BioMed News Bytes: NicOx, Allos, Pressure BioSciences, YM BioSciences

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 |  Includes: ALTH, GILD, IGK, NICXF, PBIO
by: Mike Havrilla

On 5/19/09, NicOx (OTCPK:NICXF) announced that quality of life and utility results from its first Phase 3 clinical trial for naproxcinod were presented at the International Society For Pharmacoeconomics and Outcomes Research Annual International Meeting in Orlando, FL. Naproxcinod is a novel type of anti-inflammatory agent, which completed a Phase 3 clinical program last year in patients with osteoarthritis.

The drug is designed to have an improved side effect profile (including a neutral effect on blood pressure) as compared to a standard dose of the widely used NSAID drug naproxen. Naproxcinod has completed three pivotal Phase 3 studies with positive results. On 9/25/09, NicOx submitted a NDA for naproxcinod to the FDA for an estimated decision date of 7/25/10 for a standard, 10-month review.

On 3/25/09, Allos Therapeutics (NASDAQ:ALTH) filed a NDA with the FDA for Folotyn (pralatrexate injection) in the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). ALTH received a priority (six-month) review designation on 5/26/09 with a PDUFA decision date of 9/24/09 for a final decision by the FDA. PTCL comprises a biologically diverse group of hematologic malignancies that typically has a worse prognosis than other types of lymphoma and is less responsive to traditional chemotherapy regimens.

On 9/2/09, ALTH the Oncologic Drugs Advisory Committee (ODAC) of cancer experts voted 10-4 that the Company's drug would likely benefit patients with PTCL. On 9/25/09, ALTH announced that the FDA granted accelerated approval for Folotyn for use as a single agent for the treatment of patients with relapsed or refractory PTCL as the first and only drug approved by the FDA for this indication. In connection with the accelerated approval, ALTH has agreed to undertake additional clinical studies to further verify and describe the clinical benefit of FOLOTYN in patients with T-cell lymphoma.

On 9/25/09, YM BioSciences (YMI) announced operating results and issued an update on its clinical development programs. Nimotuzumab (nimo) is being advanced globally by a network of cooperative relationships with 32 Phase 2 and 3 clinical trials ongoing, 11 of which are being conducted by YM's majority owned subsidiary, CIMYM BioSciences or its licensees.

  1. Daiichi Sankyo and Kuhnil Pharma are currently collaborating on a Phase 2 randomized, open-label trial they are conducting that is evaluating nimo plus irinotecan compared to irinotecan alone in patients with advanced or recurrent gastric cancer refractory to 5-FU-containing regimens which is designed to complete recruitment in calendar 2009. Daiichi has also launched a Phase 2 trial in first-line NSCLC bringing to three the number of NSCLC indications being investigated by YM’s direct consortium.
  2. Randomized, Phase 2, double-blind trials in brain metastases from non-small cell lung cancer (NSCLC) and in NSCLC patients ineligible for radical chemotherapy were initiated in Canada; recruitment commenced in March 2009 for NSCLC and in September for the brain metastases trial. A Phase II, second-line, single-arm trial in children with progressive diffuse intrinsic pontine glioma (DIPG) is ongoing at multiple sites in the US, Canada, and Israel.
  3. Oncoscience AG reports that it continues to recruit for a Phase 3 trial of nimo in adult glioma and a Phase II/III trial in pancreatic cancer.
  4. Innogene Kalbiotech (NYSE:IGK) reported marketing approval in the Philippines and Indonesia, bringing to 21 the number of countries that are now reported as having approved the drug for sale in specific indications. In January 2009, the National Cancer Centre of Singapore announced that it was launching a worldwide Phase 3, 710-patient trial of nimo in the adjuvant setting in head and neck cancer in cooperation with IGK. This trial is in addition to the on-going investigator-initiated Phase 2 trial in locally advanced head and neck cancer and the initiation of a Phase 2 trial in cervical cancer.
  5. YM has received a license from the US Department of the Treasury's Office of Foreign Assets Control (OFAC) to further develop its lead product, nimo, for patients in the U.S. YM's first priority is discussion with the FDA on its two IND submissions to include US citizens in the randomized, double-blind Phase 2 trial of nimo in NSCLC patients ineligible for radical chemotherapy and the parallel Phase 2 trial in patients with brain metastases from NSCLC, both of which YM initiated in Canada during the 2009 fiscal year. Development plans may also include extending one of the Phase 3 trials being conducted worldwide into the US, such as the multinational 710-patient Phase 3 trial of nimo in the adjuvant setting in head and neck cancer.
  6. YM also continues to prepare its second late-stage product, AeroLEF (aerosolized liposome-encapsulated fentanyl), for further development internationally. After consulting with regulatory bodies in Europe and Canada, the Company is now determining the optimal clinical path forward and conducting discussions with prospective partners around the Phase 3 strategy.

On 9/25/09, Pressure BioSciences (OTCQB:PBIO) announced the commercial release of ProteoSolve-CE NATIVE and ProteoSolve-CE STRINGENT, two novel, pressure cycling technology (PCT) dependent kits for the extraction of proteins from the nematode ("worm") Caenorhabditis elegans ("C. elegans"). The two kits contain proprietary reagents, consumable processing containers ("PULSE Tubes"), and instructions for use, and are intended to be used with the Company's patented PCT Sample Preparation System.

C. elegans is one of the most widely used model organisms in laboratory research today. It is an ideal study animal because it is small, not complex, easy to grow and maintain in the lab, and has a short and very predictable life cycle. Importantly, biological information learned from studying this worm has been shown to be directly applicable to more complex organisms, such as humans. Click here for my overview article from last week on PBIO, which also includes a CEO video interview.

Disclosure: No positions.

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