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No. of Recommendations: 18
Table 1
          Phase III AntiCancer Projects by Advancement Class

Disease State/   Group A                Group B                Group C
Incidence/
Mortality


Breast/  Biomira-Theratope*/**     Alza-Doxil              BriBio-Marimastat
184,000/ Matrix-Intradose**/ ***   Cell Pathways-Aptosyn
41,000   Elan-Myocet**             Immunex-Novantrone
                                   Corixa-Detox   
                                   Cangene-Leucotropine
                                   Supergen-MitoExtra

                                                                           
Prostate/Praecis/Amgen-Aberelix*/*** Berlex/Cytogen-Quadramet   
180,000/ Atrix-Leuprogel-1 mo.***    Epic-Promaxx
32,000   Cytogen/Drxs-Brachyseed *** Dendreon-Provenge   
         Cytogen/Draxis-Pd seed***   Cell Pathways-Aptosyn 
				     Supergen-SU 101
                                     Roberts-RL 0903


Lung/    Isis-Isis 3521*/**        Imclone-BeC2                 
164,000/ Ligand-Targretin**        Genentech-AntiVEGF    BriBio Marimastat
157,000                            OSI Pharma-OSI 774    SR Phar-SRL 172
                                   Aeterna-Neovastat     Agouron-Prinimastat
                                   Cell Pathways-Aptosyn


Colorectal Imclone-IMC 225*        AVI Biopharma-Avicine
134,000/   Pharmacia-SU 5416**     Titan-CEAVac
57,000     Genentech-AntiVEGF**    Aphton-Gastrimmune
                                   Medimmune-Neutrexine
                                   SuperGen-MytoExtra
                                                                                                   


NH Lymph/  IDEC-Zevalin*/**/***    Immunomedics-Lymphocide
55,000/    Corixa-Bexxar*/**/***   Peregrine-Oncolym
26,000                             SuperGen-Nipent (GVHD)


Bladder/   Bioniche-Regressin**
53,000/    Intracel-KLH**          Biogen-Intron A
12,000


Melanoma   Genta-Genasense*/**     Enzon-PEG Intron      Progenics-GMK vaccine
48,000/    Vical-Allovectin 7**                          Maxim-Maxamine
8,000      Ivax-M Vax**


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No. of Recommendations: 5
Thank you for an excellent research aid.

A few notes:

I believe companies developing cancer therapies applicable to a plurality of cancer types, but which have only one candidate in late trials, should be included as well, provided their phase II trials of the other indications show similarly promising results. This is because, according to the latest statistic I've run into, 50% of cancer therapy is administered off-label, meaning oncologists aware of the therapy's potential for treating off-label cancer types would probably use it, especially for disease conditions which have failed previous therapy treatments. Thus, Antigenics, for an example already cited, belongs in the list.

There shouldn't be a distinction between a phase III trial and any other pivotal trial. Although to the best of my knowledge phase I trials never suffice for approval, there are many cases in which a pivotal trial is carried out in lieu of phase III trials in the earlier phase II development stae (in which case, the phase II status actually indicates the potential of a much faster approval than phase III status). Ergo I would recommend reviewing and possibly adding Celsion, who are conducting a pivotal phase II trial of a thermotherapeutic breast cancer therapy.

Valedictively,
Daniel Guy.



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No. of Recommendations: 3
Here's one I just posted in response to Charly's "Wow-Cancer". I've reposted it here to follow up on Sheila's request that we use this "Candidates" thread for our discussions.

>>>>>>>Hi, Charly....glad to have you on board...and particularly glad that you shared your reasoning with us. I hope others will do the same.

First, let me respond to Are you at all open to picking an anti-cancer company that doesn't yet have a phase 3 candidate? Kind of like the 5% of funds in an "alternative investment" that many/most of the pension funds and endowments follow. Of these earlier stage companies I think ImmunoGen and Cell Therapeutics have a lot of promise as a home-run type investment. Just a thought.

Sure...Sheila has just followed up on Daniel Guy's suggestion that a portfolio be created that encompasses companies that have a single drug candidate that is being studied for several disease states which in the aggregate may have blockbuster potential. You may be thinking of that, or you may have something else in mind. I look at IMGN as a company that is supplying basic anticancer technology to others on the one hand (maytansin) and building an inhouse platform for itself on the other. Others who fit that anticancer mold are MEDX, ABGX, PDLI, et al....you could go on from here, because I think you have suggested some of these in the past. Until you decide on a better name, we could just call it "PORTFOLIO 3" and ask you to work with us to define the acceptance criteria so that we have a somewhat standard bundle of entries.

