We know that this plasmid technology works extremely well in the Oncept vaccine for oral melanoma in dogs with stage II and III cancer. The positve immune response generated in dogs is the mechanism for their survival benefit against Malignant Melanoma cells.
Sanofi Aventis and their subsidiary Merial which specializes in animal vaccines has the proof. The dogs vaccinated with Oncept after surgery survived advanced oral melanoma to die of other causes ! At the close of the study trial the median overall survival could not be calculated !
Gary Nabel the Michigan University scientist who developed the A-7 model based on the HLA-B7 and Beta-2 Microglobulin genes for the DNA plasmid vector won the Nobel Prize for his scientific achievement to advance A-7 into a SPA for VICL which the FDA approved.
VICL learned from their Phase II trial of A-7 that the durable response rate is directly related to median overall survival benefit in chemo naive patients.
VICL chose chemo naive patients with normal LDH levels, and changed the RECIST criteria to allow at least two cycles of A-7 into the Phase III protocol. They selected the optimal Melanoma patient population with stage III and IV disease.......with no liver or brain mets to benefit from the A-7 vaccine.
There were no serious adverse events associated with A-7 to date in five DSMB reviews.
It has been over a year now that the death event rate for the A-7 vaccine Phase III trial has not been reached to determine the median overall survival of the trial arms as initially predicted by VICL. REMEMBER that the durable response rate is directly related to the median overall survival benefit.
Is the DTIC chemotherapy control arm the reason that the death event rate has not been achieved for over a year to date ?
I doubt it !
Sentiment: Strong Buy
Per your initial post on this MB as drmas1025, I doubt it too. But getting FDA approval and a "clean label" for a solid tumor vaccine must be done smartly. How much is another 6 months' survival worth in the marketplace? Hundreds of millions in annual revenues IMO. Vical's commercial rights for Allovectin should be worth upwards of $1 billion in market cap, especially when you think of other derivative formulas and applications....which will take significant investment to test and scale up. The kind of investment Vical negotiated years ago with AnGes in funding the Phase 3 testing of Allovectin in exchange for certain Asian market rights.
Vical DNA Plasmid technology would be VALIDATED IN HUMANS with a successful Allovectin trial outcome. Let's all remember that Vical was formed 25 years ago and there are MANY, MANY doubters about the efficacy of their platform in humans. I think Vical IS ready for prime time this year. And I expect a 3-5X share price pop if the end points are cleared by a hefty margin.
last paragraph of article..............7 years after approval......exclusive;
SAN DIEGO, Feb. 14, 2011 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) today announced that an independent Safety Monitoring Board (SMB) for the company's Phase 3 trial of Allovectin-7® in patients with metastatic melanoma has completed the trial's fifth scheduled safety analysis and recommended that the trial continue per the protocol.
The Phase 3 trial, initiated in January 2007, is evaluating Allovectin-7® as first-line therapy in patients with Stage III or IV recurrent metastatic melanoma. Vical completed enrollment in February 2010 of 390 chemo-naive patients randomized on a 2:1 basis: 260 for treatment with Allovectin-7® and 130 for treatment with either dacarbazine or temozolomide. The company expects to complete patient follow-up and lock the Phase 3 clinical trial database in the second half of 2011.
"Published results from a completed Phase 2 trial of Allovectin-7® in 127 chemo-refractory or chemo-intolerant patients with metastatic melanoma compare favorably with historical controls from other studies. Among the 15 responders (11.8%), 4 had complete responses and 11 had partial responses. The median duration of response was 13.8 months, and all responses were durable, lasting at least 6 months. The median survival for all patients was 18.8 months.
Allovectin-7® is a novel gene-based immunotherapeutic with a unique mechanism of action that is fundamentally different from currently approved treatments, and has the potential to be the first new primary treatment approved for metastatic melanoma in nearly 20 years. Vical estimates that the worldwide market for Allovectin-7® as a treatment for metastatic melanoma could exceed $500 million annually. The novel mechanism of action of Allovectin-7® gives it the potential to be successfully used in other types of solid tumors, which could further expand its total use.
Allovectin-7® has been granted orphan drug designation for the treatment of invasive and metastatic melanoma by the FDA's Office of Orphan Products Development. Orphan drug designation provides U.S. marketing exclusivity for seven years if marketing approval is received from the FDA, in addition to certain tax benefits for qualifying expenses"
note sentiment...i'm hold you should buy.
Evidence on approved melanoma drug Oncept re: trial arm survival: "These dogs [in the trials] had a median survival time of 389 days, a dramatic increase in survival (most dogs with advanced malignant melanoma have a median survival time of only 60-90 days with presently available therapies). There has been no toxicity noted in any dogs receiving DNA melanoma vaccines to date." Source: Animal Medical Center, NYC -- one key site in Merial dog cancer drug trial using Vical's Naked DNA vaccine platform.
Eligible patients will have a 66% chance of receiving Allovectin-7® alone (an investigational product designed to train your body's immune system to recognize and destroy tumor cells) vs. a 33% chance of receiving standard chemotherapy (either dacarbazine or temozolomide).
Sentiment: Strong Buy
If it is a break-through and the trial arms is surviving longer than VICL predicted, why not stop the trial and approve the drug ASAP to save lives. Why holding it while people are dying of melanoma? This is BS. All I can say is that VICL modeled it wrong and is now realized that their calculation will not be statistical significant.