EntreMed Up on Preclinical Cancer Data

ROCKVILLE, Md. — Shares of EntreMed Inc. jumped Thursday after the drug developer said its experimental cancer drug showed activity against tumors in preclinical studies.

EntreMed shares rose 8 cents, or 3.9 percent, to $2.15 in morning trading on the Nasdaq. Shares have traded between $1.43 and $2.99 over the past 52 weeks.

The company said preclinical results for its cell cycle inhibitor MKC-1 showed that the compound interfered with tumor cells in models of lung cancer and pancreatic cancer when used by itself and with the cancer drug Tarceva.

Data showed that MKC-1 binded to tumor cells and destabilized structural components within the cells.

What is MKC-1 and how does it work?
Specifically, MKC-1 has been shown to inhibit mitotic spindle formation, prevent chromosome segregation in the M-phase (mitosis) of the cell cycle, and induce apoptosis or cell suicide, in multiple cell lines. These effects are consistent with a mechanism resulting from MKC-1 binding to its intracellular targets, tubulin and the importin beta proteins. The importin beta family of proteins plays a critical role in nuclear transport and cell division.
Tubulin is a constituent of microtubules. Microtubules are like cables inside the cell that help pull apart the chromosomes after they replicate such that each daughter cell receives an exact copy.

In the picture above the microtubules are green, attached to the chromosomes, blue, to pull the duplicated copies apart into each new cell.
The biotechnology company ENMD is slightly down in afternoon trading 5 cents to $2.02 with triple the normal volume.

New stem cell trial for heart attack patients

LONDON- British doctors said on Wednesday they plan to inject stem cells into heart attack patients in an experimental treatment aimed at preventing heart failure and deaths.

About 100 patients will receive stem cells from their own bone marrow -- or a placebo -- within five hours of a heart attack in the study, expected to begin early next year.

"We are hoping that the patients will have an increased quality of life six months after the procedure," said Professor John Martin, of University College London who will conduct the trial.

Stem cells are master cells that can turn into any cell or tissue type. Scientists believe they could act as a type of repair system and offer new treatments for illnesses ranging from heart disease and diabetes to Alzheimer's and multiple sclerosis.

Embryonic stem cells have the most potential but their use is controversial because they are derived from early embryos. Adult stem cells have a more limited range. But cells taken from the patients themselves overcome the ethical concerns and reduce the risk of their being rejected by the body.

"All other studies have put cells into the heart in small groups of patients several days or weeks after the heart attack," Martin told Reuters.

The British study will combine the normal treatment for a heart attack, along with the stem cell therapy.

The scientists believe that if the therapy is delivered quickly after an attack it can stop the damage to the heart. Earlier stem cell studies have tried to repair the heart after it has been damaged.

This has a lot of potential. Potential is the key regardless of political affiliations. All I'm saying is it's not as easy as putting in cells and curing disease. The public perception needs to be addressed.

Biotechnology Stocks Rally Tuesday Afternoon

BOSTON-- Drug stocks rallied Tuesday afternoon, but shares of Adolor Corp. fell for the second straight day following news that the Food and Drug Administration needs additional data before it can approve its drug candidate Entereg.

The Dow Jones Wilshire Pharmaceutical Index was up 0.9% at 2423.50, while the Dow Jones Wilshire Biotechnology Index advanced 1.1% at 3300.60.
Shares of Adolor were down more than 5% at $7.28, extending their losing streak from Monday. The sell-off was prompted by an FDA request a 12-month safety study be conducted on Entereg, which is used to treat bowel problems associated with the use of powerful painkillers. The agency issued an approvable letter for the drug, meaning it believes it can still be approved if certain conditions are met.
Early Tuesday, analysts at RBC Capital cut their rating of Adolor to sector perform, dropping their price target to $10 from $16 a share.
Adolor developed Entereg with U.K. drugmaker GlaxoSmithKline. Shares of Glaxo were up 1% at $54.22.

Shares of Neurocrine Biosciences Inc. were higher as well, gaining nearly 9% at $8.46 after the company was upgraded to neutral from underperform at Robert Baird on the belief that downside may be limited.