Second, thanks for the three 'pro" and six "doubtful" entries. We have them on record and consider the three as serious candidates for the final port.. I concur with your reasoning with respect to 7 out of 9, which must be some kind of record for both of us! (And I'm somewhat of a wimp about CRXA, since I grew up with the immunotherapy thrust and still have it in my blood). Your reasoning is cogent. I hope others will ask questions of you, and in fact, challenge you if they have other views.

Finally, I hope I can persuade you to rethink the following comments;.......As far as cancer types, I would be tempted to stay away from the prostate cancer.....Surgery and radiation therapy are very effective treatments with very high survival rates.....As surgery works so well, my feeling that this isn't a market with desperate need for a drug.

It is true that surgery and radiation, supported by hormone therapy before and after the initial procedure, have been the traditional means of approaching prostate cancer. But prostate cancer is the 4th most lethal cancer in this country (following lung, colorectal, and just behind breast). We have 30,000+ prostate deaths annually. That tells us that surgery and radiation are not doing the job as well as we need it done. Its mortality rate is likely to increase, given that it is an "old man's disease" and improvements in our cardiac care will be increasing the number of us "old men" still hanging around and subject to this one. But beyond this, there is the most serious incidence of metastatic bone disease stemming from prostate cancer. Prostate cancer progresses slowly and lingers poorly-detected after primary treatment. And it migrates in time to the marrow cavities of the bone. There are a reported 600,000 cases of prostate-based bone mets now living in this country....and their prognosis is for a great deal of lingering bone pain unless/until they expire. (I could probably find that reference if I tried hard.) This is not, to my mind, a disease that we can consider well-treated. And if you consider that metastatic disease is usually what gets us in the end, isn't that what we should be going after?

The only new treatment approach for bone mets that has reached Ph III, to my knowledge, is the Cytogen/Berlex Quadramet project shown in Group B. The drug is currently approved for pain relief in bone mets from prostate cancer. It does that by depositing preferentially in the reforming bone tissue surrounding the tumor and zapping the tumor with radiation. Berlex has taken this into Ph III for patients "who have not yet experienced pain". Read between the lines, that's for controlling metastatic disease progression before symptoms appear. If this does, in fact, control metastatic bone mets, it will be more than a block buster. And it won't apply only to men....a major site of metastases from breast cancer is bone, and bone pain is a common concern among women who have recurring breast disease.

So, I ask you to think about these points before you make up your mind completely on prostate cancer. And, from our previous discussions on this Board, I'm sure that you will consider this carefully.

I also must disclose that the technology that has become Quadramet was developed by a lab that I once directed, and was subsequently licensed to Cytogen. I do not own CYTO currently, but I should be considered by all readers to be biased in favor of the technology owing to having been a midwife at its birth. I make no representation regarding Cytogen or Berlex other than that both market in the oncology arena, and that Cytogen is small enough that its prospects for survivability should be carefully investigated by any prospective investor.

Charly, let's keep up the dialogue. And, since Sheila has appointed the "Candidates" post as the thread for this project, can we do it there? I'll post a copy of this one at that site to get it started.

See ya later.....Cliff<<<<<<<
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No. of Recommendations: 4
Many thanks and congratulations to the Anti-Cancer Shakeout Team for this excellent summary.

As I wade through the companies' profiles and drug candidates while considering my votes for the Anti-Cancer Port, these thoughts come to mind:

Celgene (CELG) has built an impressive series of programs for Thalomid (thalidomide) as an immunosuppressant in treating several types of cancer, including breast and prostate

http://www.celgene.com/pharmaceuticals/immunotherapeutic.htm

It is a profitable biotech (a rare beast indeed) whom many suspect is on the threshold of being acquired at a nice premium. Meanwhile, CELG is a nice Group B addition, maybe eligible for Group A.

Ivax (IVX) will be starting later this year a Phase 3 trial in lung cancer using oral paclitaxel (Paxene), a more promising formulation than the iv compound

http://www.ivax.com/ComNewsv2.htm

Cell Therapeutics (CTII), now in Phase 2 lung and colorectal cancer trials with another formulation of paclitaxel (a polyglutamate conjugate, PG-TXL), is expected to move quickly into pivotals within 6 months -- worth keeping a close eye on this one as the PG-TXL appears to be an excellent formulation

http://www.cticseattle.com/products_investigational.htm
http://www.cticseattle.com/pdf/US_Onc_4-25-01.pdf

Maxim (MAXM) and their renamed Maxamine drug, Ceplene are about to start in the 3Q this year a new international Phase 3 trial in melanoma to supplement the NDA submission that was rejected. I'd rank MAXM higher than Group C. Ceplene is only a solution of histamine dihydrochloride which putatively up-regulates the immune system, but it does seem to have growing anecdotal support from oncologists for efficacy in melanoma and leukemia (AML).

