BVTI Biovest International Inc. featured news, full reports, and detailed charts
Biovest International Inc. (BVTI/BVTI.PK) Wrap Up:
Biovest International, Inc., a biotechnology company, develops therapeutic anti-cancer vaccine for the treatment of low-grade Follicular Lymphoma in the United States. It develops BiovaxID, a Phase III clinical trial product, which is an injectable patient-specific vaccine to treat the follicular form of non-HodgkinÂ’s lymphoma. The company develops, manufactures, and markets cell culture systems, equipment, and consumable parts to pharmaceutical, diagnostic, and biotechnology companies, as well as to research institutions worldwide. Biovest International also produces mammalian and insect cells, monoclonal antibodies, recombinant and secreted proteins, and other cell culture products using hollow fiber perfusion. It is also developing an automated cell culture instrument, AutovaxID that enables production of personalized cell-based treatments. In addition, the company sells hollow fiber bioreactors, cultureware, tubing sets, and other disposable products and supplies. Further, Biovest International engages in the production and contract manufacture of biologic drugs and cell production for research institutions. Its customers include biopharmaceutical and biotech companies, medical schools, universities, research facilities, hospitals, and public and private laboratories. The company was incorporated in 1981 as Endotronics, Inc. and changed its name to Cellex Biosciences, Inc. in 1993. Further, it changed its name to Biovest International, Inc. in 2001. The company is based in Tampa, Florida. Biovest International, Inc. is a subsidiary of Accentia Biopharmaceuticals, Inc. On November 10, 2008, Biovest International Inc. filed a voluntary petition for reorganization under Chapter 11 in the U.S. Bankruptcy Court for the Middle District of Florida, Tampa, in joint administration with Accentia Biopharmaceuticals, Inc.Biovest International Inc. (BVTI:OTC)
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Key developments for Biovest International Inc. (BVTI)
Biovest International Inc. announced that BiovaxID(R), Biovest's personalized therapeutic anti-cancer vaccine, is available on a named-patient (compassionate-use) basis in Europe. Following compliance with local regulatory protocols, BiovaxID will be supplied by idis Limited to European healthcare professionals for the treatment of follicular non-Hodgkin's lymphoma and potentially for other B-cell blood cancers such as chronic lymphocytic leukemia, mantle cell lymphoma and multiple myeloma. Physicians in non-European countries may also contact idis to inquire about the potential availability of BiovaxID, as idis manages named-patient programs in more than 100 countries. The BiovaxID Phase III study results were recently presented at the American Society of Clinical Oncology (ASCO) Annual Meeting Plenary Session, reporting that an eight year pivotal, randomized, multi-center, double-blind, controlled clinical study demonstrated that BiovaxID significantly prolonged disease-free survival in follicular non-Hodgkin's lymphoma. The study found that patients who received BiovaxID experienced a median disease-free survival of 44.2 months compared to 30.6 months for those who received a control vaccine--an increase of 47%. In the study, with a median follow-up of 4.7 years, patients receiving BiovaxID experienced a 38% lower risk of disease recurrence compared to patients receiving the control vaccine. BiovaxID is the first vaccine targeting lymphoma ever to demonstrate such a disease-free survival benefit and because the vaccine is comprised of the patient's own cells (autologous), the therapy has been demonstrated to be safe and well-tolerated.
On February 24, 2009, Francis E. O’Donnell, Jr., M.D. was appointed to serve in the position of Chief Executive Officer ('CEO') of Biovest International Inc. Dr. O’Donnell will continue to serve in his role as the Company’s non-executive Chairman, in addition to the role of non-executive Chairman and CEO of parent company, Accentia Biopharmaceuticals Inc. and has agreed to accept the new position as CEO of the Company without any salary. On February 24, 2009, Samuel S. Duffey, Esq. was appointed to serve in the position of President of the Company. Mr. Duffey will continue to serve in his role as the Company’s Counsel and has agreed to accept the new position as President of the Company without any change to his current salary. Samuel S. Duffey, Esq., age 63, has served as Counsel since June 2003. Mr. Duffey also serves as President and General Counsel to Accentia. Prior to joining the Company, Mr. Duffey engaged in the private practice of business and securities law. Mr. Duffey received his B.A. and J.D. degrees from Drake University.