Charles River Labs shares moved up 3% to $43.88. The biotechnology company late Monday that said it swung to a loss in the latest quarter but backed its full-year 2006 forecast for both earnings and revenue.
MedImmune shares hopped 4% to $33.51. Analysts at FBR Research upgraded their rating of the stock to outperform, with a price target of $40 a share.

Positive data from Antisoma's AS1404 lung cancer trial presented at conference

New tumour progression findings complement data showing extended survival
London, UK, and Prague, Czech Republic: 8 November 2006 - Cancer drug developer Antisoma plc (LSE: ASM, US OTC: ATSMY) announces that the final data from its phase II trial of AS1404 in non-small cell lung cancer are presented today at the EORTC-NCI-AACR meeting in Prague by Professor Joachim von Pawel of Asklepios Hospital, Gauting, Germany, one of the leading investigators in the trial. Final time to tumour progression data are included in the presentation along with the updated survival and safety data released during October.

Key findings from the trial are:

* Patients who received AS1404 in addition to standard chemotherapy had a median survival 5.2 months longer (14.0 vs 8.8 months) than that of patients who received standard chemotherapy alone. This is one of the largest differences in survival ever reported from a trial combining a novel agent with first-line chemotherapy for lung cancer. Addition of AS1404 reduced the risk of death by 27%.

* Patients who received AS1404 in addition to standard chemotherapy had 23% increases in both median (5.4 vs 4.4 months) and mean (6.3 vs 5.1 months) time to tumour progression compared with patients on standard chemotherapy, according to an updated and final assessment by trial investigators. This analysis was conducted after follow-up of all patients for at least 12 months and shows a greater delay in progression with AS1404 than that reported at ASCO in June based on interim data from the trial.

AS1404 or it's chemical name, dimethylxanthenone acetic acid, may stop the growth of tumor cells by blocking blood flow to the tumor. It works by intiating cytokine release (manily TNF), that recruits other immune cells to the tumor. The TNF also causes necrosis of the surrounding blood vessels that feed the tumor, leading to tumor reduction.
Preliminary findings from a phase II trial in non-small cell lung cancer show that patients receiving AS1404 in addition to standard chemotherapy have a higher frequency of tumour responses than patients receiving chemotherapy alone, while side effects are consistent in the two groups.

The biotechnology company is up almost 8% in Europe.

Colorectal Cancer, NSCLC, Breast and Ovarian Cancer Represent the Most Common Indications Targeted By Drugs in Development

The biotechnology index for the last 5 days.


The Cancer Market Outlook To 2011

DUBLIN, Ireland-Nov 8, 2006 - Research and Markets has announced the addition of The Cancer Market Outlook to 2011 to their offering.

Innovation is the key driving force in the cancer market, creating strong opportunities for biotech and pharma companies to launch new products and benefit from high volume sales and a strong competitive position.

'The Cancer Market Outlook to 2011' provides detailed analysis on 9 indications in the cancer market, identifying growth brands, key drug classes and leading companies.

The 6-year epidemiology and product sales forecasts detailed in this report will enable you to evaluate the changes in the competitive positions of leading companies in the cancer market and ensure your R&D pipeline is aligned with future market opportunity to sustain revenue growth.

Use this report to benchmark the strategies behind the market-leading products of today and identify which products will be best positioned for growth over the period 2006-2011.

Key findings of the report...

-- New launches such as Erbitux, Avastin and Tarceva are set to continue to drive the rapid growth of the innovative market due to their utility across multiple indications, and superior efficacy profiles.

-- Colorectal cancer, NSCLC, breast and ovarian cancer represent the most common indications targeted by drugs in development, with an increasing focus also around indications such as renal cell carcinoma and NHL, which while offering a small patient base pose significant incentives if molecules are granted orphan drug status.

-- The cytostatic hormonals market, which has benefited from strong growth over the previous five years, no longer appears to be the growth driver it once was, as generic competition and a lack of innovation reduces prospects for growth.

-- Product and development failure, low investment in emerging technologies and various R&D pipeline constructs are forecast to catalyze a shift in the top players over the forecast period. While Roche is forecast to extend its leading position within the cancer market through strong sales of MabThera, Avastin, Herceptin, Pegasys and Tarceva, increasing genericization is expected to cannibalize AstraZeneca's cancer franchise.

Targeted Genetics shares jump on debt deal with Biogen Idec

SAN FRANCISCO-- Targeted Genetics Corp. shares jumped 22% to $2.62 in Tuesday morning trade after the Seattle-based biotech company said it has agreed to restructure repayment of $8.15 million of debt with Biogen Idec. Inc. Under the terms of the new deal, Biogen has agreed to convert $5.65 million of debt into 1 million shares of Targeted Genetics common stock. Targeted Genetics said it will pay $500,000 of the remaining debt immediately, with the remaining $2 million to be paid on a new repayment schedule. As a result of the agreement, Biogen's stake in Targeted Genetics will increase to 19.9%.

Targeted Genetics Corporation, a clinical-stage biotechnology company, engages in the research and development of gene therapy products and technologies for the treatment of acquired and inherited diseases. Its products include tgAAC94, a Phase I/II trial product for the treatment of inflammatory arthritis and other inflammatory diseases; and tgAAC09, a Phase II clinical product, which is used for the treatment of HIV/AIDS. The company also engages in the development, manufacture, and clinical evaluation of AAV-based therapies with Celladon’s portfolio of genes and cardiovascular expertise for the treatment of congestive heart failure. In addition, Targeted Genetics provides novel therapies for the treatment of Huntington's disease, an incurable neurodegenerative disorder.

Gene therapy gets a ton of funding right now for the treatment of just about any disease that a gene has been identified and located. Remember there are lots of forms of gene therapy, such as gene disruption by RNAi; DNAi, or over-expression of a functional gene to overcompensate for the disease causing gene.

tgAAC94 is a special delivery vector for the expression of genes (they are using it by introducing it intra-articular [injection directly into the joint space] to express the TNF receptor ( a cytokine the immune system naturally makes) for arthritis.

TGEN finished after hours trading up another 5% to close up the day at $3.05.

Lots of approvals today: Will get the info posted later today.

ANA975 in a New 13-Week Pre-Clinical Toxicology Study Using Crystalline Form

A Key Step Towards Objective of Re-initiating Clinical Trials :

Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS - News) announced today that it has initiated in collaboration with Novartis Pharma A.G ("Novartis") a new 13-week pre-clinical toxicology study of ANA975 to assess safety and tolerability in animals. The recently initiated study, which utilizes a new crystalline form of ANA975 developed by Novartis, should further the understanding of the toxicology profile of ANA975.

"The Anadys and Novartis joint development team has been working diligently over the summer to gain a better understanding of what occurred in the initial 13-week toxicology study in animals," said Steve Worland, Ph.D., Anadys' President, Pharmaceuticals. "While lymphocyte proliferation is an expected consequence of TLR7 activation, we wish to better understand the extent of this proliferation and its reversibility. This new study, which will explore proliferation and reversibility at multiple doses, should provide information helpful to our objective to resume dosing ANA975 in clinical trials."

In June 2006, Anadys suspended dosing in its ANA975 Phase 1b trial in patients with chronic hepatitis C pending additional analysis of recently obtained information from pre-clinical 13-week toxicology studies in animals. Preliminary analysis of that information revealed various new observations which appear consistent with intense immune stimulation in animals. Subsequently, the ANA975 IND was put on full clinical hold by the U.S. Food and Drug Administration. There have been no serious adverse events in humans during the Phase 1b trial. All adverse events have been mild to moderate and have not posed any safety concerns to date, and there were no clinical findings that contributed to the decision to suspend the Phase Ib trial.

TLR's, from an earlier post, are part of the passive immune system. TLR-7 is a receptor that activates this passive immune reaction. Activation of innate immunity is known to be an important component of the human immune defense. ANA975 has been administered to more than 90 healthy volunteers in three completed Phase I trials (501, 502, and 503) and 14 HCV infected patients prior to the suspension of the Phase 1b trial (504), without serious adverse events.

