Home About Us Become a Member Contact Us WinPicks Software Scoresline Talksport Advertise
 Forum   Terms of Service   Research   Market News   Mutual Funds   IPO's   Other Tools   
 
Forums   Register   Profile   Inbox   Address Book   Subscribe   My Forums   Search   FAQ   Login   Log Out

Immunovaccine Receives Clearance From FDA 2 Proceed With Phase 1 Clinical Trial 4 Its Therapeutic   Logged in as: Guest
Users viewing this topic: none
  Printable Version
All Forums >> [Market Sectors] >> Healthcare and Pharmaceutical Stocks >> Immunovaccine Receives Clearance From FDA 2 Proceed With Phase 1 Clinical Trial 4 Its Therapeutic Page: [1]
Login
Message << Older Topic   Newer Topic >>
Immunovaccine Receives Clearance From FDA 2 Proceed Wit... - 12/13/2009 11:04:18 AM   
michaelisin4u

 

Posts: 5653
Joined: 5/31/2008
Status: online
Immunovaccine Receives Clearance From FDA to Proceed With Phase 1 Clinical Trial for Its Therapeutic

Immunovaccine Inc. (TSX VENTURE:IMV) announced today that its Investigational New Drug (IND) application for its therapeutic cancer vaccine, DPX-0907, has been cleared by the U.S. Food and Drug Administration (FDA). DPX-0907 is Immunovaccine's lead therapeutic vaccine candidate. The vaccine uses the DepoVax™ platform to deliver tumor specific antigens. DPX-0907 is designed to cause a depot effect that has the potential to stimulate the body's immune system to seek out and destroy cancer cells in patients with breast, ovarian and prostate cancer.

"The successful FDA review of our IND submission confirms our confidence in our regulatory and development strategy," said Dr. Randal Chase, Immunovaccine's president and CEO. "DPX-0907 is an appealing vaccine candidate to advance into human clinical trials because it combines the strength of our DepoVax™ platform with cancer signature antigens."

The Phase 1 clinical trial for DPX-0907 will be conducted at five sites in the US and is on track to begin enrolling patients with breast, ovarian, and prostate cancers by the end of Q1 2010. The Phase 1 clinical trial will evaluate the safety and tolerability of Immunovaccine's patented DepoVax™ delivery system and seven tumor-associated antigens.

The activity of DPX-0907 has been demonstrated in preclinical models whereby the vaccine produced a specific cellular immune response that was superior to immune responses achieved with other oil depot vaccines. Preclinical research also reveals DPX-0907 does not induce regulatory T-cell immune suppression, therefore enabling a longer lasting anti-tumor immune response. The DepoVax™ delivery platform used to formulate DPX-0907 was capable of achieving 100% therapeutic tumor elimination using established preclinical models.

Therapeutic cancer vaccines represent one of the most promising and rapidly advancing frontiers in drug discovery. DepoVax™, Immunovaccine's patented vaccine delivery system, has strong preclinical data that has shown it to be a safe and effective way to deliver antigens. The DepoVax™ platform is protected by a strong portfolio of issued patents and pending patent applications.

Immunovaccine Inc. (TSX VENTURE:IMV) is focused on the commercialization of its novel vaccine technology and product candidates. The company continues to strengthen its vaccine pipeline through licensing and strategic partnerships to develop therapeutic cancer and infectious disease vaccines

http://pr-usa.net/index.php?option=com_content&task=view&id=302330&Itemid=29


< Message edited by michaelisin4u -- 12/13/2009 11:13:12 AM >
Post #: 1
RE: Immunovaccine Receives Clearance From FDA 2 Proceed... - 12/13/2009 11:11:31 AM   
michaelisin4u

 

Posts: 5653
Joined: 5/31/2008
Status: online
Q2 09 Quarterly Report

http://www.deliveringbreakthroughs.com/library/Immunovaccine%20Inc%20-%20September%2030%202009%20_Final%20To%20SEDAR_.pdf



http://www.imvaccine.com/investors.php




http://www.imvaccine.com/



http://investdb.theglobeandmail.com/invest/investSQL/gx.estimate_prof?symbol_in=imv



http://bigcharts.marketwatch.com/advchart/frames/main.asp?time=6&freq=1&compidx=aaaaa%3A0&comp=NO_SYMBOL_CHOSEN&ma=4&maval=9+15+50&uf=7168&lf=1&lf2=4&lf3=1073741824&type=4&style=320&size=3&sid=0&o_symb=ca:imv&startdate=&enddate=&show=true&symb=ca:imv&draw.x=51&draw.y=12




