nucs

Spectrum Pharma: Zevalin Sales Ramp Up

Justin,

I sent my info under email projectchris. I would be honored to be included in your network.

Chris


On Nov 27 08:02 PM Justin M. Hall wrote:

> NUCS:
>
> Thank you!
>
> Regardless of your title, the invitation stands. I am confident that
> you would be a valuable addition to the team of advisors, which I
> periodically consult.
>
> Justin

Spectrum Pharma: Zevalin Sales Ramp Up

"I would be honored to include you in my group of expert advisors.
I work with a number of physicians, including medical oncologists
and other doctors. From time to time, I seek their opinions (via
email) on a relevant medical issue or particular treatment as it
pertains to investing of course. If you are interested, then feel
free to drop me an email some time. Any and all of our correspondence
will remain strictly confidential."

Justin, thanks for the kind words. I would hardly call myself an expert, but can at times provide a little clarity into the inner workings of radioisotope delivery. I have enjoyed your articles, and know you will continue what your doing. If I have any news, I will post in these comment sections. Although I'm confident, zevalin has a big challenge in front of it. I will continue to enjoy following this story.


P.S. look forward towards your continued coverage of Spectrum.


Chris CNMT







On Nov 24 08:49 AM nucs wrote:

> Justin,
>
> I am a nuclear med tech. Sorry if somehow I gave the impression I
> was a doctor.
> To follow up on the RML (radioactive material license) Endocrinologist
> don't seem to have a problem with the current therapy model in regards
> radioactive isotopes. They order I-131 therapies for hyperthyroid,
> and thyroid cancer routinely.
>
> Reitinvestor,
> Community hospitals offer zevalin services, so it is not all academic
> facilities. I agree, that there isn't much uptake in the community
> setting, but thats another issue to tackle- more accessiblility.
>

Spectrum Pharma: Zevalin Sales Ramp Up

Justin,

I am a nuclear med tech. Sorry if somehow I gave the impression I was a doctor.
To follow up on the RML (radioactive material license) Endocrinologist don't seem to have a problem with the current therapy model in regards radioactive isotopes. They order I-131 therapies for hyperthyroid, and thyroid cancer routinely.

Reitinvestor,
Community hospitals offer zevalin services, so it is not all academic facilities. I agree, that there isn't much uptake in the community setting, but thats another issue to tackle- more accessiblility.


On Nov 24 01:52 AM Justin M. Hall wrote:

> Dr. Nucs:
> Thank you for setting the record straight, again. I always welcome
> and appreciate your insight (since July).
>
> Please retain my email address: [e-mail]
>
> I would be honored to include you in my group of expert advisors.
> I work with a number of physicians, including medical oncologists
> and other doctors. From time to time, I seek their opinions (via
> email) on a relevant medical issue or particular treatment as it
> pertains to investing of course. If you are interested, then feel
> free to drop me an email some time. Any and all of our correspondence
> will remain strictly confidential.
>
> Thank you again.
>
> Justin

Spectrum Pharma: Zevalin Sales Ramp Up

"the fact is that very few medical oncologists are trained or have any experience in the handling and administration of radioisotopes."

If it is really that big of an issue refer out. I think the patients deserve the best care possible, regardless of the oncologist incompetence or experience with radioisotopes, correct?

Does this mean that medical oncologist will not order a PET scan because they don't know what an RML consists of? Highly doubtful. And frankly, if you are that far behind the curve, why even bother practicing. Just retire, and let folks who have an interest in bringing better standards of care to patients for there benefit.
We've come a long way in the past decade, and hopefully we can benefit from those in search of better means to improving the lives of patients. The future of nuclear oncology maybe starting to shape up, similar to what we have seen from nuclear cardiology over the past 20 years.(thats the buzz I'm hearing from Cardinal Health,SNM meetings, etc.) Many oncologist's are starting to provide PET services, and this is a good thing. Even if it means, not referring out to radiology, who cares. Just support the quality services in house, and help provide these valuable services.

I will give you education, if that is your point. Yes, many are not educated.(all the more reason for patients to become more involved, as not all doctors that great--get the second opinions, research your options, etc) Spectrum is tackling these issues. Will Spectrum succeed? Who knows, lets just hope so. Spectrum is a speculative stock, and many folks know that turnarounds rarely turnaround. So if you are warning folks about the risks, good for you. If your message is to misinform, well thats another issue.