Biovest International Inc.’s common stock has been deleted from OTC Bulletin Board effective February 18, 2009 on account of its failure to comply with NASD 6530. The company has been added to NBB.
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More Recent News About Biovest International Inc.
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BIOVEST INTERNATIONAL INC Files SEC form 8-K, Regulation FD Disclosure, Financial Statements and Exhibits
Item 7.01. Regulation FD Disclosure. On September 21, 2009, Biovest International, Inc. (the "Company") and certain of its affiliates (collectively, the "Debtors") filed their unaudited combined monthly operating report for the period August 1, 2009 through August 31, 2009 (the "Monthly Operating Report") with the United States Bankruptcy Court for the Middle District of Florida, Tampa Division (the "Bankruptcy Court"). Exhibit 99.1 to this Current Report on Form 8-K contains the unaudited Monthly Operating Report as filed with the Bankruptcy Court. The Monthly Operating Report is limited in scope, covers a limited time period and has been prepared solely for the purpose of complying with reporting requirements of the Bankruptcy Court and the Bankruptcy Code, 11 U.S.C. §§ 101-1532 (the "Bankruptcy Code"). The financial information contained in the Monthly Operating Report is preliminary and unaudited and does not purport to show the financial statements of any of the Debtors in accordance with accounting principles generally accepted in the United States of America ("GAAP") and, therefore, may exclude items required by GAAP, such as certain reclassifications, eliminations, accruals and disclosure items. The Company cautions readers not to place undue reliance on the Monthly Operating Report. The Monthly Operating Report may be subject to revision. The Monthly Operating Report is in a format required by the Bankruptcy Court and the Bankruptcy Code and should not be used for investment purposes. The information in the Monthly Operating Report should not be viewed as indicative of future results. This Current Report on Form 8-K sets forth statements that are not strictly historical in nature constitute "forward-looking statements". Such statements include, but are not limited to, statements about BiovaxID®, AutovaxID™, and any other statements relating to products, product candidates, product development programs...Click here to read the whole Article (external link)
BIOVEST INTERNATIONAL INC Files SEC form 8-K, Regulation FD Disclosure, Financial Statements and Exhibits
Item 7.01. Regulation FD Disclosure. On August 20, 2009, Biovest International, Inc. (the "Company") and certain of its affiliates (collectively, the "Debtors") filed their unaudited combined monthly operating report for the period July 1, 2009 through July 30, 2009 (the "Monthly Operating Report") with the United States Bankruptcy Court for the Middle District of Florida, Tampa Division (the "Bankruptcy Court"). Exhibit 99.1 to this Current Report on Form 8-K contains the unaudited Monthly Operating Report as filed with the Bankruptcy Court. The Monthly Operating Report is limited in scope, covers a limited time period and has been prepared solely for the purpose of complying with reporting requirements of the Bankruptcy Court and the Bankruptcy Code, 11 U.S.C. §§ 101-1532 (the "Bankruptcy Code"). The financial information contained in the Monthly Operating Report is preliminary and unaudited and does not purport to show the financial statements of any of the Debtors in accordance with accounting principles generally accepted in the United States of America ("GAAP") and, therefore, may exclude items required by GAAP, such as certain reclassifications, eliminations, accruals and disclosure items. The Company cautions readers not to place undue reliance on the Monthly Operating Report. The Monthly Operating Report may be subject to revision. The Monthly Operating Report is in a format required by the Bankruptcy Court and the Bankruptcy Code and should not be used for investment purposes. The information in the Monthly Operating Report should not be viewed as indicative of future results. This Current Report on Form 8-K sets forth statements that are not strictly historical in nature constitute "forward-looking statements". Such statements include, but are not limited to, statements about BiovaxID®, AutovaxID™, and any other statements relating to products, product candidates, product development programs, the F...Click here to read the whole Article (external link)