FREE RealTime Charts ---- IMV.V Immunovaccine
http://www.bestfreecharts.com/









< Message edited by michaelisin4u -- 2/5/2010 12:01:28 PM >

(in reply to michaelisin4u)
Post #: 2
RE: Immunovaccine Receives Clearance From FDA 2 Proceed... - 12/13/2009 12:27:19 PM   
michaelisin4u

 

Posts: 5653
Joined: 5/31/2008
Status: online
N.S. lab gets green light for cancer vaccine... VIDEO

CTVca News Staff

Date: Sat. Dec. 12 2009 8:37 AM ET

A small Halifax laboratory has received permission from the U.S. Food and Drug Administration to conduct human trials on a cancer vaccine.

Created 10 years ago at Dalhousie University in Halifax, N.S., Immunovaccine Inc. is a publicly-traded biotechnology company that develops vaccines for human health.

Genevieve Weir, a research project manager for Immunovaccine, emphasized that the vaccine is unique both in its content and delivery system.

"It contains seven different antigens to target seven different pathways in cancer," she told CTV Atlantic in Halifax. "The vaccine itself will stay in the body for two weeks, but the immune response is long-lasting and will be maintained over several years."

With the administration's approval, Immunovaccine will enter the first phase of human clinical trials. It aims to develop a "therapeutic cancer vaccine" for breast, ovarian and prostate cancers, said Brian Lowe, the company's vice-president.

"If we can have success through phase one of human clinical trials, that will prove that our technology is safe on humans," he told CTV Atlantic.

But the vaccine must pass a total of three tests to be approved. If there are no problems, it may available on the market by 2015.

Twenty patients whose cancer is in remission will participate in the first phase. If these trials are successful, then the number of tested patients will increase in the second phase, which Lowe said will cost from $22- to $25-million. The third and final phase will be the most expensive, costing hundreds of millions of dollars.

Lowe said he is confident that the vaccine will be successful.

"We feel after a phase two and proven success, we will be able to partner with Big Pharma (the largest pharmaceutical companies in the U.S.) with an enhanced value proposition," he said.

Wier added that she is encouraged by the FDA's support.

"For them to say...'it meets the standard, it looks promising, go ahead and inject into humans; we're confident in you,' it's wonderful," she said.

The company will begin testing its cancer vaccine in five American cities early next year.

http://www.ctv.ca/servlet/ArticleNews/story/CTVNews/20091210/ns_pharma_091212/20091212?hub=Health

(in reply to michaelisin4u)
Post #: 3
RE: Immunovaccine Receives Clearance From FDA 2 Proceed... - 12/28/2009 10:20:33 PM   
michaelisin4u

 

Posts: 5653
Joined: 5/31/2008
Status: online
Immunovaccine to proceed with trial for its cancer vaccine

by Paul Tinder on December 26, 2009

HALIFAX, NOVA SCOTIA — Immunovaccine Inc. announced Dec. 9 that its Investigational New Drug (IND) application for its therapeutic cancer vaccine, DPX-0907, has been cleared by the U.S. Food and Drug Administration.

DPX-0907 is Immunovaccine's lead therapeutic vaccine candidate. The vaccine uses the DepoVax platform to deliver tumor-specific antigens. DPX-0907 has the potential to stimulate the body's immune system to seek out and destroy cancer cells in patients with breast, ovarian and prostate cancer.

"The successful FDA review of our IND submission confirms our confidence in our regulatory and development strategy," said Dr. Randal Chase, Immunovaccine's president and CEO. "DPX-0907 is an appealing vaccine candidate to advance into human clinical trials because it combines the strength of our DepoVax™ platform with cancer signature antigens."

