ASCO 12.05-15.05 - 500 Beiträge pro Seite

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Vom 12.05 bis 15.05 findet der Kongress der American Society of Clinical Oncology statt, so dass mit einigen Veröffentlichungen zu rechnen sein dürfte!! Unter anderem wird z.B Novartis das Leukämiemedikament Glivec vorstellen.

SAN FRANCISCO (CBS.MW) - The financial and scientific communities will be paying close attention to news coming from the 37th annual American Society of Clinical Oncology meeting, which starts this weekend in San Francisco.

The cancer conference, which runs from May 12th to May 15th, is regarded as one of the most important medical meetings of the year. Some 25,000 cancer specialists are expected to attend.

The word among financial analysts is that companies developing drugs that inhibit the epidermal growth factor receptor (EGF) are likely to garner lots of attention at this year`s meeting.

Banc of America Securities analyst Eric Ende said data suggest the drugs may increase the effectiveness of chemotherapy in some solid tumors.



Drug firms working in this area include Abgenix (ABGX: news, msgs, alerts) in partnership with Immunex (IMNX: news, msgs, alerts) , Genentech (DNA: news, msgs, alerts) and OSI Pharmaceuticals (OSIP: news, msgs, alerts) , ImClone Systems (IMCL: news, msgs, alerts) , Astra Zeneca (AZN: news, msgs, alerts) and Pfizer (PFE: news, msgs, alerts) .

Robertson Stephens analyst Mike King said he believes the EGF receptor is an important new target in oncology.

Antibodies

Abgenix is expected to present preliminary results from a Phase I study of ABX-EGF, a fully human antibody that blocks the EGF receptor. It`s being studied as a treatment for kidney cancer.

Abgenix and Immunex have begun a Phase II study and also plan to begin additional Phase II trials in different cancers this year. Idec Pharmaceuticals (IDPH: news, msgs, alerts) and Corixa (CRXA: news, msgs, alerts) are expected to present additional data on Zevalin and Bexxar, monoclonal antibodies that treat non-Hodgkins lymphoma. On Thursday, Idec said the U.S. Food and Drug Administration requested more data on Zevalin. The FDA is currently reviewing Idec`s application to market the drug.

Green light for Gleevec

Banc of America`s Ende said Novartis` (NVS: news, msgs, alerts) drug Gleevec, which was approved for sale by the U.S. Food & Drug Administration on Thursday (see full story), could be "the focal point" of the conference. "Through new clinical trial data, we expect that during the next several years, it will become increasingly apparent that Gleevec has activity in several other cancers," Ende said. Data will be presented on Monday, May 14th.

Among the larger biotechnology companies, Genentech is also presenting data on Rituxan, which could "provide a foundation for the next leg up in growth" of the drug`s sales, Ende said in a note to clients. The drug also treats non-Hodgkins lymphoma. Genentech will also present research on its breast-cancer drug Herceptin, for which it also hopes to expand the market.

Genentech will show results of studies of Herceptin in breast, colon and non-small cell lung cancer, as well as studies of Herceptin used with other drugs. There will also be data on toxicity, which has caused concern in the past year.

Amgen (AMGN: news, msgs, alerts) will be presenting data on its second-generation version of its blockbuster drug Epogen, which is used to treat anemia. Robertson Stephens` King said he believes new markets for the drug, called Aranesp, will be in chemotherapy-induced and cancer related anemia.

Other presenters include Celgene (CELG: news, msgs, alerts) , which will release data on its drug Thalomid which is being studied as a treatment for various solid tumors and in other cancers.

Among the large drug makers with a presence at the meeting are Pharmacia (PHA: news, msgs, alerts) , Schering-Plough (SGP: news, msgs, alerts) Bristol-Myers Squibb (BMY: news, msgs, alerts) , Eli Lilly & Co. (LLY: news, msgs, alerts) and Roche.