BIOVEST INTERNATIONAL INC Files SEC form 8-K, Regulation FD Disclosure, Financial Statements and Exhibits
Item 7.01. Regulation FD Disclosure. On July 20, 2009, Biovest International, Inc. (the "Company") and certain of its affiliates (collectively, the "Debtors") filed their unaudited combined monthly operating report for the period June 1, 2009 through June 30, 2009 (the "Monthly Operating Report") with the United States Bankruptcy Court for the Middle District of Florida, Tampa Division (the "Bankruptcy Court"). Exhibit 99.1 to this Current Report on Form 8-K contains the unaudited Monthly Operating Report as filed with the Bankruptcy Court. The Monthly Operating Report is limited in scope, covers a limited time period and has been prepared solely for the purpose of complying with reporting requirements of the Bankruptcy Court and the Bankruptcy Code, 11 U.S.C. §§ 101-1532 (the "Bankruptcy Code"). The financial information contained in the Monthly Operating Report is preliminary and unaudited and does not purport to show the financial statements of any of the Debtors in accordance with accounting principles generally accepted in the United States of America ("GAAP") and, therefore, may exclude items required by GAAP, such as certain reclassifications, eliminations, accruals and disclosure items. The Company cautions readers not to place undue reliance on the Monthly Operating Report. The Monthly Operating Report may be subject to revision. The Monthly Operating Report is in a format required by the Bankruptcy Court and the Bankruptcy Code and should not be used for investment purposes. The information in the Monthly Operating Report should not be viewed as indicative of future results. This Current Report on Form 8-K sets forth statements that are not strictly historical in nature constitute "forward-looking statements". Such statements include, but are not limited to, statements about BiovaxID®, AutovaxID™, and any other statements relating to products, product candidates, product development programs, the FDA...Click here to read the whole Article (external link)
BIOVEST INTERNATIONAL INC Files SEC form 8-K, Regulation FD Disclosure, Financial Statements and Exhibits
Item 7.01. Regulation FD Disclosure. The following information is also being furnished under Item 7.01 of Form 8-K: Press release dated June 28, 2009, by the Company, titled "Personalized Anti-Cancer Vaccine, BiovaxID®, Targeting B-cell Lymphomas Available in Europe on a Named-Patient Basis". A copy of this press release is attached as Exhibit 99.1 to this Form 8-K. On June 22, 2009, Biovest International, Inc. (the "Company") and certain of its affiliates (collectively, the "Debtors") filed their unaudited combined monthly operating report for the period May 1, 2009 through May 31, 2009 (the "Monthly Operating Report") with the United States Bankruptcy Court for the Middle District of Florida, Tampa Division (the "Bankruptcy Court"). Exhibit 99.2 to this Current Report on Form 8-K contains the unaudited Monthly Operating Report as filed with the Bankruptcy Court. The Monthly Operating Report is limited in scope, covers a limited time period and has been prepared solely for the purpose of complying with reporting requirements of the Bankruptcy Court and the Bankruptcy Code, 11 U.S.C. §§ 101-1532 (the "Bankruptcy Code"). The financial information contained in the Monthly Operating Report is preliminary and unaudited and does not purport to show the financial statements of any of the Debtors in accordance with accounting principles generally accepted in the United States of America ("GAAP") and, therefore, may exclude items required by GAAP, such as certain reclassifications, eliminations, accruals and disclosure items. The Company cautions readers not to place undue reliance on the Monthly Operating Report. The Monthly Operating Report may be subject to revision. The Monthly Operating Report is in a format required by the Bankruptcy Court and the Bankruptcy Code and should not be used for investment purposes. The information in the Monthly Operating Report should not be viewed as indicative of future results...Click here to read the whole Article (external link)
BIOVEST INTERNATIONAL INC Files SEC form 8-K, Regulation FD Disclosure, Financial Statements and Exhibits
