primary and key secondary PSG endpoints.
Parameter
n=149
Placebo
EVT 201
1.5 mg
EVT 201
2.5 mg
Adjusted mean TST (mins) / % change from placebo
338.6
369.5 / 9%
p=0.0001
395 / 17%
p=<0.0001
Adjusted mean WASO (mins) / % change from placebo
101.4
86.2 / 15%
p=0.0140
65.3 / 36%
p=<0.0001
Adjusted mean LPS (mins) / % change from placebo
46.5
30.5 / 34%
p=0.0091
26.5 / 43%
p=0.0014
The PSG analysis also showed that EVT 201 generally preserved sleep architecture.
These PSG results were supported by patient reported measures including subjective Total Sleep Time (sTST), subjective Sleep Onset Latency (sSOL) and subjective Wake After Sleep Onset (sWASO).
Subjectively, sleep quality was improved on all nights and there was no residual sedation assessed 30-minutes post wake time (approximately 9 hours post dose).
An additional element of the study design was to assess daytime function on Day 8. This included the Multiple Sleep Latency Test (MSLT), an objective assessment of daytime sleepiness. Initial analyses showed that both doses of EVT 201 produced a statistically significant overall improvement in the MSLT compared to placebo, indicating that patients were less sleepy during the day following treatment with EVT 201.
Daytime function was further assessed objectively using the Rey Auditory Verbal Learning Test (RAVLT), a short-term verbal memory test, and Psychomotor Vigilance Task (PVT), a measure of sustained attention and reaction time and subjectively using the Karolinska Sleepiness Scale (KSS). Initial analyses suggest overall that there was no significant difference between EVT 201 and placebo. Further analyses of these endpoints are ongoing.
EVT 201 was well tolerated. No serious treatment emergent adverse events were reported during the study. The majority of adverse events reported were mild and infrequent. The most common adverse events were dizziness, headache and somnolence and the percentage of patients reporting these events is shown in the table below:
Treatment emergent adverse events
Placebo
(n=44)
EVT 201
1.5 mg
(n=53)
EVT 201
2.5 mg
(n=52)
Dizziness
0
5.7%
9.6%
Headache
0
9.4%
5.8%
Somnolence
2.3%
1.9%
11.5%
No significant difference was seen between either dose of EVT 201 and placebo in the Benzodiazepine Withdrawal Questionnaire.
The results of this study confirm the effects of EVT 201 on sleep onset and sleep maintenance seen in the adult population in Study 2004 and indicate that the same doses 1.5 mg and 2.5 mg have hypnotic efficacy in the elderly with no significant residual effects.
Further analysis of the remaining secondary and exploratory endpoints is ongoing.
“We’re delighted that these results in elderly insomniacs again confirm the excellent profile of EVT 201 as a potential treatment that helps patients to fall asleep quickly, maintains their sleep throughout the night and yet enables them to wake in the morning without hangover effects and feeling like they’ve had a good night’s sleep,†said Dr John Kemp, Chief Research & Development Officer, Evotec AG. “Due to its partial positive allosteric modulation of GABAA receptors, EVT 201 provides a novel approach to the treatment of insomnia, yet since the GABAA system is a well understood pathway, the risk of unexpected side effect findings are low compared to completely novel mechanisms.â€
Jörn Aldag, President and Chief Executive Officer, Evotec AG, said: “The positive outcome of this second clinical Phase II trial with EVT 201 is particularly encouraging as elderly patients are particularly underserved by current treatments. The study’s confirmation of our earlier Phase II data in adults underscores the finding that EVT 201 has hypnotic efficacy in both adults and elderly primary insomniacs and we believe that these data make EVT 201 an extremely attractive partnering opportunity.â€
“We now have two sets of data which robustly demonstrate the same profile of EVT 201 in both adults and the elderly – effects upon sleep onset and sleep maintenance throughout the night with minimal residual effects. This is exceptional for a compound at this stage of developmentâ€, added Dr Tim Tasker, Executive Vice President Clinical Development, Evotec AG. “The results also show that elderly patients with insomnia and daytime sleepiness were significantly less sleepy during the day following seven nights treatment measured using the objective MSLT test. The size of this effect was clinically significant, and has not been demonstrated in other recent hypnotic studies. This exciting headline finding will now be fully investigated in further analysis of the 2005 data.â€
Principal Investigator Dr James Walsh, Executive Director of the Sleep Medicine and Research Center, St John’s Mercy Medical Center, Chesterfield, Missouri, US, said: “In this second Phase II study with EVT 201 the robust efficacy seen previously in the adult population was duplicated with the same doses in elderly insomnia patients. It is exciting that the sleep-promoting effects seen throughout the night, coupled with no significant sedative activity of the drug during the daytime, allowed the improvement of sleep to be accompanied by significantly improved alertness during the day. This combination gives the compound a very attractive profile as a sleep promoting agent which improves both night-time and daytime symptoms of insomnia in the elderly."
R&D Update in London
Webcast Presentation and Conference Call
Evotec has scheduled an R&D Update in London at 13.00 pm BST (14.00 pm CET, 08.00 am US time East Coast) today which will be broadcast live on the internet. Evotec will also present details on this positive Phase II study in insomnia at that meeting.
