Monday, August 29, 2005 7:19:42 AM
“Peregrine Pharmaceuticals and New Approaches to Brain Tumor Therapy (NABTT) Consortium Initiate Cotara Brain Cancer Trial”
http://ir.peregrineinc.com/phoenix.zhtml?c=74236&p=irol-newsArticle&ID=749945
TUSTIN, CA., Aug. 29 2005: Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM) and the New Approaches to Brain Tumor Therapy (NABTT) Consortium today announced the initiation of a clinical trial designed to confirm the dosing, safety and efficacy of a single intratumoral infusion of Cotara in the treatment of glioblastoma multiforme (GBM), a common and deadly form of brain cancer.
The National Cancer Institute-approved protocol titled, "An Open-Label, Dose Confirmation and Dosimetry Study of Interstitial 131I-chTNT-1/B (Cotara) for the Treatment of Glioblastoma Multiforme at 1st or 2nd Relapse," will evaluate safety, radiation exposure and efficacy of a single dose of Cotara. The study represents the first part of Peregrine's FDA-approved product registration clinical trial for Cotara.
The trial will enroll patients at 4 NABTT institutions; Wake Forest Univ., Emory Univ., Univ. of Alabama at Birmingham and Univ. of Pennsylvania. Up to 28 patients will be enrolled in this trial.
"Glioblastoma multiforme is an aggressive and fatal cancer with few treatment options, and we are anxious to evaluate this novel study drug in patients," said Dr. Kevin Judy of the Univ. of Pennsylvania, the Neurosurgery Chair for the study.
About Glioblastoma Multiforme:
Glioblastoma multiforme (GBM) is the most common and clinically aggressive brain cancer and is associated with a grave prognosis. Approximately 80% of patients relapse within 6-12 months after treatment, with an overall median survival time for patients with newly diagnosed GBM of approximately 12 months.
In 2004, the American Cancer Society estimated that 18,400 new cases and 12,690 deaths were attributed to primary malignant brain (e.g. GBM) and central nervous system cancers in the U.S. Current therapeutic modalities include surgery, radiotherapy, and chemotherapy. However, most glioblastomas cannot be completely resected or irradiated due to the infiltrating fingers of tumor that characterize their growth. Additionally, the "blood-brain barrier" prevents most chemotherapeutic agents from reaching the tumor at therapeutic concentrations.
About Cotara in the Treatment of Brain Cancer:
Cotara is the registered trademark for a chimeric tumor-necrosis therapy (TNT) antibody attached to Iodine-131, a radioactive agent. Cotara is designed to bind to the dead or dying tissue present in virtually all solid tumors. Using this necrotic core as a stable anchorage, Cotara delivers a cytotoxic radioisotope to the heart of the tumor, irradiating and killing nearby, living tumor cells.
In a prior phase 2 study, a subset analysis of recurrent GBM patients who received a therapeutic dose of Cotara between 1.25 and 2.5 mCi/cc of tumor volume demonstrated a 58% improvement in median survival (38 versus 24 weeks) compared to patients treated with temozolomide, which is the current standard of care for GBM.
About NABTT: www.nabtt.org
The primary objective of the New Approaches to Brain Tumor Therapy (NABTT) CNS Consortium is to improve the therapeutic outcome for adults with primary brain tumors. This consortium is one of two nationwide that is funded by the National Cancer Institute to conduct Phase I and II clinical evaluations of promising new treatment strategies (surgery, radiation, chemotherapy, and biologic therapies), routes of administration, and clinical trial design in the treatment of primary malignancies of the central nervous system. The NABTT CNS Consortium is specifically designed to combine and focus the experience, resources, and capabilities of nine outstanding medical institutions (Emory Univ., Cleveland Clinic, Henry Ford Hospital, Johns Hopkins Univ., Mass General Hospital, Moffitt Cancer Center, NCI Neuro-Oncology Intramural Program, Univ. of Alabama, Univ. of Pennsylvania, Wake Forest Univ.) to bear on primary brain tumors. Additional information about NABTT can be found at http://www.nabtt.org.