The Phase 1 clinical trial for DPX-0907 will be conducted at five sites in the United States and is on track to begin enrolling patients with breast, ovarian and prostate cancers by the end of April. The Phase 1 clinical trial will evaluate the safety and tolerability of Immunovaccine's DepoVax delivery system and seven tumor-associated antigens.

http://vaccinenewsdaily.com/news/211416-immunovaccine-to-proceed-with-trial-for-its-cancer-vaccine

(in reply to michaelisin4u)
Post #: 4
RE: Immunovaccine Receives Clearance From FDA 2 Proceed... - 1/29/2010 5:47:11 AM   
michaelisin4u

 

Posts: 5653
Joined: 5/31/2008
Status: online
Immunovaccine Grants Stock Options

By: Marketwire .
Jan. 28, 2010 06:00 PM

HALIFAX, NOVA SCOTIA -- (Marketwire) -- 01/28/10 -- Immunovaccine Inc. ("IMV" or the "Company") (TSX VENTURE: IMV) today announced that pursuant to terms and conditions of the Company's stock option plan, it has granted 937,000 stock options to employees, consultants and directors. Employees and consultants were granted an aggregate of 812,000 options and directors were granted an aggregate of 125,000 options. The stock options were granted on December 14, 2009 at an exercise price of $1.46, and will vest one-third in 6, 12, and 18 months from date of grant. The Options are set to expire five years from the date of grant.

Immunovaccine Inc. (TSX VENTURE: IMV) is a clinical stage vaccine development company focused on the commercialization of its patented DepoVax™ vaccine delivery technology and product candidates. The company continues to strengthen its vaccine pipeline through licensing and strategic partnerships to develop therapeutic cancer and infectious disease vaccines.

http://www.yachtchartersmagazine.com/node/1264991

< Message edited by michaelisin4u -- 1/29/2010 5:51:39 AM >

(in reply to michaelisin4u)
Post #: 5
RE: Immunovaccine Receives Clearance From FDA 2 Proceed... - 1/29/2010 5:53:18 AM   
michaelisin4u

 

Posts: 5653
Joined: 5/31/2008
Status: online
YouTube ~ VIDEO ~ 5 Feb 2009
Cure For Cancer - Halifax Nova Scotia
http://www.youtube.com/watch?v=hR3x3NS5GEk



YouTube ~ VIDEO ~ November 26, 2008
Interview with Dr. Randal Chase, CEO of ImmunoVaccine Technologies on Vimeo.flv
http://www.youtube.com/watch?v=JqHFB55XEKI

(in reply to michaelisin4u)
Post #: 6
RE: Immunovaccine Receives Clearance From FDA 2 Proceed... - 2/5/2010 11:17:48 AM   
michaelisin4u

 

Posts: 5653
Joined: 5/31/2008
Status: online
Cancer vaccine set for clinical trials, being pitched to investors

By BILL POWER Business Reporter
Fri. Feb 5 - 7:43 AM
With human clinical trials beginning soon, Immunovaccine Inc. officials in Halifax are about to pitch their therapeutic cancer vaccine before some of the world’s most in­fluential investors. “It is a major transition to go from doing the research to actually going into clinical trials," Randal Chase, the president and chief executive officer, said Thursday in an interview.

Company representatives will also be talking to potential backers about their De­poVax vaccine-delivery platform when they take in the 2010 BIO CEO & Investor Conference, beginning in New York City on Monday.

“We’re a company that’s reached a new plateau in our development," Dr. Chase said.

He said preparations are underway to begin clinical trials in a couple of months of the company’s DPX-0907 therapeutic cancer vaccine that will treat patients who have breast, ovarian or prostate cancers.

Clearance to begin the clinical trials was obtained from the U.S. Food and Drug Ad­ministration in December.

Immunovaccine was invited to make a presentation to potential investors and partner companies at the start of the con­ference. Dr. Chase said about two full days of talks are also scheduled for the Nova Sco­tia delegation.

During the fourth quarter, which ended Dec. 31, the company said it raised about $1 million in licence fees from new animal health agreements.

Pfizer Animal Health , a division of phar­maceutical giant Pfizer Inc. , is using Immu­novaccine’s vaccine-delivery technology.

