Status: U Return-Path: Received: from whmx-nag.pas.sa.earthlink.net ([127.0.0.1]) by whmx-nag.pas.sa.earthlink.net (EarthLink SMTP Server) with SMTP id 1ocB1o6973NZFmC0; Thu, 13 May 2010 09:12:26 -0700 (PDT) Received: from smtp171.iad.emailsrvr.com ([207.97.245.171]) by whmx-nag.pas.sa.earthlink.net (EarthLink SMTP Server) with ESMTP id 1ocB1k6ZC3NZFmC0 for ; Thu, 13 May 2010 09:12:22 -0700 (PDT) Received: from relay17.relay.iad.mlsrvr.com (localhost [127.0.0.1]) by relay17.relay.iad.mlsrvr.com (SMTP Server) with ESMTP id 2ACE51B96A4; Thu, 13 May 2010 12:12:07 -0400 (EDT) Received: by relay17.relay.iad.mlsrvr.com (Authenticated sender: merilee-AT-marketmediaconnect.com) with ESMTPA id 89C391B96A1; Thu, 13 May 2010 12:12:06 -0400 (EDT) Message-ID: <5200C22038C54168BC74E11918197EF4@merilee07cf8a9> Reply-To: "Merilee Kern" From: "Merilee Kern" To: , Subject: DOTmed Business News Placement Date: Thu, 13 May 2010 09:12:09 -0700 MIME-Version: 1.0 Content-Type: multipart/related; boundary="----=_NextPart_000_01A4_01CAF27C.5DAD85C0"; type="multipart/alternative" X-Priority: 3 X-MSMail-Priority: Normal X-Mailer: Microsoft Outlook Express 6.00.2900.5931 X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2900.5931 X-ELNK-AV: 0 X-ELNK-Info: sbv=0; sbrc=.0; sbf=00; sbw=000; This is a multi-part message in MIME format. ------=_NextPart_000_01A4_01CAF27C.5DAD85C0 Content-Type: multipart/alternative; boundary="----=_NextPart_001_01A5_01CAF27C.5DAD85C0" ------=_NextPart_001_01A5_01CAF27C.5DAD85C0 Content-Type: text/plain; charset="utf-8" Content-Transfer-Encoding: quoted-printable http://www.dotmed.com/news/story/12673/ =20 The DCVax vaccine is a personalized cancer treatment that uses a patient's own tumor cells.Banking on Success: Keeping Tumor Tissue for = Use in Cancer Treatment May 13, 2010 by Heather Mayer, DOTmed Staff Reporter When Robert Gibbs, 41, was diagnosed with a Grade 2 brain tumor in 2004, = he didn't have many treatment options other than the traditional = chemotherapy, radiation and surgery. But unfortunately for Gibbs, his = 2005 surgery didn't completely wipe out the cancer, and in 2008 it was = back.=20 "I had everything going for me," he said. "And it all came to a = screeching halt."=20 His second surgery left him legally blind and searching for a better = treatment option. It was then he turned to a clinical trial testing a = tumor vaccine called DCVax.=20 "Other than being legally blind due to the tumor, I'm going through no = other treatment," Gibbs, now six years cancer-free, told DOTmed News. = "[The vaccine] works."=20 The DCVax is a personalized cancer treatment that uses a patient's own = tumor cells, after surgery, to fight off remaining cancers, working like = any other vaccine, explained Linda Powers, chair of the Northwest = Biotherapeutics board, which manufacturers the vaccine.=20 "We found, although heartbreaking, a lot of patients are getting in = touch with Northwest after the tumor tissue was thrown away," Powers = said of patients trying to participate in the company's third clinical = trial, currently underway.=20 Gibbs and his wife, Barb, co-founded the Florida-based national = organization, Miles for Hope, in order to raise money for brain cancer = research and to help spread the word about banking tumor tissue, which = can be used in a treatment vaccine. The organization also helps people = access clinical trials, which could save their lives, as it did for = Gibbs.=20 "If it wasn't for family or friends with frequent flyer miles, we may = not have opted to participate [in the trial]," he said. "[Miles for = Hope] makes sure people have access to cutting-edge treatment to save = lives."=20 PERSONALIZED THERAPY=20 Northwest Biotherapeutics, is not the first to come out with a = personalized cancer vaccine. Dendreon was the first company to get FDA = approval to commercially market a personalized vaccine for prostate = cancer last month. But Northwest Biotherapeutics is following the trend = of immune-system-based treatments.=20 Unlike Dendreon, Northwest Biotherapeutics uses individual patient = tissue as opposed to a tumor-specific antigen, making DCVax even more = personalized, explained Linda Liau, vice chair of neurosurgery at UCLA = and the trial's lead researcher.=20 "Everyone has written off immune therapies," said Powers. "Finally, = after all this time, the research community has continued to work on = understanding the biology...Dendreon had FDA approval for immune = therapy. There will be a flood of more immune therapies."=20 he DCVax, which is in its third stage of clinical trials, sends a = message to the entire immune system to fight remaining tumor cells, = literally picking up the pieces of the tumor not removed through = surgery.