BSD Medical Corporation (NASDAQ:BSDM) today announced that their published study results demonstrated improvement in the overall survival, tumor response rates, and local tumor control from the addition of hyperthermia therapy delivered through BSD-2000 Hyperthermia System. This therapy was delivered as a standard treatment regimen for the 45 patients suffering from high-risk bladder cancer.

The multi-institutional study was named as Quadrimodal treatment of high risk T1 and T2 bladder cancer. The research was conducted by eight well-known medical researchers who are the front-runners in the field of oncology research. The study was conducted at three prestigious medical centers one being one of the largest universities in Germany, University of Erlangen, which provides an unique range of interdisciplinary research, and also at University of Frankfurt and Hospital Martha-Maria in Germany. The study was published in Radiotherapy and Oncology which is the official publication of the European Society for Therapeutic Radiology and

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Recently, Dendreon Corp. (DNDN) announced that it intends to file an amendment to its existing Biologic License Application (BLA) for its prostate cancer vaccine Provenge in Nov. 2009. We believe that the US Food and Drug Administration (FDA) will approve Provenge in the first half of 2010 based on the positive phase III IMPACT (IMmunotherapy for Prostrate AdenoCarcinoma Treatment) trial results announced in Apr. 2009.   If approved, Dendreon will become the first company to receive approval for an anti-cancer immunotherapy based vaccine. In development studies, Provenge boosted survival rates in men with advanced prostate cancer beyond any currently available treatments. Unlike traditional vaccines that prevent diseases, Provenge treats it by stimulating the body's own immune system to attack cancer cells. We also expect the company to announce a partner for Provenge in Europe soon while Dendreon itself will market the drug in the U.S.   Prostate cancer ...

In a major breakthrough, Allos Therapeutics (ALTH) received FDA-accelerated approval for Folotyn (pralatrexate injection) last week.

The company was seeking approval of the drug for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). Folotyn becomes Allos' first drug to receive FDA approval.

While the drug will be available to patients within a month, the commercial launch is scheduled for January 2010. Allos is increasing its sales force from the current level of 25 to 50, and doing the necessary preparations for its launch.

Allos has agreed to conduct additional clinical trials to further verify the benefit of Folotyn. The requirement of additional trials comes with accelerated FDA approval as the agency requires further studies after the launch to confirm the drug's benefits to patients.

Earlier this month, Folotyn received a favorable recommendation from the FDA advisory panel, which voted 10-4 in favor of the drug along with stating

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We are awaiting the US Food and Drug Administration’s (FDA) decision regarding Allos Therapeutics’ (ALTH) lymphoma drug Folotyn. The company, which is seeking approval of Folotyn for the treatment of relapsed or refractory peripheral T-Cell lymphoma (PTCL), was assigned a Prescription Drug User Fee Act (PDUFA) date of Sept. 24.

We are optimistic about the approval of Folotyn based on the FDA advisory panel’s favorable recommendation earlier this month. The board voted 10-4 in favor of the drug and said that new treatments were required for the disease.

However, we are still wary as the studies conducted by Allos did not record robust data. The number of patients who responded to the treatment was rather low (27% of 115 patients) with the majority of them responding only partially. Moreover, effect of the treatment lasted for less than 14 weeks in more than half of these patients. The panel

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Yesterday, the US Food and Drug Administration’s (FDA) panel came out with a favorable recommendation regarding the approval of Allos Therapeutics’ (ALTH) lymphoma drug Folotyn (pralatrexate). The company is seeking approval of Folotyn for the treatment of relapsed or refractory peripheral T-Cell lymphoma (PTCL). Although the FDA is not required to follow the panel’s advice, it generally does so. The agency is supposed to take a final decision on the drug by Sept 24.

The FDA panel voted 10-4 in favor of the drug along with stating that new treatments are required for the disease. Studies conducted by the company did not record robust data. The number of patients who responded to the treatment was quite less (27% of 115 patients) with majority of them responding only partially. Benefit of the treatment lasted for less than 14 weeks for more than half of the responding patients. The panel voted in

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We are awaiting the decision of the US Food and Drug Administration's (FDA) cancer advisory committee regarding approval of Allos Therapeutics’ (ALTH) Pralatrexate at a meeting scheduled for September 2, 2009. The company is seeking FDA approval for Pralatrexate for the treatment of patients with T-cell lymphoma. Although the FDA is not bound to follow the decision of the advisory panel, it generally does so. A positive recommendation from the panel increases the possibility of gaining approval for pralatrexate from the FDA. The final decision is expected by September 24th. In February this year, Allos Therapeutics came out with encouraging data from the clinical trials of pralatrexate and filed a New Drug Application (NDA) in March based on it. Pralatrexate has "orphan drug" status from the FDA and European Medicines Agency (EMEA) for the treatment of patients with T-cell lymphoma, indicating that Allos will obtain seven ...

Biomoda, Inc.

(Public, OTC:BMOD)

StocksHaven Investments profiles one of the most promising up and coming small cap biotech companies, Biomoda Inc, which has established a medical breakthrough for early lung cancer detection. It is a development-stage company. The Company is an invitro diagnostics company that develops assays, or tests, to detect cancer. These assays are performed in clinical reference laboratories using body-fluid samples. This technology is based on a licensed patent from Los Alamos National Laboratories. The technology is based on a molecule that has an affinity to bind with cancer cells and it fluoresces red under ultra violet light. It is a porphyrin molecule. This technology works with a range of cell types. The Company is in the process of developing a line of assays for a variety of cancers based on adaptations of this technology. Biomoda’s first product

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Last week, Allergan Inc. (AGN) said that the U.S. FDA has granted fast-track status to apaziquone, an antineoplastic agent which is being studied for the treatment of non-muscle invasive bladder cancer. Apaziquone is being developed by Allergan under a development and commercialization agreement with Spectrum Pharmaceuticals (SPPI).

Fast-track designation is usually granted to drugs which are being developed for the treatment of serious diseases and which show the potential to address unmet medical needs. The designation helps accelerate the development and review process.

Non-muscle invasive bladder cancer is a form of cancer localized on the surface of the bladder that has not spread to the deeper muscle layer. The companies estimate that about 70% of all patients newly diagnosed with bladder cancer have non-muscle invasive bladder cancer. More than 1 million patients in the U.S. and Europe are estimated to be affected by the disease, which is

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Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.

Allos Therapeutics [ALTH: 7.19, -0.13 (-1.78%)]: On 5/30/09 , ALTH updated data from the Company’s pivotal Phase 2 PROPEL study of pralatrexate in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The overall response rate for pralatrexate as evaluated by central independent

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BSD Medical Corp. (Nasdaq: BSDM) is part of the global fight against cancer. The company develops systems for cancer therapies requiring precision-focused heat through microwave technologies. Today the company announced its European distributor was awarded a contract from Azienda Ospedaliera Institui Ospitalieri Di Verona (the Institute) to replace its existing hyperthermia system with BSD’s BSD-2000/3D system.

The BSD-2000/3D deep regional hyperthermia system is scheduled for delivery in August 2008, and will replace the Institute’s current system, which has been used since 1996. The BSD-2000/3D will be the first of its kind in Italy, and the 15th utilized in Europe.

“We are pleased to further expand our activities in the field of clinical hyperthermia, the single most potent radiation sensitizer available. We are looking forward to close working relationships with all of the ESHO [European Society for Hyperthermic Oncology] member institutes in advancing hyperthermia cancer treatment,” Dr. Sergio Maluta, head of the

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