Shares of Arena Pharma (ARNA) (AH $6.58, +34% at 5:10pm ET on heavy, above-average volume for the day) are surging on news that the Company will conduct a conference call Friday 18-September at 8am ET to discuss the BLOSSOM (Behavioral modification and Lorcaserin Second Study for Obesity Management) Phase 3 study (its second pivotal Phase 3 study for this compound) results for its experimental weight loss drug lorcaserin and expects to submit a NDA for FDA approval by year-end based on guidance provided in late March, which is outlined below.
On 3/30/09, ARNA announced top-line results from its BLOOM clinical trial of experimental weight loss drug lorcaserin. The BLOOM results satisfy the efficacy benchmark in the most recent FDA draft guidance for the development of drugs for weight management. Lorcaserin treatment for up to two years was not associated with evidence of heart valve damage and rates for the development of echo-cardiograph FDA-defined valvulopathy were similar to placebo throughout the study.
On 9/17/09, ImmunoCellular Therapeutics (follow previous link for IMUC’s Facebook page) (IMUC) ($1.11, +3%) (heavy, above-average volume) announced that the Company is featured in an in-depth industry research report published by Griffin Securities earlier this week which focuses on the importance of targeting cancer stem cells (CSCs) as a new, add-on approach to the treatment of cancer. The report highlights the stem cell hypothesis of cancer, which postulates that all tumor types have a common cell group of CSCs that typically account for a very small proportion of all cancer cells, but which are resistant to standard treatments and responsible for the spread and recurrence of the disease.
IMUC’s ICT-121 is an example of active cancer immunotherapy that is being developed as an off-the-shelf antigen to stimulate the immune system to recognize a nine amino acid epitope of CD133, which is found on many different types of CSC. IMUC has a patent on this molecule and on its use as a vaccine and expects to begin a Phase I/II clinical trial in early 2010. In addition, IMUC is developing a passive immunization approach to combating cancer through a monoclonal antibody discovery platform and recently signed a deal worth up to $32 million with Roche (OTCQX:RHHBY) for ICT-69 in the diagnosis and treatment of multiple myeloma and ovarian cancer.
Two new categories have been added to the BioMedReports.com research section for industry reports and medical/scientific publications, including a new report uploaded earlier this week that was written by Keith Markey, PhD, of Griffin Securities on the emerging field of cancer stem cells (CSCs). The report highlights a variety of companies and therapeutic approaches aimed at targeting the emerging stem cell theory of cancer. In addition, four new scientific publications and articles were uploaded for privately-held Quantum Immunologics (QI) related to its experimental dendritic cell (DC) cancer immunotherapy (CI) that targets OFA-iLRP (oncofetal antigen – immature laminin receptor protein) as a universal cancer antigen.
On 9/17/09, YM BioSciences (YMI) ($1.77, +14% on heavy, above-average volume) announced that nimotuzumab (nimo) has been approved for marketing in Mexico and that it has enrolled the first two patients in its randomized, double-blind trial evaluating nimo in patients with brain metastases from non-small-cell lung cancer (NSCLC). Mexico represent the 21st country which has approved nimo for marketing, although YM Bio’s license for nimo does not include this country. The approval was granted to Laboratorios PiSA in Guadalajara, Mexico and nimo will be commercialized under the name VECTHIX in that country.
Nimo is a humanized monoclonal antibody that targets the epidermal growth factor receptor (EGFR), licensed to a majority-owned subsidiary of YMI and developed at the Center of Molecular Immunology in Cuba. Nimo is currently approved in two of the countries in the Company’s licensed territories. The drug has demonstrated efficacy in clinical trials without producing the numerous and severe toxicities observed with the other marketed EGFR-targeting drugs. Mexican regulatory authorities have approved nimo for the treatment of squamous cell carcinoma of the head and neck in addition to adult/pediatric gliomas (a type of brain cancer).
Click here for my overview article on YMI from early August at BioMedReports.com when the stock was trading below cash at 58 cents and below is a clinical and regulatory development summary for nimo:
Nimo is an IgG1, humanized EGFR-targeting monoclonal antibody which is similar to Erbitux ($1.5 billion in sales) without severe toxicities such as rash due to a differentiated binding to EGFR. The following are expected milestones for nimo clinical data: (1) nimo post-marketing data 150 patients in epithelial-derived tumors 3Q09; (2) nimo Phase 2 first-line NSCLC in 2010; (3) nimo European final Phase 3 first-line pediatric glioma data in 2010; (4) nimo European Phase 3 first-line adult glioma data in 2010; (5) nimo North American Phase 2 recurrent pediatric glioma data in 2010; (6) nimo esophageal Phase 2 first-line data (Brazil) in 2010; (7) nimo Phase 2 (Japan) recurrent gastric cancer data possibly in 2010; (8) recruitment by Oncoscience AG in nimo Phase 3 trial among newly diagnosed pediatric pontine glioma patients is concluded; and (9) recruitment by Oncoscience AG in a Phase 3 trial for adult glioblastoma grade IV will be completed in 2009.
On 8/10/09, YMI announced it 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 with solid tumor cancers in the US. YMI stated this will allow the Company to immediately discuss its IND submissions with the FDA to include US patients in its randomized, double-blinded lung cancer and brain metastases trials as well as expanding some other Phase 3 nimo trials into the US.
YMI also applied to OFAC for a license to make nimo available to US patients upon marketing approval by the FDA, which is consistent with a 2009 Staff Report to legislators, which recommended pharmaceutical imports from Cuba's rapidly developing biotech industry. Such licenses have been previously granted to two companies seeking to commercialize Cuban-origin therapeutics in the US and YMI has ongoing discussions with OFAC in this regard.
Disclosure: Long IMUC.OB. See my full disclaimer at MikeHavRx.com at the bottom of any page.