=20 Researchers found that the immune system could fight off everyday = infections -- influenza, colds, pneumonia -- but it was obviously = succumbing to a tumor. What they discovered was that the dendritic cells = or the "generals" of the immune system, as Powers explained, were not = getting the message to fight off the malignant tumor.=20 "The immune system is keeping you healthy other than your cancer," = Powers said. "That's the perplexing thing. Why is it not doing the job = on cancer?"=20 "The problem in the body is not a lack of dendritic cells," she said. = "It's that they're sitting around on a battlefield not receiving orders. = The signals are not getting through. Tumors have a variety of ways of = blocking signals."=20 The vaccine not only tells the dendritic cells to shift out of = surveillance and into attack mode, it also provides the immune system = with the biomarkers of the tumor, which come from the patient's tumor = tissue. This tells the cells what they need to attack.=20 Once these signals are received, "they go right to work," Powers = explained. "They do their normal job in a normal way."=20 What differentiates this type of cancer treatment from traditional = methods like radiation and chemotherapy is the vaccine merely restores = the natural function of the immune system, which has been interfered = with by the tumor. There are no chemicals or drugs involved, eradicating = the severe side effects from traditional cancer treatments.=20 "It works like a regular vaccine," Gibbs said. "What makes it different = is that it's patient-specific. There's no rejection [from the body] and = no toxic side effects."=20 The only reported side effects have been fever, skin irritation at the = injection site, fatigue -- side effects similar to any vaccine, said = Liau.=20 While hundreds of clinical trials have not reported toxicity with = dendritic treatment, Liau pointed out that there is always a possibility = of seeing side effects later on, especially with an autoimmune response. = "When you induce the immune response against its own tumor, the concern = is the risk that you can over-activate it against its own normal = tissue," she said. "We haven't seen that...The thought is that tumor = tissue is so different from a patient's own normal brain tissue that the = immune system can differentiate [the two.]"=20 Northwest Biotherapeutics has reported from previous trials that = patients who received standard treatment in addition to the vaccine = lived, on average, 36 months after diagnosis, compared with just 14 to = 16 months for those who did not receive the vaccine.=20 Currently, more than 20 percent of patients reached the six-year mark or = more, said Powers.=20 "With conventional treatment -- surgery, radiation, chemotherapy -- no = one makes it to six years," she said.=20 But because the vaccine is still in clinical trial, patients also must = go through traditional treatments, Powers said.=20 "You have to give standard of care," she said. "If something is = experimental, it can only be additional."=20 TUMOR BANKING=20 What makes the DCVax vaccine possible is the utilization of a patient's = tumor tissue and blood sample. In order for the vaccine to be created, = patients need to store their tumor tissue after surgical removal in a = tissue bank, not unlike an umbilical cord bank or blood bank.=20 After surgery, hospitals collect a small sample of the tumor for their = archives, but that does not belong to the patient, explained Powers.=20 "Hospitals only store a small sample," she said. "Today, the rest gets = thrown into the trash can," which makes a vaccine treatment impossible.=20 "Once tissue is out of the patient and the hospital takes a sample, = that's it," she said. "Patients can't access it. Who does it belong to? = Who gets to use it? Not the patient."=20 For this reason, HealthBank, a bio banking company, recently announced = that it will store tumor tissue. According to HealthBank, the initial = process of freezing a patient's tumor tissue and the first year of = storage costs $1,995. After the first year, it costs $195 per year of = storage.=20 In order for a patient to store his or her tissue, arrangements are made = prior to surgery to put together a kit, which is delivered to = HealthBank, or a similar storage bank, like Wake Forest University = Baptist Medical Center or Penn State Hershey Cancer Institute, and then = delivered to a doctor or clinic where the tissue will be used for = treatments, like personalized vaccines.=20 But tissue banking offers more opportunities than just personalized = medicine. Researchers can genetically profile a patient's tumor, which = can evaluate the cancer and its prognosis. This allows doctors and = researchers to cater treatment to a specific patient.