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SAN FRANCISCO, May 13 /PRNewswire/ -- Cell Genesys, Inc. (Nasdaq: CEGE) today reported interim clinical data from its multicenter Phase I/II GVAX(R) lung cancer vaccine trial which demonstrates objective evidence of antitumor activity including a major response rate of 18 percent in patients with advanced non small-cell lung cancer who have failed chemotherapy and/or radiation therapy. These data were presented on behalf of the GVAX (R) Lung Cancer Clinical Investigators by John Nemunaitis, M.D. of U.S. Oncology at the American Society of Clinical Oncology (ASCO) Meeting in San Francisco, Calif. The presentation was one of 17 selected for ASCO`s Official Press Program from the more than 3,300 submitted to the meeting.

The interim clinical trial data includes results on 30 currently evaluable patients with advanced or early-stage lung cancer. Of 22 patients with advanced-stage lung cancer, three patients, two of whom had failed chemotherapy and one who failed radiation therapy, showed a complete disappearance of metastatic tumors following treatment with GVAX(R) lung cancer vaccine. One other patient who failed radiation and chemotherapy had partial (greater than 50 percent) reduction in his tumor. In addition to these major responses, four patients currently have stable (non-progressive) disease. All of these responses are continuing with a median follow-up time of approximately five months. In addition to the responses in patients with advanced disease, seven of eight patients with early-stage lung cancer who received GVAX(R) vaccine following surgery, currently remain free of disease with a median follow-up time of seven months.

"We are very encouraged by what we have seen to date with GVAX(R) lung cancer vaccine, particularly with respect to the major tumor responses in patients with metastatic lung cancer who have failed chemotherapy," stated Dr. Nemunaitis. "These findings are all the more noteworthy given that lung cancer patients who fail chemotherapy have little chance of responding to further chemotherapy or other treatment."

"These exciting clinical results with our GVAX(R) lung cancer vaccine are yet another reason we have increased our investment in the clinical and manufacturing development required to bring a GVAX(R) product to market," stated Joseph J. Vallner, Ph.D., executive vice president and chief operating officer of Cell Genesys. "GVAX(R) vaccines have demonstrated objective evidence of antitumor activity in all five types of cancer in which they have been tested -- lung, prostate, pancreatic, kidney and melanoma -- as well as a very favorable safety profile compared to chemotherapy which has been documented in over 300 patients treated to date."

The currently ongoing Phase I/II trial of GVAX(R) lung cancer vaccine for which the interim results were reported has recently completed enrollment. A final report on the trial is expected during the next year. In this trial, patients were administered up to six vaccine treatments every other week for three months as an intradermal (under the skin) injection. Patients received no other anticancer treatments during the trial evaluation period. As has been demonstrated in all GVAX(R) cancer vaccine trials to date, the vaccine was shown to be safe and well tolerated -- a side effect profile which compares favorably to other cancer treatments such as chemotherapy. No dose limiting toxicities have been observed. In addition to the antitumor activity noted above, the interim trial results also demonstrate that GVAX(R) lung cancer vaccine induces an anti-lung cancer cellular immune response as well as the formation of new anti-lung cancer antibodies in the blood. Update on Initial Trial of GVAX(R) Lung Cancer Vaccine

An earlier Phase I/II trial of GVAX(R) lung cancer vaccine in patients with advanced non small-cell lung cancer which was conducted by Dr. Glenn Dranoff and colleagues at Dana-Farber/Partners Cancer Care, an affiliate of Harvard Medical School, was reported at the Ninth World Conference on Lung Cancer in Tokyo, Japan in September 2000. This trial demonstrated antitumor immunity in 18 of 25 patients. In addition, two patients who received GVAX(R) lung cancer vaccine following surgery remain in complete remission more than three years after GVAX(R) treatment. Future Clinical Trials for GVAX(R) Lung Cancer Vaccine

