Russia approved CANCER VACCINE (made from YOUR cancer)

April 09, 2008

Tuesday morning, a little biotech company, Antigenics (AGEN), announced that Russia has approved its kidney cancer drug, Oncophage. It's the first so-called therapeutic cancer vaccine to win full-out approval anywhere in the world.

This is not a traditional preventive vaccine where you'd get a shot to stave off coming down with something. Therapeutic means you'd unfortunately have to get the cancer first and then your own cells are mixed with the "vaccine" to empower your body's immune system to fight off the disease.

Anyway, a test showed that a subset of patients on Oncophage lived 1.7 years longer without the cancer coming back. But because the clinical trial didn't meet its main goal and the aforementioned benefit was only discovered in a re-analysis of the data, the drug didn't pass muster with the Food and Drug Administration.

The agency wanted AGEN to do a bigger, longer and expensive study. But like most baby biotechs, Antigenics didn't have that kind of cash. So, the company turned to Russia where it had enrolled 125 patients in the same clinical trial. And after a 10-month process, AGEN won approval of the drug there making Russia the first country in the world to allow a therapeutic cancer vaccine onto the market.

The lead clinical trial investigator, Dr. Christopher Wood at the MD Anderson Cancer Center, says the company has given him verbal assurances that it will use the Russian revenue to pay for another study here that might eventually satisfy the FDA. Dr. Wood, an associate professor of urology and cancer biology, says he doesn't own AGEN stock--he just consults for Antigenics and ran the clinical trial.

Over the phone he told me, "Absolutely no question about it (that the drug works). I've looked at the data," he said, "and there's clear activity in the intermediate risk subgroup." That means he believes the drug works on patients whose tumors are of a certain size and confined to the kidney and the fatty tissue around the organ. If it has spread, then this drug, he said, is not for you. Dr. Wood says he and his colleagues have just submitted the study for possible publication in a major, but unidentified, peer-reviewed medical journal. That could give the drug even more cred.


There are many companies working on various types of therapeutic cancer vaccines. The most famous is Dendreon (DNDN). Please keep in mind many of these stocks are micro caps, but some of the others are Cell Genesys (CEGE), Geron (GERN), Vical (VICL), and Favrille (FVRL)

Vitespen

Oncophage (vitespen; formerly HSPPC-96) is a patient-specific therapeutic cancer vaccine tested in over 800 patients in multiple cancers in more than 15 Phase 1, 2 and 3 clinical trials. Oncophage is approved in Russia for the adjuvant treatment of kidney cancer patients at intermediate-risk for disease recurrence. Oncophage contains the heat shock protein, gp96, and associated peptides which are purified from the patients' own tumor tissue and has been the primary focus of Antigenics' research and development efforts since the company's founding. Treatment with Oncophage is designed to target only cancerous cells — not healthy normal cells. As a result, Oncophage is designed to limit the toxicities associated with traditional broad-acting cancer treatments.

Oncophage first entered the clinic in the 1990's where it was studied in a number of different tumor types in advanced disease settings. The objectives of these early Phase 1/2 trials were to assess the feasibility of vaccine manufacture and corresponding logistics, safety and to identify signals of activity. The early findings supported the initiation and completion of two Phase 3 randomized trials in stage IV melanoma and adjuvant renal cell carcinoma (RCC).

The accumulated clinical data has revealed a pattern of findings that is entirely consistent with the biological premise:

• Oncophage is well tolerated and has demonstrated a very low toxicity profile
• Oncophage elicits tumor-specific T cell responses and innate immune response irrespective of tumor type
• Oncophage efficacy is most significant in patients with early-stage disease/ low tumor burden (patients with better prognostic features)

To make Oncophage, patients first have surgery to remove part or all of the cancerous tissue, and the tumor tissue is shipped frozen to Antigenics' state-of-the-art GMP manufacturing facility in Massachusetts. The facility is capable of making vaccine for 10,000 patients with on site expansion to enable vaccine production for 100,000 patients. Using a proprietary, standardized, quality-controlled procedure, the product is isolated from the tumor in 8-10 hours. The product is sterile-filtered, packaged in vials, and shipped frozen back to the hospital pharmacy or clinician for use when the patient has recovered from surgery.

Oncophage is administered as a simple weekly or biweekly intradermal injection during an office visit.

Oncophage received fast track and orphan drug designations from the US Food and Drug Administration (FDA) for both kidney cancer and metastatic melanoma as well as orphan drug designation from the EMEA for kidney cancer. In 2009, Oncophage also received orphan drug designations from the FDA and EMEA for glioma. Antigenics has developed crucial management and logistics expertise in patient-specific vaccines.