On Nov 23 04:19 PM reitinvestor wrote:

> Here we go, round and round; again;This fact a word of caution on
> investing in SPPI because of Zevalin, and having nothing to do with
> its efficacy and/or toxicity, short or long term.......the fact is
> that very few medical oncologists are trained or have any experience
> in the handling and administration of radioisotopes. This fact alone
> will impede its utilization, imho, so take the potential patient
> poipulation with a large grain of salt

Spectrum Pharma: Zevalin Sales Ramp Up

According to NCI, there will be over 30,000 new cases of indolent NHL in the U.S. in 2009. Still pretty sizable market to capture. Certainly not a 2700 patient population you cite in non indolent type. Did you want to expand your thinking 1996? Not specific enough, and need more thoughts on what your trying to say? I am looking forward to some constructive critcisim-- emphasis on constructive, and would love to hear your expanded thoughts.


On Nov 23 03:17 AM 1996 wrote:

> Are these cumulative sales results?
> Q1 2009= 34 patients/mo.
> Q2 2009= 44 patients/mo.
> Q3 2009= 62 patients/mo.
> Q4 2009= your figures 320patients/mo.
> Q2 2010= 1000 patients/mo.
> However, incidence of non-indolent NHL (DLBCL) will be roughly 33,000
> in 2009. Approx 88% will have Complete Response to R-CHOP.
> That means potentially 3900 patients in the US/year might benefit
> from Zevalin in relapsed/ refractory state of which 30% won't have
> bone marrow reserve to be eligible. That leaves 2700 patients/ year
> who I have to assume are insured are healthy enough and have the
> resources to travel to and stay in a major metro area/ teaching institution
> to have the Zevalin administered and then have local oncology support
> when their counts bottom.
> You should identify that numerator by Q2 or sooner assuming there's
> anyone left to administer it.
> Leave the light on.

Peregrine: Continuing to Accumulate on Any Dips

O.K. so it appears this monoclonal antibody attaches itself to dieing tumors cells within the tumor itself. From what I can tell from the description of mechanism of action, there is no immune response thus not an RIT. It appears that all the killing activity is done by the radiation only, right? When I first looked into the company, I assumed RIT. I figured that all monoclonal antibodies created an immune response. Just a little confused is all.


On Nov 15 12:03 PM nucs wrote:

> O.K. my mistake this is not RIT, but TNT. I will have to look into
> more to see how this gets into the core of the tumor. As I don't
> know its mechanism of action. It is not intravenously injected,
> and appears to be injected directly into the tumor.

Peregrine: Continuing to Accumulate on Any Dips

O.K. my mistake this is not RIT, but TNT. I will have to look into more to see how this gets into the core of the tumor. As I don't know its mechanism of action. It is not intravenously injected, and appears to be injected directly into the tumor.

Peregrine: Continuing to Accumulate on Any Dips

VFC,

I am a big fan of Cotara. Another RIT with seemingly overwhelming efficacy data.(some instances of survival out 10 years in aggressive gbm- amazing stuff) I haven't bought any shares yet, as the balance sheet has been a big concern for me. I will probably look into the stock again. Are they on firm financial footing? When do you think they could start a pivotal trial for Cotara? Hopefully Zevalin can lead the push into more uptake in RIT, and then pave the way for some promising RIT like Cotara.

Spectrum Pharma: Zevalin Has Blockbuster Potential

" to kind of understand side effects of radiation- google medical s/s
> of nuclear attack and read about bone marrow/gi/cns death esp. bone
> marrow."

Although not Zevalin, this study would suggest a little discrepancy in your thoughts about radiation. It would seem to me that the Chemo drugs are the toxic part of the equation.

It concerns me that you are worried about educating a seeking alpha poster, when you really should be educating yourself. Maybe a little continuing ed could help relieve your status quo way of thinking. Also, would this gentlemen fit into your neat box of ridicule for being old and not with the times?
blog.newsweek.com/blog......


The most concerning of the toxicities related to the administration of tositumomab is the potential for the development of secondary malignancy, most notably MDS and AML. Secondary MDS and AML have long been recognized as potential complications of treatment for NHL even before the era of radioimmunotherapy (Armitage et al 2003). With the prolonged survival observed in patients treated with tositumomab, it is unclear whether the development of subsequent MDS/AML is related to the radioimmunotherapy or to the longer period of observation after chemotherapy in patients who are living longer. Bennett and colleagues examined this question in a review of 1071 patients treated with radiolabeled tositumomab (Bennett et al 2005). A 6.3% 5-year cumulative incidence of MDS/AML was observed in patients who received radiolabeled tositumomab in the relapsed/refractory setting. However, with a median follow up of 5 years, no cases of MDS/AML were observed in patients who received tositumomab as initial therapy. Longer follow up is needed, but these initial data suggest that radiolabeled tositumomab is safe and that the development of secondary MDS/AML may be attributable to both the duration and amount of prior chemotherapy as well as to effects of the radioimmunotherapy itself.