The GVAX(R) lung cancer vaccine trials to date, including the current study, have employed a patient-specific product format in which the vaccine is directly prepared from the patient`s own tumor cells in an overnight process. In the near future, Cell Genesys plans to launch a clinical trial in advanced lung cancer to evaluate a non patient-specific GVAX(R) product which will be centrally manufactured by Cell Genesys and then mixed with patients` own irradiated tumor cells prior to vaccination. This new product format for GVAX(R) lung cancer vaccine is expected to have significant development and commercialization advantages compared to the first generation product used in the trial reported today. Given the encouraging results demonstrated in ongoing clinical trials for prostate and pancreatic cancer, Cell Genesys is emphasizing non patient-specific GVAX(R) products which can be developed and commercialized as "off-the-shelf" pharmaceuticals. Background on GVAX(R) Cancer Vaccines
GVAX(R) cancer vaccines are comprised of tumor cells which have been genetically modified to secrete granulocyte-macrophage colony stimulating factor (GM-CSF), a hormone which plays a key role in stimulating the body`s immune response to vaccines. The genetically modified tumor cells are then irradiated for safety and used to vaccinate patients to stimulate an immune response against their tumor. The company`s lead GVAX(R) cancer vaccine program targets patients with recurrent hormone refractory prostate cancer and is currently being evaluated in two multicenter Phase II trials. A series of Phase I/II trials was recently initiated utilizing the company`s new high-potency GVAX(R) prostate cancer vaccine. Additionally, a Phase I/II trial for GVAX(R) vaccine for myeloma was recently initiated, and a Phase II trial of GVAX(R) pancreatic cancer vaccine and a Phase I/II trial of GVAX(R) vaccine for leukemia are expected to commence in mid 2001. Cell Genesys Profile

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SAN FRANCISCO -- The combination regimen of a new kind of drug and a gold- standard chemotherapy agent may offer hope to sufferers with advanced colorectal cancer.

Results from a highly anticipated trial testing ImClone Systems Inc.`s (IMCL) targeted compound IMC-C225 and irinotecan chemotherapy have demonstrated the combination produces responses in some patients with advanced colorectal cancer who no longer respond to standard chemotherapy.

The study findings, presented at the 37th annual meeting of the American Society of Clinical Oncology in San Francisco, showed that tumors shrank more than 50% in 27 of the 121 patients given the combination regimen.

Meanwhile, trial results presented at the meeting suggest a new intravenous drug from Amgen inc. (AMGN) could cut nearly in half the number of days a cancer patient suffers from the side effects of certain treatments, while the antidepressant Paxil was shown to be effective in combating chemotherapy-induced depression in cancer patients who participated in a recent study.

The gathering was also buzzing from Thursday`s lightning-fast approval for Novartis AG`s (NVS) Gleevac leukemia drug.

Researchers from Memorial Sloane Kettering Cancer Center in New York considered the 23% response rate for the InClone drug cocktail a major response. They were looking for at least a 15% response rate to conclude the compound induced activity.

"The quality of the results was better than my best hope," Leonard Saltz, lead investigator and medical oncologist at Memorial Sloan-Kettering, said in an interview with Dow Jones Newswires. "To see any response would have been exciting; but to see [a 22.5% response rate], it knocks your socks off."

The phase II study aimed at colorectal cancer patients whose cancer has spread and have no treatments available to them because they have tried conventional chemotherapy and their tumors failed to shrink. All of the 121 patients tested had failed irinotecan chemotherapy, marketed as Camptosar, which Pharmacia Corp. (PHA) had approved as a first-line and second-line treatment to fight cancer.

According to the American Cancer Society, colorectal cancer is the second- leading cause of death from cancer. About 56,700 patients, or 10% of those who suffer from cancer, will succumb to the disease this year. If the cancer is caught early and hasn`t spread throughout the body, patients have a five-year survival rate of 90%. However, if the cancer scatters but stays in the colorectal area, patients have a 65%, five-year survival rate and if the cancer becomes pervasive, the rate slides precipitously lower to 8%.

"These patients have run out of chemotherapy options ... but IMC-C225 is proving to reverse drug resistance," said Dr. Saltz. "This is not a cure for colorectal cancer; everyone at stage IV still dies from the disease. But this is an exciting tool, a solid line-drive single."

