Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Relevant to HEPH
Interesting but skewed (obviously, given the source):
http://www.thenation.com/doc/20051128/scahill
Vaxgen mentioned:
'Even within the "war on terror" community, Bioshield has proved controversial. That's because more than 80 percent of the nearly $1 billion allocated under the program has gone to a scandal-plagued company that has never successfully produced an FDA-licensed vaccine. In November 2004 California-based VaxGen was handed one of the largest government vaccine contracts in history. The company is largely known for its failed AIDS vaccine, and just a few months before VaxGen won the Bioshield contract, the Nasdaq took the unusual step of delisting it from trading because of financial irregularities. So why did it get the contract? "I have no idea why VaxGen was selected," admits Henderson, who remains chair of the influential Secretary's Advisory Council at HHS. "It's not for me to decide whether it's a good idea or not."
Saltz with YMI
As io_io said, it was announced at the annual meeting. His input will certainly lend an air of legitimacy to nimotuzumab results. Just the fact that they got him to sign on says something positive about their clinical program.
Through Dr Saltz, YMI now has a solid link to a number of big pharmas: he has acted as a consultant for Genentech, Sanofi, Pfizer, and Taiho and has performed contract work for ImClone, Bristol-Myers Squibb, Pfizer, Roche, and Taiho, all within the past two years. Of these, I think that Genentech, Sanofi, and/or Pfizer may develop a keen interest in nimotuzumab in the near future.
Anyway, I am very pleased by this development. Saltz was the lead author on many cetuximab papers, including the BOND-2 study. I have pasted below a list of related/semi-related references from my EndNote library. He writes frequently on the connection between rash and response.
************************************************************
Chung KY, Shia J, Kemeny NE, Shah M, Schwartz GK, Tse A, Hamilton A, Pan D, Schrag D, Schwartz L, Klimstra DS, Fridman D, Kelsen DP, Saltz LB. Cetuximab shows activity in colorectal cancer patients with tumors that do not express the epidermal growth factor receptor by immunohistochemistry. J Clin Oncol. 2005;23(9):1803-1810.
Conti JA, Kemeny NE, Saltz LB, Huang Y, Tong WP, Chou TC, Sun M, Pulliam S, Gonzalez C. Irinotecan is an active agent in untreated patients with metastatic colorectal cancer. J Clin Oncol. 1996;14(3):709-715.
Hwang JJ, Eisenberg SG, Marshall JL. Improving the toxicity of irinotecan/5-FU/leucovorin: a 21-day schedule. Oncology (Huntingt). 2003;17(9 Suppl 8):37-43.
Perez-Soler R, Delord JP, Halpern A, Kelly K, Krueger J, Sureda BM, von Pawel J, Temel J, Siena S, Soulieres D, Saltz L, Leyden J. HER1/EGFR inhibitor-associated rash: future directions for management and investigation outcomes from the HER1/EGFR inhibitor rash management forum. Oncologist. 2005;10(5):345-356.
Saltz LB. Cetuximab (IMC-C225) plus irinotecan (CPT-11) is active in CPT-11-refractory colorectal cancer that expresses epidermal growth factor receptor (EGFR) [abstract no. 7]. Proc Am Soc Clin Oncol. 2001;203a.
Saltz LB, Cox JV, Blanke C, Rosen LS, Fehrenbacher L, Moore MJ, Maroun JA, Ackland SP, Locker PK, Pirotta N, Elfring GL, Miller LL. Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. Irinotecan Study Group. N Engl J Med. 2000;343(13):905-914.
Saltz LB, Douillard JY, Pirotta N, Alakl M, Gruia G, Awad L, Elfring GL, Locker PK, Miller LL. Irinotecan plus fluorouracil/leucovorin for metastatic colorectal cancer: a new survival standard. Oncologist. 2001;6(1):81-91.
Saltz LB, Lenz H, Hochster H, Wadler S, Hoff P, Kemeny N, Hollywood E, Gonen M, Wetherbee S, Chen H. Randomized phase II trial of cetuximab/bevacizumab/irinotecan (CBI) versus cetuximab/bevacizumab (CB) in irinotecan-refractory colorectal cancer. Proc Am Soc Clin Oncol. 20053508.
Saltz LB, Meropol NJ, Loehrer PJ, Sr., Needle MN, Kopit J, Mayer RJ. Phase II trial of cetuximab in patients with refractory colorectal cancer that expresses the epidermal growth factor receptor. J Clin Oncol. 2004;22(7):1201-1208.
