BioMed News Bytes: BioCryst, Antigenics, Exelixis, Impax, Cel-Sci Print E-mail
Monday, 26 October 2009 16:48

The FDA Calendar service includes a database with over 400 entries of (1) pending new drug, biological agent, or medical device new product decisions at the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and sBLA filings); (2) pending new submissions to the FDA; (3) pending complete response letter (CRL) re-submissions to the FDA; and (4) pending clinical trial results.

On 10/26/09, Antigenics (NASDAQ: AGEN) reported updated Phase 2 data for Oncophage (vitespen) in the treatment of recurrent, high-grade glioma. Data reported in the first 20 patients treated with Oncophage show a median survival of 10.1 months. While survival data continues to accrue on all patients in the study, to date six patients (30%) have survived at or beyond 12 months. These early data show an improvement in overall survival over the previous long standing historical median survival of 6.5 months, and slightly favorable to the recently reported median survival of 9.2 months with Avastin (bevacizumab) in patients with recurrent high-grade glioma.

Exelixis (NASDAQ: EXEL) is co-developing XL184 (BMS-907351) along with Bristol-Myers (NYSE: BMY). A Phase 2 trial of XL184 in subjects with progressive or recurrent GBM in first or second relapse is ongoing. XL184 inhibits MET, VEGFR2, and RET, which are key drivers of tumor formation, growth, and metastasis. The entries for XL184 / GBM (NCT00704288 and NCT00960492) include an estimated primary outcome data collection date of December 2010.

On 10/23/09, EXEL and BMY reported updated phase 2 clinical data which show that XL184 demonstrated activity in patients with GBM. As of 9/25/09, the overall rate of confirmed partial response in the intent-to-treat population of all patients treated at 175 mg was 8/46 (17%). Of the 46 patients treated at the 175 mg dose level, 21% attained 6-month progression-free survival (PFS) rate with 16/46 (35%) patients censored for PFS at the time of analysis. The median duration of response was 5.9 months. The median PFS interval was 3.7 months.

On 10/26/09, Impax Labs (NASDAQ: IPXL) announced that it has initiated a Phase 3 trial of its late-stage drug candidate IPX066 in advanced Parkinson's disease (PD) patients. IPX066 is an investigational extended release carbidopa-levodopa product intended to rapidly achieve and then sustain effective blood concentrations of levodopa, potentially improving PD clinical symptom management.

This is the second of two Phase 3 studies designed to support marketing approval of IPX066 in Parkinson's disease. Impax Pharmaceuticals previously reported in June the initiation of the first Phase 3 study of IPX066 in naïve PD patients.The ADVANCE-PD study will evaluate the safety and efficacy of IPX066 versus immediate-release (IR) carbidopa-levodopa (CD-LD) in advanced PD patients with motor fluctuations and is expected to enroll approximately 420 subjects who will be on treatment for approximately 22 weeks.

On 10/26/09, CEL-SCI Corp. (AMEX: CVM) announced that it has received over $10 million over the past 60 days through the exercise of warrants by investors to purchase the Company's common stock. These additional funds increased the gross proceeds raised in the last 60 days to approximately $30 million. CEL-SCI plans to use the additional proceeds towards its pivotal Phase 3 clinical trial with its cancer drug Multikine and to accelerate the development of its LEAPS compound for the treatment of H1N1 hospitalized patients.

CVM previously reported that it planned to commence its first study in humans aimed at improving the treatment of hospitalized H1N1 patients by inducing an effective anti-H1N1 immune response in patients without the raging pro-inflammatory cytokine response that can follow the natural response to infection and which may lead to a patient's death. CVM is developing lead product Multikine, which is being prepared for a global Phase 3 trial in advanced primary head and neck cancer, and is also developing a treatment for hospitalized H1N1 patients using its L.E.A.P.S. technology platform, and expects to soon finish the validation of its state-of-the-art manufacturing facility in Maryland.

On 10/23/09, BioCryst Pharma (NASDAQ: BCRX) announced that the FDA issued an emergency use authorization (EUA) for the investigational anti-viral drug intravenous (IV) peramivir in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza infection who are admitted to a hospital.

Specifically, IV peramivir is authorized only for hospitalized adult and pediatric patients for whom therapy with an IV drug is clinically appropriate, based on one or more of the following reasons: 1) the patient is not responding to either oral or inhaled anti-viral therapy, or 2) when drug delivery by a route other than an IV route such as enteral (absorbed by the intestines) or inhaled is not expected to be dependable or feasible; 3) for adults only, when the clinician judges IV therapy is appropriate due to other circumstances.

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