Just a few points for now. Thanks for the great list and all the effort behind it.

NN
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No. of Recommendations: 4
Thanks for your proposed additions to the Table, NN. Yes, we should add them to the Table at the next printing. But first, if you can spare the time, we could use your help in deciding where to put them. There may be another place that you prefer over Table 1 for some of them.

As a result of comments from Daniel Guy and Charly, and Sheila's own inclinations, we seem to be moving in the direction of several portfolios with somewhat different acceptance criteria, namely;

(1) Ph III Blockbuster potential, only the "10 best" as decided by BBers. In the original cut, I tried to hold off on the ones that said "soon we're gonna do Ph III" and accept only the "we've already started Ph III" (or a "pivotal trial for a Fast Track"). Otherwise we'd be thought of as pretty wishy-washy in our selection criteria (and we'd be getting a lot of candidates that couldn't possibly have an FDA approval in 3-4 years).


(2) Ph II/III, the aggregate of several indications giving Blockbuster potential, probably the "ten best" per above. (Sheila and Daniel)

(3) Other "potential stars" like IMGN, CTII, ABGX et al., who don't have their own blockbuster drugs as far along as Ph III yet, but have some unique technology or raw material supply position that leads BBers to think that in a couple of years, they may be in the Ph III Blockbuster or Aggregate Blockbuster ballgame alone or with a collaborator. (My interpretation of Charly's thoughts).

We don't yet have a good definition of the acceptance criteria for this third category. Any suggestions that you make will be appreciated.

And after you've thought about the Port 3 criteria and perhaps suggested some wording, where do YOU feel that each of your four candidates fits?

We know you're busy, so...whenever you can find the time and the inclination.....


With thanks.....Cliff


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No. of Recommendations: 2
Hello all,
Didn't these guys do a good job!!
As for criteria from here on, one that has to count is "How soon do you want a result on your investment?"
The time factor. Those int he first list will gove us the earliest returns for the longest time, balanced against those who will eventually rpovide that return also for a length of time, just taking longer to get there, if they make it! and that last phrase is always going to be the decider. "Many a slip twixt the cup and the lip".
List one, the best earliets soundest returns, the second list, probable next best earliest returns as a follow on and to broaden the choice available to discerning investors.
Regards all Barb.
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No. of Recommendations: 2
Hi, Terry...glad you dropped in. I've seen your posts on the Biomira Board. I, too, am a believer in vaccines, and in fact, most other forms of immunotherapy including radioimmunotherapy.

One of your comments Not terribly fond of the groupings classifications. prompts me to offer an explanation to you and to other BBers who may feel the same way.

Table 1 has the following screen criteria;

1. Gotta be a Biotech company, because that's where we are investing.

2. Gotta be a blockbuster drug candidate, because that's what attracts institutional investors/mutual funds in the belief that eventually high earnings and growth momentum will develop.

3. Gotta be in Ph III with their blockbuster anticancer candidate, because as investors, we can't wait forever for a drug to hit the bottom line and we shouldn't take too big a risk on the dream world and the 30-40% share price crash when a Ph II failure is reported, as it will be fairly often. (As you no doubt know, only in Ph III does a drug candidate have a better than 50/50 chance of eventually getting FDA approval, and only in Ph III can one count on getting that approval within 3-4 years....unless it has Fast Track status, in which case you can knock a year or so off that schedule. And for that reason, Fast Track was added as a screening criterion.)

So we screened ALL of the anticancer drug candidates by these criteria, and came up with Table 1. We may have missed some candidates, and hope you'll add them if you know of them.

Table 1 is not intended to define classes of therapy or technology (like the vaccines which you and I respect). It's intended to include EVERYTHING in Ph III w/ Blockbuster potential. And then, most importantly, it is intended "to separate the sheep from the goats". The Sheep are in Group A, the Goats are in Group C, and only time and clinical reports and FDA responses to Fast Track applications will tell us where the big mob in Group B will wind up. We'd like most of those to graduate to Group A within the next year, but realistically, the historical odds tell us that about 1/3 of them will wind up in the Goat herd. Which ones? I wish we knew now, but.....

We could have some fun betting on whether PGNX will ever rescue GMK-M with their "longer-time-to-efficay" measurement approach---and maybe they'll succeed with it---but until they do, they gotta stay with the Goats, or we don't have a cleanly defined portfolio.

