orphan drug

Advaxis requests orphan drug designation for treatment of HPV-associated head and neck cancer with ADXS-HPV

Source: www.marketwatch.com Author: press release Advaxis, Inc., a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced that it has submitted an Application for Orphan Drug Designation with the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) for ADXS-HPV, its lead drug candidate, for the treatment of human papillomavirus (HPV)-associated head and neck cancer. There are about 50,000 new cases of head and neck cancer annually, with about 15,000 deaths. HPV infection is estimated to account for 20-50% of current incidence. Orphan Drug Designation is granted to drug therapies intended to treat diseases or conditions that affect fewer than 200,000 people in the United States. Orphan Drug Designation entitles the sponsor to clinical protocol assistance with the FDA, as well as federal grants, tax credits, and a seven year market exclusivity period. "HPV-associated head and neck cancer is growing at an epidemic rate in the United States and other regions throughout the world. According to the U.S. Centers for Disease Control and Prevention (CDC), over 80% of new cases occur in men, who are not typically part of HPV vaccination programs," commented Dr. Robert Petit, Chief Scientific Officer of Advaxis. "Data from our Phase 2 study in recurrent cervical cancer show that ADXS-HPV is an active treatment in this HPV-associated cancer. We believe that ADXS-HPV immunotherapy will show similar activity in HPV-associated head and neck cancer, given the shared causality of the cancers. We have one ongoing Phase 1/2 study in [...]

Oral Cancer Foundation News Team - A2013-06-12T07:27:15-07:00June, 2013|Oral Cancer News|

EU grants orphan drug status to BioAlliance Pharma’s clonidine Lauriad

Source: www.pharmabiz.com Author: staff European Commission has granted orphan drug designation to BioAlliance Pharma SA's clonidine Lauriad for prevention of radiotherapy-induced oral mucositis in patients with head and neck cancer. Oral mucositis is a very frequent inflammation of the oral mucosa in head and neck cancer patients treated with radio- and chemotherapy (98,000 new patients estimated per year in Europe). Severe oral mucositis occurs in 60% of these patients and may induce intense oral pain and eating disability requiring artificial nutritional support. In 20 to 30% of cases, patients have to be hospitalized and the disease may result in a modification or a stop of the radiotherapy treatment in more than 10% of them. Radiotherapy-induced oral mucositis has currently no preventive cure. In Europe, the orphan designation is granted for medicinal products in diseases affecting less than 5/10,000 patients. This status permits to benefit from incentives related to the clinical development, thus enabling a faster registration, and an extra protection with a 10- year commercial exclusivity after market authorization. “The European designation for clonidine Lauriad as an orphan drug is key in shortening its development timeline, optimizing costs and reinforcing its future market access. Clonidine Lauriad, currently in Phase II clinical trial, is the second product from our “Orphan Oncology Products” portfolio to be granted orphan status in Europe. The portfolio comprises assets with high commercial potential and will leverage our future growth”, stated COO, Judith Greciet. Dedicated to cancer and supportive care treatment with a focus on resistance targeting [...]

Oral Cancer Foundation News Team - A2011-11-06T10:14:20-07:00November, 2011|Oral Cancer News|

Cancer vaccines get coveted “Orphan” go-ahead

Source: www.zampbioworld.org/bionews Author: staff Two experimental vaccines from the University of Maryland, Baltimore (UMB) recently received a federal orphan drug designation for advanced head and neck cancer, according to a company official. The vaccine candidates were licensed by Gliknik, Inc., located at the University of Maryland BioPark. Orphan status for the vaccines means that the startup firm will receive tax credits and marketing incentives from the Food and Drug Administration (FDA), which may hasten its development of the treatments. The vaccines were eligible because they are personalized for a limited number of patients. “Advanced head and neck cancer is a challenging disease with limited treatment options. Even with chemotherapy, radiation, and surgery, people with advanced head and neck cancer may have a limited life expectancy of six to eight months,” says David Block, MD, MBA, co-founder, president, and CEO of Gliknik. The vaccines were designed in a precise manner to boost the immune system. They were invented by Scott Strome, MD, a professor at the University of Maryland School of Medicine. “The survival of head and neck cancer patients has not really improved in 30 years,” says Strome, who included in the two vaccines certain compounds that act as biological recognition points for specific substances associated with some head and neck cancerous tumors. Head and neck cancer is different from brain cancers and may include cancers of the tongue, tonsils, nasal cavity, sinuses, lips, mouth, salivary glands, throat, and larynx. Any proposed treatment for the total number of all head [...]

Oral Cancer Foundation News Team - A2009-04-10T12:49:39-07:00April, 2009|Oral Cancer News|