Encouraging Data Presented on Oncophage(R) Vaccine at International Conference

Antigenics (NASDAQ: AGEN) today announced that data from a multi-center Phase 1/2 clinical trial of Oncophage (vitespen) for recurrent high-grade glioma (brain cancer) was presented at the International Conference on Brain Tumor Research and Therapy. The study was conducted by the Brain Tumor Research Center at the University of California, San Francisco (UCSF).

Data from 32 evaluable patients suggest that vaccination with Oncophage may improve overall survival in patients with recurrent high-grade glioma. An overall median survival of 44 weeks after tumor resection was observed. Approximately 70% of the evaluable patients survived beyond 36 weeks, and 41% survived up to or longer than one year. This is considered a significant achievement in the treatment of recurrent high-grade glioma. In addition, Oncophage was well tolerated, with no serious adverse events attributable to the vaccine.

Sen. Kennedy’s Death Puts Focus On Brain Cancer

The recent death of Senator Ted Kennedy has focused new attention on brain cancer. Glioblastoma multiforme (GBM), the aggressive brain tumor that took Sen. Kennedy’s life, is one of the deadliest brain tumors that can occur in both adults and children.

It is also one of the most difficult tumors to treat. Oral drugs can’t cross the blood-brain barrier, and tumor removal surgery has limited effectiveness. Malignant gliomas are prone to infiltrating healthy tissue. Small pieces of tumor, invisible during surgery, may later take root and grow back into other tumors. Patients generally live less than a year after diagnosis.

Like many other companies in the field, NeoPharm of Lake Bluff, Ill. has encountered challenges in its efforts to develop a treatment for GBM. NeoPharm’s drug candidate, IL 13-PE38QQR (IL-13), is designed to kill malignant glioma cells while preserving healthy tissue. The company uses a method called convection-enhanced delivery to deliver IL-13 through catheters inserted in the brain tissue. Further trials for IL-13 were put on hold in late 2006 after the drug candidate failed to meet its primary endpoint in a Phase III clinical trial. The company went head-to-head with the current standard-of-care treatment, the Gliadel Wafer, developed by MGI Pharma. The NeoPharm study found that IL-13 was just as effective, but not more so, than the Gliadel Wafer.

In the meantime, NeoPharm is exploring other options for IL-13. The company recently signed a Comparative Research and Development Agreement (CRADA) with the National Institute of Neurological Diseases and Stroke (NINDS), a division of the National Institutes of Health (NIH) to start a Phase I trial for various brain diseases. As part of the agreement, NeoPharm will be starting a Phase I trial for brain stem cancer. The trial will combine NeoPharm’s IL-13 with NINDS’ convection-enhanced delivery, which the agency had previously licensed to NeoPharm.

Other companies developing treatments for brain cancer include Boneca, ZGene, and ImmunoCellular Therapeutics.

TransMolecular starts new Phase 1 trial of brain cancer drug

TransMolecular Inc. reports that it has begun a Phase 1 trial to test non-radiolabeled TM601 for the treatment of malignant glioma, the type of brain cancer recently identified as afflicting Sen. Edward Kennedy.

The Cambridge-based biotech will target adult patients with progressive or recurrent brain cancer who have failed initial standard therapy, to determine the safety, tolerability, dosing and pharmacokinetics of TM601.

ABC News: Vaccine Helps Man Survive Deadly Cancer

Ryan DeGrand Was Given Less Than Two Years to Live Before He Tried an Experimental Cancer Vaccine:

Developing an effective cancer vaccine has been a frustratingly elusive goal in medicine. Now researchers at Duke University Medical Center believe they might have one, harnessing the most effective and efficient of all disease fighters: the body's own immune system. Watch the story on "World News Tonight" at 6:30 p.m. ET. It appears to have helped Ryan DeGrand. DeGrand was living the American dream. Married with two children, he runs a successful golf equipment company in St. Louis,...

Brain Tumor Vaccine Seeks Candidates

Monica Robins Created: 2/12/2008 6:31:07 PM Updated:2/12/2008 7:28:05 PM

CLEVELAND -- University Hospitals Case Medical Center has opened a new brain tumor vaccine trial and candidates are needed.

Researchers in the Neurological Institute and Ireland Cancer Center at University Hospitals Case Medical Center are in late-stage trials for an experimental vaccine for the treatment of glioblastoma (GBM), the most aggressive form of brain cancer.