=20 Another promising possibility of tissue banking is chemo-sensitivity = testing, which can help identify which drugs the tumor will respond to. = This allows patients to avoid unnecessary chemotherapy treatments.=20 "With chemo-sensitivity testing, you can test a particular drug regimen = directly in a lab dish and learn what works the best," said Powers. = "Most cancer drugs only work, clinical research has shown, in 25 to 30 = percent of patients, but all of the patients get the toxicity. Instead = of finding out the hard way, you can start to find out with = chemo-sensitivity testing."=20 A WONDER DRUG?=20 Cancer experts aren't dubbing the investigational personalized vaccine = the wonder drug just yet. In fact, it may never be used on its own as a = cancer treatment, said William Chambers, director of clinical research = and immunology at the American Cancer Society.=20 "I would hesitate to call it the wonder drug," he told DOTmed News. = "They've done a really great job, and let's continue to look and see = where it goes from here."=20 Chambers pointed out that the researchers were smart to include = vaccination as a part of treatment for brain tumors. The vaccine is a = good way to attack certain elements of the tumor that are hard to get to = through surgery or chemotherapy.=20 But ultimately, a multiple-strategy approach is best, said Chambers.=20 "With most tumors, it's a pretty good idea to have a one, two ... three = punch because of the ability of tumors to change," he said.=20 COST OF LIFE=20 Because Gibbs was part of a clinical trial, his treatment has been = completely free, barring travel costs. Powers was unable to disclose how = much vaccine manufacturing costs Northwest Biotherapeutics, but she said = it's very affordable.=20 "Our pricing will be dramatically lower than pricing that Dendreon = announced," she said.=20 Dendreon charges $31,000 per infusion; a full-course treatment includes = three infusions over the course of one month.=20 She also pointed out that analyses indicate the vaccine will fall "well = within the zone for reimbursement."=20 While the widely held belief is that personalized medicine is extremely = expensive, Powers explained that for each patient, Northwest = Biotherapeutics can manufacture three years worth of vaccination, making = the process cost-effective, similar to mass manufacture of prescription = pills.=20 "The concept is, the manufacturing itself is really expensive because = it's personalized," she said. "But storage is cheap. Northwest makes the = biggest batch it can make from a quantity of tissue and freezes it in = single doses. After that, it's cheap; it turns into an off-the-shelf = product."=20 Patients in the trial receive a vaccination every couple of weeks = starting six weeks after surgery. The dose administration is reduced to = every couple of months and then twice a year until the product runs out. = "The amount of tissue is the limiting factor," Powers said.=20 Northwest Biotherapeutics will be able to ever further lessen its costs = by making the process completely automated. Currently, the FDA has = approved partial automation for the company, Powers said.=20 "Costs are already manageable to charge less than current antibodies = that are not personalized," she said.=20 But when it comes to the patient, this vaccine would be covered by = insurance.=20 MOVING FORWARD=20 Due to FDA policy, clinical testing for drug treatments can focus on = only one disease at a time. In the case of DCVax, it is only being = tested on brain cancer, but that doesn't mean it wouldn't work on other = cancers, explained Powers.=20 "It should work on any type of cancer," she said. "We're just restoring = the natural function of the immune system."=20 The patients in the Northwest Biotherapeutics trials, which started = about 10 years ago, all had Grade 4 tumors, with a few Grade 3 = exceptions like the reappearance of Gibbs' condition. If approved for = commercial sale, DCVax would only be for Grade 4 tumors, explained Liau. = "It's up to the FDA, what they feel is safe," she said. "Scientifically = there is not a huge reason to think it wouldn't also be applicable [to = lower-grade tumors]."=20 A successful personalized cancer vaccine blows the door wide open for = personalized medicine and immune therapies, said Liau.=20 "If we're able to show efficacy, I think it really does help to = transition the concept of personal medicine into reality," she said. = "One reason we don't have a cure for cancer yet is because not every = cancer is the same. There's not going to be one drug for all types of = brain cancer."=20 ------=_NextPart_001_01A5_01CAF27C.5DAD85C0 Content-Type: text/html; charset="utf-8" Content-Transfer-Encoding: quoted-printable =EF=BB=BF
 