This grouping won't fit everyone's investment style. That's OK. Sheila and Daniel seem to be moving in the direction of a portfolio of companies whose PhII/III clinical trials aggregated over several cancer disease states will reach Blockbuster potential. And Charly has raised questions about another possible port, details not yet defined. Maybe one of these emerging portfolios will fit your style. Whatever works for each of us, that's the important thing.

Hope we'll see you regularly on these pages.

Cheers.....Cliff

P.S. I'm copying this on the AntiCancer Shakeout thread so that we can keep that thread intact on all of our "definitions"

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No. of Recommendations: 2
Hi Cliff

This is already a great thread, not only providing an education about some interesting companies in a (arguably, the most) important biotech field, but also in the investing lessons inherent in choosing a single company, a basket or an index of cancer biotechs.

There hasn't been any discussion in the thread about this last concept -- although I pointed out a guide to Steve in a previous post

http://boards.fool.com/Message.asp?mid=15147770

There's some merit in the index approach. We should think about it.

But, I do like your increasing focus in post 7796 about having several cancer ports depending on the maturity of the company and trial status. I like Barbara's advice too, post 7791.

I need some more time to research the 4 companies I mentioned in post 7780 then suggest their positions for The Table or a port.

Bottom line suggestion: let's throw the ports together here at the end of 1H01 and celebrate a fresh quarter next week with a bunch of port updates. I'm working on mine and hope to have them completed over the weekend. There's value in seeing the companies in a table, comparing them, and going into the charts to see where they've been.

Can't say thanks enough for all the effort the cancer team has put into proposing this valuable analysis.

CYA later. NN
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No. of Recommendations: 3

Soar like an eagle
Phase two data shown
Drop like a rock. Plonk.

Hearty salutations everyone,

Supergen is conducting phase III trials for the indication of pancreatic cancer of their chemotherapeutic durg Rubitecan, which is also concurrently in phase II trials for hematological, ovarian, colorectal, breast and lung cancer. It could be a candidate for the derivative portfolio. Two comments on that:

1. While it is a promising drug with blockbusting potential, Supergen may not be a sound investment vehicle due to issues with management. I am not very familiar with the whole story, but apparently, management engages in extreme nepotism, and there are signs of other problems. As a consequence, the people who are responsible for the development of their current pipeline, Rajesh Shrotriya and Luigi Lenaz, two highly distinguished individuals who have previously worked for Bristol Myers-Squibb and played key roles in the development of its cancer product line (including Taxol and Cisplatin) have left and are currently in Neotherapeutics - Rajesh as president, Luigi as head of the oncology division.

2. I'm not sure we can find enough companies that satisfy the criteria of:
A. sufficiently promising phase III trial for an initial small population.
B. Concurrent phase II trials of the same compound in the same formulation and vector for various other indication of which the aggregate presents blockbusting potential.
to justify the creation of a separate shake-out portfolio. Rather, I believe they should be part of the regular portfolio, as the potential they represent for mass sales is due to the application of the therapy off-label upon its approval for the pivotal trial indication. Thus, it is comparable to other therapies in the portfolio.

Ear turned into gill
We regret to inform
Gene trial halted.

Valedictively,
Daniel Guy.

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No. of Recommendations: 2
Thanks, Daniel, for your latest post (TWO haiku, yet...I'm impressed!)

Supergen has two candidates on the B list. The pancreatic Ph III didn't make Group B because pancreatic CA doesn't meet the 50,000 incidence cut-off. It's a very poorly-treated disease, though, and we should keep Supergen in mind for the other portfolio that will have different entrance criteria than this first one. Hope you'll keep us posted on their management situation.

Toward the end, you say I'm not sure we can find enough companies that satisfy the criteria of:
A. sufficiently promising phase III trial for an initial small population.
B. Concurrent phase II trials of the same compound in the same formulation and vector for various other indication of which the aggregate presents blockbusting potential to justify the creation of a separate shake-out portfolio. Rather, I believe they should be part of the regular portfolio, as the potential they represent for mass sales is due to the application of the therapy off-label upon its approval for the pivotal trial indication. Thus, it is comparable to other therapies in the portfolio.


From the standpoint of finding enough GOOD companies in Group A to form a 10 company port, I agree that it will be difficult in this first round. But that will change with time, maybe even before the year is out.

I'm afraid we were not thorough enough in explaining the selection criteria, so I'll amplify here. For Goup A they were,

a) A clearly started (recruitment begun) Ph III trial for which either Ph II results or early Ph III results showed greater than 50% Objective Response or greater than 50% increase in Survival Time, or
b) An announcement that Fast Track status had ALREADY been acknowledged by FDA, or
c) An announcement by the company that a BLA/NDA in the U.S had ALREADY been filed.