ANDS is Bio/Pharmaceutical company and is trading at $3.72 or up 2 cents in afternoon trading.

Accentia Biopharmaceuticals (ABPI) Commences Fast-Tracked Phase 3 Clinical Trial Of SinuNase For The Treatment Of Chronic Sinusitis

Accentia Biopharmaceuticals will begin enrolling patients for its Phase 3 study of SinuNase™ in November and will include patients with severe chronic sinusitis refractory to sinus surgery. The Company believes that SinuNase, which has been Fast Tracked by the Food and Drug Administration (FDA), is the first product candidate to be in a Phase 3 trial for chronic sinusitis. Despite the fact that there are 31 million affected U.S. patients, and that chronic sinusitis is by far the most common chronic respiratory disease with a market twice the size of asthma, there is currently no approved prescription pharmaceutical for chronic sinusitis.

If this takes off, it will make BILLIONS! I need it right now with these crazy Santa Ana winds!

ABPI Pharmaceuticals is trading (NASDAQ) at $3.29 or down 3 cents per share.

CombinatoRx Arthritis Drug Shows Results

CombinatoRx Says Arthritis Medication Shows Promising Early Phase II Trial Data

CAMBRIDGE, Mass.-- Drug maker CombinatoRx Inc. said Monday that early data in a midstage clinical trial for its experimental arthritis medication showed it reached both primary and secondary endpoints.
Shares jumped $1.45, or 20.6 percent, to $8.50 in premarket activity on the INET electronic exchange, after closing at $7.05 Friday on the Nasdaq. Shares have traded between $5.50 and $14.50 over the past 52 weeks.

In a Phase II clinical trial, rheumatoid arthritis patients were given either study drug CRx-102 or a placebo, and all patients were given an unnamed disease-modifying anti-rheumatic drug.

The primary endpoint looked for the presence of C-reactive protein, which is associated with the inflammation in rheumatoid arthritis. Patients in the CRx-102 group had an average 50 percent reduction in the protein after 42 days compared with 19 percent in the placebo group.

CRx-102 and CRx-139 are oral synergistic combination drug candidates with novel mechanisms of action targeting multiple biological pathways simultaneously. Synergistic combinations are comprised of two compounds acting together to provide a novel therapeutic effect which neither compound can achieve alone. CRx-102 contains the cardiovascular drug dipyridamole [a drug used in coagulation disorders]and an unconventionally low dose of the steroid prednisolone. CRx-139 contains paroxetine, an SSRI,[selective serotonin reuptake inhibitor] and a low dose of the steroid prednisolone. The goal here is to slow down or stop the immune system from attacking the body without immune comprimise in chronic inflammation.



In secondary endpoints, 63 percent of CRx-102 users had at least a 20 percent improvement in their tender and swollen joint count, compared with 30 percent of patients in the placebo group.

CRXX is up almost 15% in afternoon trading on the NASDAQ exchange.

Exelixis, Inc. Announces November 9 Webcast Of Clinical Investigator Discussions Of XL999, XL880, XL820 And XL184 Data

A continuation and new results from November 2 post.

SOUTH SAN FRANCISCO, Calif.-- Exelixis, Inc. announced that clinical investigators will discuss clinical data on XL999, XL880, XL820 and XL184 in conjunction with data presentations at the 18th EORTC-NCI-AACR Symposium on "Molecular Targets and Cancer Therapeutics" to be held in Prague, Czech Republic at 6:00 p.m. (local time) / 12:00 p.m. (ET) / 9:00 a.m. (PT) on Thursday, November 9, 2006.

So what are these XL... drugs and what do they do?

XL999 is an inhibitor of a receptor tyrosine kinase called VEGF, (vascular endothelial growth factor) which tells cells for form new blood vessels. It also inhibits other receptors that tells cells to grow.

XL880 stops VEGFR2 (vascular endothelial growth factor receptor 2) anther receptor that is overexpressed and upregulated in tumor cells that are growing rapidly and need to feed themselves with new blood vessels.