Leonard Saltz has become an advisor to YMI.
Good news.
What happened here?
I'm impressed. I just got back from ACR and it seems this board has had a dramatic jump in activity. More interest in biotechs?
Dew--I did a "fly-by" at ACR and did not make it to the poster session.
Looks like I have some reading to do...by the way, I agree that CR+ PR is considered the response rate, CR+PR+SD is the "disease stabilization" rate. Either I'm right or I'll have to take back my posters that were presented at ECCO!
J
Telintra Phase II results
I have to admit, Telintra is not the reason I own TELK. Can anyone with greater insight into MDS tell me if this is good?
Just by the way, response rate with decitabine is ~50%. But I do not know if they used the same definition of response. Also, no idea if hematologic improvement=response.
It does not appear TELK has issued a press release for this one.
J
Hematologic Improvement (HI) by TLK199 (Telintra™), a Novel Glutathione Analog, in Myelodysplastic Syndrome: Phase 2 Study Results. Session Type: Poster Session 724-II
Introduction: Glutathione S-transferase (GST) P1-1 has shown to be an important negative regulator of cellular growth and differentiation. The effect is mediated through binding to Jun kinase (JNK) which causes a decrease in kinase activity. TLK199, a novel analog of glutathione, binds selectively to GSTP1-1 resulting in its dissociation from JNK and subsequent kinase activation. Exposure of hematopoietic progenitor cells to TLK199 led to activation of JNK followed by cellular growth and maturation. TLK199 has shown significant myelostimulant activity in vitro in human bone marrow cell cultures as well as in several in vivo preclinical models of myelopoeisis. In Phase 1, TLK199 treatment resulted in hematologic improvement (HI) in MDS patients at all dose levels. Methods: The objectives of this multicenter Phase 2 study in MDS were to determine the safety (by NCI-CTC) and efficacy (by modified IWG MDS response criteria) of two dose schedules of TLK199 HCl Liposomes for Injection administered at 600 mg/m2 over 60 minutes by constant rate IV infusion daily x 3 or daily x 5 every 3 weeks. Patients (pts) were treated until lack of response or unacceptable toxicity. Results: 52 MDS pts (33 M/19 F),(29 RA, 9 RARS, 8 RAEB, 3 RAEB-t, 1 CMML, 2 UK), median age 69 years (range 22-90), received 244+ cycles (1099+ treatments), median 4 (range 1-13+). Thirty-seven pts (71%) were red cell transfusion dependent and 10 pts (19%) were platelet transfusion dependent prior to entry. Pts had failed a median of 1 prior therapy (range 0-6) including: erythropoietin (27/52%), G-CSF (9/17%), thalidomide (10/19%), azacitidine (7/14%), steroids (6/12%), hormones (2/4%), and other therapies (14/27%). Thirty-nine pts were evaluable for efficacy, 32 pts (82%) experienced HI in one or more blood cell lineages, 14 of 16 pts (88%) with trilineage dysfunction, 8 of 13 pts (62%) with bilineage dysfunction, and all 10 pts (100%) with unilineage dysfunction experienced HI. Lineage response was HI-P (14 of 22/64%), HI-N (9 of 27/33%), and HI-E (22 of 35/63%). Responses were accompanied by clinical symptom improvement, decreases in RBC and platelet transfusion requirements including transfusion independence and improvements in bone marrow maturation, differentiation, M/E ratios, and dysplastic morphology. Most common adverse events were mild to moderate acute infusion related reactions commonly seen with liposomal formulations: back pain (9/17%), nausea (8/15%), chills (8/15%), and bone pain (6/12%). Conclusions: TLK199 is well tolerated and an active agent in all FAB types of MDS. These data support the further clinical development of TLK199 in MDS as well as in other hematologic malignancies characterized by cytopenias.
Abstract #2520 appears in Blood, Volume 106, issue 11, November 16, 2005
The alternative hypothesis is, of course, that Neulasta is FDA-approved. But I believe the price differential, need for refrigeration, sheer impracticality of treatment in this setting, and ability to treat only the less important of the two major symptoms of ARS argues for my primary theory.
Don't ask me to diagram that last sentence.
I wouldn't call it a conclusion, just a suspicion:
1) Apparently the draft SOW that appeared initially on the HHS website mentioned thrombocytopenia and neutropenia. Several hours later, it was updated with just a mention of neutropenia. Please note that I did not see the original SOW because it disappeared, this is just what I heard.
2) What treats neutropenia? Neulasta.