The cash will be used to cover costs asso­ciated with upcoming clinical trials, said Dr. Chase.

The company has not yet officially re­leased it fourth-quarter 2009 results but in­dicated in a news release it will soon report cash on hand and equivalents of about $7.7 million.

Immunovaccine said in a statement last week it was bringing in SectorSpeak Inc. to assist with investor relations, road shows and introductions to institutional inves­tors and analysts.

SectorSpeak is receiving $5,000 per month and stock options in exchange for its services.


http://thechronicleherald.ca/Business/9015115.html

< Message edited by michaelisin4u -- 2/5/2010 11:21:44 AM >

(in reply to michaelisin4u)
Post #: 7
RE: Immunovaccine Receives Clearance From FDA 2 Proceed... - 2/12/2010 9:15:05 AM   
michaelisin4u

 

Posts: 5653
Joined: 5/31/2008
Status: online
Immunovaccine Presents Results for an Enhanced Anthrax Vaccine Candidate
HALIFAX, NOVA SCOTIA, Feb 08, 2010 (MARKETWIRE via COMTEX) -- Immunovaccine Inc. /quotes/comstock/11v!imv (CA:IMV 1.30, -0.08, -5.80%) announced today that it has been invited to present at the Canada - U.S. Partners in Biomedical Defense II Conference in Washington, D.C. on Wednesday, February 10, 2010. At the Conference the Company will present positive new research, done in collaboration with Defence Research and Development Canada (DRDC), confirming the number of required doses for an anthrax vaccine candidate can be reduced when formulated in DepoVax(TM).

The new research shows that a single-dose of anthrax antigen, when formulated in DepoVax(TM), is able to raise antibody levels that are 10 times higher on average than a comparable alum-adjuvanted anthrax vaccine. Enhanced vaccine antibody titres were noted in separate studies performed by Immunovaccine and DRDC in two different animal models. A single vaccination with anthrax antigen formulated in DepoVax(TM) performed better than two doses of the control vaccine. Persisting high antibody levels were induced within 4 weeks following a single dose of anthrax antigen with DepoVax(TM).

DepoVax is a vaccine delivery platform that uses liposomes to bring active vaccine components - antigens and immune enhancers - into an oil depot. This patented formulation creates a long lasting 'depot effect' that produces a potent humoral and/or cellular immunity, often with a single dose.

"We are pleased that our collaboration with DRDC is progressing well. The results we achieved with anthrax in two different animal species confirms DepoVax's ability to significantly enhance a vaccine against yet another important infectious disease agent," commented Marc Mansour, vice president of R&D at Immunovaccine.

Anthrax is a potential bioterrorism agent that can be life-threatening. Currently, to provide protection from anthrax individuals receive a 6-dose regime with three injections given 2 weeks apart, followed by three additional injections given at 6, 12, and 18 months. Annual booster injections of the vaccine are recommended thereafter.

Immunovaccine Inc. /quotes/comstock/11v!imv (CA:IMV 1.30, -0.08, -5.80%) is a clinical stage vaccine development company focused on the commercialization of its patented DepoVax(TM) vaccine delivery technology and product candidates. The company continues to strengthen its vaccine pipeline through licensing and strategic partnerships to develop therapeutic cancer and infectious disease vaccines.

This press release contains forward-looking information pursuant to applicable securities law. All information that addresses activities or developments that

http://www.marketwatch.com/story/immunovaccine-presents-results-for-an-enhanced-anthrax-vaccine-candidate-2010-02-08?reflink=MW_news_stmp

(in reply to michaelisin4u)
Post #: 8
RE: Immunovaccine Receives Clearance From FDA 2 Proceed... - 2/22/2010 5:39:09 AM   
michaelisin4u

 

Posts: 5653
Joined: 5/31/2008
Status: online
Partnership Aims to Advance a Therapeutic HIV Vaccine

Tuesday, May 26, 2009

ImmunoVaccine Technologies, a Canadian vaccine development company, announced a research partnership with FIT Biotech, a Finland-based clinical-stage company that develops DNA vaccines. This research will formulate FIT Biotech's GTU MultiHIV DNA plasmid with IVT's DepoVax vaccine delivery system to advance a therapeutic HIV vaccine.


