EntreMed, Inc. (Nasdaq: ENMD), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, announced the presentation of results for its cell cycle inhibitor, MKC-1, in preclinical renal cell carcinoma (RCC) models. The results were presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in San Francisco, California.

Activation of the oncogenic kinase Akt and the mTOR pathway are known to be adverse prognostic factors and contributors to the pathology of metastatic RCC, therefore inhibitors of these pathways are of significant interest for treatment of this disease. Human RCC cell lines in vitro were shown to have marked sensitivity to MKC-1. MKC-1 inhibited both Akt and mTOR pathway activation in vitro, and was further evaluated in a preclinical model consisting of a xenograft of the human RCC cell line, Caki-1. Orally- administered MKC-1, but not sunitinib malate (Sutent(R)), significantly increased survival of tumor-bearing animals in this model. Examination of tumors following five days of oral treatment with MKC-1 revealed inhibition of the Akt-mTOR pathway, as well as decreased angiogenesis and cell proliferation within the tumors. These preclinical results support further evaluation of MKC-1 for the treatment of renal cell carcinoma.

MKC-1 is a novel, orally-active cell cycle inhibitor with in vitro and in vivo efficacy against a broad range of human solid tumor cell lines, including multi-drug resistant cell lines. Data from previous studies with MKC-1 demonstrate broad-acting antitumor effects, showing tumor growth inhibition or regression in multiple preclinical models, including paclitaxel-resistant models. 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. Furthermore, MKC-1 inhibits the Akt-mTOR signaling pathways, which may occur through inhibition of the mTOR/rictor pathway. The Akt-mTOR pathway is the most frequently mutated pathway in human tumors and mutations have been shown to promote tumor progression and decrease survival in cancer patients.

Mark R. Bray, Ph.D., EntreMed Vice President, Research, commented on the results, "Data from preclinical studies with MKC-1 continue to support its therapeutic potential in a variety of tumor types. The data are consistent with MKC-1 targeting the mTOR pathway by a mechanism that is distinct from rapamycin-like agents, such as Temosirolimus. These results, along with the recent success of agents that target the mTOR pathway, provide validation that clinical studies with MKC-1 in cancers such as renal cell are warranted. MKC- 1 is currently in clinical trials in metastatic breast cancer, non-small cell lung cancer, and leukemia."

To view the poster presentation, visit the Company's web site at entremed.

Sutent(R) is a registered trademark of its owner and is not a registered trademark of EntreMed, Inc.

About EntreMed

EntreMed, Inc. is a clinical-stage pharmaceutical company developing therapeutic candidates primarily for the treatment of cancer and inflammation. Panzem(R) NCD (2-methoxyestradiol or 2ME2) is currently in multiple Phase 2 clinical trials for cancer. MKC-1, an oral cell-cycle regulator, is in multiple Phase 1 and 2 studies for cancer. ENMD-1198, a novel tubulin-binding agent, is in Phase 1 studies in advanced cancers. Panzem(R) is also in preclinical development for rheumatoid arthritis, and ENMD-2076, a dual-acting Aurora-angiogenesis inhibitor, is in preclinical development for cancer. EntreMed's goal is to develop and commercialize new compounds based on the Company's expertise in angiogenesis, cell-cycle regulation and inflammation - processes vital to the treatment of cancer and other diseases, such as rheumatoid arthritis. Additional information about EntreMed is available on the Company's web site at entremed and in various filings with the Securities and Exchange Commission.

Forward Looking Statements

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act with respect to the outlook for expectations for future financial or business performance (including the timing of royalty revenues and future R&D expenditures), strategies, expectations and goals. Forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Forward-looking statements speak only as of the date they are made, and no duty to update forward-looking statements is assumed. Actual results could differ materially from those currently anticipated due to a number of factors, including those set forth in Securities and Exchange Commission filings under "Risk Factors," including risks relating to the need for additional capital and the uncertainty of additional funding; variations in actual sales of Thalomid(R), risks associated with the Company's product candidates; the early-stage products under development; results in preclinical models are not necessarily indicative of clinical results, uncertainties relating to preclinical and clinical trials; success in the clinical development of any products; dependence on third parties; future capital needs; and risks relating to the commercialization, if any, of the Company's proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks).

EntreMed, Inc.
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Black raspberries are highly effective in preventing the development of cancerous tumors, according to a study published in the October issue of Acta Pharmacologica Sinica published by Wiley-Blackwell.

The black raspberries will, however, have no therapeutic value if the tumors have already developed.

Dr. Gary Stoner, lead author of "Prevention and Therapy of Squamous Cell Carcinoma of the Rodent Esophagus by Freeze-dried Black Raspberries", finds that black raspberry powder - when fed to tumor-induced rats - inhibits harmful chemicals from producing cancer in the oral cavity, the esophagus and the colon. The research also found that black raspberry powder has the ability to lower the growth rate of pre-cancerous cells and to reduce cell DNA damage.

