Physicians Financial News: March 9, 2011

Oncology & Biotech News, December 2010, Volume 4, Issue 12

PFN presents a quick snapshot financial news as it relates to recent drug developments, clinical trials, mergers and acquisitions, etc.

Access Pharma, which manufactures MuGard to prevent oral mucositis, has made agreements with investors that will generate $6 million. Access intends to use the funds to help market MuGard and further develop its proprietary drug delivery technologies. The company said it has also secured agreements from private health insurers to cover MuGard for patients with cancer.

Medivation, Inc and Astellas Pharma announced that the enrollment target had been reached for the phase III AFFIRM trial investigating MDV3100 in men with advanced prostate cancer. The randomized, placebo-controlled trial has enrolled 1199 patients at various sites in the North and South America, Europe, and Africa.

The relatively new biopharmaceutical company Genesis Biopharma has received a patient in Europe to protect its anti-CD55 antibody technology and is pursuing patents in the United States and other countries. CD55 is overexpressed in as many as 80% of solid tumors, according to the company, which plans to find partners to help develop the therapies further.

The FDA has given 510(k) clearance to Tomophase in Burlington, Massachusetts, to market its noninvasive optical coherence tomography imaging system (OCTIS), which contains a disposable optical catheter and imaging console. It is designed to image tissue in airways and lungs.

Boehringer Ingelheim is initiating the multinational phase III LUX-Breast 1 trial of afatinib (BIBW 2992) in patients with advanced metastatic breast cancer. The oral drug is an irreversible inhibitor of epidermal growth factor receptor and HER2 and is being investigated in lung cancer and head and neck cancer.

Cell Therapeutics is appealing the FDA’s rejection of its New Drug Application for pixantrone in patients with relapsed or refractory, aggressive non-Hodgkin’s lymphoma. The company had requested accelerated approval; in a complete response letter, the FDA said the trial failed to prove the drug’s efficacy and requested the company conduct another clinical trial.

Novartis has launched phase III trials that will investigate whether the mTOR inhibitor Afinitor (everolimus) is effective in women with advanced breast cancer after a phase II study demonstrated 6-month progression-free survival (PFS) for women treated with Afinitor and hormonal therapy.

Spectrum Pharma said it would submit data to the FDA from a mid-stage trial of Zevalin showing an 84% response rate in patients with non-Hodgkin’s lymphoma and from a late-stage trial that showed an improvement in PFS after response. Spectrum is asking the FDA to remove the requirement that patients receive a bioscan before getting an injection of Zevalin.

Radient Pharmaceuticals and Jaiva Technologies have jointly formed NuVax Therapeutics, a wholly owned subsidiary, to develop novel immune-gene therapeutics for patients with cancer. Radient is transferring rights to its Combined Immunogene Therapy technology to NuVax.

AltheaDx and Compendia Bioscience have launched the Breast Cancer Segregation Panel Assay, which measures 96 genes identified from an analysis of cancer genomic data from 5000 tissue samples. AltheaDx will process and analyze the samples, and Compendia will manage data analysis and handle correlation of the data to patient outcomes in clinical trials.

Peregrine Pharmaceuticals reported that its second quarter losses were worse than projected due to declining revenue from its subsidiary Avid Bioservices and higher expenses from phase IIb trials of bavituximab in lung cancer. The company’s consolidated net loss was $7.51 million compared with $2.78 million in the second quarter of 2009. Peregrine is proceeding with several phase II oncology trials for bavituximab.

Neoprobe of Dublin, Ohio, is working with the FDA on plans to begin testing RIGScan, an investigational new drug that helps identify cancer cells in patients with colorectal cancer by attaching to the cells. The RIGScan-linked cells are visible with a handheld device that detects radiation. The company has a development deal with Laureate Pharma to develop RIGScan.