RELATED ARTICLES
Nobel Winner Hopeful on Therapeutic Vaccines
Hopes for Curbing HIV Ride on Therapeutic Vaccines
Researchers Find Genes That Can “Turn Off” HIV

"DepoVax will act as a vector to deliver FIT Biotech's GTU MultiHIV DNA vaccine, and our goal is to develop a more sophisticated and efficient HIV vaccine candidate," said Marc Mansour, vice president of research and development at IVT.

"By testing DepoVax in combination with GTU MultiHIV plasmid, we are working toward developing a superior vaccine candidate for therapeutic use against HIV and AIDS," said Kalevi Reijonen, president and CEO at FIT Biotech.

The World Health Organization reports that 33 million people are living with HIV and the epidemic is expanding rapidly with 2.7 million people newly infected in 2007. Nearly all of them will develop AIDS-related complications, creating an urgent need for effective HIV therapeutic vaccines. Therapeutic vaccination offers the most hope for HIV-infected individuals because it maintains a low viral load and has the potential to modify the course of the infection and its progression toward AIDS.

http://www.hivplusmag.com/NewsStory.asp?id=20592&sd=05/26/2009

(in reply to michaelisin4u)
Post #: 9
RE: Immunovaccine Receives Clearance From FDA 2 Proceed... - 3/11/2010 7:49:44 AM   
michaelisin4u

 

Posts: 5653
Joined: 5/31/2008
Status: online
Pfizer Animal Health assets purchased by Lilly
Posted on 09/03/2010 in Animal Health Supplier News

Pfizer Animal Health has agreed a deal which will see it transfer a number of its assets to fellow healthcare group Lilly.

The veterinary pharmaceutical company is selling the European rights to several vaccines, parasiticides and feed additives to Lilly's animal health division Elanco, as part of the terms of its recent acquisition of Wyeth.

As a result, Lilly will also take control of one of Pfizer Animal Health's manufacturing facilities in Sligo, Ireland, with all staff set to be offered positions at Lilly.

In return, Pfizer will receive an undisclosed upfront payment, with the closing of this transaction still subject to approval from the appropriate regulatory bodies.

Jeff Simmons, president of Elanco, welcomed the purchase, saying that Pfizer's product portfolio and facility represent "a natural fit for Elanco and positions us well for sustained growth".

Last week, Pfizer Animal Health licensed a vaccine enhancement and delivery developed by Immunovaccine in order to produce a new livestock treatment.

http://www.zenopa.com/news/19658302/Pfizer_Animal_Health_assets_purchased_by_Lilly

---------------------------------------------------------------------------

End goal: to make a difference for mankind
Published Saturday March 6th, 2010

Biotech: Halifax firm taking its cancer vaccine into first phase of human clinical trials

HALIFAX - It's a small Maritime startup, but one with a lofty goal.

"Not everyone can say they're working to cure cancer," says Brian Lowe, vice-president and co-founder of Immunovaccine Inc. (TSX-V:IMV), a Halifax biotechnology company that feels it is on the verge of a major cancer-fighting breakthrough.

Such ambition reveals just how far the company has come from its early days at Dalhousie University, where researchers were battling far less sexy health quandaries, like how to curb the seal population.

Back then, the problem facing researchers was how to deliver a contraceptive vaccine to wildlife in just one dose - without the traditional need for a follow-up dose.

"They couldn't ask a seal to come back for a booster shot," says Lowe with a chuckle at the company's downtown Halifax headquarters, just a short hop from Immunovaccine's lab facilities.

That Dalhousie research eventually led to Immunovaccine's patented vaccine delivery system, DepoVax. The system essentially amplifies a vaccine's effectiveness, allowing it to stay in the body long enough for a single dose to take full effect. The result: no need for a booster shot.

But the leap from university lab to commercial success is not an easy one to make. That's where Lowe came in. Back in 1992, at the age of 38, Lowe sold three environmental companies and became a millionaire. An active investment angel, he knew how to secure capital and launch a company.