Item 7.01. Regulation FD Disclosure. The following information is also being furnished under Item 7.01 of Form 8-K: Press release dated May 31, 2009, by the Company, titled "Positive, Clinically Significant Phase III Results for Personalized Anti-Cancer Vaccine, BiovaxID®, Presented at ASCO Plenary Session". A copy of this press release is attached as Exhibit 99.1 to this Form 8-K. This Current Report on Form 8-K sets forth statements that are not strictly historical in nature constitute "forward-looking statements". Such statements include, but are not limited to, statements about BiovaxID®, AutovaxID™, 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, the intent to treat analysis, accelerated approval and all aspects of 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," "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 Biovest 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 Exchang...Click here to read the whole Article (external link)
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BIOVEST INTERNATIONAL INC Files SEC form 8-K, Regulation FD Disclosure, Financial Statements and Exhibits
Item 7.01. Regulation FD Disclosure. The following information is also being furnished under Item 7.01 of Form 8-K: Press release dated May 20, 2009, by the Company, titled "Personalized Anti-Cancer Vaccine Pivotal Phase III Results to be Presented at ASCO Plenary Session". A copy of this press release is attached as Exhibit 99.2 to this Form 8-K. On May 20, 2009, Biovest International, Inc. (the "Company") and certain of its affiliates (collectively, the "Debtors") filed their unaudited combined monthly operating report for the period March 1, 2009 through March 31, 2009 (the "Monthly Operating Report") with the United States Bankruptcy Court for the Middle District of Florida, Tampa Division (the "Bankruptcy Court"). Exhibit 99-1 to this Current Report on Form 8-K contains the unaudited Monthly Operating Report as filed with the Bankruptcy Court. The Monthly Operating Report is limited in scope, covers a limited time period and has been prepared solely for the purpose of complying with reporting requirements of the Bankruptcy Court and the Bankruptcy Code, 11 U.S.C. §§ 101-1532 (the "Bankruptcy Code"). The financial information contained in the Monthly Operating Report is preliminary and unaudited and does not purport to show the financial statements of any of the Debtors in accordance with accounting principles generally accepted in the United States of America ("GAAP") and, therefore, may exclude items required by GAAP, such as certain reclassifications, eliminations, accruals and disclosure items. The Company cautions readers not to place undue reliance on the Monthly Operating Report. The Monthly Operating Report may be subject to revision. The Monthly Operating Report is in a format required by the Bankruptcy Court and the Bankruptcy Code and should not be used for investment purposes. The information in the Monthly Operating Report should not be viewed as indicative of future results. This Curre...Click here to read the whole Article (external link)
BIOVEST INTERNATIONAL INC Files SEC form 8-K, Regulation FD Disclosure, Financial Statements and Exhibits
Item 7.01. Regulation FD Disclosure. On April 20, 2009, Biovest International, Inc. (the "Company") and certain of its affiliates (collectively, the "Debtors") filed their unaudited combined monthly operating report for the period March 1, 2009 through March 31, 2009 (the "Monthly Operating Report") with the United States Bankruptcy Court for the Middle District of Florida, Tampa Division (the "Bankruptcy Court"). Exhibit 99-1 to this Current Report on Form 8-K contains the unaudited Monthly Operating Report as filed with the Bankruptcy Court. The Monthly Operating Report is limited in scope, covers a limited time period and has been prepared solely for the purpose of complying with reporting requirements of the Bankruptcy Court and the Bankruptcy Code, 11 U.S.C. §§ 101-1532 (the "Bankruptcy Code"). The financial information contained in the Monthly Operating Report is preliminary and unaudited and does not purport to show the financial statements of any of the Debtors in accordance with accounting principles generally accepted in the United States of America ("GAAP") and, therefore, may exclude items required by GAAP, such as certain reclassifications, eliminations, accruals and disclosure items. The Company cautions readers not to place undue reliance on the Monthly Operating Report. The Monthly Operating Report may be subject to revision. The Monthly Operating Report is in a format required by the Bankruptcy Court and the Bankruptcy Code and should not be used for investment purposes. The information in the Monthly Operating Report should not be viewed as indicative of future results. This Current Report on Form 8-K sets forth statements that are not strictly historical in nature and such statements are referred to as "forward-looking statements." The forward-looking statements in this Form 8-K may include statements about our product development programs, clinical trials for our BiovaxID® product and potenti...Click here to read the whole Article (external link)
