Big article on avxt late in the day at stockhouse.com smack dab on the front page. avxt allready up over 1 point in after hours. stockhouse.com
stockhouse.com
June 13, 2000
StockHouse News Desk
By Bob Sicignano (bsicignano@stockhouse.com)
BioMedical Columnist
AVAX Technologies To Market World's First Cancer Vaccine
AVAX's personal cancer vaccines are increasing survivability in
some very stubborn, hard-to-treat cancers. All is set to go in
Australia, and the FDA approvals are not far behind, resulting in
Gruntal issuing a "strong buy."
Miami, FL, June 13 /SHfn/ -- The revolution in personal products is about to
reach a new level with the introduction of AVAX's personalized cancer vaccines
made from a patient's own tumor. The positive results in difficult-to-treat cancers
are pouring in, but the company's stock price refuses to budge. With the
introduction of M-VAX? in Australia, and continued successes here in the US, this may change.
A recent StockHouse story devoted to Maxim Pharmaceutical's [MAXM] new malignant melanoma drug therapy elicited a
tremendous reader response. All claimed that AVAX Technologies, Inc. [AVXT] was actually closer to marketing its therapy for
malignant melanoma than was Maxim. Indeed they are right. Further, some stated the stock price was in the bargain basement
and getting ready to ride the express elevator up to the top floor. Gruntal apparently agrees, issuing a "strong buy" last week, with
intermediate and long-term targets of $18 and $24, respectively. AVAX is trading at $9.
AVAX Technologies, Inc. is a development-stage biotechnology company that licenses various
technologies, primarily vaccines for the treatment of cancer.
The company is developing and testing autologous vaccines designed to stimulate the immune
system into action in order to fight cancer. An autologous vaccine harvests a patient's own tumor
cells, modifies them, and then injects them back into the body. The AVAX testing protocol, as it
relates to melanoma, pits the vaccine against the standard treatment, the drug alpha interferon.
The modification is known as "haptenization." Simply stated, the tumor cells are altered in order to make them appear foreign to
the immune system. Once injected back into the patient, the immune system recognizes the cells as enemies, and destroys
them. The immune response is lasting in that the effects extend to unmodified cancerous cells.
AVAX's lead product is the M-VAX vaccine for malignant melanoma. AVAX president and CEO Jeffrey Jonas stated, "We are now
in pivotal trials for US approval for melanoma, with the largest trial being stage 3 melanoma." One of things that distinguishes AVAX
from others is the consistent five-year data with stage 3 melanoma patients. "Most of our data," Jonas continued, "when compared
to historical controls, have typically shown consistent prolongation of survival in the two- to three-fold area." A typical regimen is an
injection once a week for seven weeks followed by a six-month booster shot.
The company has established a very aggressive timeline to introduce this product. Through a 65%-owned partnership in Australia,
AVAX will be up and running in that country later on this month. According to Jonas, he believes that not only will this be the first
commercially available individualized cancer vaccine in the world, it will be the first cancer vaccine in the world of any variety.
AVAX is also testing is its O-VAX? vaccine for treatment of ovarian cancer. In a small study of
women who failed to respond to conventional chemotherapy, eight out of 10 patients responded
favorably to the O-VAX, as measured by a skin test designed to indicate a patient's immune
response. The company reported a complete regression in one woman.
In fact, the results have been so good with O-VAX that management may measure its clinical
results against survivability alone, avoiding more subjective measures such as tumor shrinkage, as
other companies do. As any researcher knows, shrinking a tumor does not necessarily lead to a
longer life. Ovarian cancer is a major gynecological disease diagnosed in 25,400 women last year.
14,000 women are expected to die this year from the disease.
The O-VAX data is looking so good that it may actually eclipse M-VAX in efficaciousness and go to market in the US more quickly
than M-VAX. Whatever the indication, Gruntal targets a US product launch in 2003. The company has spent a good deal of time
perfecting the manufacturing process and it is confident that, because it is a personalized vaccine, without need for things like
inventory and shelf space, the company can market the product without a strategic partner. With a burn rate of $10 million a year,
its $33 million cash position should take AVAX through the marketing phase.
Patient-specific drugs have their share of detractors. Skeptics wonder how a drug that is different every time it is administered can
be pure and efficacious, and analysts wonder if Big Pharma will ever become interested in this class of drugs because they are
only interested in off-the-shelf varieties that cost less than tailor-made drugs. But the only way to evaluate a development-stage
biotech company, or any drug company for that matter, is to determine whether or not the product works better than the
competition. For patients and investors, inconvenient manufacturing arrangements and a slightly higher cost to market are the least
of their worries. The product works.
Patient-specific vaccines will have to rely more on Good Manufacturing Practices (GMP) than other drug companies in order to
obtain FDA approval. Every vaccine, being different than the one before, will have to adhere to the strictest GMPs in order to ensure
that haptenization is standard within the context of that particular vaccine. Management has made GMP a priority, spending time
and money on this at the front-end of this project. While difficult, FDA approval is not impossible, and, in fact, is likely, given the
clinical results.
One of the advantages AVAX has is that management comes from the pharmaceutical industry, either in drug development or
marketing. President and CEO Jonas, for example, was the former president of Clinical Development and Chief Medical Officer at
the Upjohn Company. Scanning the roster reveals a depth of experience rarely seen in a company so small.
The scientific evidence suggests that a drug developed from a patient's own tumor is superior to an off-the-shelf, non-autologous
product. The exciting thing for both patients and investors is the broad potential of these vaccines in many different cancers. David
Berd, MD, inventor of the vaccine, said recently that in theory, the AC Vaccine? technology is applicable to any tumor. If true,
AVAX will no longer be a lone voice in the wilderness. |
