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NY-ESO-1 recombinant proteins to be used in clinical trials for treating melanoma and ovarian cancer

The Bioproduction Facility at Cornell University has produced the first batch of NY-ESO-1 recombinant protein-a cancer vaccine-that will be used in clinical trials for patients facing either ovarian cancer or melanoma. The facility was developed as a partnership between The Ludwig Institute for Cancer Research and Cornell University.

21 Aug 2009

Peplin completes four-week enrolment phase for REGION-Ib trial

Peplin, Inc. (ASX:PLI) today announced completion of enrolment in its second Phase 3 clinical trial for the use of PEP005 (ingenol mebutate) Gel to treat actinic (solar) keratoses (AK), a common pre-cancerous skin lesion, on non-head treatment areas, which include the trunk and extremities. This completes enrolment in the final of four pivotal trials planned for the submission of the New Drug Application (NDA) for AK.

20 Aug 2009

InterMune receives $20 million event payment from Roche for initiating the Phase 2b trial of RG7227/ ITMN-191

Roche (SIX: ROG.VX; RO.S, OTCQX: RHHBY) and InterMune, Inc. (Nasdaq: ITMN) today announced that the first patient has been dosed in a Phase 2b study evaluating the hepatitis C virus (HCV) protease inhibitor, RG7227/ ITMN-191, in combination with PEGASYS(R) (pegylated interferon alfa-2a) and COPEGUS(R) (ribavirin). The study, to be conducted at 45 sites globally, will further define the safety and efficacy profile of RG7227/ ITMN-191, for a treatment duration of up to 24 weeks. Approximately 300 treatment-naive patients chronically infected with HCV genotype 1 - the most difficult to treat form of the virus - will participate.

20 Aug 2009

Light Sciences Oncology announces Phase 2 trial of Aptocine in Benign Prostatic Hyperplasia

Light Sciences Oncology, Inc. (LSO) today announced the treatment of the first patients in a Phase 2 clinical trial of its innovative targeted drug treatment Aptocine(TM) (talaporfin sodium) in Benign Prostatic Hyperplasia (BPH). The Phase 2 trial expands the Aptocine BPH development program on the basis of a Phase 1 study at escalating light doses. In the open-label Phase 2 trial, Aptocine is being tested for safety and efficacy in 40 patients with lower urinary tract symptoms (LUTS) due to BPH. Aptocine is also in two Phase 3 clinical trials for solid tumors in the liver as well as preclinical development for prostate cancer.

19 Aug 2009

Gentium reports results from phase 3 trial of defibrotide for severe veno-occlusive disease

Gentium S.p.A. has announced top-line results from a historically controlled, multicenter, open label, Phase III trial designed to evaluate the safety and efficacy of 25 mg/kg/day of Defibrotide for the treatment of severe veno-occlusive disease (sVOD) in hematopoietic stem cell transplant (SCT) patients.

19 Aug 2009

Sinovac Biotech announces positive results from clinical trial of H1N1 vaccine

Sinovac Biotech Ltd. announced today positive top-line results from the completed clinical trial for its internally-developed H1N1 vaccine. The clinical data unblinding conference was held in Beijing on the afternoon of August 17, 2009. Notably, Sinovac is the first company worldwide to complete clinical trials for the H1N1 vaccine.

19 Aug 2009

Arzoxifene phase 3 study results reported by Lilly

Eli Lilly and Company announced today that initial results from its pivotal, five-year, Phase III GJAD "GENERATIONS" trial for arzoxifene met its primary endpoints of significantly reducing the risk of vertebral fracture and invasive breast cancer in postmenopausal women.

19 Aug 2009

Hard to Treat Diseases' swine flu clinical trials in progress

Hard to Treat Diseases (HTDS.PK) Mellow Hope, an operating subsidiary of HTDS, is pleased to report that its clinical trial is currently being processed.

19 Aug 2009

Low-dose estrogen effective for metastatic breast cancer

When estrogen-lowering drugs no longer control metastatic breast cancer, the opposite strategy might work. Raising estrogen levels benefited 30 percent of women whose metastatic breast cancer no longer responded to standard anti-estrogen treatment, according to research conducted at Washington University School of Medicine in St. Louis and collaborating institutions.

19 Aug 2009

Results of Phase IIb dose range finding of oglemilast in chronic obstructive pulmonary disease announced

Forest Laboratories, Inc. (NYSE: FRX) and Glenmark Pharmaceuticals S.A. (Switzerland), a wholly owned subsidiary of Glenmark Pharmaceuticals India (GPL) today announced top-line results from a Phase IIb dose range-finding study of oglemilast in patients with Chronic Obstructive Pulmonary Disease (COPD). Once-daily treatment with oglemilast did not show a statistically meaningful increase from baseline compared to placebo in the primary endpoint trough FEV1, a measure of pulmonary function that is decreased in patients with COPD. Oglemilast was well tolerated at all doses studied.

19 Aug 2009

Amarex joins OmniComm Systems' CRO Preferred Program

OmniComm Systems, Inc., a leader in integrated electronic data capture (EDC) solutions for clinical trials, announced today that it has been selected by Amarex, a Mid-Atlantic based Contract Research Organization (CRO) to provide eClinical solutions for an upcoming Phase III trial investigating the use of a medical device for wound healing.