The DCVax vaccine = is
a=20 personalized cancer
treatment that uses a
patient's own tumor=20 cells.

Banking on Success: Keeping Tumor Tissue = for Use in=20 Cancer Treatment

May 13, = 2010
by Heather Mayer, DOTmed Staff=20 Reporter
 
When Robert Gibbs, 41, was diagnosed with a Grade 2 brain = tumor in=20 2004, he didn't have many treatment options other than the traditional=20 chemotherapy, radiation and surgery. But unfortunately for Gibbs, his = 2005=20 surgery didn't completely wipe out the cancer, and in 2008 it was back.=20

"I had everything going for me," he said. "And it all came to a=20 screeching halt."

His second surgery = left him=20 legally blind and searching for a better treatment option. It was then = he turned=20 to a clinical trial testing a tumor vaccine called DCVax.

"Other = than=20 being legally blind due to the tumor, I'm going through no other = treatment,"=20 Gibbs, now six years cancer-free, told DOTmed News. "[The vaccine] = works."=20

The DCVax is a personalized cancer treatment that uses a = patient's own=20 tumor cells, after surgery, to fight off remaining cancers, working like = any=20 other vaccine, explained Linda Powers, chair of the Northwest = Biotherapeutics=20 board, which manufacturers the vaccine.

"We found, although=20 heartbreaking, a lot of patients are getting in touch with Northwest = after the=20 tumor tissue was thrown away," Powers said of patients trying to = participate in=20 the company's third clinical trial, currently underway.

Gibbs = and his=20 wife, Barb, co-founded the Florida-based national organization, Miles = for Hope,=20 in order to raise money for brain cancer research and to help spread the = word=20 about banking tumor tissue, which can be used in a treatment vaccine. = The=20 organization also helps people access clinical trials, which could save = their=20 lives, as it did for Gibbs.

"If it wasn't for family or friends = with=20 frequent flyer miles, we may not have opted to participate [in the = trial]," he=20 said. "[Miles for Hope] makes sure people have access to cutting-edge = treatment=20 to save lives."

PERSONALIZED THERAPY

Northwest = Biotherapeutics,=20 is not the first to come out with a personalized cancer vaccine. = Dendreon was=20 the first company to get FDA approval to commercially market a = personalized=20 vaccine for prostate cancer last month. But Northwest Biotherapeutics is = following the trend of immune-system-based treatments.

Unlike = Dendreon,=20 Northwest Biotherapeutics uses individual patient tissue as opposed to a = tumor-specific antigen, making DCVax even more personalized, explained = Linda=20 Liau, vice chair of neurosurgery at UCLA and the trial's lead = researcher.=20

"Everyone has written off immune therapies," said Powers. = "Finally,=20 after all this time, the research community has continued to work on=20 understanding the biology...Dendreon had FDA approval for immune = therapy. There=20 will be a flood of more immune therapies."
he DCVax, which is in its third stage of clinical trials, = sends a=20 message to the entire immune system to fight remaining tumor cells, = literally=20 picking up the pieces of the tumor not removed through surgery.=20

Researchers found that the immune system could fight off = everyday=20 infections -- influenza, colds, pneumonia -- but it was obviously = succumbing to=20 a tumor. What they discovered was that the dendritic cells or the = "generals" of=20 the immune system, as Powers explained, were not getting the message to = fight=20 off the malignant tumor.