3) The number of doses was 100,000, instead of the widely expected 10-20 million or more. Sounds to me like the cost of Neulasta drove the number of doses proposed.
Political pressure?
The way the RFP was originally written, HE2100 was the only drug available that addressed the request. The use of Neulasta following a nuclear incident is ridiculous. Patients would need to be hospitalized and monitored during treatment and they would require platelet transfusions to treat thrombocytopenia.
I have a great report on the whole story. I would post it here, but I think it is proprietary. Would be happy to send it to anyone interested.
I heard about it after 9/11--I lived two blocks from the WTC site at the time and the company was a hot topic in the NY/NJ biotech community. I followed up on it recently after the big crash caused by the SOW that neglected to mention thrombocytopenia.
With recent events and the political pressure that is coming to bear on HHS, I think there is a reasonable probability that the revised SOW will ask for 10-25 million doses and include both neutropenia and thrombocytopenia.
I am favorably impressed with Hollis-Eden's execution. They have jumped through all the hoops. The data from ASTRO seem incontrovertably good--you'll see that in the big study at 400cGy (N=140) once-daily HE2100 reduced the number of days with severe neutropenia from 12 to 3 and the number of days with severe thrombocytopenia from 8 to 0. Plus the safety and tolerability were impressive in human studies. Of course, I am aware that I am saying this without the support of a peer-reviewed publication in a major journal.
Longer-term, if the animal data can be extrapolated to humans, the market opportunity is tremendous. You'll also note that in a pilot study HE2100 appeared to provide protection in a model of chemo-induced neutropenia and thrombocytopenia. Unlike most animal studies, these preclinicals were conducted in monkeys, so the probability of congruence with human results may be greater than that seen with non-primate studies.
I am also very impressed with their communications strategy. Unlike most biotechs, they err on the side of too much information. Which I appreciate.
The key here is to get that contract. If they get it, they'll have all the money they need to develop all of their products.
Video: Australia's Nuclear Attack Fear
I can't post the direct link, but the video is on this page:
http://news.yahoo.com/fc/us/terrorism
http://news.yahoo.com/s/ap/20051114/ap_on_re_au_an/australia_terror_arrests;_ylt=Ar14wEsAWxdM.dnx4CA...
Why am I posting this? While frightening, it bodes well for HEPH.
A month ago, I wrote a 20-page piece on the Medicare drug benefit that has been distributed to seniors across the nation. I have never written anything so difficult in my life, in part because it had to be written in sixth-grade English, but also because the plan is so complex.
I see few mentions of the "hole" between in the press. Many seniors will fall into the gap. The bar for extra financial help for people with limited income/assets to cover the gap is ridiculous--income needs to be <$14,355/year. Can a retired person making $20,000/year afford the $32 monthly premium, $250 deductible, $500 for the first $2000 in drugs, plus $2850 for the gap?
I am so tempted to make political comments here, but I won't. Suffice it to say that I am a very unhappy libertarian.
Hollis-Eden Pharmaceuticals (HEPH) Read Me First
http://www.holliseden.com/
Near-term drivers
1) Publication of final HHS Statement of Work (my guess: between December 15, 2005 and March 31, 2005)
2) Potential Department of Defense contract (currently under review)
3) Partners for Neumune for indications beyond acute radiation sickness (according to CEO, they are in daily discussions regarding partners. Take that for what it’s worth)
Pipeline
Neumune (HE2100): Adrenal steroid hormone, active metabolite of DHEA
“NEUMUNE is being co-developed with the U.S. Department of Defense for use in protecting the body's bone marrow from acute radiation syndrome. The compound is being developed pursuant to a new rule enacted by the U.S. Food and Drug Administration (FDA) under which approval may be granted on the basis of demonstrating efficacy in animals and safety in humans [The FDA “Animal Rule”]. NEUMUNE is a candidate for procurement by the U.S. government under Project BioShield for addition to the Strategic National Stockpile.”
http://www.holliseden.com/content/?page_id=79
Recent Neumune publications
In a primate model of chemotherapy-or radiation-induced myelosuppression, HE2100 reduced days of severe neutropenia (<500 cells/microliter) from 7 days to 2 days in irradiated monkeys and from 5.3 days to 0.7 days in carboplatin-treated monkeys. http://www.asco.org/ac/1,1003,_12-002636-00_18-0026-00_19-004241,00.asp
ASTRO 2004 Report: In 30 monkeys, 90% of HE2100-treated animals survived vs 55% of those who received placebo. Results of pilot study approached statistical significance (P=0.07) despite the fact that original calculations suggested 100-200 animals would be required to achieve significance. Statistically significant improvements in thrombocytopenia and febrile neutropenia
http://www.acr.org/s_acr/sec_healthnews.asp?CID=3155&DID=19060
ASTRO 2005 Report: I can’t get my hands on these abstracts, but according to the company, “data from human phase I indicate that Neumune is safe and well tolerated and that a 5-day course of Neumune produces a statistically significant increase in neutrophils and platelets in healthy human volunteers.” In animal studies with a large number of animals, Neumune provided statistical significant reductions in days of neutropenia and thrombocytopenia as well as improved survival
http://phx.corporate-ir.net/phoenix.zhtml?c=113795&p=irol-newsArticle&ID=768893&highligh....
Radiation overview: prepared by Hollis-Eden, but a good place to start:
http://www.holliseden.com/resources/RadiationOverview_8-15.pdf
The Neumune Saga
DHHS requests information on therapeutics to treat thrombocytopenia and neutropenia for Strategic National Stockpile: http://phx.corporate-ir.net/phoenix.zhtml?c=113795&p=irol-newsArticle&ID=634510&highligh....
The original request for information (October 2004). Note that it asks for information on therapeutics to treat neutropenia and thrombocytopenia: http://www1.eps.gov/spg/HHS/OOS/OASPHEP/Reference%2DNumber%2DRFI%2DORDC%2D05%2D01/SynopsisR.html
Hollis-Eden’s response, filed Dec 21, 2004:
http://phx.corporate-ir.net/phoenix.zhtml?c=113795&p=irol-newsArticle&ID=656564&highligh....
IND filed For HE2100 May 2005:
http://phx.corporate-ir.net/phoenix.zhtml?c=113795&p=irol-newsArticle&ID=714909&highligh....
IND accepted July 5, 2005; Hollis-Eden initiates phase I studies:
http://phx.corporate-ir.net/phoenix.zhtml?c=113795&p=irol-newsArticle&ID=726138&highligh....
Statement of Work (SOW) issued, suddenly the focus is changed from therapeutics that treat neutropenia and thrombocytopenia to neutropenia alone. In addition, instead of the expected 12 to 20 million doses, the SOW requests 100,000 doses. HEPH stock takes a huge dive. Draw your own conclusions as to why the sudden change in direction:
http://phx.corporate-ir.net/phoenix.zhtml?c=113795&p=irol-newsArticle&ID=763129&highligh....
November 1, 2005: Hollis-Eden submits an impressive response to SOW:
http://media.corporate-ir.net/media_files/irol/11/113795/DraftRFPresponserelease.pdf
Early November 2005: Leading members of Congress, including Henry Waxman, send a letter to HHS Secretary Michael Leavitt expressing “grave concerns” about agency’s handling of radiation therapies. “Congressmen ask for an explanation on why, four years after 9-11, HHS has yet to begin an ARS procurement that addresses the full effects of ARS, and question plans to procure only 100,000 doses of an ARS therapy.”
http://www.holliseden.com/content/index.asp?page_id=315
Bioshield Articles of Interest
Hollis-Eden criticizes BioShield:
http://www.washingtonpost.com/wp-dyn/content/article/2005/09/27/AR2005092701717.html
October 4, 2005: New worries on BioShield Effort (Hollis Eden mentioned):
http://www.washingtonpost.com/wp-dyn/content/article/2005/10/03/AR2005100301522.html?nav=rss_busines....
October 19, 2005: Senate panel backs bill to create biodefense agency:
http://www.govexec.com/dailyfed/1005/101905gsn1.htm
Note: I will complete these at a later date
Phosphonol
“PHOSPHONOL, a non-IRH compound, has the potential to protect against DNA mutations (mutagenesis) that can occur as a result of radiation injury or chemotherapy. Mutagenesis has been associated with an increased risk of a variety of different cancers and is believed to be one of the primary causes of the harmful long-term effects of radiation injury. Currently there are no medical treatments suitable for stockpiling that prevent DNA mutations due to radiation exposure. With PHOSPHONOL and NEUMUNE, Hollis-Eden could offer products to treat both the short and long-term effects of radiation injury.”
http://www.holliseden.com/content/?page_id=308
Immunitin
“IMMUNITIN has shown activity in Phase II clinical trials in malaria, HIV and late-stage AIDS and preclinical benefit in a number of tuberculosis models. In addition, it has attributes that make it potentially useful on a global basis. Given the compound's anti-inflammatory and immune stimulating activities in clinical and preclinical studies, the Company is pursuing public/private partnerships with organizations that may provide funding to allow it to conduct a Phase II/III clinical trial with IMMUNITIN in infectious disease.”
http://www.holliseden.com/content/?page_id=90
Links of interest:
http://www.immune-therapy.de/Kurzvortrag/Reading.htm
http://www.holliseden.com/content/?page_id=91
http://www.mult-sclerosis.org/news/Nov2001/HollisEdenPharmaceuticalsAntiInflammatoryImmuneRegulating....
http://www.aidsmeds.com/news/v08110003.html
http://www.thebody.org/sfac/he2000.html
http://www.aegis.com/news/pr/2000/PR000726.html
Hi Dew,
Will do--I am preparing for ACR so probably next weekend.
John
Holiday Giving
Hi all,
If you are interested in giving to charity this holiday season, please consider the Multiple Myeloma Research Foundation. I consult for them regularly, know the founder, and can attest to the care with which they handle their money. Most recently, I was involved in a roundtable to develop priorities for the translational research initiative, and will likely be involved in an upcoming meeting at ASH.
The investment angle? As you know, many oncology drugs are tested first in patients with multiple myeloma. The MMRF is active in promoting industry/academia collaboration and in funding new trials.
http://www.multiplemyeloma.org/
Just a word on restenosis--systemic approaches to the prevention of restenosis have a long, long history of failure and marginal results. Not to mention that systemic therpy for restenosis is like taking a sledgehammer to a teacup.
Calculating return
I am really hesitant to ask this question in this forum, but if anyone could help, I'd appreciate it. I did search on the internet for a good answer before asking.
This is the first full year that I have added cash to my account and I am unsure how to calculate the rate of return. Before that, I was working with a lump sum I had invested at the beginning of grad school.
So the percentage gain on my average balance is ridiculous because I the amount of cash I added to the account over the year is 5 times the amount of the beginning balance. However, calculating based on my final balance isn't fair becuase it includes cash that hasn't even been put to work yet. How do you calculate return for a fair comparison?
As you can see, accounting skills are not an essential part of the skill set for a molecular biologist. Or maybe my brain is frozen from spending the day in the coldroom.
PGS,
Actually, adding any sort of management change--not just upper management--might be useful. I've found that middle management tends to leave en masse when a takeover is imminent.
It would be great if we could share a real spreadsheet with all of these data. I don't think IHub has the capability.
J
I haven't thought this through thoroughly, but what about HE2000 from HEPH?
http://www.holliseden.com/content/?page_id=91
http://www.mult-sclerosis.org/news/Nov2001/HollisEdenPharmaceuticalsAntiInflammatoryImmuneRegulating...
http://www.aidsmeds.com/news/v08110003.html
http://www.thebody.org/sfac/he2000.html
http://www.aegis.com/news/pr/2000/PR000726.html
Any idea of what is driving TELK today? I normally don't concern myself with a few percent up or down, but the recovery is remarkable.
I did end up exchanging my shares for Jan '07 $15 calls yesterday. Could it be that just this once I bought at the bottom?
Wow, this article is misleading. Keep in mind that it is sponsored by Reliant.
1. I agree that triglyceride lowering is important; however, the majority of patients with elevated LDL-C already have triglycerides that are at a reasonable level. A 30% reduction in triglyceride levels with a statin is sufficient for most patients to bring them into a normal range, if they weren't there already. The exception to this would be patients with hypertriglyceridemia and some patients with diabetes, who frequently have a unique dyslipidemia consisting of elevated triglycerides, reduced HDL-C, and shifts toward a highly atherogenic small, dense LDL-C, all superimposed over the normal LDL-C range.
2. Regarding HDL, I'm surprised that Dr Packard is surprised. We already know that high levels of HDL substantially reduce cardiovascular risk, I find it unsurprising that statins failed to have a large impact in groups with high HDL.
The flip side to the argument--which the news article ignored--is that benefit was not linked to baseline LDL levels. So while the small percentage of patients with HDL >45 mg/dL might not need treatment, everyone else does, regardless of pretreatment cholesterol levels. This is consistent with NCEP ATP III guidelines suggesting that many patients will benefit from LDL-C <70 mg/dL.
In PROSPER, an inclusion criteria was TG <200 mg/dL. Pretty standard for statin trials.
I don't think any of this has an impact on FM-VP4. However, I am not endorsing FM-VP4 just yet--I think it is too early to tell.
I have done a lot of work on statins and antihypertensive agents--in fact, I started my career working on Lipitor and Norvasc. Just not sure what your question is.
Anyone have an opinion on TELK '07 calls vs buying the stock?
I am considering exchanging my holdings in TELK for calls. My rationale is that if we get negative results the underlying security stands to loose a lot more than $4.20 (the current price of Jan '07 $15 calls)
John
Biowatch,
As you are probably aware, an intravenous formulation of the bisphosphonate ibandronate is under review by the FDA. I believe it will be administered once yearly. Zolendronic acid, another bisphosphonate, is already approved as a twice-yearly injection for patients with multiple myeloma and certain other disorders. Busy postmenopausal women (those that don't have time for the complicated dosing regimen associated with oral bisphosphonates) are already receiving off-label intermittent IV zolendronic acid.
So denosumab will be entering a crowded intermittent IV dosing marketplace, not to mention that ibandronate is available as a once monthly oral dose.
I see no real advantages here, plus it doesn't have the long term safety and efficacy data that the bisphosphonates have. I bet it's going to be hideously expensive, and probably not reimbursable for a few years.
I'm writing this off the top of my head--without checking facts--so dosing frequency and indications may be a little off.
John
The Department of Health and Human Services posted a purchasing-related document on its web site a month or two ago that suggests that only 100,000 doses of a radioprotectant will be purchased. Originally, it was expected that tens of millions of doses would be purchased. It has been speculated that the number of doses that might be purchased has been reduced to accommodate lobbying efforts by Amgen.
Recently, it was reported that several senators wrote to the HHS requesting information as to why the number of doses was so low and why thrombocytopenia was not mentioned in the RFP.
Two potential therapeutic options exist for adults exposed to high levels of radiation: the first, filgrastim (Neupogen), is a cytokine approved for use in cancer patients with bone marrow damage due to chemotherapy or radiotherapy. Neupogen suffers from serious limitations, including the inability to self-administer, extremely high cost, need for extended treatment, need for physician supervision/hospitalization, and need for refrigeration. Moreover, Neupogen only treats neutropenia not thrombocytopenia. Both conditions must be treated to protect against acute radiation sickness.
The second potential option for acute treatment of radiation sickness is Hollis-Eden's Neumune. Neumune protects against both neutropenia and thrombocytopenia, is inexpensive, and can be self-administered.
I am willing to bet that HHS comes around, particularly given the political pressure. Responses to the draft RFP are due by Nov 28; I would expect a final RFP in late December or early January. There is also the potential that the DoD will place an order before that, plus it seems that there are partnering discussions underway.
HEPH Highlights
From Q3 Conference Call and R&R Presentation. I need to listen one more time to ensure accuracy, but this is what I heard:
1) Discussing partners for Neumune "on a daily basis." These partnerships would be to extend the indications for Neumune into oncology patients and other populations, such as those with thrombocytopenia
2) For additional indications, their safety database is adequate, they'd probably launch right into phase II
3) Waiting to hear from FDA on appropriate end points for primate radiation studies (neutropenia, thrombocytopenia, or survival). The company is "confident" that they can address any end point selected
4) On the Q3 webcast, the company presented a strong argument for 20-25 million Neumune doses
5) Several well-respected senators, including Waxman and three or four others I couldn't remember, have sent a letter to the HHS demanding to know why the number of doses requested in the draft RFP was so low. The letter also questioned why thrombocytopenia was not included in the draft RFP
Dew, I am considering generating a Read Me Now for HEPH--any interest?
YMI at Rodman and Renshaw
I am not going, but you can view the presentation here:
http://wsw.com/webcast/rrshq7/ym/
The whole list of presenting companies is here:
http://www.rodmanandrenshaw.com/rodman.asp?link=Conferences7/ConferenceWebcasters&bgcolor=wht
The schedule is here:
http://www.rodmanandrenshaw.com/rodman.asp?link=Conferences7/ConferenceSchedule&bgcolor=wht
I believe YMI is presenting at 3:10, at the same time as Novelos, ViroPharma, and Tapestry Pharmaceuticals.
HEPH--Any opinions
Now, I know I said I try to avoid political risk, but after listening to their last conference call twice, I think HEPH has reasonable risk/reward.
Learned a valuable lesson on NABI (and I'm glad I'm diversified) and bought a small number of June '06 $5.00 calls rather than buying the underlying security.
YMI Valuation--Still Don't Get It
Why is it that Abgenix is worth $1.2 billion (and ~800 million before the panitumumab results) and YMI is worth $110 million? Given the relative strengths of their pipelines, shouldn't YMI be worth several multiples of its present value?
I keep reading and rereading the data and corporate presentation; it's good stuff. I am baffled as to why YMI remains a $100 million company.
GPCB
Doing my DD on GPCB. Just one question: is my computer broken, or did it really not trade at all today? Why? If anyone holds GPCB, does this bother you at all?
John
Just to be clear...the YMI presentation is public, and available from IR if you ask.
John
One last thing...
I frequently see 10% or greater swings in individual stocks. But I try very hard to buy when everyone else is throwing in the towel because of overall market or sector conditions. A 10% drop in a stock that I've already made money in doesn't bother me, as long as it is due to sector or market conditions and not because of a fundamental reason.
We'll see what happens. At some point, perhaps program survival bias will catch up with me.
John
Words to live by?
http://www.thestreet.com/comment/barryritholtz/10250118_4.html
“If you're going to manage your own investments, it is crucial to ensure that no one disaster results in utterly catastrophic losses. The goal is to protect yourself -- not only from outright frauds such as Enron, WorldCom, and Global Crossing -- but from the legitimate firms whose shares got shellacked.”
“In my opinion, managing risk and limiting losses are the most consequential -- and underappreciated -- aspect of investing. Loss limitation has a much greater impact on portfolio performance than either stock selection or market timing. How you manage the risk in your holdings will have a more profound bearing on financial success than your stock selection.”
Stopped out
You inspired me to go to E-Trade's handy new Gains & Losses feature to revisit everything I've been stopped out at -10% over the past two years.
HEPH
INCY
MYOG (repurchased later at a substantially higher cost)
ISRG (forgot about this one--definite regret)
NKTR
PTIE
RNVS
STGN
With the exception of ISRG and MYOG, I view all of these retrospectively as really bad decisions on my part--either because of timing or because it just plain wasn't a good decision. No criticism intended if any of the above are part of anyone's portfolio.
There are, of course, others that I've sold for <10% losses or small gains because I felt they were dead money. Many of which I also regret.
Regarding cutting my losses--there has only been one time that I have regretted it. I dropped MYOG and ended up repurchasing later. I prefer to preserve my capital.
For myself, proper DD on ten to twelve biotech stocks is not an issue becuase it is a natural extension of my job--as is reading this board. There have been multiple times that I have learned something here that I've passed on to clients or used for my work. After checking it out for myself, of course.
I can understand that keeping track would pose a problem if the industry is not one's primary focus.
In reply,
I found IHUB via a post by Randy on the YMI Yahoo board.
I currently own: CONR, NBIX, DSCO, YMI, AGIX, SNUS, CRME, NABI, TELK
Looking at:
GTCB
PANC (very interesting becuase their drug represents the first viable, entirely new, class of HIV meds plus it isn't metabolized by the CYP450 system). I do not think integrase inhibitors have a high chance for success. Will wait a year or more to buy this one, though.
INSM
CVTX
And always looking for other new opportunities....
I would welcome being challenged on any of my picks.
One of these days I'm going to have time to post my investment strategy, but briefly (and in no particular order):
*With few exceptions, I buy after phase III has been initiated
*I have a fondness for companies with approvable letters
*I keep my risk spread out among 10-12 biotech stocks
*Incremental advances (SNUS) are less risky than paradigm shifts (NABI)
*Avoid political risk. The results of clincal trials are far easier to predict than politicians. I'm talking specificially about anything to do with stem cells or gene therapy.
*I'd rather have a bunch of 2-baggers than one 10-bagger, which is part of the reason I wait for later phases
*Always cut your losses at 10%
*BUT if you have a big disaster (eg, denial of approval), wait for the dead cat bounce
*Only buy what you understand. I'm in the biotech/pharma business and the market has been kind since I shifted to an all-biotech strategy two years ago. Before that, I can't tell you how many times I got burned on chicken farms, semiconductors, shipping, brokers....
*Therapies should be practical--I've always been a skeptic about cancer vaccines for this reason.
*Continuous reevaluation of risk:benefit both for a particular company and in the context of other opportunities
*Buy what physicians are excited about
*Analyze news flow, avoid dead money
*A good story doesn't necessarily make a good investment
I have a lot more to say on the topic, including specific examples and some discussion of handicapping...but maybe some other time.
John
Agree completely!
Dew,
I'm not going to get into this argument--in fact, I haven't even evaluated the claims because I wouldn't touch NVGN with a ten-foot pole--but you would be suprised at the sheer lack of qualifications among those that write press releases, particularly at the smaller biotech companies.
There are numerous examples of inaccurate, incomplete, and potentially misleading press releases that can be attributed to incompetence on behalf of the writer. Remember the Supergen debacle a couple years ago? The stock dropped 30% or so in one day because the press release neglected to specify whether the results were signficant or not. I didn't follow the ultimate outcome.
John
Reopro
This result is interesting but unsuprising, given the long half-life of ReoPro (~11 hours, I believe, but I'm too lazy to look it up right now) and its relative propensity to cause severe thrombocytopenia. Just as a guess, I think Integrilin may confer benefit in stroke patients because it has a substantially lower rate of thrombocytopenia; moreover, it has a relatively short half life so if issues do develop platelet activity can be rapidly restored upon discontinuation.
John
Randy, io_io, Urche et al
Just managed to get a complete package of information together on TheraCim--I'm writing a CME article on anti-EGFR therapies so I had an excuse. I have sent these articles/posters/presentations to you.
If anyone else would like them, please let me know.
John
Merrimack
It looks like they have one poster. I'll see if I they have copies to distribute. The abstract is below.
Title:
A Randomized Double-Blind, Placebo-Controlled Trial of MM-093, a Recombinant Version of Human Alpha-Fetoprotein, in Patients with Active Rheumatoid Arthritis (RA)
Category:
18. RA treatment — biologics and gene therapy
Author(s):
Louise C. Pollard1, Jim Murray2, Ernest H. Choy1. 1Sir Alfred Baring Garrod Clinical Trials Unit, Academic Department of Rheumatology, King's College London, London, United Kingdom; 2Merrimack Pharmaceuticals Inc., Cambridge, MA
Presentation Number:
267
Poster Board Number:
267
Background: Clinical observations indicate that RA remits during pregnancy. Remission tends to occur in the third trimester, which coincides with an increase in maternal and fetal levels of alpha fetoprotein (AFP). In vitro and animal studies have shown that AFP has immunomodulatory properties. MM-093 is a non-glycosylated version of human AFP produced by recombinant DNA technology in a transgenic goat system.
Objective: This was a 12 week, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of MM-093 in patients with active RA.
Methods: Twelve patients with active RA, who were taking stable doses of at least 10mg of MTX, received weekly subcutaneous injections of placebo or 21mg of MM-093. Eight patients were randomized to receive MM-093 and 4 patients to receive placebo. Disease activity assessments were carried out at baseline and weekly for 12 weeks based on WHO/ILAR and EULAR core data sets. Patients were allowed stable doses of prednisolone (£ 10mg). Patients receiving immunosuppressants or biologics were excluded.
Results: Baseline demographics were similar in both groups except that in the active group the male to female ratio was 1:1 and in the placebo group all patients were female. Patients had active RA with mean values for DAS28 of 6.5, TJC of 16.8 and SJC of 12.7 (28 joint counts). Eleven of the 12 patients completed the study; the only dropout was in the placebo group. This was due to a flare of disease requiring medication not permitted in the study protocol. Treatment with MM-093 was well tolerated. No serious adverse events were observed. The majority of adverse events were mild and there was no statistical difference between the groups. There were 2 mild local injection site reactions in the MM-093 group. There were no apparent trends in any of the other safety parameters and none of the patients made antibodies to MM-093. Patients treated with MM-093 had statistically significant improvements in DAS28 scores and numeric improvements in components of the core data compared to placebo (table 1). After 12 weeks of treatment, 2 patients treated with MM-093 achieved an ACR20 response as compared with none on placebo.
Table 1 Improvement from Baseline (wk 12) P value
MM-093 Placebo
DAS28 0.913 0.008 0.033
TJC 32.44% 18.66% 0.191
SJC 37.40% -2.5% 0.076
Conclusion: This is the first randomized, controlled trial of MM-093 in RA. Although the sample size was small, the results showed that MM-093 was well tolerated with evidence of efficacy. A multi-center Phase 2 dose-ranging study is currently underway to examine the potential of MM-093 as a treatment for RA.
Study sponsored by Merrimack Pharmaceuticals, Inc.
Going to ACR
Hi all,
I am going to be attending the American College of Rheumatology meeting in a few weeks. I will be going to many of the symposia, the poster session, and some of the CME activities.
If you have any specific requests for first-hand data, let me know. I'd be happy to report from the meeting.
John