IMC-C225 is a member of a new class of drugs that seeks out the epidermal growth factor and blocks the interaction between the tumor cells and the receptor. The disturbance prevents the tumors from dividing and growing larger and spreading throughout the body.

All of the study`s patients were screened for and expressed the epidermal growth factor receptor on the surface of their tumors. As long as their tumors had these receptors present on the surface, the patients were included in the study.

Based on results from the laboratory, IMC-C225 wasn`t able to kill the cancer. However, it can weaken cancer cells` ability to grown and make them far more vulnerable to chemotherapy drugs. The study also indicated that patients` quality of life improved and were able to tolerate the combination regimen.

Despite any hard evidence of survival, Dr. Saltz suspects IMC-C225 and irinotecan could prolong survival. However, he said nothing conclusive can be determined until a randomized study compares the combination therapy against a control group.

ImClone plans to conduct a national pilot study to test the combination of IMC-C225 and irinotecan in 1,200 patients who have never been treated before and haven`t developed resistance to any chemotherapy treatments to see if the tumors shrink and survival is extended. The study would begin this summer.

Dr. Saltz said it would be inappropriate and unethical to test for survival in patients who have become resistant to chemotherapy in a study pitting the combination regimen against irinotecan alone. The patients given irinotecan would derive no benefit from the treatment but would experience the toxic side effects.

ImClone isn`t waiting for results from the first-line study to file for approval of IMC-C225. The company has spoken with the Food and Drug Administration and plans to submit the first part of its filing in June. As more information is gleaned, the company will add to its application that will receive a shortened review because the FDA granted IMC-C225 fast-track status for its fulfilling an unmet medical need. Usually, the fast-track review lasts six months.

ImClone is testing IMC-C225 in patients with head and neck cancer, pancreatic cancer and non-small cell lung cancer, all of which express the EGF receptors on the surface of the tumorous cells.

If IMC-C225 proves capable of shrinking solid tumors in a variety of cancers, ImClone Chief Operating Officer Harlan Waksal said the possible market opportunity could reach $1 billion.

Meanwhile, Paxil was shown to help combat depression caused by chemotherapy, but the drug had no effects on the patients` fatigue. The study in which Paxil was tested examined the GlaxoSmithKline PLC (GSK) drug`s effectiveness in patients suffering from both depression and fatigue, which are common among chemotherapy-treated patients.

Dr. Gary R. Morrow of the University of Rochester Cancer Center, who prsented the findings at the Clinical Oncology society meeting, said it was hoped that chemotherapy patients could be treated for depression and fatigue by the same medication. However, the 738-patient study showed Paxil didn`t impact fatigue any more than a placebo sugar pill.

Although many patients suffer from depression, Dr. Morrow said it isn`t always treated among patients on chemotherapy. "It`s inadequately treated," he explained, citing reports that 25% to 50% of chemotherapy patients are clinically depressed, while a larger percentage experience some form of depression from the time they`re diagnosed.

Also, a phase II clinical trial showed Amgen`s recombinant human keratinocyte growth factor, or KGF, when given before and after treatment reduced the number of days cancer patients suffered from severe oral mucositis to four days from 7.7 days. As a result, the quality of life of these patients improved, said Ricardo Thomas Spielberger, lead researcher and staff physician at the City of Hope National Medical Center in Duarte, Calif.

Patients suffering from leukemia, lymphoma, multiple myeloma and Hodgkin`s disease often will develop severe oral mucositis after they have received radiation, chemotherapy and stem-cell transplants. Suffering from ulcers, swelling and bleeding in their mouths, those patients can`t eat or drink and are susceptible to infections. Currently, there aren`t any approved therapies to prevent mucositis, which usually lasts about a week.

Researchers asked patients daily about how they felt, and whether they could talk and eat, and then rated the replies. The scores indicated that patients treated with KGF before and after felt better than those placebo, said Mr. Spielberger, adding, "Patients said they felt better and we could see improvement in their mouths."