"The = immune=20 system is keeping you healthy other than your cancer," Powers said. = "That's the=20 perplexing thing. Why is it not doing the job on cancer?"

"The = problem=20 in the body is not a lack of dendritic cells," she said. "It's that = they're=20 sitting around on a battlefield not receiving orders. The signals are = not=20 getting through. Tumors have a variety of ways of blocking signals." =

The=20 vaccine not only tells the dendritic cells to shift out of surveillance = and into=20 attack mode, it also provides the immune system with the biomarkers of = the=20 tumor, which come from the patient's tumor tissue. This tells the cells = what=20 they need to attack.

Once these signals are received, "they go = right to=20 work," Powers explained. "They do their normal job in a normal way."=20

What differentiates this type of cancer treatment from = traditional=20 methods like radiation and chemotherapy is the vaccine merely restores = the=20 natural function of the immune system, which has been interfered with by = the=20 tumor. There are no chemicals or drugs involved, eradicating the severe = side=20 effects from traditional cancer treatments.

"It works like a = regular=20 vaccine," Gibbs said. "What makes it different is that it's = patient-specific.=20 There's no rejection [from the body] and no toxic side effects." =

The=20 only reported side effects have been fever, skin irritation at the = injection=20 site, fatigue -- side effects similar to any vaccine, said Liau. =

While=20 hundreds of clinical trials have not reported toxicity with dendritic = treatment,=20 Liau pointed out that there is always a possibility of seeing side = effects later=20 on, especially with an autoimmune response.

"When you induce the = immune=20 response against its own tumor, the concern is the risk that you can=20 over-activate it against its own normal tissue," she said. "We haven't = seen=20 that...The thought is that tumor tissue is so different from a patient's = own=20 normal brain tissue that the immune system can differentiate [the two.]" =

Northwest Biotherapeutics has reported from previous trials that = patients who received standard treatment in addition to the vaccine = lived, on=20 average, 36 months after diagnosis, compared with just 14 to 16 months = for those=20 who did not receive the vaccine.
Currently, more than 20 percent of = patients=20 reached the six-year mark or more, said Powers.

"With = conventional=20 treatment -- surgery, radiation, chemotherapy -- no one makes it to six = years,"=20 she said.

But=20 because the vaccine is still in clinical trial, patients also must go = through=20 traditional treatments, Powers said.

"You have to give standard = of=20 care," she said. "If something is experimental, it can only be = additional."=20

TUMOR BANKING

What makes the DCVax vaccine possible is = the=20 utilization of a patient's tumor tissue and blood sample. In order for = the=20 vaccine to be created, patients need to store their tumor tissue after = surgical=20 removal in a tissue bank, not unlike an umbilical cord bank or blood = bank.=20

After surgery, hospitals collect a small sample of the tumor for = their=20 archives, but that does not belong to the patient, explained Powers.=20

"Hospitals only store a small sample," she said. "Today, the = rest gets=20 thrown into the trash can," which makes a vaccine treatment impossible.=20

"Once tissue is out of the patient and the hospital takes a = sample,=20 that's it," she said. "Patients can't access it. Who does it belong to? = Who gets=20 to use it? Not the patient."

For this reason, HealthBank, a bio = banking=20 company, recently announced that it will store tumor tissue. According = to=20 HealthBank, the initial process of freezing a patient's tumor tissue and = the=20 first year of storage costs $1,995. After the first year, it costs $195 = per year=20 of storage.

In order for a patient to store his or her tissue,=20 arrangements are made prior to surgery to put together a kit, which is = delivered=20 to HealthBank, or a similar storage bank, like Wake Forest University = Baptist=20 Medical Center or Penn State Hershey Cancer Institute, and then = delivered to a=20 doctor or clinic where the tissue will be used for treatments, like = personalized=20 vaccines.

But tissue banking offers more opportunities than just = personalized medicine. Researchers can genetically profile a patient's = tumor,=20 which can evaluate the cancer and its prognosis. This allows doctors and = researchers to cater treatment to a specific patient.

Another = promising=20 possibility of tissue banking is chemo-sensitivity testing, which can = help=20 identify which drugs the tumor will respond to. This allows patients to = avoid=20 unnecessary chemotherapy treatments.

