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Biotech / Medical : BSD Medical (Long Term Investment Oriented) -- Ignore unavailable to you. Want to Upgrade?


To: fwhco who wrote (102)2/6/2013 6:44:39 PM
From: fwhco  Read Replies (1) | Respond to of 178
 
Ray, I believe this is the link to the recent p/r from BSD.

ncbi.nlm.nih.gov
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Int J Hyperthermia. 2013;29(1):8-16. doi: 10.3109/02656736.2012.740764. Epub 2012 Dec 17.
Gemcitabine and cisplatin combined with regional hyperthermia as second-line treatment in patients with gemcitabine-refractory advanced pancreatic cancer.
Tschoep-Lechner KE, Milani V, Berger F, Dieterle N, Abdel-Rahman S, Salat C, Issels RD.
Source Department of Internal Medicine III, Klinikum Grosshadern Medical Centre, Ludwig-Maximilians-University , Munich , Germany.

Abstract
Purpose: There is no standard second-line therapy for patients with advanced pancreatic cancer (APC) after gemcitabine (G) failure. Cisplatin (Cis)-based chemotherapy has shown activity in APC. It is proven that cytotoxicity of G and Cis is enhanced by heat exposure at 40° to 42°C. Therefore G plus Cis with regional hyperthermia (RHT) might be beneficial for patients with G-refractory APC. Patients and methods: We retrospectively analysed 23 patients with advanced (n?=?2) or metastatic (n?=?21) pancreatic cancer with relapse after G mono first-line chemotherapy (n?=?23). Patients had received G (day 1, 1000?mg/m(2)) and Cis (day 2 and 4, 25?mg/m(2)) in combination with RHT (day 2 and 4, 1?h) biweekly for 4 months. We analysed feasibility, toxicity, time to second progression (TTP2), overall survival (OS) and clinical response. Results: Between October 1999 and August 2008 23 patients were treated. Haematological toxicity was low with no grade 4 event. Hyperthermia-associated toxicity consisted of discomfort because of bolus pressure (3%), power-related pain (7%) or position-related pain (17%). Median TTP1 was 5.9 months (95% confidence interval (CI): 2.6-9.2), median TTP2 was 4.3 months (95%CI: 1.2-7.4) and OS 12.9 months (95%CI: 9.9-15.9). The disease control rate in 16 patients with available CT scans was 50%. Conclusion: We show first clinical data of G plus Cis with RHT being clinically active in G-pretreated APC with low toxicity. A prospective controlled phase II second-line clinical trial (EudraCT: 2005-003855-11) and a randomised phase III adjuvant clinical trial offering this treatment (HEAT; EudraCT: 2008-004802-14) are currently open for recruitment.



To: fwhco who wrote (102)2/7/2013 12:03:21 PM
From: pleonastic  Respond to of 178
 
Thanks, fwco. There are some very interesting comments in that abstract; every statement, in fact. It provides a good venue for reviewing the reasons for the proven successes of hyperthermia (and *microwave* hyperthermia is the BEST – and BSD Medical is the *worldwide leader* in microwave hyperthermia):



“The hallmarks of hyperthermia and its pleotropic effects are in favour of its combined use with chemotherapy.”



A long list of successful trials are provided at BSD Medical.com.



“Thermal enhancement of drug cytotoxicity is accompanied by cellular death and necrosis without increasing its oncogenic potential. “



One reason for this is the strong tendency of heated tumors to be more permeable to whatever drug is involved. Also, the tumor’s defense mechanisms tend to be defeated at the raised temperatures. Also, the body’s defense mechanisms are stimulated (as below). These things should provide much-enhanced drug therapy, and many trials have shown that they do.



“The induction of genetically defined stress responses can deliver danger signals to activate the host’s immune system.”



I’ve seen this claim in at least several places. It seems well established.



“The positive results of randomised trials have definitely established hyperthermia in combination with chemotherapy as a novel clinical modality for the treatment of cancer.”



Again, these results are listed at the BSD Medical website. Seems to me that the success of these trials – with very substantial positive results and little to no negatives (efficacy failures or serious additional side effects) – reasonably assure eventual wide acceptance of hyperthermia (even in the world-lagging U.S.!)



As a side note (drawn mainly from scuttlebutt from long-time investors), initial investigations (decades ago) of hyperthermia were badly flawed and led to mistaken views about the therapy. This has, no doubt, slowed acceptance of the practice. I think these early trials are no longer influential.



“Hyperthermia targets the action of chemotherapy within the heated tumour region without affecting systemic toxicity. In specific clinical settings regional hyperthermia (RHT) or hyperthermic perfusion has proved its value and deserve a greater focus and investigation in other malignancies.”



Well – duh! J



“In Europe, more specialised centres should be created and maintained as network of excellence for hyperthermia in the field of oncology. “



“The European cancer centers have been way ahead of the U.S. in seeing the positive effects of hyperthermia as an adjunct to chemo drugs.”



Indeed! And, the same goes for microwave ablation, as well.