Most of the 25 that are in Group B are there because they are newly in Ph III and have not yet reported survival results or response rates that meet Group A selection criteria. That should be done soon for the "winners", and the losers we will be glad to weed out.

There were to be no wannabees or maybes in this first portfolio. "Pivotal trials" were not considered for inclusion unless the statement was accompanied by clear Fast Track status, or unless reported data met the OR or Survival tests.. And there are other issues that will rule companies out, even after they make the Group A cut.. Companies trading for less than $5/share face special restrictions at the broker level and generally don't get much institutional support. Personally, having been burned more than once by these stocks, I wouldn't want them in my portfolio again. We (BBers) will rule out other companies when we look at their burn rates and cash/security reserves and question their survivability from now until FDA approval time (nearly always longer than the PR suggests). Some folks may question inclusion in the absence of collaborators at this level (where would Biomira be today without Merck-Darmstadt?) So-o-o, it's not gonna be easy to find 10 Group A companies at the end of this exercize. But there's no law that we have to have 10 companies in this "cream of the advanced crop" portfolio for starters. With 25 other companies in Group B, and more entering Ph III every month or so, we should get to 10 in port A fairly soon. (And after that, the job gets even tougher, because then we have to figure out which one to drop from the A port list to make room for the next (better) one coming along.)

The make-up of the second port, it seems to me, is the remaining big question. What SHOULD the selection criteria be? You've made some suggestions; Charly, NN, & Terry have also. I look at Sheila as the coordinator of that selection mechanism, but at the moment she's wrapped up in a publication deadline. Perhaps you would be willing to email her your suggestions which, of course, may go far beyond the very tight criteria we set for the first port.

BTW. I looked into Celsion at your suggestion. (For other BBers, Celsion has a heat-activated liposomal doxorubicin in the clinic). Since they state they are "moving toward commencement of pivotal Ph II trials for breast cancer", we will include them as soon as they meet one of the criteria listed above.

Thanks again for the depth of your thinking on this....we are really benefitting from your posts.

Cliff


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No. of Recommendations: 3
"we should keep Supergen in mind for the other portfolio that will have different entrance criteria than this first one. Hope you'll keep us posted on their management situation."

My knowledge of Supergen stems only from my investment in NeoTherapeutics, where Rajesh and Luigi currently are.
(it is their work which is refered to in this UBS Warburg presentation slide: http://www.neotherapeutics.com/ubs/sld006.htm). Consequently, I do not actively follow the company closely enough. I would suggest that a current or former investor write a summary of Supergen's management situation before it is considered for a recommandation, though.

"BTW. I looked into Celsion at your suggestion. (For other BBers, Celsion has a heat-activated liposomal doxorubicin in the clinic)"

The thermosensitive liposomes are actually in a pre-clinical stage (along with a thermosensitive gene therapy platform) and reportedly exhibit *very* promising results (but then again, that has been said of many a future flop). The pivotal phase II trial is for a focused phase-array microwave thermotherapy. Is it being targeted at breast cancer due to the higher water content in relation to surrounding tissue of the cancer cells. Consequently, only they are ablated. The treatment has two goals: in breast cancer patients scheduled for masectomy, the goal is to reduce the size of the tumor by thermotherapy combined with chemotherapy so that a lumpectomy will suffice; in patients scheduled for a lumpectomy procedure, destroy as many cancer cells as possible before the operation, in order to increase operation efficacy and safety, and reduce the risk of reccurence.
http://www.celsion.com/List_of_breast_sites_phase2_celsion.htm (contains the trial protocol)

(though I can just imagine clinic technicians using it to heat individual olives in their microwave dinner in between operations)

I've looked at the criteria you've listed for Group A selection (thanks for delineating them!):

"a) A clearly started (recruitment begun) Ph III trial for which either Ph II results or early Ph III results showed greater than 50% Objective Response or greater than 50% increase in Survival Time, or
b) An announcement that Fast Track status had ALREADY been acknowledged by FDA, or
c) An announcement by the company that a BLA/NDA in the U.S had ALREADY been filed."

One obvious problem is the absence of a prospective time-to-market value. Rather, phase III trial status is used as a criterion, which leads to varying timelines which can range from about half a year (NDA filed, under review) to about four and a half years (enrollment in a three-year trial series has begun). These are huge differences from an investment point of view.

Valedictively,
Daniel Guy.
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