In the 129-patient study, researchers tested KGF`s effectiveness when used three days before radiation and compared it to when it was used three days before radiation and three days after transplantation as well as placebo. Patients who received KGF before and after treatment experienced severe oral mucositis not only for the shortest time but also needed less pain medication to treat the ulcers and the bleeding.

"These studies suggest a new approach to intervening at the cellular level to protect mucosal cells and limit or possibly even prevent damage to these sensitive tissues caused by toxic cancer therapies," said Mr. Spielberger.

Amgen is currently testing KGF in a larger, late-stage phase III clinical trial for treating sever oral mucositis in cancer patients receiving stem-cell transplants.

While the various study results were being released, researchers and scientists at the Clinical Oncology society meeting were also talking about the about-face of identifying cancers. Instead of doing so by tumor location, soon the array of diseases may be diagnosed, treated and possibly named according to the molecule responsible for the abnormal growth.

Targeting the actual cause of the disease will hopefully be more effective, with fewer side effects. The first major step in that direction cleared regulatory hurdles in record time Thursday when the FDA approved Novartis` Gleevec for treating a rare leukemia. Although only about 4,400 Americans are diagnosed with the disease annually, the major news is that the drug is the first to target and treat a specific molecule that causes the deadly cancerous mutations.

"This is a sea change in the way we practice cancer medicine," said Dr. Lawrence H. Norton, president-elect of the cancer group.

Likening the impact to the discovery of penicillin, Dr. Norton said in the pre-antibiotic era, patients were diagnosed based on where they had infections, like a lung or the skin. Now, infections are treated based on what organism has invaded the body and what drug will kill the bug. Similarly, cancer treatment will be moving toward attacking the underlying cause rather than the tumor site.

Gleevec and other much anticipated targeted molecular therapies will be among 3,500 studies presented at the meeting of close to 25,000 cancer specialists that kicked off Saturday and concludes Tuesday.

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UNIONDALE, N.Y., SOUTH SAN FRANCISCO, Calif., and BASEL, Switzerland, May 12 /PRNewswire/ -- OSI Pharmaceuticals, Inc. (Nasdaq: OSIP), Genentech, Inc. (NYSE: DNA) and Roche announced today updated findings from two ongoing, Phase II clinical studies of the anti-cancer drug candidate Tarceva(TM) (OSI-774), an inhibitor of the epidermal growth factor receptor tyrosine kinase (EGFR). Clinical results presented at the 37th Annual Meeting of the American Society of Clinical Oncology (ASCO) demonstrated encouraging anti-cancer activity of Tarceva(TM) (OSI-774) and its potential utility as a single agent for the treatment of patients with refractory non-small cell lung (NSCLC) and head and neck cancer. The companies also announced that Tarceva(TM) has been chosen by the alliance as the trademark for OSI-774. Phase II Non-Small Cell Lung Cancer Trial

Roman Perez-Soler, M.D., a lead investigator and Associate Director for Translational Research at New York University School of Medicine -- Kaplan Comprehensive Cancer Center, reported data from a Phase II study of 57 evaluable patients with advanced, refractory, non-small cell lung cancer (NSCLC). Out of the 57 evaluable patients, one complete response (2 percent) and 8 partial responses (14 percent) were documented (2 unconfirmed). A total of 15 patients (26 percent) demonstrated evidence of disease stabilization for periods of three or more months. Furthermore, 28 patients (50 percent) in the study were still alive at the date of data assessment (3/30/01) with 10 patients (18 percent) having survived for over 300 days. In addition, 14 patients (25 percent) remained on study for six or more months. Median survival of patients in the study was 257 days and statistical analysis indicated a one year survival rate of 48 percent for patients in this uncontrolled study.

"The activity of Tarceva(TM) in patients with NSCLC was clearly demonstrated in this study," stated Dr. Perez-Soler. "Although this patient population is a highly selected group of stage IIIb and IV NSCLC patients who have progressed through multiple prior therapies, the information on patient survival is noteworthy. We look forward to controlled studies designed to substantiate this encouraging observation."

Qualification criteria for the open label, single agent study required failure of at least one round of platinum-based chemotherapy and to have tumors that are EGFR-positive. Tarceva(TM) (150 mg) was given orally as a single agent on a once-a-day dosing schedule. Objective clinical responses were evaluated at 8 and 12 weeks and classified as either complete responses, partial responses (>50 percent reduction in tumor size), stable disease, or progressive disease (>25 percent increase in tumor size). Phase II Head and Neck Cancer Trial

Neil Senzer, M.D., a lead investigator and Director of Research Radiation, U.S. Oncology in Dallas, Texas, presented data from a Phase II study of 124 evaluable patients with advanced squamous cell carcinoma of the head and neck. Qualification criteria for the open label, single agent study required patients to have advanced head and neck cancer that was inoperable. Dosing and endpoints were similar to those in the NSCLC study.

Of the 124 patients, seven partial responses (1 unconfirmed) (6 percent) were observed, while 49 patients (39 percent) showed documented evidence of disease stabilization for periods of three or more months. Overall 45 percent of patients had either a response or disease stabilization. The number of partial responses is less than previously reported at last November`s EORTC meeting in Amsterdam and results from the re-classification of several previously reported responses as stable disease (up to 50 percent tumor shrinkage) following third party assessment of the imaging data. Median survival of the patients in this study was 174 days, with 42 of the patients (39 percent) alive at the date of data assessment (3/28/01) and 14 patients having survived for over 300 days.

"Although data from these kinds of single agent studies in highly selected cancer patients can sometimes be over-interpreted, we are none-the-less very encouraged by these results documenting that Tarceva(TM) is active in both of these trials," stated Colin Goddard, Ph.D., Chairman and Chief Executive Officer of OSI Pharmaceuticals. Tarceva(TM) Safety and Tolerability Data

Preliminary analysis of the safety, tolerability and activity is ongoing and has thus far documented that Tarceva(TM) therapy can be administered to most patients with advanced cancer. Treatment has been generally well tolerated at the Phase II dose of 150 mg/day with a generally reversible acneiform rash and occasional diarrhea that responds to therapy being the most common side-effects reported to date. Consistent with other EGFR inhibitors in clinical development, rash has been the most common adverse event observed in all of the Tarceva(TM) trials. In the Phase II NSCLC study, a rash or rash related disorders were observed in 65 percent of the patients with 24 patients experiencing a mild rash and 12 patients having moderate rash and only one patient in this trial having a rash characterized as severe. The acneiform rash was more severe in the head and neck study with rash seen in approximately 72 percent of patients with 80 patients experiencing mild to moderate rash and 10 patients with documented severe rash.

"These early findings could mean a real chance for patients with NSCLC and head and neck cancer. We remain hopeful that results from further controlled clinical trials will prove beneficial to these patients who today have too few therapeutic options," said Dr. Don MacLean, Life Cycle Leader at Roche. "Tarceva(TM) will compliment the existing Roche oncology portfolio, as it is another targeted anti-cancer treatment." Tarceva(TM) Comprehensive Clinical Development Program

OSI, Genentech and Roche also revealed further details of their development program for Tarceva(TM). Genentech and Roche will initiate registration studies (Phase III) in front-line NSCLC later this year and will be responsible for the alliance program in breast cancer. OSI will initiate Phase III studies in pancreatic and refractory NSCLC and is responsible for the ongoing Phase Ib program examining the use of Tarceva(TM) with various chemotherapeutic regimens for advanced cancer patients. Genentech has opened a single agent, open label Phase II trial of Tarceva(TM) in patients with advanced breast cancer. OSI is conducting two additional Phase Ib clinical trials to determine the safety, tolerance, pharmacokinetics and preliminary anti-cancer activity of escalating doses of Tarceva(TM) in combination with carboplatin (Paraplatin(R)) and paclitaxel (Taxol(R)) in one study and gemcitabine (Gemzar(R)) and cisplatin (Platino(R)) in another study.