"With chemo-sensitivity = testing,=20 you can test a particular drug regimen directly in a lab dish and learn = what=20 works the best," said Powers. "Most cancer drugs only work, clinical = research=20 has shown, in 25 to 30 percent of patients, but all of the patients get = the=20 toxicity. Instead of finding out the hard way, you can start to find out = with=20 chemo-sensitivity testing."
A WONDER DRUG?

Cancer experts = aren't=20 dubbing the investigational personalized vaccine the wonder drug just = yet. In=20 fact, it may never be used on its own as a cancer treatment, said = William=20 Chambers, director of clinical research and immunology at the American = Cancer=20 Society.

"I would hesitate to = call it the=20 wonder drug," he told DOTmed News. "They've done a really great job, and = let's=20 continue to look and see where it goes from here."

Chambers = pointed out=20 that the researchers were smart to include vaccination as a part of = treatment=20 for brain tumors. The vaccine is a good way to attack certain elements = of the=20 tumor that are hard to get to through surgery or chemotherapy. =

But=20 ultimately, a multiple-strategy approach is best, said Chambers. =

"With=20 most tumors, it's a pretty good idea to have a one, two ... three punch = because=20 of the ability of tumors to change," he said.

COST OF LIFE=20

Because Gibbs was part of a clinical trial, his treatment has = been=20 completely free, barring travel costs. Powers was unable to disclose how = much=20 vaccine manufacturing costs Northwest Biotherapeutics, but she said it's = very=20 affordable.

"Our pricing will be dramatically lower than pricing = that=20 Dendreon announced," she said.

Dendreon charges $31,000 per = infusion; a=20 full-course treatment includes three infusions over the course of one = month.=20

She also pointed out that analyses indicate the vaccine will = fall "well=20 within the zone for reimbursement."

While the widely held belief = is that=20 personalized medicine is extremely expensive, Powers explained that for = each=20 patient, Northwest Biotherapeutics can manufacture three years worth of=20 vaccination, making the process cost-effective, similar to mass = manufacture of=20 prescription pills.

"The concept is, the manufacturing itself is = really=20 expensive because it's personalized," she said. "But storage is cheap. = Northwest=20 makes the biggest batch it can make from a quantity of tissue and = freezes it in=20 single doses. After that, it's cheap; it turns into an off-the-shelf = product."=20

Patients in the trial receive a vaccination every couple of = weeks=20 starting six weeks after surgery. The dose administration is reduced to = every=20 couple of months and then twice a year until the product runs out. =

"The=20 amount of tissue is the limiting factor," Powers said.

Northwest = Biotherapeutics will be able to ever further lessen its costs by making = the=20 process completely automated. Currently, the FDA has approved partial = automation=20 for the company, Powers said.

"Costs are already manageable to = charge=20 less than current antibodies that are not personalized," she said. =
But when=20 it comes to the patient, this vaccine would be covered by insurance.=20

MOVING FORWARD

Due to = FDA policy,=20 clinical testing for drug treatments can focus on only one disease at a = time. In=20 the case of DCVax, it is only being tested on brain cancer, but that = doesn't=20 mean it wouldn't work on other cancers, explained Powers.

"It = should=20 work on any type of cancer," she said. "We're just restoring the natural = function of the immune system."

The patients in the Northwest=20 Biotherapeutics trials, which started about 10 years ago, all had Grade = 4=20 tumors, with a few Grade 3 exceptions like the reappearance of Gibbs' = condition.=20 If approved for commercial sale, DCVax would only be for Grade 4 tumors, = explained Liau.

"It's up to the FDA, what they feel is safe," = she said.=20 "Scientifically there is not a huge reason to think it wouldn't also be=20 applicable [to lower-grade tumors]."

A successful personalized = cancer=20 vaccine blows the door wide open for personalized medicine and immune = therapies,=20 said Liau.

"If we're able to show efficacy, I think it really = does help=20 to transition the concept of personal medicine into reality," she said. = "One=20 reason we don't have a cure for cancer yet is because not every cancer = is the=20 same. There's not going to be one drug for all types of brain cancer."=20
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