On 6/1/09, Antigenics (NASDAQ:AGEN) announced results of an interim analysis from the Company’s ongoing global patient survival registry, which showed that patients with kidney cancer at intermediate risk of disease recurrence demonstrated an approximately 46% lower risk of death when treated with Oncophage (vitespen) cancer vaccine compared with observation (n = 362; P = 0.036; hazard ratio [HR] = 0.54). The interim analysis from the patient registry, INSPIRE, reflects a median follow-up of 4.5 years from the largest, randomized Phase 3 kidney cancer trial ever completed to date in the adjuvant setting. The patient registry was launched in order to confirm encouraging overall survival trends observed from the Phase 3 non-metastatic kidney cancer study. Final results from INSPIRE are expected mid-2010.
In October 2008, AGEN submitted a marketing authorization application to the European Medicines Agency (EMEA) requesting conditional approval for Oncophage in earlier-stage, localized renal cell carcinoma (kidney cancer). AGEN expects a decision on its European marketing application by late 2009 and the Company has not filed for U.S. marketing approval of the drug as of yet. On 10/21/09, AGEN announced that the Committee for Medicinal Products for Human Use (CHMP) of the EMEA has verbally informed the Company at an oral meeting to anticipate a negative opinion on the marketing authorization application (MAA) for Oncophage in early-stage, localized renal cell carcinoma.
On 10/21/09, Shire (SHPGY) announced that it plans to file a BLA with the FDA for REPLAGAL (agalsidase alfa), its enzyme replacement therapy for Fabry disease, by the end of 2009. The Company also announces that a treatment protocol for REPLAGAL, filed at the request of FDA, has been approved, and that it will support emergency IND requests as part of the early access program in place due to the supply restriction of the only currently marketed treatment for Fabry disease in the US. REPLAGAL is a human form of enzyme alpha-galactosidase A (a-Gal A) manufactured in a human cell line by gene activation.
REPLAGAL is approved in 45 countries worldwide. REPLAGAL is not currently approved for commercial sale in the U.S. REPLAGAL is the only human-cell-line-derived form of enzyme replacement therapy (ERT) that is indicated for the long-term treatment of patients with a confirmed diagnosis of Fabry disease (alfa-galactosidase A deficiency).
On 10/21/09, King Pharma (KG) announced that it received a complete response letter (CRL) for its NDA seeking approval of CorVue (binodenoson) for injection as a cardiac pharmacologic stress agent for use as an adjunct in SPECT (single-photon-emission computed tomographic) cardiac imaging intended for use in patients with or at risk for coronary artery disease (NYSEARCA:CAD) who are unable to perform a cardiac exercise stress test. King is currently evaluating the Agency’s CRL complete response letter and expects to respond to the questions as quickly as possible.
On 7/28/09, an FDA Advisory Panel voted that King’s experimental heart imaging agent, CorVue, failed to demonstrate equivalent imaging results as an older, approved agent (adenosine). In an 11-5 vote, the FDA Advisory Panel stated that the Company’s study results failed to establish a high degree of similarity between images generated by CorVue and adenosine.
On 8/31/09, Delcath Systems (NASDAQ:DCTH) announced the FDA granted orphan drug status to doxorubicin, an approved chemotherapy agent, for the treatment of primary liver cancer. The Company said it tested doxorubicin with its unique drug delivery technology, Percutaneous Hepatic Perfusion (PHP), which results in significantly higher doses (e.g. 10X the FDA approved standard dosing with 100X exposure of drug to the tumor site) of anti-cancer drugs such as doxorubicin to the liver without exposing the patient's entire body. Delcath plans to carry out the necessary clinical work for a regulatory submission of PHP with doxorubicin.
On 8/25/09, DCTH reported that it has exceeded 90% enrollment for its pivotal Phase 3 Metastatic Melanoma Trial which will enroll a total of 92 patients. This study is testing the PHP System for the regional delivery of melphalan to the liver to treat patients with metastatic melanoma (a deadly type of skin cancer) who have tumors in the liver, which cannot be removed by surgery (unresectable). On 10/21/09, DCTH announced that its pivotal Phase 3 Metastatic Melanoma Trial has met its goal of 92 patients and is fully enrolled. With the achievement of complete enrollment, the company remains on-track for a FDA submission of its Delcath PHP System with melphalan by mid-2010 based on previous guidance.
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