For those who prefer to listen to the presentation via phone, please dial:
From Europe:
+49.(0)69.5007 1308 (Germany)
+44.(0)20.7806 1956 (UK)
From the US: +1.718.354 1388
Pass Code: 2793143
The on-demand version of the webcast will be available on our website: www.evotec.com - Investors – Webcasts.
GAITHERSBURG, Md.--(BUSINESS WIRE)--Gene Logic Inc. (NasdaqGM: GLGC - News) announced today that it had signed an agreement to sell its Genomics assets to Ocimum Biosolutions Ltd.,
they probably spent over a 100 million discovering those assets
a global life sciences R&D enabling company. Under the agreement, Gene Logic will exchange its genomics assets to Ocimum for $10 million cash, of which $7 million is to be paid at closing and $3 million is payable pursuant to a promissory note due 18 months from the date of closing. The purchase price is subject to adjustment based on certain potential revisions to the balance sheet at date of closing. Additionally, Ocimum will assume certain liabilities associated with the Genomics assets and business. Consummation of the sale is subject to certain conditions, including the approval of the Gene Logic shareholders who will be asked to authorize this transaction at a special meeting to be held for that purpose.
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“This is a transforming event of significant strategic proportion,” said Charles L. Dimmler, III, President and Chief Executive Officer of Gene Logic. “This agreement stands as another major milestone on the Company’s path to build a drug repositioning and development business. This event represents the culmination of a rigorous assessment of the Company’s
I wonder if this was submitted to the FDA in July ? Is it not a bit late (80 days to 94 days) to be claiming a direct benefit from orBec
this was in some kind of publication but I am not sure where. I am sure it was filed with the original NDA but Pazdur relied on his underlings to review everything and they just figured it wasn't important because it wasn't a secondary so it wasn't important.
hopefully this was resubmitted in June and pointed out to Dr. Pazdur and it of course should make an impression on him.
If Maha Hussein and the rest of the panel were impressed with the 80 day endpoint they would go nuts, with this one
duration of response
I am not sure where I found this data but I had some notes I will post here. I checked the article in Blood and the briefing docs and couldn't find them in there.
when you go passed the 80 day secondary endpoint for two weeks to day 94 the effect of orbec is even more pronounced.
placebo 80 day failure .............. placebo 94 day failure
39 out of 67 9 additional failures ..... 48 of of 67
bdp 80 day failure .................. bdp 94 day failure
22 out of 62 3 additional failures ...... 25 out of 62
I wish I could figure out where I found this information
I don't think anyone wanted to count on the durability of the effect beyond the treatment period to make the 80 day the primary endpoint
actually you are incorrect. Dor was told by the fda prior to running the phase 3 that if they met the primary endpoint at 50 days but failed the 80 day endpoint the drug would probably not get approved. so they had to prove that the drug effect was durable
However, the assumption of proportional hazards in these time-to-event analyses was shown to be in error, as GVHD treatment failure occured during the first 10 days of prednisone treatment in 12 of the 48 patients with GVHD treatment failure by study day 50 (8 BDP and 4 placebo). Thus, the more clinically relevent analyses were the proportion of patients who were GVHD treatment failures by the last day of study drug (study day 50) and 30 days laters (study day 80).
this is what I have been saying all along
At 50 days treatment failure was p value was .0515.
In the odac panel minds i think they thought the treatment failure rate was .1177. the p value of .1177 was a weighted average of the treatment failure throughout the 50 days so the problems in the first 10 days were actually magnified even though the drug didn't have a chance to take effect.
the important thing is at 50 days how many people were saved from undergoing high dose prednisone, not when they failed.
[$$] Mylan's Acquisition Gambit
at Barron's Online (Fri 11:33am)
does anyone have access to this
analyts raises target by saying making an assumption that a phase one drug has a 100 percent chance of success and will be in the market. then they can actually raise the earnings by 15 cents 10 years from now.
Transition Therapeutics, Inc. (TTHI) – Outperform -- $225MM Mkt. Cap – (William Tanner/Aileen Salares/Jing Shang)
Share price weakness presents attractive entry point
$B!|(B TTHI shares have been weak recently, possibly the result of confusion regarding the company's diabetes program.
$B!|(B Interest in TTHI has been predominantly focused on ELND-005 (AZD-103), a small molecule drug candidate being tested as a treatment for Alzheimer's disease (AD).
$B!|(B In partnership with ELN, development remains on track with the start of Phase II trials anticipated for late 2007 or early 2008.
$B!|(B Questions have arisen regarding TTHI's other major R&D program designated as I.N.T. (islet neogenesis therapy), a novel diabetic treatment involving pancreatic regeneration.
$B!|(B Recall I.N.T. is a combo approach involving peptide hormones epidermal growth factor (EGF) or glucagon-like peptide 1 (GLP-1) with gastrin, a hormone that regulates gastric acid secretion.
$B!|(B With proof of concept achieved with E1-I.N.T. in the Phase IIa trials completed to date, it remains unlikely that partner Novo Nordisk would exercise its option to continue development of this therapy.