"Black raspberries prevent the formation of blood vessels that feed developing cancers by reducing the production of growth factors for the cells that make up the blood vessels". They also prevent the conversion of pre-malignant cells to malignant cells, and stimulate pre-cancerous cells to function normally again; or to die rather than grow", says Dr. Stoner.

However, this study suggests that the berries are not effective in curing cancers that have already developed. When administered to the rats at the papilloma stage, the berry diet had no effect on the development of the tumors or on the animals' survival.

Dr. Stoner adds. "Preliminary results in humans suggest that black raspberries prevent pre-cancerous lesions in the mouth, esophagus and colon from progressing to cancer. Thus, black raspberries seem to be a very promising in future studies into the prevention and treatment of esophageal cancer."

About Acta Pharmacologica C?­nica

Acta Pharmacologica Sinica, published monthly, is the official journal of the Chinese Pharmacological Society and Shanghai Institute of Materia Medica, Chinese Academy of Sciences. The Journal welcomes current original research on all aspects of life sciences, both experimental and clinical, from any part of the world. Reviews based primarily on authors' own research of internationally important topics are especially welcome. Acta Pharmacologica Sinica was registered as an English international journal in 2000.

About Wiley-Blackwell

Wiley-Blackwell was formed in February 2007 as a result of the merger between Blackwell Publishing Ltd. and John Wiley & Sons, Inc.'s Scientific, Technical, and Medical business. Together, the companies have created a global publishing business with deep strength in every major academic and professional field. Wiley-Blackwell publishes approximately 1,250 scholarly peer-reviewed journals and an extensive collection of books with global appeal.

blackwellpublishing

Women who are obese, have type 2 diabetes or a family history of type 2 diabetes could one day have more successful pregnancies because of a study at Washington University School of Medicine in St. Louis.

This study, performed in mice, suggests that Metformin, the most commonly prescribed anti diabetes drug, could potentially improve pregnancy outcomes in women with insulin resistance.

"We found that embryos of insulin-resistant mice also have some degree of insulin resistance, and if we correct the insulin resistance in the embryo with this drug, we improve the quality of the embryo," says Kelle Moley, M.D., lead author and professor of obstetrics and gynecology.

The finding, published online in Diabetes, suggests that Metformin could benefit women with type 2 diabetes or polycystic ovary syndrome (PCOS). About 8 percent of women trying to conceive have insulin resistance, Moley says, and even more are suspected to be borderline. In some cases, a family history of type 2 diabetes or being overweight may be the only indication that the patient may be prone to insulin resistance.

Metformin is often given to women with PCOS, an endocrine disorder that affects insulin and results in higher rates of miscarriage. These women often share the same pregnancy complications as women with type 2 diabetes and obesity.

Recent studies have shown that metformin not only aids conception in women with PCOS but also reduces the high miscarriage rates; however, how the drug does this has been unclear.

Using early-stage mouse embryos, Moley and her colleagues showed for the first time that metformin improves insulin action in insulin-resistant embryos. That allowed the embryos to absorb glucose, an important energy source, and prevented the death of cells in the embryos. As a result, the embryos were more likely to successfully implant in the uterus and to continue growing.

Moley's group also identified the molecular mechanism that accounts for metformin's positive effects. They found the drug triggers an important sensor of the energy level of cells, which sets off a chain of reactions that help insulin do its job. Previously it was not known that this sensor molecule was active in early embryos.

Moley hypothesizes that in insulin-resistant women, high levels of insulin and related factors cause their embryos to compensate by shutting down insulin signaling mechanisms. That impairs the early embryo's ability to take in glucose at a critical stage of development and can lead to pregnancy failure.

"We found that Metformin improves glucose uptake and improves the survival of the early embryo as a result," Moley says. "Mouse embryos in a high-insulin environment that were not exposed to Metformin did not survive."

Most miscarriages are due to chromosomal abnormalities. But Moley says this study provides new scientific evidence that miscarriages related to insulin resistance possibly could be avoided through the use of metformin.

"This will help physicians know better how to treat these women and reassure them that they're being correctly treated for their medical problems and that their babies will benefit from that treatment," she says.

Washington University School of Medicine's full-time and volunteer faculty physicians also are the medical staff of Barnes-Jewish and St. Louis Children's hospitals. The School of Medicine is one of the leading medical research, teaching and patient care institutions in the nation, currently ranked fourth in the nation by U.S. News & World Report. Through its affiliations with Barnes Jewish and St. Louis Children's hospitals, the School of Medicine is linked to BJC HealthCare.