Vitespen (HSPPC-96) for Immune Response Assessment Following Treatment of Resectable Renal Cell Carcinoma

This study is currently recruiting participants.

Verified by M.D. Anderson Cancer Center, August 2010

First Received: February 19, 2010   Last Updated: August 3, 2010   History of Changes

Sponsor:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT01073254

  Purpose

The goal of this clinical research study is to learn if patients receiving HSPPC-96 after surgery have an immune response against kidney cancer and how long the immune system response may last.

Primary Objective:

• to determine whether patients exhibit a measurable immune response after multiple administrations of HSPPC-96, including evaluation of immune response after 12 weeks of treatment (corresponding to 8 doses of HSPPC-96) as assessed by ELISPOT assay.

Secondary Objectives:

• to assess if the immune response is durable beyond 12 weeks of treatment with the administration of 2 additional doses of HSPPC-96 or placebo at 6 and 12 months.
• to assess natural killer (NK) cell activity during the treatment with HSPPC-96.
• to assess safety following administration of HSPPC-96.

Condition	Intervention	Phase
Kidney Cancer Renal Cell Carcinoma	Biological: Vitespen (HSPPC-96)	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	A Phase 2, Multicenter, Randomized, Single-Blind Study of Vitespen (HSPPC-96, Oncophage) for Immune Response Assessment Following Treatment of Patients With Resectable Renal Cell Carcinoma at Intermediate Risk of Recurrence Further study details as provided by M.D. Anderson Cancer Center: Primary Outcome Measures: Number of patients who exhibit a measurable immune response after multiple administrations of HSPPC-96 [ Time Frame: After 12 weeks of treatment (corresponding to 8 doses of HSPPC-96) ] [ Designated as safety issue: No ] Estimated Enrollment: 80 Study Start Date: January 2010 Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure) Arms Assigned Interventions Part 1A: Experimental Biological: Vitespen (HSPPC-96) 8 administrations of HSPPC-96 over 12 weeks (weeks 14-17, 19, 21, 23, 25) Part 1B: Experimental Biological: Vitespen (HSPPC-96) 8 vaccine doses (4 weekly doses, followed by 4 bi-weekly doses at study weeks 1-4, 6, 8, 10, 12) over 12 weeks Part 2: Experimental Biological: Vitespen (HSPPC-96) 8 vaccine doses (4 weekly doses, followed by 4 bi-weekly doses at study weeks 1-4, 6, 8, 10, 12) over 12 weeks Criteria Inclusion Criteria: Patients with higher risk MDS (IPSS int-2 or high, or >/= 10% blasts as defined by WHO or FAB). - No prior intensive chemotherapy or high-dose cytarabine (>/= 1 g/m2). - Prior biologic therapies (</= 1 cycle of prior decitabine or azacitidine), targeted therapies, or single agent chemotherapy is allowed. - Off chemotherapy for 2 weeks prior to entering this study with no toxic effects of that therapy, unless there is evidence of rapidly progressive disease. - Hydroxyurea is permitted for control of counts prior to treatment. - Hematopoietic growth factors are allowed. . Age >/= 18 years. ECOG performance status </= 2. Have adequate renal function as indicated by the following laboratory values: Serum creatinine </= 1 mg/dL; if serum creatinine > 1 mg/dL, then the estimated glomerular filtration rate (GFR) must be > 60 mL/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease equation where Predicted GFR (ml/min/1.73m2) = 186 x (serum creatinine)-1.154 x (age in years)-0.023 x (0.742 if patient is female) x (1.212 if patient is black). Serum bilirubin </= 1.5 x upper limit of normal (ULN) Aspartate transaminase (AST) or alanine transaminase (ALT) </= 2.5 x ULN Alkaline phosphatase </= 2.5 x ULN Provide signed written informed consent. Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent. Female patients of childbearing potential must have a negative pregnancy test within 2 weeks prior to enrollment. Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment. Exclusion Criteria: Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol. Use of investigational agents within 30 days or any anticancer therapy within 2 weeks before study entry with the exception of hydroxyurea. The patient must have recovered from all acute toxicities from any previous therapy. Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo treatment. Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment) Pregnant or lactating patients. Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results Have had a diagnosis of another malignancy, unless the patient has been disease-free for at least 3 years following the completion of curative intent therapy with the following exceptions: a) Patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed; b) Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (PSA) values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed.   Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT01073254 Contacts Contact: Stefan Faderl, MD 713-745-4613 Locations United States, Texas UT MD Anderson Cancer Center Recruiting Houston, Texas, United States, 77030 Principal Investigator: Stefan Faderl, MD