"Access to capital is extremely challenging in our region," said Lowe, who also serves as director of the First Angel Network, which helps fund Atlantic Canadian businesses. "I think we've been very shrewd and creative in funding this largely with angel capital."

Between March 2000 and September 2009, the firm raised $11 million from angels spanning from the Maritimes to the U.S. to Europe - including Gary Smith.

The retired pharmacist from Saint John was actually one of the first investors to jump aboard, back in late 2003. And Smith has continued to increase his stake in the company over the subsequent seven years.

According to Smith, the growing use of vaccines means there is an expanding market for Immunovaccine.

"There are endless applications if it's demonstrated that the technology is successful in humans. So I'll stay along for the ride," he said in a recent interview.

"It's a Maritime company and could have a significant impact on the region. If we become a leader in that kind of biotechnology, then it brings a lot of attention to us."

Incorporated in 2000, Immunovaccine quickly found success in licensing its vaccine delivery system in the animal health field, specifically for fighting infectious disease in livestock. For example, last Tuesday, Immunovaccine announced that Pfizer Animal Health will be using the company's technology in a third livestock vaccine.

But in 2006, a "major event" occurred. That's when the company used its own vaccine to completely eradicate cancerous tumours in mice - at a late stage when the mice would normally be put down.

"The tumour totally disappeared. Nobody has ever done that. Nobody in the world has had the success we had," Lowe said. "It appears as though we have the potential for a major breakthrough."

The results convinced company officials to move beyond the simple licensing of their vaccine delivery system. The decision was made to delve into human trials for Immunovaccine's own cancer vaccine.

In the coming months, Immunovaccine will take its therapeutic vaccine for ovarian, breast and prostate cancer into the first phase of human clinical trials.

The trials, to take place in the U.S., could launch the company into a lucrative industry.

Sarah Chiasson, an analyst with Halifax-based Beacon Securities Ltd., says the firm is well positioned for an early-stage company.

"Its technology has been used on animals for several years and has had positive results. Its pre-clinical testing has been positive and it has an experienced management team," she said. "I see a lot of potential in their technology."

The plan now for Immunovaccine, which went public last October and has more than 20 employees, is to get through its phase-1 human cancer trials. The cost of entering further trials is steep. So if phase-1 proves successful, the company could very well be gobbled up by a big pharmaceutical firm, Lowe said.

"The road in our sector is a very long one," said the 56-year-old. "The ideal situation would see us help cure cancer, and in the process, see our shareholders get a nice return on their investment.

"That's the end goal - to really make a difference for mankind. But only time will tell."

http://nbbusinessjournal.canadaeast.com/journal/article/975154

< Message edited by michaelisin4u -- 3/11/2010 7:51:15 AM >

(in reply to michaelisin4u)
Post #: 10
RE: Immunovaccine Receives Clearance From FDA 2 Proceed... - 3/30/2010 5:28:07 PM   
michaelisin4u

 

Posts: 5653
Joined: 5/31/2008
Status: online
Immunovaccine Begins Patient Recruitment for Phase 1 Trial of DPX-0907 Cancer Vaccine

HALIFAX, NOVA SCOTIA, Mar 29, 2010 (MARKETWIRE via COMTEX) -- Immunovaccine Inc. /quotes/comstock/11v!imv (CA:IMV 1.40, +0.11, +8.53%) today announced that it has started screening patients for its Phase 1 clinical trial, investigating the company's therapeutic cancer vaccine, DPX-0907, as a treatment for patients with advanced stage breast, ovarian and prostate cancer. The primary goal of the trial is to establish the safety of the vaccine candidate which includes the DepoVax(TM) delivery platform. Secondary goals include an evaluation of dosing and an assessment of immune response.

"This study has significant implications for the company as it will determine the safety of the DPX-0907 vaccine in humans and contributes to our knowledge of the DepoVax(TM) platform," said Dr. Randal Chase, president and CEO of Immunovaccine. "A positive outcome from the Phase I study would be a catalyst for human therapeutic licensing deals for our DepoVax(TM) platform and allow us to move DPX-0907 further into the clinic."