Washington University in St. Louis
One Brookings Dr., Campus Box 1070
St. Louis, MO 63130
United States
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Synta Pharmaceuticals Corp. (NASDAQ: SNTA), a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, announced that additional results from its Phase 3 trial (SYMMETRYSM) of elesclomol in combination with paclitaxel in metastatic melanoma was presented at the Perspectives in Melanoma XIII Conference by Steven O'Day, M.D., principal investigator and Chief of Research and Director of the Melanoma Program at the Angeles Clinic in Santa Monica, California.

"The data from the SYMMETRY trial presented at the Perspectives in Melanoma XIII Conference shows an important connection between patients' baseline level of LDH (lactate dehydrogenase), an established biomarker in melanoma, and treatment outcome with elesclomol," said Dr. O'Day. "Patients with low and normal baseline levels of LDH showed an improvement in progression free survival (PFS), the primary endpoint of the study. The OS (overall survival) data for these groups are still highly censored and evolving; no difference has been observed to date between the treatment and control arms. In contrast, patients with high baseline level of LDH showed no PFS benefit and a decreased survival time relative to the control arm. These results, along with the results of other recent randomized clinical trials, suggest that baseline LDH status may evolve from a prognostic factor for the disease to a potentially predictive factor for treatment. This could pave the way for a more personalized approach to treating this disease that considers markers such as LDH in determining an optimal approach to therapy."

"We believe there are three emerging findings from the SYMMETRY trial that are important for the future of the elesclomol program," said Vojo Vukovic, M.D., Ph.D., Senior Vice President and Chief Medical Officer, Synta Pharmaceuticals. "First, there are clear signs of clinical benefit in the normal LDH population. In this patient group, which represents 68% of the trial population, the PFS endpoint was achieved. Second, any potential adverse effect on survival in favor of the control arm appears to be restricted to the high LDH patient population. Finally, and importantly in considering development of elesclomol beyond melanoma, there were no substantial differences in Grade 3 or 4 toxicities between the two arms of the trial, consistent with safety findings from prior trials, indicating that elesclomol was well tolerated."

"Additional survival data, as well as a further understanding of the interaction between oxidative stress induction and LDH level, will be important for determining the future of the program," continued Dr. Vukovic. "Both the elesclomol oxidative stress mechanism and LDH relate to metabolic pathways. Together with our academic collaborators we are actively investigating the connection between the two, and expect to present initial results at scientific meetings later this year. We expect to present SYMMETRY survival data with 12 months minimum follow-up, and announce further decisions related to the future of the elesclomol program, in the first half of 2010."

SYMMETRY Results Presented at Melanoma XIII

Updated results for PFS, OS, response rate, and safety were presented, including prespecified exploratory analyses of the effects of baseline LDH levels on treatment outcomes. The complete presentation can be found here.

Progression Free Survival

Updated progression free survival data showed no substantial changes from results presented May 30 this year at the American Society for Clinical Oncology meeting. Results for the overall Intent to Treat (ITT) population presented at the Melanoma XIII meeting showed a trend in favor of elesclomol in combination with paclitaxel as compared to paclitaxel alone (3.4 vs. 1.9 months, HR=0.88, p=0.188). The normal LDH population, 68% of patients, experienced a significant improvement in median PFS (3.6 vs. 2.1 months, HR=0.76, p=0.027). In contrast, the high LDH population, 32% of patients, showed no benefit (1.8 vs. 1.9 months, HR=1.10, p=0.549).

Response Rate

The Overall Response Rate (complete response plus partial response) was measured based on RECIST objective tumor response criteria for those patients with at least one follow-up assessment. Overall Response Rates for ELPAC vs. PAC were 7.4% vs. 4.4% for all randomized patients (N=595, p=0.121); 8.4% vs. 3.9% for the normal LDH population (N=407, p=0.065); and 5.3% vs. 5.4% for the high LDH population (N=188, p=1.00). Of the responders, two were complete responses, which occurred in the ELPAC arm in the normal LDH population; all other responses were partial responses.

Overall Survival

Survival results presented represent a minimum of six months follow-up since study termination on February 26, 2009. This data set shows a 55% censoring rate, indicating that results are not yet mature and may change. The hazard ratio in the full patient population (ITT analysis) is 1.17 (95% C.I. 0.93-1.48, p=0.173). The hazard ratio in the high LDH population (LDH?‰?1x ULN) is 1.49 (1.05-2.11); in the normal LDH population (LDH

Northwest Biotherapeutics, Inc. (OTC Bulletin Board: NWBT.OB), a biotechnology company focused on cancer immunotherapy, today announced that the first two patients in its pivotal Phase II clinical trial have undergone surgery for newly diagnosed Glioblastoma multiforme (GBM), which is the first step in the preparation of the Company's DCVax(R)-Brain treatment. The surgeries took place at Henry Ford Hospital in Detroit, MI.