XL820 is a inhibitor of mutationally activated forms of KIT found in human cancers. In tumor models of breast carcinoma, glioma and leukemia the compound exhibits dose-dependent growth inhibition and has been shown to cause tumor regression.
KIT is another receptor tyrosine kinase that binds and signals when stem cell growth factor binds to it. In tumors, it is mutated such that it continually sends signals to the nucleus.

XL184 inhibits VEGFR2 and Met, key drivers for tumor formation and growth. MET receptor is a tyrosine kinase that transduces motility, proliferation, and morphogenic signals of scatter factor/hepatocyte growth factor in epithelial cells.

(EXEL) closed up 35 cents friday, at $8.56. I'm watching this one and may get in before the data is announced.

U.S. stocks set for choppy week

Investors expected to continue locking in recent gains

U.S. stocks are expected to come under pressure next week as investors await the outcome of the midterm elections and consolidate gains that have pushed the major indexes close to multiyear highs.
The voting public will have their say on Tuesday on a wide variety of issues in races around the country. Political strategists expect Democrats to gain seats in the House and Senate, but Republicans have been working to ensure that they don't lose more than the 15 House seats or six Senate seats needed to cede control of the chambers to the opposition.
"The market is still going to be choppy and on a downward note regardless of what the outcome is," said Barry Hyman, equity market strategist at EKN Financial Services. Success by the Republicans may lead to an upside pop in stocks in the middle of the week but "within a day or two that would be reversed," said Hyman. Read Election Trading Strategies.
The calendar of economic data will be light, with figures due on consumer credit and sentiment, trade, import prices and wholesale inventories. Most of the reports are slated for release on Thursday.
Hyman said stocks are likely to struggle as traders go back to worrying that the economy is heading for a recession after softer data this week. Last Friday's weaker-than-expected gross domestic product number set the tone for a weak performance on Wall Street, with the major indexes all losing ground.
The market found some support Friday after the Labor Department said the U.S. unemployment rate unexpectedly dropped to a 5 1/2 year low of 4.4%.

A lot of clinical data came out yesterday; going through it now and will post relevant material soon.

AVANIR Pharmaceuticals (AVNR) Announces $15 Million Sale Of Common Stock

SAN DIEGO--Avanir Pharmaceuticals (NASDAQ:AVNR) announced that it has entered into definitive purchase agreements with institutional investors for the offering of approximately 5,265,000 shares of Class A common stock at a price of $2.85 per share. As part of the offering of the common stock, the purchasers will also receive warrants to purchase 1,053,000 shares of Class A common stock at an exercise price of $3.30 per share. The warrants become exercisable six months after the closing and then remain exercisable for a period of six months. The gross proceeds of the offering are expected to be approximately $15 million, before offering expenses and commissions, and the net offering proceeds are expected to be approximately $14.4 million. The securities are being sold by AVANIR. The offering is expected to close on or about November 6, 2006.

I may have to get in on some of this action. I will post when of if I decide to pull the trigger.
AVNR stock trading in the biotechnology was down 20 cents to close at $3.10.

Biotechnology Sector finishes down Friday, 3 points

Index Value: 1,102.91
Trade Time: 4:15PM ET
Change: 3.68 (0.33%)
Prev Close: 1,106.60
Open: 1,105.57
Day's Range: 1095.96 - 1107.33

NovaDel Pharma (NVD) Receives FDA Approval Of NitroMist(TM)

FLEMINGTON, N.J.--(BUSINESS WIRE)--NovaDel Pharma Inc. (AMEX: NVD - News) today announced that NitroMist(TM) (Nitroglycerin Lingual Aerosol) has been approved by the U.S. Food and Drug Administration (FDA) for acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease. NitroMist(TM) is NovaDel's first product approval utilizing its proprietary oral spray technology. The North American commercial rights for NitroMist have been licensed to Par Pharmaceutical Companies, Inc. (NYSE: PRX - News).

