|CytRx Initiates Phase 1b in Patients with Advanced Solid Tumors; FDA Clears Roche's Vitamin D Lab Test|
|By Staff and Wire Reports|
|Wednesday, 25 July 2012 19:11|
CytRx Corporation (NASDAQ: CYTR), announced the initiation of a Phase 1b clinical trial to determine the maximum tolerated dose and to evaluate preliminary efficacy of aldoxorubicin (formerly INNO-206) administered in combination with the commonly used chemotherapeutic agent doxorubicin in patients with advanced solid tumors who have failed other therapies. Aldoxorubicin is a tumor-targeting conjugate of doxorubicin.
Recent trials conducted by Dr. Felix Kratz of the Tumor Biology Institute in Freiburg, Germany using animal models of human tumors showed that the combination of aldoxorubicin and free doxorubicin administered at 50% each of their respective maximum tolerated dose provided complete and prolonged remissions in ovarian and pancreatic cancers with minimal weight loss compared with each drug administered individually at its maximum tolerated dose, said Sant P. Chawla, M.D., F.R.A.C.P., Director of the Sarcoma Oncology Center in Santa Monica, Calif. Given these favorable results, the combination of aldoxorubicin plus doxorubicin warrants further evaluation as a treatment for patients with solid tumors.
The single-center Phase 1b clinical trial will be conducted under the direction of Dr. Chawla and will enroll up to 24 patients. Doxorubicin will be administered at 50% of its maximum tolerated dose in combination with escalating doses of aldoxorubicin to determine the maximum tolerated dose of the combination of these two drugs in this patient population.
In June, CytRx reported results for a Phase 1b/2 clinical trial indicating that aldoxorubicin administered at its maximum tolerated dose showed clinical benefit (defined as partial response and stable disease of more than four months following up to eight cycles of treatment) in 10 of 13 (77%) evaluable patients with relapsed or refractory soft tissue sarcoma. All patients in the Phase 1b/2 trial had either not responded to or relapsed after treatment with between one and three prior chemotherapy regimens. Based on the results of this trial CytRx plans to meet with the FDA in the second half of 2012 to discuss a potential Phase 3 pivotal trial as a therapy for patients with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy.
We are delighted that such a distinguished sarcoma expert as Dr. Chawla has agreed to serve as principal investigator for yet another trial with aldoxorubicin, said CytRx CEO Steven A. Kriegsman. Dr. Chawla led our Phase 1b/2 clinical trial with aldoxorubicin in patients with advanced solid tumors and presented clinical results from this trial at the American Society of Clinical Oncology (ASCO) conference last month. He also is leading our global Phase 2b clinical trial designed to compare aldoxorubicin head-to-head with doxorubicin as a first-line treatment for patients with advanced soft tissue sarcoma. Enrollment completion and data analysis are expected for this trial in 2013.
Roche (OTC: RHHBY) announced it has received clearance from the U.S. FDA for a fully automated vitamin D test for use on cobas® modular platforms, further expanding the company's bone metabolism test menu.
Vitamin D is an important building block for human health and is mainly produced in the skin by exposure to sunlight. Vitamin D deficiency plays a major role in bone metabolism disorders, and in recent years studies have linked vitamin D deficiency with many other disease states, including cancer, cardiovascular disease and diabetes.
Acura Pharmaceuticals, Inc. (NASDAQ: ACUR), a specialty pharmaceutical company innovating abuse deterrent drugs, today announced that the company plans to report financial results for the second quarter of 2012 following the close of financial markets on Tuesday, August 7, 2012.
Assisted Living Concepts, Inc. (NYSE: ALC) announced that it plans to release its 2012 second quarter financial results prior to the opening of the New York Stock Exchange on Friday, August 3, 2012.
Cepheid (NASDAQ: CPHD) today announced the release of an updated Xpert® BCR-ABL Monitor test, now incorporating lot-specific standardization using the WHO (World Health Organization) BCR-ABL standards.
EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced that it will host a conference call on Tuesday, August 7, 2012 at 11:00 AM Eastern Time to discuss corporate updates and financial results for the second quarter ended June 30, 2012.
Life Technologies Corporation (NASDAQ: LIFE) today announced the acquisition of Pinpoint Genomics, Inc., and its early-stage non-small cell lung cancer test that can help doctors identify those early-stage patients at high risk for progression to late-stage disease.
MELA Sciences, Inc. (NASDAQ: MELA), the medical device company that has developed and is commercializing MelaFind®, today announced that it will release its 2012 second quarter financial results after the close of trading on Tuesday, August 7, 2012.
Northwest Biotherapeutics, Inc. (OTC.BB: NWBO) (the "Company" or "Northwest Bio") announced today that its partner in Germany, Fraunhofer IZI, has received the official approval and certification from the regional and national regulatory agencies in Germany (including the Paul-Ehrlich-Institut, or PEI – the German equivalent of the U.S. FDA) for the manufacture of Northwest Bio's DCVax®-L immune therapy for human patients with Glioblastoma multiforme brain cancer.
Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) announced today that Blood, the medical journal of the American Society of Hematology, has published results from the 003-A1 Phase 2b trial, a single-arm, multicenter clinical trial evaluating Kyprolis™ (carfilzomib) for Injection for the treatment of patients with advanced multiple myeloma, who had received a median of five prior anti-myeloma regimens.
PDI, Inc. (Nasdaq: PDII) today announced the signing of several new and extended contracts, including two new wins from Top 10 global pharmaceutical companies.
Verenium Corporation (Nasdaq: VRNM), a leading industrial biotechnology company focused on the development and commercialization of high-performance enzymes, today announced that it has received regulatory authorization from the Environmental Protection Agency (EPA) to market its next-generation cellulase enzyme for non-food applications, including use as a biocatalyst to break down the guar-based gel used in hydraulic fracturing.