"Our experience in developing targeted therapies such as Rituxan and Herceptin for advanced cancer showed us that the ability of a single agent therapy to demonstrate objective responses in a heavily pre-treated patient population provides a strong rationale for randomized clinical trials that combine Tarceva(TM) with traditional therapies and in earlier stage advanced disease," said Susan D. Hellmann, Genentech`s executive vice president, Development and Product Operations and chief medical officer.

Further studies are in discussion with the U.S. National Cancer Institute`s Cancer Therapy Evaluation Program (CTEP) to collaborate with OSI to conduct clinical trials in multiple tumor types including epithelial malignancies of the gastrointestinal and genitourinary tracts, gynecological malignancies and brain tumors.

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SAN FRANCISCO and ROCKVILLE, Md., May 13 /PRNewswire/ -- EntreMed, Inc. (Nasdaq: ENMD) today announced, at the American Society of Clinical Oncology (ASCO) Annual Meeting, data from a Phase 1 clinical trial of rhAngiostatin that showed this agent to be very well tolerated in patients with advanced cancer -- a significant finding for this angiogenesis inhibitor. Dr. Eduardo D. DeMoraes of Thomas Jefferson Medical College, Philadelphia, Penn., presented data from the first Phase I study of rhAngiostatin at an integrated symposium on angiogenesis inhibitors and endothelin antagonists for cancer therapy. In this study, "Recombinant Human Angiostatin: A Phase I Clinical Trial Assessing Safety, Pharmacokinetics and Pharmacodynamics," patients were administered daily iv infusion of the drug in doses ranging from 15 to 240 mg/m2. These data indicate the drug is safe, has linear and predictable pharmacokinetics, and does not alter important blood clotting mechanisms.

"Importantly, given that rhAngiostatin is a fragment of a natural blood protein, no significant effects were seen on extensive testing of coagulation parameters. This means rhAngiostatin does not affect normal blood clotting and patients that underwent surgery healed normally after receiving rhAngiostatin, " said DeMoraes.

"This is the first human data we`ve seen of rhAngiostatin -- and these data confirm the safety profile demonstrated in our preclinical animal models," Dr. Edward Gubish, EntreMed`s president and chief operating officer. "Based on rhAngiostatin profile, we believe it to have promise as a single agent and wish to explore its synergy with combination therapies. This certainly adds to our excitement as we continue to move forward with rhAngiostatin`s development."

In preclinical testing, rhAngiostatin inhibited the growth of both primary and metastatic tumors, and demonstrated synergy with radiation therapy. Combination trials in the clinic with radiation are already underway and will be discussed in future scientific meetings later this year.

EntreMed`s rhAngiostatin and its two other angiogenesis inhibitors in clinical trials, Panzem and rhEndostatin, were highlighted as promising candidates in cancer therapies. These antiangiogenic product candidates also have the potential to be used as therapeutics in a wide range of non-cancer related diseases such as heart disease, blindness, psoriasis and endometriosis, as well as chronic inflammatory conditions such as arthritis. EntreMed also performed the early clinical development of thalidomide, conducting four Phase II clinical trials in patients with cancer and securing two orphan drug designations prior to licensing that drug to Celgene in 1998. The antiangiogenic drug, THALOMID(R), is now currently on the market for leprosy and provides a revenue stream to EntreMed.

EntreMed, Inc., The Angiogenesis Company(TM), is a clinical-stage biopharmaceutical company emphasizing antiangiogenesis therapeutics that inhibit abnormal blood vessel growth associated with a broad range of diseases such as cancer, blindness and atherosclerosis. The company`s strategy is to accelerate development of its core technologies through collaborations and sponsored research programs with university medical departments, research companies and government laboratories.

EntreMed`s majority owned subsidiary, TheraMed, Inc., develops targeted therapeutic products to treat severe and chronic diseases, including cancer, serious infections, cardiovascular disease and genetic disorders, based on its proprietary technology that uses blood cells for drug and non-viral gene delivery. For further information, please visit the EntreMed web site at http://www.entremed.com .

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