"We are very pleased to begin the patient accrual process for this Phase II trial, and anticipate completing enrollment in Q4 of this year. We are also working with nine other clinical sites to accelerate patient accrual during the next few months," stated Alton Boynton, President of Northwest Biotherapeutics. Dr. Boynton further stated, "I consider this a major milestone for NWBT and look forward to rapid patient accrual in this important clinical trial."

The DCVax(R)-Brain treatment consists of three initial immunizations at 2 week intervals, followed by four booster injections at 2- and 4-month intervals for the remainder of year one, and thereafter semi-annual maintenance injections for an additional two years. DCVax(R)-Brain showed no toxicity in previous studies in over 100 patients.

The DCVax(R)-Brain Phase II clinical trial is based on two Phase I studies carried out at UCLA under the direction of Linda Liau, M.D., Ph.D., Director of the Malignant Brain Tumor Program at the UCLA School of Medicine. Each of the trials included both newly diagnosed (early stage) GBM, and recurrent (late stage) GBM. DCVax(R)-Brain has doubled the time to progression and the overall survival time in both the early and the late stage patients. The data for those trials continue to mature.

In the newly diagnosed GBM patients, DCVax(R)-Brain has increased the time to recurrence or progression of disease as described in Kaplan Meier plots from 8.1 months with standard of care treatments to 18.1 months with DCVax(R)- Brain (p< 0.00001). Kaplan Meier plots also showed that DCVax(R)-Brain increased median overall survival from 17 months with standard of care treatments to 33.8 months (p=0.0044) for DCVax(R)-Brain treated patients. Ten of the 19 patients remain alive for periods ranging to date from 10 to 80 months. Similarly, in recurrent (late stage) patients, DCVax(R)-Brain has increased median survival from 6.4 months for historical controls receiving standard of care to 13.2 months for patients receiving DCVax(R)-Brain.

DCVax(R)-Brain uses a patient's own tumor, surgically removed as part of the standard of care, to prepare a mix of their personal cancer biomarkers. These personal cancer biomarkers are then loaded into the patient's own dendritic cells (the master cells responsible for starting and managing the body's overall immune response), and injected back into the patient through a simple intra-dermal injection, similar to an insulin shot, at various intervals over a three year period. The DCVax(R)-Brain Phase II trial is designed and powered as a pivotal trial, and will involve 141 patients. All patients will receive full standard of care treatment, which includes surgery, radiation and chemotherapy, and approximately 94 of these patients will also receive DCVax(R)-Brain. A sufficient quantity of each patient's personal therapeutic cancer vaccine is prepared in a single manufacturing procedure to provide for 3 years of treatment.

About Northwest Biotherapeutics

Northwest Biotherapeutics is a biotechnology company focused on developing immunotherapy products that treat cancers more effectively than current treatments, without toxicity, on a cost-effective basis. The Company has two broad platform technologies: dendritic cell-based vaccines, and therapeutic antibodies. The Company's three lead product candidates are:

DCVax(R)-Brain, a personalized dendritic cell vaccine for treatment of Glioblastoma multiforme, which has entered into a large Phase II pivotal clinical trial cleared by the FDA;

DCVax(R)-Prostate, a personalized dendritic cell vaccine for treatment of hormone independent non-metastatic prostate cancer, which is ready to enter a Phase III clinical trial cleared by the FDA; and

Monoclonal antibodies to CXCR4, which are in late pre-clinical development for the treatment of multiple cancers. For further information, please visit the company web site at nwbio/.

The Company also has a robust pipeline of additional products cleared by FDA for early stage clinical trials in multiple other cancers.

Statements made in this news release that are not historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "expects," "believes," "intends," and similar expressions are intended to identify forward-looking statements. Actual results may differ materially from those projected in any forward-looking statement. Specifically, there are a number of important factors that could cause actual results to differ materially from those anticipated, such as the company's ability to raise additional capital, risks related to the company's ability to enroll patients in its Phase II clinical trial of DCVax(R)-Brain and complete the trial on a timely basis, the uncertainty of the clinical trials process, the timely performance of third parties, and whether DCVax(R)-Brain will demonstrate safety and efficacy and the timely performance of third parties. Additional information on these and other factors, which could affect the company's results, is included in its Securities and Exchange Commission ("SEC") filings. Finally, there may be other factors not mentioned above or included in the company's SEC filings that may cause actual results to differ materially those projected in any forward-looking statement. You should not place undue reliance on any forward-looking statements. The company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by securities laws.

Northwest Biotherapeutics, Inc.
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