"The FDA's approval of NitroMist(TM) is a major milestone for NovaDel, as it represents the first approval of a drug using our proprietary oral spray technology. This achievement also further validates our ability to develop innovative drugs and gain FDA approval using the 505(b)(2) regulatory pathway," commented Jan Egberts, M.D., President and CEO of NovaDel. "With this approval, we will now focus our resources on the rapid advancement of our pipeline of compounds that promise to provide faster onset of action and more patient-friendly dosing. We are particularly excited about the potential of Sumatriptan Oral Spray and Zolpidem Oral Spray, which respectively target patients suffering from migraines and insomnia."

"We are very pleased that our partnership with NovaDel has successfully delivered an additional treatment option for those patients who suffer from acute angina," stated Paul Campanelli, Senior Vice President, Business Development & Licensing at Par. "At this time, we are finalizing our commercialization strategy for the product."

NitroMist is an oral spray formulation of the drug most often used to treat angina pectoris, nitroglycerin. Angina is pain in the chest due to lack of blood and oxygen supply to the heart muscle resulting from an acute coronary syndrome and must be treated emergently. Nitroglycerin is most often, until now, placed as a dissolving pill under the tongue. It's mechanism of action is by relaxing the smooth muscle surrounding the arteries in the heart as well as reducing the volume of blood in the heart. Its effects are very short, 20 minutes, and is not indicated for maintenance therapy. This is a novel mechanism of delivery. I am keeping an open eye on this stock

The biotech/pharmaceutical company NVD is trading up 7% to $1.34.

Viacell up on new analyst ratings

UBS rates VIAC as buy.

3-Nov-06 UBS Upgrade FROM: Reduce TO: Buy


ViaCell, Inc., a biotechnology company, engages in the research, development, and commercialization of cellular therapies in the United States and Singapore. It develops a pipeline of proprietary umbilical cord blood-derived and adult-derived stem cell product candidates as treatments for cancer, cardiac disease, and diabetes. The company conducts a Phase I clinical trial of CB001, its lead umbilical cord blood-derived stem cell therapy product candidate as a treatment for hematopoietic stem cell reconstitution in patients affected by various cancers. It also sells ViaCord, a product offering through which expectant families can preserve their baby’s umbilical cord blood for possible future medical use. In addition, the company develops ViaCytesm, its investigational product candidate that intended to expand reproductive choices for women through the cryopreservation of human unfertilized eggs. It has an agreement with Stem Cell Internal Venture of Centocor Research & Development, Inc. to collaborate on studying a treatment for cardiac disease.

VIAC is trading up 7% to $4.22 in afternoon trading with double volume.

InterMune, Inc. Teams With Roche Milestone Payments Could Reach $470M

BRISBANE, Calif., Nov. 2-- InterMune, Inc. (Nasdaq: ITMN - News) announced today that on October 30, 2006, it successfully closed its Exclusive License and Collaboration Agreement with Roche for the exclusive worldwide development and commercialization of InterMune's hepatitis C virus (HCV) protease inhibitor program. The parties received notice of early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvement Act of 1976, on October 30, 2006.

Having closed the transaction, InterMune will receive an upfront payment of $60 million. Roche is now funding 67% of the global development costs associated with ITMN-191, InterMune's lead HCV protease inhibitor drug candidate. Assuming the successful development and commercialization of ITMN-191 in the U.S. and other countries, InterMune could receive up to $470 million in milestones, including a potential $35 million within the next 12 months.

The NASDAQ traded company closed at $21.72, down 37 cents.
InterMune, Inc., a biotechnology company, engages in the research, development, and commercialization of therapies in pulmonology [Lung] and hepatology [liver]. The company has a product portfolio addressing idiopathic pulmonary fibrosis (IPF) [scarring of the lung] and Hepatitis C Virus (HCV) infections. Its pulmonology portfolio includes two compounds in phase III development for IPF, a disease characterized by progressive scarring of the lungs for which there are no FDA-approved treatment options.

Australian Market on fire at this hour!

Asian shares were mixed in early trading Friday, as Australia's benchmark stock index rose to a record high after the nation's biggest lender, National Australia Bank, reported earnings, while South Korea's leading index fell back, pacing weakness on Wall Street.