BIOVEST INTERNATIONAL INC Files SEC form 8-K, Regulation FD Disclosure, Financial Statements and Exhibits
Item 7.01. Regulation FD Disclosure. On March 20, 2009, Biovest International, Inc. (the "Company") and certain of its affiliates (collectively, the "Debtors") filed their unaudited combined monthly operating report for the period February 1, 2009 through February 28, 2009 (the "Monthly Operating Report") with the United States Bankruptcy Court for the Middle District of Florida, Tampa Division (the "Bankruptcy Court"). Exhibit 99-1 to this Current Report on Form 8-K contains the unaudited Monthly Operating Report as filed with the Bankruptcy Court. The Monthly Operating Report is limited in scope, covers a limited time period and has been prepared solely for the purpose of complying with reporting requirements of the Bankruptcy Court and the Bankruptcy Code, 11 U.S.C. §§ 101-1532 (the "Bankruptcy Code"). The financial information contained in the Monthly Operating Report is preliminary and unaudited and does not purport to show the financial statements of any of the Debtors in accordance with accounting principles generally accepted in the United States of America ("GAAP") and, therefore, may exclude items required by GAAP, such as certain reclassifications, eliminations, accruals and disclosure items. The Company cautions readers not to place undue reliance on the Monthly Operating Report. The Monthly Operating Report may be subject to revision. The Monthly Operating Report is in a format required by the Bankruptcy Court and the Bankruptcy Code and should not be used for investment purposes. The information in the Monthly Operating Report should not be viewed as indicative of future results. This Current Report on Form 8-K sets forth statements that are not strictly historical in nature and such statements are referred to as "forward-looking statements." The forward-looking statements in this Form 8-K may include statements about our product development programs, clinical trials for our BiovaxID® product and p...Click here to read the whole Article (external link)
BIOVEST INTERNATIONAL INC Files SEC form 8-K, Change in Directors or Principal Officers
Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. On February 24, 2009, Francis E. O'Donnell, Jr., M.D. was appointed to serve in the position of Chief Executive Officer ("CEO") of Biovest International, Inc. (the "Company"). Dr. O'Donnell will continue to serve in his role as the Company's non-executive Chairman, in addition to the role of non-executive Chairman and CEO of our parent company, Accentia Biopharmaceuticals, Inc. ("Accentia") and has agreed to accept the new position as CEO of the Company without any salary. Dr. O'Donnell was granted an option to purchase up to 1.0 million shares of the Company's common stock at an exercise price of $0.06 per share with termination of the option as described in the Company's 2006 Equity Incentive Plan. The option shall vest in three equal tranches over the period of 180 days after confirmation of a Plan of Reorganization by the Court in the pending Chapter 11 Reorganization Proceeding. The following is biographical information regarding Dr. O'Donnell: Francis E. O'Donnell, Jr., M.D., age 59, has been a Director of our Company since June 2003. Dr. O'Donnell is our Chairman (non-executive). Dr. O'Donnell is the non-executive Chairman, CEO and a director of Accentia, our parent corporation since its inception in 2002. He is also the CEO, President, Chairman and a Director of BioDelivery Sciences International, Inc. ("BDSI"). Dr. O'Donnell was the founder and for more than the last five years has served as managing director of The Hopkins Capital Group ("HCG"), an affiliation of limited liability companies which engage in business development and venture activities. Included in companies in which HCG entities are significant stockholders include Accentia and BDSI. On February 24, 2009, Samuel S. Duffey, Esq. was appointed to serve in the position of President of the Company. Mr. D...Click here to read the whole Article (external link)