19 Aug 2009

4SC starts phase 2 trial in hepatocellular carcinoma with 4SC-201 (resminostat)

4SC AG, the German drug discovery and development company, today announced the dosing of the first patient in its Phase II trial with 4SC-201 (resminostat), a pan-histone deacetylase (HDAC) inhibitor, as a new potential treatment option for patients with advanced hepatocellular carcinoma (HCC), the most frequent form of liver cancer.

18 Aug 2009

Genentech announces Phase III study results for Avastin (bevacizumab) in combination with chemo in HER2-negative breast cancer

Genentech, Inc. today announced that a Phase III study (RIBBON 2) of Avastin (bevacizumab) in combination with chemotherapy increased the time women with metastatic HER2-negative breast cancer whose initial chemotherapy had stopped working lived without the disease worsening (progression-free survival or PFS), compared to chemotherapy alone.

18 Aug 2009

Human Genome Sciences achieves systemic lupus goals with candidate drug

Human Genome Sciences announced that BENLYSTA™ met the primary endpoint in BLISS-52, the first of two pivotal Phase 3 trials in patients with serologically active systemic lupus erythematosus (SLE). These results show that BENLYSTA™ has the potential to become the first new approved drug in decades giving hope to people living with systemic lupus.

17 Aug 2009

Aeterna Zentaris announces results from trials of Cetrorelix in benign prostatic hyperplasia

AEterna Zentaris Inc. today reported Phase 3 results for its North American efficacy trial Z-033 and the safety trial Z-041 in benign prostatic hyperplasia (BPH), with its lead endocrinology compound for urology, cetrorelix pamoate. As announced on March 6, 2009, sanofi-aventis U.S. LLC entered into an agreement with AEterna Zentaris for the development, registration and marketing of cetrorelix in BPH for the U.S. market.

17 Aug 2009

New immune therapy for kidney cancer tested

Researchers at The Cancer Institute of New Jersey (CINJ) have opened a clinical trial to evaluate whether the standard treatment for a common form of kidney cancer works better by itself or when combined with a certain type of blood cell that comes from a patient’s relative. CINJ is a Center of Excellence of UMDNJ-Robert Wood Johnson Medical School.

14 Aug 2009

First batch of cancer vaccine from Cancer Vaccine Collaborative goes into trial

The first batch of NY-ESO-1 recombinant protein produced in a facility supported entirely by non-profit entities has successfully cleared regulatory review and has entered clinical testing. The clinical trials are part of the Cancer Vaccine Collaborative, a joint program of the Cancer Research Institute, Inc. (CRI) and the Ludwig Institute for Cancer Research Ltd. (LICR).

13 Aug 2009

Antigenics’ Oncophage cancer vaccine trial starts enrolling patients

Antigenics Inc. (NASDAQ:AGEN) today announced that the Brain Tumor Research Center at the University of California, San Francisco, has begun enrolling patients into a Phase 2 clinical trial of Oncophage (vitespen) in combination with the standard of care - radiation therapy plus Temodar (temozolomide) - for newly diagnosed glioma patients.

13 Aug 2009

Study looks at imipramine in the treatment of irritable bowel syndrome

IBS remains a common intestinal disorder causing significant discomfort and poor quality of life in patients who have the diagnosis. TCAs have been shown to improve abdominal pain in patients with IBS; however, there is insufficient evidence of global symptom relief. The search for an optimal treatment to improve symptoms and quality of life in IBS remains ongoing.

12 Aug 2009

Cannabis Science reports on future plans for cannabis drug trials

Cannabis Science, Inc. (OTCBB: CBIS) has announced that it has completed its review of the FDA licensing requirements and has made key progress with mapping out its initial cannabis drug medicines for FDA clinical trials.

12 Aug 2009

Drug Trial News

NY-ESO-1 recombinant proteins to be used in clinical trials for treating melanoma and ovarian cancer

Peplin completes four-week enrolment phase for REGION-Ib trial

InterMune receives $20 million event payment from Roche for initiating the Phase 2b trial of RG7227/ ITMN-191

Light Sciences Oncology announces Phase 2 trial of Aptocine in Benign Prostatic Hyperplasia

Gentium reports results from phase 3 trial of defibrotide for severe veno-occlusive disease

Sinovac Biotech announces positive results from clinical trial of H1N1 vaccine

Arzoxifene phase 3 study results reported by Lilly

Hard to Treat Diseases' swine flu clinical trials in progress

Low-dose estrogen effective for metastatic breast cancer

Results of Phase IIb dose range finding of oglemilast in chronic obstructive pulmonary disease announced

Amarex joins OmniComm Systems' CRO Preferred Program

4SC starts phase 2 trial in hepatocellular carcinoma with 4SC-201 (resminostat)

Genentech announces Phase III study results for Avastin (bevacizumab) in combination with chemo in HER2-negative breast cancer

Human Genome Sciences achieves systemic lupus goals with candidate drug

Aeterna Zentaris announces results from trials of Cetrorelix in benign prostatic hyperplasia

New immune therapy for kidney cancer tested

First batch of cancer vaccine from Cancer Vaccine Collaborative goes into trial

Antigenics’ Oncophage cancer vaccine trial starts enrolling patients

Study looks at imipramine in the treatment of irritable bowel syndrome

Cannabis Science reports on future plans for cannabis drug trials

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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