The new vaccine ? CDX-110 ? attempts to marshal the power of the patients? own immune system to fight against remnants of the tumor which typically remain in the brain following surgery and radiation treatment.

So far, the vaccine has been used to treat about 70 patients nationally with virtually no side-effects. Currently 14 patients have enrolled at UH, the only site in Ohio to have opened the study and one of 20 national sites.

At UH, the patients currently have had surgery and are now going through radiation treatment to shrink their tumors. They will then receive the vaccine to induce an immune response against the tumor.

According to UH neurosurgeon Andrew Sloan, M.D., early results, although not published, seem encouraging. Half of the patients receiving the vaccine have survived for more than 30 months after treatment.

?This is impressive considering that survival after standard treatment is less than a year. Even more impressive is the finding that 65 percent of patients treated with the vaccine were still alive after two years which is very rare for patients treated with conventional radiation and chemotherapy alone. In fact, several patients treated with the experimental vaccine have survived for more than three years,? said Dr. Sloan.

Normally, vaccines are used to prevent disease, but in this case, the vaccine is used to jump-start an immune response against an existing tumor.

The vaccine is designed to teach the body?s immune system to attack the tumor without attacking the normal brain cells. Another advantage of the vaccine compared to other experimental treatments is that there are few side-effects to vaccines.

Dr. Sloan, an Associate Professor of Neurosurgery at Case Western Reserve University with an NIH-funded grant to study the use of vaccines in brain tumors, said, ?This therapy has the potential to help not only patients suffering from this deadly disease, but if it lives up to its promise, it could potentially be used for other cancers as well.?

Glioblastoma is the most common form of adult brain cancer. It strikes more than 10,000 adults annually in the United States. It is highly malignant and the average survival is usually less than a year even after maximal surgical resection and radiation. Even the addition of a chemotherapy drug only adds an average of two months survival to patients? lives.

For more information or to enroll in the study call 216 844 6054.

Celldex Therapeutics Announces Orphan Drug Designation For CDX-110, A Novel EGFRvII Vaccine For Glioblastoma Multiforme

PR Newswire

December 7, 2007

PHILLIPSBURG, N.J. -- Celldex Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for Celldex's CDX-110 for the treatment of EGFRvIII expressing Glioblastoma Multiforme (GBM). GBM is the most common and aggressive form of brain cancer. CDX-110 is an immunotherapy that targets the tumor-specific growth promoter EGFRvIII. Celldex Therapeutics announced a definitive merger agreement with AVANT Immunotherapeutics, Inc. (Nasdaq: AVAN) in October 2007.

In the ACTIVATE phase IIa study, CDX-110 treated GBM patients showed a median survival time of 30 months, more than a 100 percent increase in survival, versus the historical control's median of 14.5 months. The study has demonstrated a median time-to-progression of 13 months (p=0.0001) versus the historical control's median of 6.4 months. An extension study, ACT II, which combines CDX-110 with chemotherapy in a similar patient population, has not yet reached median time-to-progression or survival. However, preliminary progression free survival (PFS) and overall survival (OS) data in ACT II look very similar to the ACTIVATE experience, and the data suggest that chemotherapy and CDX-110 can be administered concurrently while still maintaining strong immune responses.

In September, Celldex randomized its first patient into ACT III, a definitive Phase II/III randomized study of CDX-110 with radiation and temozolomide in patients with newly-diagnosed GBM. The clinical trial is investigating the anticancer activity, impact on survival, and safety of the addition of CDX-110 vaccine to standard of care, versus standard of care alone. Celldex has currently enlisted 18 clinical centers throughout the United States, and also recently received approval from Health Canada to open enrollment in Canada. Furthermore, The National Cancer Institute (NCI) has agreed to collaborate with Celldex in expanded clinical development of CDX-110 under a Clinical Trials Agreement.

"Obtaining orphan designation for CDX-110 is an important milestone for Celldex," said Thomas Davis, M.D., Chief Medical Officer of Celldex Therapeutics. "Approval to expand clinical research into Canada and the scientific and clinical collaboration from the National Cancer Institute all promote our ability to fully explore the promise of CDX-110."

Genentech Reveals Encouraging Avastin Data - Update [DNA]

11/19/2007 11:19:39 AM Monday morning, biotechnology company Genentech Inc. (DNA) announced that its cancer drug Avastin showed encouraging results in a Phase II study in treatment of patients with the most aggressive form of brain cancer, over a six-month period. The company said that the findings exceeded its expectations and it plans to discuss next steps with the U.S. Food and Drug administration or FDA.