About Peregrine Pharmaceuticals:
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a broad portfolio of products under development directed towards the treatment of cancer, viruses and other diseases. In addition to the Cotara clinical trial for the treatment of brain cancer, the company has opened patient enrollment in two separate clinical trials using its Anti-Phospholipid Therapy product, Tarvacin, for the treatment of solid cancers and for the treatment of Hepatitis C virus infection. Peregrine Pharmaceuticals is also developing Vascular Targeting Agents, Anti-Angiogenesis, and Vasopermeation Enhancement Agents for the treatment of cancer and other diseases.
Peregrine Pharmaceuticals also has in-house expertise to develop and manufacture antibodies and recombinant proteins through its wholly-owned subsidiary, Avid Bioservices, Inc., (http://www.avidbio.com). Avid is engaged in providing contract manufacturing services and development of biologics for biopharmaceutical and biotechnology companies, including Peregrine.
Copies of PR’s / FWD-Looking .. . *snip*
Investor Inquiries:
Krista Mallory, Dir. of Investor Relations, 714-508-6000, info@peregrineinc.com
Media Inquiries:
Rachel Martin, Edelman Rachel.Martin@edelman.com
323-202-1031 / 323-893-9047
= = = = = = =
6-1-05: Cotara w/CED Brain Delivery pub. in Neurosurgery Journal:
”Cotara Holds Promise for Treating Brain Cancer - P1/P2 Data Suggests Extended Survival in a Number of Patients"
http://ir.peregrineinc.com/phoenix.zhtml?c=74236&p=irol-newsArticle&ID=715495
5-2005 NABTT Cotara/Brain Cancer trial goes "ACTIVE": http://www.nabtt.org/protocols.htm#D
Recent CDMO News
- Avid Bioservices Announces Receipt of Deficiency Notice from Nasdaq Regarding Late Form 10-Q • GlobeNewswire Inc. • 03/20/2024 11:00:10 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/07/2024 11:30:11 AM
- Avid Bioservices Announces Pricing of Private Placement of Convertible Notes • GlobeNewswire Inc. • 03/07/2024 04:58:48 AM
- Avid Bioservices Announces Proposed Private Placement of Convertible Notes • GlobeNewswire Inc. • 03/06/2024 09:32:07 PM
- Avid Bioservices Announces Certain Preliminary Financial Results for Third Quarter Ended January 31, 2024 • GlobeNewswire Inc. • 03/06/2024 09:31:28 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/06/2024 09:30:18 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 01/26/2024 09:57:52 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/13/2024 12:34:35 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/12/2024 12:39:18 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/12/2024 12:38:30 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/12/2024 12:37:38 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/12/2024 12:36:27 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/12/2024 12:35:47 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/11/2024 12:56:02 AM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 01/08/2024 09:32:36 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 12:56:18 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 12:55:07 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 12:53:58 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 12:51:57 AM
- Form SC 13G - Statement of acquisition of beneficial ownership by individuals • Edgar (US Regulatory) • 12/19/2023 09:05:52 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/19/2023 12:34:08 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/19/2023 12:33:03 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/19/2023 12:32:11 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/19/2023 12:31:12 AM
Endexx Corporation (EDXC) Leverages Global Market Trends and Legislative Reforms to Spearhead Growth in the Cannabis and Plant-Based Wellness Sectors • EDXC • Mar 27, 2024 3:01 PM
Applied UV, Inc. Announces Pricing of $2.76 Million Registered Direct and Private Placement Priced at the Market Under Nasdaq Rules • AUVI • Mar 27, 2024 2:51 PM
POET and MultiLane Collaborate to Develop High-Speed Pluggable Transceivers for AI Networks • POET • Mar 27, 2024 10:52 AM
Maybacks Global Entertainment Opens 23 More Stations in Important Major Cities • AHRO • Mar 27, 2024 9:00 AM
NxGen Brands Inc. Forecast to Deliver 140% Growth in Q1 2024 • NXGB • Mar 27, 2024 7:30 AM
Kona Gold Beverages, Inc. Strategic Advancements: Covert LLC Introduces Federally Legal D9 Gummies and Revamps Innovative eCommerce Platform, Propelling Toward $12 Million Annual Revenue Goal • KGKG • Mar 26, 2024 8:30 AM