Markets in Japan were closed for a public holiday.
Australia's S&P/ASX 200 was up 0.1% to 5,413.10, after touching an intraday record of 5,426.70 earlier in the session.
Elsewhere around the region, South Korea's Kospi rose 0.1%, Taiwan's Weighted Price Index was up 0.7% and Malaysia's KLSE Composite Index was up 0.1%. Singapore's Straits Times Index fell 0.5%.

Shares of National Australia Bank rose 2.3%.
The resource sector lost ground, pacing declines in crude oil and natural resource prices. Miner BHP Billiton fell 0.8% while Woodside Petroleum fell 0.7%. End of Story

Wall Street Extends Its Decline After Flat Productivity Report, Mixed October Sales Report

Wall Street Extends Its Decline After Flat Productivity Report, Mixed October Sales Report


NEW YORK (AP) -- Wall Street extended its decline Thursday, dipping lower after the Labor Department said productivity was flat in the third quarter while wages rose nearly 4 percent. The data touched off concerns that the Federal Reserve will continue to wrestle with inflation, possibly raising interest rates again.

The Dow Jones industrial average posted its first five-day consecutive decline since June 2005 following the economic news and amid mixed reports from retailers on October sales, including Wal-Mart Stores Inc., which had disappointing results last month and warned that November sales would also come in below expectations.

The economic data, which showed wage pressure was increasing at the fastest rate in more than 20 years, rattled investors who have grown concerned that the economy might be slowing too quickly. Wall Street wants a gradual slowdown so the Fed will cut interest rates.

One market observer wasn't worried, noting that the decline was modest. "In the grand scheme of what's happened today and this week I'd say the markets are hanging in there," said Brian Williamson, an equity trader at The Boston Company Asset Management.

Exelixis, Inc. Suspends Enrollment Of New Patients In XL999 Phase II Clinical Trial Program

Exelixis, Inc. today announced that it has suspended enrollment of new patients in the XL999 clinical trial program until further data have been collected and analyzed. The company currently anticipates that it will incur a delay in the clinical program for XL999 of between two weeks and three months. Exelixis suspended enrollment after a preliminary review of patient data relating to cardiovascular adverse events for the month of October. Through the end of September, 117 patients had been dosed with XL999, of whom 12 (10.3%) experienced serious adverse cardiovascular events. However, 4 of the 14 patients enrolled during October also experienced such events, which raised a concern with the company's internal safety monitoring committee. The company therefore decided to suspend enrollment of new patients pending further review of the data. Because 115 of the 131 subjects enrolled in the XL999 clinical program to date have received repeated doses of XL999 (every week or every other week) ranging from 2 doses (2 weeks) to 53 doses (approximately 2 years) with no reported cardiac toxicities, the company has elected to allow patients already enrolled to continue to receive XL999.

"The apparent increase in the frequency of cardiovascular events during October concerns us," said George A. Scangos, PhD, president and chief executive officer of Exelixis. "These are recent observations, and we are in the process of collecting and analyzing all of the relevant primary data. Our primary responsibility is the safety of the patients in the trial, and so we are suspending the enrollment of new patients until we have had a chance to analyze the data. Since all but one of the events occurred on first administration of XL999, we are continuing to treat those patients presently enrolled in the trial. We will of course keep you informed as we go forward analyzing the data."

WHAT is XL-999?
XL999 is a potent inhibitor of key receptor tyrosine kinases [receptors on the cell surface that transmit signals to the nucleus such as to grow] implicated in the development and maintenance of tumor vasculature and in the proliferation of some tumor cells. It inhibits the FGFR, VEGFR and PDGFR RTKs and also is a potent inhibitor of FLT3, an important driver of leukemia cell proliferation in some patients with acute myelogenous leukemia (AML). Those receptors are all growth oriented telling the cell to grow, put out new vessels to feed the tumor and to divide.

The Biotech/pharmaceutical company trades on the NASDAQ and closed down 12% today to $8.21