"The DPX-0907 vaccine is a promising new approach that includes a collection of novel tumor antigens combined with a unique delivery and adjuvant platform. The Phase 1 clinical development program will enhance our understanding of this exciting new technology," said Dr. Neil Berinstein, M.D. who helped design the multicentre clinical trial.

Dr. Berinstein is a medical oncologist and expert in cancer immunotherapy. As the former head of Sanofi Pasteur's cancer vaccine program, he led the global R&D of therapeutic cancer vaccines. He has considerable experience designing and conducting translational clinical trials evaluating novel immunotherapies for cancer. He is an executive member of the Cancer Vaccine Consortium sponsored by the Cancer Research Institute.

DPX-0907 combines seven essential peptide antigens with Immunovaccine's potent DepoVax(TM) delivery platform. Together the vaccine is designed to attack antigens in critical tumor cell processes to kill tumor cells without injury to normal, healthy cells. The patented DepoVax(TM) delivery technology creates a strong depot effect that distinguishes it in the competitive vaccine sector. The DepoVax(TM) platform is a vaccine-in-oil delivery system whereby the antigens and adjuvant are presented to the immune system for a prolonged period, significantly enhancing the immune response. The seven peptide antigens in DPX-0907 are believed to be present on the surface of breast, ovarian and prostate cancer cells.

DPX-0907 is formulated as a lyophilized (freeze-dried) product and easily reconstituted for injection. A clinical batch of the vaccine was successfully produced in accordance with good manufacturing practice (GMP). The vaccine passed Immmunovaccine's extensive quality analysis and is ready to be transferred to the clinical research sites participating in this study.

Study Details

The clinical trial is an open label Phase 1 study designed to sequentially evaluate the safety of two dosing regimens. The trial will enroll up to 24 patients with advanced breast, ovarian or prostate cancer. According to the protocol, DPX-0907 will be administered to patients with stable breast cancer or ovarian cancer, or those with minimal biochemical or metastatic prostate cancer.

The primary objectives of the study is to determine the safety of DPX-0907, maximum tolerated dose (MTD), dose limiting toxicity (DLT) and safety profile of the DepoVax(TM) delivery system. The secondary objective will determine levels of cell mediated immunity (CMI) to the seven cancer antigens that will help establish a recommended dose for Phase 2 studies.

continued...

http://www.marketwatch.com/story/immunovaccine-begins-patient-recruitment-for-phase-1-trial-of-dpx-0907-cancer-vaccine-2010-03-29?reflink=MW_news_stmp

(in reply to michaelisin4u)
Post #: 11
RE: Immunovaccine Receives Clearance From FDA 2 Proceed... - 4/5/2010 11:25:37 AM   
michaelisin4u

 

Posts: 5653
Joined: 5/31/2008
Status: online
If cancer can be eradicated by simple vaccination imagine the panic among investors who overweighted their investments in 'chemotherapy drug manufacturers'.

Chemotherapy Drugs - Drug Names...

http://www.chemocare.com/bio/

I would assume those investors would be keeping a very close eye on Immunovaccine's clinical trials.

< Message edited by michaelisin4u -- 4/5/2010 11:31:00 AM >

(in reply to michaelisin4u)
Post #: 12
RE: Immunovaccine Receives Clearance From FDA 2 Proceed... - 4/6/2010 6:53:43 AM   
michaelisin4u

 

Posts: 5653
Joined: 5/31/2008
Status: online
Immunovaccine Announces the Publication of DPX-0907 Preclinical Study
Study shows the DepoVax(TM) platform provides a superior immune response against cancer antigens

April 5, 2010, 4:49 p.m. EDT

HALIFAX, NOVA SCOTIA, Apr 05, 2010 (MARKETWIRE via COMTEX) -- Immunovaccine Inc. /quotes/comstock/11v!imv (CA:IMV 1.37, -0.01, -0.72%) , a clinical stage vaccine development company, announced today the publication of data from a preclinical study with its candidate cancer vaccine, DPX-0907, in human class I MHC transgenic mice. The study compares Immunovaccine's novel DepoVax(TM) vaccine platform to a vaccine formulation commonly used to deliver peptide antigens in the clinic today. The study shows that the company's DepoVax(TM) platform promotes antigen specific immune responses, however, unlike the control vaccine, the DepoVax(TM) formulation does not induce problematic immune regulatory responses.