$B!|(B Instead, gastrin-based combos with metformin and GLP-1 analogs could hold greater potential in their ability to regulate blood glucose levels and regenerate pancreatic islet cells.
$B!|(B TTHI retains the rights to all other gastrin-based combos outside of E1-I.N.T. and anticipates advancing gastrin+metformin and GLP1-I.N.T. into Phase II trials in 2H:07.
$B!|(B While no guidance has been provided by the company on timing of a partnership for the diabetes program, we believe TTHI may look to extract greater value from these assets by seeking out-licensing agreements at a later stage in development.
$B!|(B We are updating our 12-month fair value estimate for TTHI shares from $21 to $24 as a result of AZD-103 completing Phase I development. Using Monte Carlo simulation analysis, we had assumed a 90% of success. Eliminating that failure increases the expected 2017 EPS estimate from $2.10 to $2.25.
$B!|(B Under our assumptions, we estimate the value of the AD program alone is $10 per share, which suggests that the market is ascribing little or no value to a diabetes program with substantial potential.
Threshold Pharmaceuticals to Stop Enrollment in Clinical Trial
Thursday October 11, 4:00 pm ET
another way of saying the drug sucks
REDWOOD CITY, Calif., Oct. 11 /PRNewswire-FirstCall/ -- Threshold Pharmaceuticals, Inc. (Nasdaq: THLD - News), today announced that, as part of a planned interim analysis, it would stop enrollment in a Phase 2 clinical trial evaluating the efficacy and safety of glufosfamide in patients with recurrent, sensitive small cell lung cancer.
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The clinical trial utilized a two stage design to ensure there would be an adequate response rate to justify complete enrollment. Tumor response was evaluated at baseline and every six weeks using the Response Evaluation Criteria In Solid Tumors (RECIST). The first stage enrolled 21 patients as planned, but only one confirmed partial response was observed. If three or more responses were observed, an additional 29 patients would have been enrolled. Patients currently enrolled in the clinical trial will be given the option to continue in the trial.
"We are disappointed in the study results. While we recognize that response is not a perfect surrogate for survival, the low response rate indicates that glufosfamide is not sufficiently effective as a single agent for patients with small cell lung cancer. We had hoped to develop a better treatment option for patients with this disease, for whom the quality of life and treatment outcomes need improvement," said Barry Selick, Ph.D., chief executive officer of Threshold. "We want to thank the investigators, patients and their families for their participation in the study."
Phase 2 Clinical Trial Design
Approximately 50 patients with extensive recurrent sensitive small cell lung cancer, who had progressed at least 60 days after completing chemotherapy, were planned to enroll in the Phase 2, open-label, clinical trial at various sites in the United States, Ukraine and Russia. All patients were to receive glufosfamide every three weeks for up to six cycles. The study utilized a Simon two-stage design which was designed to stop development if the true response rate was 10% or less and to continue development if the true response rate was 25% or higher.
The primary efficacy endpoint of the trial was objective response rate. The secondary endpoints of the trial evaluated duration of response, progression-free survival, overall survival and various safety and pharmacokinetic parameters. The study also evaluated the effects of glufosfamide on lung cancer symptoms utilizing the Lung Cancer Symptom Scale (LCSS).
About Small Cell Lung Cancer
The National Cancer Institute estimates that 174,470 people were diagnosed with lung cancer in the United States in 2006, and approximately 160,000 people will die each year from the disease. Small cell lung cancer is less common than non-small cell lung cancer. About 15 to 20 percent of all lung cancers are the small cell type. This cancer usually starts in the bronchi near the center of the chest but has often spread outside of the lung by the time of diagnosis. Small cell lung cancer is strongly associated with a history of cigarette smoking.
About Threshold Pharmaceuticals
Threshold is a biotechnology company focused on the discovery and development of small molecule therapeutics for the potential treatment of cancer. By selectively targeting abnormally-proliferating tumor cells, the Company's drug candidates are designed to be potentially more effective and less toxic to healthy tissues than conventional treatments. For additional information, please visit our website (http://www.thresholdpharm.com).
Forward-Looking Statements
Except for statements of historical fact, the statements in this press release are forward-looking statements, including statements regarding Threshold's product candidates, clinical trial progress and results, and potential therapeutic uses and benefits of our product candidates. These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, Threshold's ability to commence, enroll or complete its anticipated clinical trials, the time and expense required to conduct such clinical trials and analyze data, issues arising in the regulatory or manufacturing process and the results of such clinical trials (including product safety issues and efficacy results). Further information regarding these and other risks is included under the heading "Risk Factors" in Threshold's Quarterly Report on Form 10-Q, which was filed with the Securities Exchange Commission on August 7, 2007 and is available from the SEC's website (http://www.sec.gov) and on our website (http://www.thresholdpharm.com) under the heading "Investors." We do not intend to update any forward-looking statement made in this news release.
Contact:
Denise T. Powell
Sr. Director, Corporate Communications
Threshold Pharmaceuticals, Inc.
650-474-8206
dpowell@thresholdpharm.com