www.ncbi.nlm.nih.gov/p.../


On Nov 01 08:34 AM 1996 wrote:

> zevalin.com prescribing info section 6.1 p.7 roughly
> 5% of pts in initial trial of relapsed NHL developed acute myelogenous
> leukemia/myelodysplastic syndrome at a median 2.9 years.
> to kind of understand side effects of radiation- google medical s/s
> of nuclear attack and read about bone marrow/gi/cns death esp. bone
> marrow.
> I'm a huge fan of pitchblende products but to analyze a product/company,
> I think it helps to understand the science. unless you're just daytrading
> a ticker symbol. which is ok ,too.

Spectrum Pharma: Zevalin Has Blockbuster Potential

Lets nip this in the but, and start educating truths, 1996. www.haematologica-thj....

Czuczman and colleagues recently reviewed a database including 746 patients treated with ibritumomab tiuxetan radioimmunotherapy.20 At a median of 4.4 years of follow-up, there were 19 cases of secondary AML or MDS with a crude incidence rate of 2.5%. Interestingly, comparing patients who developed secondary MDS/AML with those who did not, follicular histology and prior treatment with a purine analog were the only significant differences in risk factors. The association with purine analog treatment remained significant even in multivariate analysis; fludarabine was the purine analog in all cases. Increased age, prior radiation and alkylating agents did not seem to be overly represented in the patients who developed AML or MDS after ibritumomab tiuxetan. Similar risks have been reported with iodine-131 tositumomab, although the purine analog treatment status of those patients did not appear to increase the risk of MDS/AML.21

Importantly, the use of upfront radioimmunotherapy has not been associated with MDS or AML,22 except when combined with chemotherapy.23 One other important finding in the study by Sacchi and colleagues was that the cumulative incidence of secondary cancers continued to increase over the period of follow-up without evidence of a plateau. As previously mentioned, this phenomenon has been recognized in the setting of breast cancer after treatment of Hodgkin’s lymphoma, in which increased risk continues to be present for up to 30 years after radiation therapy. Longer follow-up of this and other non-Hodgkin’s lymphoma cohorts will be important to define the period of risk, which will have implications for the follow-up of these and other patients treated for indolent non-Hodgkin’s lymphoma.


On Nov 01 08:34 AM 1996 wrote:

> zevalin.com prescribing info section 6.1 p.7 roughly
> 5% of pts in initial trial of relapsed NHL developed acute myelogenous
> leukemia/myelodysplastic syndrome at a median 2.9 years.
> to kind of understand side effects of radiation- google medical s/s
> of nuclear attack and read about bone marrow/gi/cns death esp. bone
> marrow.
> I'm a huge fan of pitchblende products but to analyze a product/company,
> I think it helps to understand the science. unless you're just daytrading
> a ticker symbol. which is ok ,too.

Spectrum Pharmaceuticals: Optimistic About Zevalin's Prospects

Michael,

Yes, you know all to well. I know early in my Nuclear Medicine career, we used Strontium for bone palliation. Was that one not approved? I have given all of those drugs from the then company you headed at Cytogen, except Prostascint. Too bad, some of these diagnostics, and therapies haven't caught on. I think some of these products are wonderful. I believe RIT in general has awesome potential for improvement over existing naked antibodies for cancer therapy.


On Jun 29 07:46 AM Michael Becker wrote:

> CHowe - I also have extensive experience with radiopharmaceutical
> products and agree with your commentary. This issue is not specific
> to Zevalin, as several other companies have experienced challenges
> making this class of product successful. In fact, three radiopharmaceuticals
> have been FDA approved to treat cancer or support cancer therapy
> - including Bexxar which is similar to Zevalin and marketed by GlaxoSmithKline
> (seekingalpha.com/symbo...). It is naive to believe that
> Zevalin has simply been marketed incorrectly, as that would imply
> that GSK also didn't market Bexxar correctly. Radiopharmaceutical
> products have not been adopted by oncologists. If you want additional
> background on this topic, go to the following link and read the 9/1/07
> article I authored for Oncology Business Review titled "Radiopharmaceuticals
> Need a Jump-STaRT" at www.mdbpartners.com/ar...;br/>
>
> On Jun 28 08:30 AM CHowe wrote: