Pharmacyclics Inc. (PCYC)
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PCYC Forum Topics
- All Comments on PCYC
- General Discussion on PCYC
- Cancer Stocks on the Go: Winners and Losers [view article]
- Cancer Stocks Hammered Once Again [view article]
- A Triple Catalyst Biotech Play [view article]
- Cancer Stocks Slide Again [view article]
- Cancer Stocks Plunge Following ASCO Meeting [view article]
- Cancer Stocks Soar With Annual ASCO Meeting [view article]
- Biotech Day In Review: Roche Buys BioVeris For $600 Million [view article]
loading ...Recent PCYC Articles
- A Triple Catalyst Biotech Play
- Cancer Stocks: Tracking the Market
- Cancer Stocks Hammered Once Again
- Cancer Stocks Slide Again
- Cancer Stocks Plunge Following ASCO Meeting
- Cancer Stocks Soar With Annual ASCO Meeting
- Cancer Stocks on the Go: Winners and Losers
- Biotech Day In Review: Roche Buys BioVeris For $600 Million
- Biotech Day In Review: Genentech Loses Cabilly Patent Ruling
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Earnings Schedule & Estimates for Thursday, August 24, 2006
on Aug 24, 2006| by
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Cancer Stocks on the Go: Winners and Losers [view article]
I agree with paviov, However I would like to know about the new developments the phase II and III studies that are going well, where is the advancement taking place, how close to a cure, what company has the potential winning drug ?? ReplyEditors
General Discussion on PCYC
Is this a buy or a sell? ReplyCancer Stocks Hammered Once Again [view article]
Alan,What are your thoughts on Chemokine Therapeutics Corp (CHKT)?
And Meridian Co LTD (MRDAF)?
Reply
Cancer Stocks Hammered Once Again [view article]
please ignore the comment above. it was posted in the wrong thread.Reply
Cancer Stocks Hammered Once Again [view article]
Maybe BofA should by this one too.Which bank took the highly rated debt at a discount from TMA? Reply
Brochstein
Cancer Stocks Hammered Once Again [view article]
I don't know the company, but it sure looks interesting. Technically, it would be nice to hold 1.75. The company is seemingly deficient in cash - it would appear that there will be either an equity or debt offering this year. If they become profitable as forecast this year, the stock could get some attention - diagnostics have been hot. ReplyCancer Stocks Hammered Once Again [view article]
Hi Alan,What is your current opinion on Clarient (CLRT)?
Thanks very much,
Don Reply
A Triple Catalyst Biotech Play [view article]
wow! gino, was 95% of that necessary?? ReplyA Triple Catalyst Biotech Play [view article]
Also, look for Phase 3 results out for Biovest Internationals, BVTI , NHL personalized cancer vaccine results out in April 2008. Has been in clin ical trials for over 10 years. OTCBB BVTI.OB @ .45 Here is the news:Accentia Announces That Biovest Has Closed an $8.5M Financing to Support Unblinding and Data Analysis of Fast Tracked Pivotal Phase 3 Study of BiovaxID for Non-Hodgkin's Lymphoma with Public Release of Results Anticipated by April 2008
Tuesday December 11, 8:00 am ET
An Independent Clinical Study Previously Has Demonstrated 100% of Responding Patients Achieving and Sustaining Significant Disease Free Survival Benefit Measured in Terms of Years
TAMPA, Fla.--(BUSINESS WIRE)--Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI - News) announced today that its majority owned subsidiary, Biovest International, Inc. (OTCBB:BVTI - News) (“Biovest”), has secured an $8.5M debt financing from two institutional investors. The proceeds from the loan will be used in part to finance the analysis of unblinded data on BiovaxIDTM, an active immunotherapeutic in a pivotal Phase 3 study of Non-Hodgkin’s Lymphoma. Biovest has closed the trial to new enrollment and downsized its vaccine production staffing in Worcester, MA, as it unblinds the study for the independent Data Monitoring Committee’s (DMC) review and performs analysis of the trial data. The trial was initiated by the National Cancer Institute in 2000 then acquired by Biovest in 2005. Accordingly, some patients in the trial have now been followed for nearly 7 years.
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An independent clinical study at the University of Navarra in Spain, results of which were published in October 2006, has demonstrated that the administration of a BiovaxID formulation given to patients with relapsed follicular Non-Hodgkin’s Lymphoma following chemotherapy can induce complete long-lasting remissions. The median duration of the second complete response has not been reached after nearly 3 years of follow-up and, as a result, 100% of those immunologic responding patients are sustaining significant disease free survival benefit measured in terms of years.
In the Phase 2 BiovaxID clinical study conducted at the National Cancer Institute (NCI), 20 patients in continuous first complete remission (CR) after chemotherapy treatment were treated with a series of 5 monthly vaccinations of BiovaxID conjugated to KLH and administered with local GM-CSF. After vaccination, 95% of patients showed autologous tumor-specific cellular T-cell responses and 75% of patients showed humoral antibody responses. With a median follow-up of 9.2 years, 45% of patients remained in continuous first CR and the median Disease Free Survival (DFS) for the cohort was 96.5 months, 8.0 years (American Society of Hematology, December 2005, Abstract #2441). Furthermore, 73% of evaluable patients were converted into molecular remission (bcl-2 negative) after the administration of BiovaxID and, thus, cleared their blood of residual cancer cells (American Society of Clinical Oncology, June 2006). At 9.2 years of follow-up, 95% of the patients remained alive, comparing favorably to historical controls where an approximate 50% survival would be expected at that time.
Furthermore, a Phase 2 trial conducted by the NCI shows BiovaxID yielded an 89% survival rate in mantle cell lymphoma patients. The median follow-up was 3.8 years. Historically, patients with this type of lymphoma only have had a 50% chance of surviving 3 years and a 20% chance of surviving 5 years. The data were published in a recent edition of Nature Medicine (Nat Med.2005; 11(9):986-91).
Biovest believes that the unblinding of its pivotal Phase 3 study will provide strong evidence supporting the appropriateness of BiovaxID for accelerated approval in the US under subpart E and conditional approval in the EU. The company may use molecular data for the purposes of detecting early recurrence of the cancer prior to clinical evidence on physical exam and CT scans. The Company believes that this molecular data will provide additional evidence of efficacy for BiovaxID. The Company intends to prepare an application for accelerated and conditional approval in the US and EU, respectively, where it has orphan status.
The financing was provided to Biovest by two of Biovest’s existing secured lenders, Valens Offshore SPV II, Corp. (“Valens Offshore”) and Valens U.S. SPV I, LLC. (“Valens US” and collectively “Valens”) pursuant to a Note Purchase Agreement. Biovest issued secured Promissory Notes in the aggregate amount of $8,500,000 to Valens, which bear interest at Prime + 2% with a six-month term. Biovest paid closing fees and costs of approximately $300,000 and a portion of the loan proceeds was used to prepay interest and principal due to Biovest’s senior secured lender, Laurus Master Fund Ltd., with the balance of the proceeds to be used for operating capital and to complete the interim analysis of the BiovaxID clinical trial data. Biovest also granted a royalty in the aggregate amount of seven percent (7%) of worldwide net sales of the BiovaxID vaccine to Valens Offshore and Valens U.S. pursuant to a Royalty Agreement. The loan is secured by a security interest in all assets of Biovest and its subsidiaries.
Accentia and Biovest utilize a shared resource model for certain administrative, investor relations, accounting, and legal functions. James A. McNulty, CPA, serves as Secretary and Treasurer of Accentia and has been Biovest’s Chief Financial Officer since Accentia Biopharmaceuticals’ investment in June 2003, along with officer responsibilities in other related companies. Due to the requirement to devote more time to non-Biovest matters, Mr. McNulty will relinquish his Biovest CFO responsibilities effective December 31, 2007. Alan Pearce, CFO for Accentia, will assume the CFO role for Biovest at that time.
About Accentia Biopharmaceuticals, Inc.
Accentia Biopharmaceuticals, Inc. and its subsidiaries (collectively referred to as the "Company" or "Accentia") is a vertically integrated biopharmaceutical company focused on the development and commercialization of drug candidates that are in late-stage clinical development and typically are based on active pharmaceutical ingredients that have been previously approved by the FDA for other indications. Usually these drug candidates can access the accelerated 505(b)(2) regulatory approval pathway, which is generally less time-consuming and less expensive than the typical 505(b)(1) pathway that must be used for new chemical entities. The Company's lead product candidate is SinuNaseTM, a novel application and formulation of a known therapeutic to treat chronic rhinosinusitis. SinuNaseTM has been granted Fast Track status by the FDA and it is currently in a pivotal Phase 3 clinical trial. During this fiscal year, the Company also plans to file an Investigative New Drug (IND) for a pivotal Phase 3 clinical trial of Revimmune, to treat numerous autoimmune diseases with an initial indication targeting refractory relapsing-remitting Multiple Sclerosis. Revimmune is based on pulsed, ultra-high dosing of a well-known chemotherapeutic agent under a risk management program. Additionally, through an investment strategy, the Company has acquired the majority ownership interest in Biovest International, Inc. ("Biovest"), (BVTI.OB) and a royalty interest in Biovest's lead drug candidate, BiovaxIDTM and any other biologic products developed by Biovest. Biovest is currently conducting a pivotal Phase 3 clinical trial for BiovaxIDTM which is a patient-specific anti-cancer vaccine focusing on the treatment of follicular non-Hodgkin's lymphoma. BiovaxIDTM has been granted Fast Track status by the FDA. In addition to these product candidates, the Company has a specialty pharmaceutical business, which markets products focused on respiratory disease and an analytical consulting business that serves customers in the biopharmaceutical industry. For further information, visit the Company Web site at accentia.net.
About Biovest International, Inc.
Biovest International, Inc. is a pioneer in the development of advanced individualized immunotherapies for life-threatening cancers of the blood system. Biovest is a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc., (NASDAQ:ABPI - News) with its remaining shares publicly traded. Biovest has a foundation in the manufacture of biologics for research and clinical trials. In addition, Biovest develops, manufactures and markets patented cell culture systems, including the innovative AutovaxIDTM, which is being marketed as an automated vaccine manufacturing instrument and for production of cell-based materials and therapeutics. Biovest is currently conducting a pivotal Phase 3 clinical trial for BiovaxIDTM, which is a patient-specific anti-cancer vaccine focusing on the treatment of follicular non-Hodgkin's lymphoma. BiovaxIDTM has been granted Fast Track status by the FDA. For further information, visit the Company Web site at biovest.com.
Forward-Looking Statements
Statements in this release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, statements about RevimmuneTM, SinuNaseTM, BiovaxIDTM, AutovaxIDTM, SinuTestTM and any other statements relating to products, product candidates, product development programs, the FDA or clinical study process including the commencement, process, or completion of clinical trials or the regulatory process. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, expectations and intentions, and other statements identified by words such as "may," "could," "would," "should," "believes," "expects," "anticipates,&quo... "estimates," "intends," "plans," or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause the actual results of Accentia to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval for product candidates; competition from other pharmaceutical or biotechnology companies; and the additional risks discussed in filings with the Securities and Exchange Commission. All forward-looking statements are qualified in their entirety by this cautionary statement, and Accentia undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. The product names used in this statement are for identification purposes only. All trademarks and registered trademarks are the property of their respective owners.
Contact:
Accentia Biopharmaceuticals, Inc., Tampa
Susan Bonitz, PhD, 813-864-2554; Ext. 277
sbonitz@accentia.net
or
Biovest International, Inc., Worcester, Mass.
Steven Arikian, MD, Chairman and Chief Executive Officer
212-686-4100, ext. 8640
sarikian@biovest.com
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Source: Accentia Biopharmaceuticals, Inc.
Reply
Brochstein
Cancer Stocks Hammered Once Again [view article]
Thanks for the comment and the compliment. Thanks also for the information. Contact me by phone or email if you would like to discuss your ideas. ReplyCancer Stocks Hammered Once Again [view article]
Great post! It would be quite useful if your excel file could be downloaded, then someone could sort on other attributes, or even add some, e.g. #drugs in phase 3, total #drugs in pipeline, #big pharma collaborations, PADUFA dates, if any, etc. I'm offering a few comments vis-à-vis individual companies: I think EXEL, which probably has the deepest pipeline on your list, is gaining because investors believe Glaxo will take XL647. I believe it's, "show's over", for TELK (Telcyta is finito). Onyx is declining because it faces stiff competition from Pfizer's Sutent & now Wyeth's Torisol in renal cell carcinoma. Any sales increases for Onyx's Nexavar will come from off-label use in liver cancer, but that is not, in my opinion, a reason to invest. CEGE's recent decline is a gift - when European Revlimid sales appear on their balance sheet, along with clinical milestone press releases, it'll get back into the 60's. GNTA has been on a slippery slope for some time now - their CEO, Ray Warrell, is very smart, very committed, and held in high regard by his oncology peers at his alma mater, MSKCC. He is making use of FDA's dispute process for Genasense in CLL, so some investors are betting FDA will offer up a conditional approval in subsets of patients. The key here is that CLL is a very heterogeneous disease - therapy needs to be more individualized. Finally, in my opinion, ISRG is absolutely the future of surgery. Any decline into the low 130's is a bargain. Thanks again for your article! ReplyBrochstein
Cancer Stocks Slide Again [view article]
I wanted to point out an error in the article - GNVC is developing a pancreatic cancer treatment (not vaccine). ReplyBrochstein
Cancer Stocks Plunge Following ASCO Meeting [view article]
Miles, I have a negative bias towards small biotech companies, especially ones like this that have a terrible history of underperforming the stock market, generating losses and diluting with equity issuance. That isn't to say that one might find a diamond in the garbage can, but, I think that one is actually more likely to find a diamond in the garbage can. If one of these companies is creating a truly novel, revolutionary treatment, I personally believe that an investor would have plenty of time to buy later at a higher price and still make a ton of money.Note, I don't have an opinion specifically on Insmed other than my general observations in the above paragraph. Reply
s
Cancer Stocks Plunge Following ASCO Meeting [view article]
Dear Sir,What is your current opinion on Insmed?
Thank you very much,
Miles Roberts Reply
Cancer Stocks Soar With Annual ASCO Meeting [view article]
Your table is too over-crowded to be useful. Next time skip the industry, HQ city and state as it is meaningless except for job seekers. Nice try though. Reply