The paper entitled, "A Novel Breast or Ovarian Cancer Peptide Vaccine Platform That Promotes Specific Type-1 but not Treg or Tr1-type Responses" is published in the April 2010 issue of the Journal of Immunology, Volume 33, Number 3.

"The results of this study, indicate that our DepoVax(TM) vaccine platform may be able to improve the delivery and performance of cancer vaccines, by tipping the scales in favor of an active and uninhibited immune response following vaccination. If successful, such a platform may help potentiate other cancer immunotherapies," remarked Dr. Marc Mansour, vice president of R&D at Immunovaccine.

The immune system has two paradoxical roles in cancer; the first, an adaptive immune response, such as a T-cell response, capable of attacking tumor cells, and the second, a regulatory or pro-tumor response that favors tumor progression. Regulatory T cells have been shown to accumulate at the site of the tumor, creating an immunosuppressive tumor environment that can ward off anti-tumor Type-1 CD8+T-cell responses. Potent vaccines that are injected repeatedly can also induce regulatory mechanisms that counteract the desired effect of the vaccine. This poses a serious problem as most therapeutic cancer vaccines are administered repeatedly to avert the threat of resumed tumor growth after surgical removal or chemotherapy.

The major challenges in designing an effective peptide-based vaccine to treat cancer is enhancing the immunogenicity of chosen peptides and overcoming tumor induced immune suppression. To have a fighting chance at producing more prolonged cellular immune responses that can affect tumor cells, a vaccine must first activate the immune system against the targeted antigens without activating or amplifying antigen-specific regulatory mechanisms. The DepoVax(TM) formulation used in DPX-0907 was capable of achieving this in the preclinical mouse model.

Transgenic mice vaccinated with DPX-0907 exhibited more than double the number of peptide-specific (CD8+IFN-g+), T-cells when compared with the control oil emulsion-based vaccine. In fact, mice that received follow-up booster immunizations of DPX-0907 maintained the high levels of interferon gamma (a cytokine indicative of vaccine-induced T cell immunity), whereas the mice immunized with the control vaccine displayed significantly lower levels of the T cell activation cytokine. This study suggests that the novel DepoVax delivery platform may provide better sustained antigen-specific immune responses compared to other peptide vaccine delivery methods. Interestingly, DPX-0907 formulation also provided a safer vaccine alternative to the control emulsion vaccine.

DPX-0907 is an oil-depot vaccine formulation that is currently being tested in a phase 1 clinical trial for the therapy of breast, ovarian or prostate cancer patients. DPX-0907 uses lyophilized (freeze-dried) liposomes, containing seven antigens and an adjuvant, and an oil delivery. The seven peptide antigens were identified from the surface of breast and ovarian tumor cell lines, but were not found on normal cells. The antigens were selected on the basis of their association with pathways essential for tumor growth and survival. Given DPX-0907's favorable safety profile, its ability to differentially promote type-1 versus Treg-type immunity, and its lyophilized format for enhanced shelf-life and stability, the DepoVax(TM) technology appears to be a promising platform for the development of the next generation of therapeutic/prophylactic vaccines for cancer and infectious diseases.

continued

http://www.marketwatch.com/story/immunovaccine-announces-the-publication-of-dpx-0907-preclinical-study-2010-04-05?reflink=MW_news_stmp

(in reply to michaelisin4u)
Post #: 13
Page:   [1]
All Forums >> [Market Sectors] >> Healthcare and Pharmaceutical Stocks >> Immunovaccine Receives Clearance From FDA 2 Proceed With Phase 1 Clinical Trial 4 Its Therapeutic Page: [1]
Jump to:





New Messages No New Messages
Hot Topic w/ New Messages Hot Topic w/o New Messages
Locked w/ New Messages Locked w/o New Messages
 Post New Thread
 Reply to Message
 Post New Poll
 Submit Vote
 Delete My Own Post
 Delete My Own Thread
 Rate Posts


Forum Software © ASPPlayground.NET Advanced Edition 2.4.5 Unicode

0.078