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CANBRIDGE CAN-CAN

BY STEPHEN HANSEN, ASSOCIATE EDITOR

Canbridge Life Sciences Ltd.’s deal with Aveo Pharmaceuticals Inc. will see the Chinese biotech developing its first programs outside Asia. But Chairman and CEO James Xue says the company is not deviating from its strategy, which is focused on in-licensing clinical assets from the West to target diseases prevalent in Asia. In this particular case, it made sense to take rights to Aveo’s AV-203 in all territories outside North America because the target indication also plays to Canbridge’s experience with Orphan diseases in the West.
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CANbridge Looks Beyond Asia With AVEO’s Oncology Drug

PharmasiaNews

CANbridge Looks Beyond Asia With AVEO’s Oncology Drug

By Jung Won Shin / Mar. 24, 2016 8:00 AM GMT

Executive Summary

In its first venture outside of Asia and a rare move by a Chinese biopharma firm, CANbridge Life Sciences is acquiring global rights to AVEO’s clinical-stage ErbB3 (HER3) inhibitory antibody candidate, in a step CANbridge’s CEO explains fits well with the company’s global strategy and therapeutic focus.

SEOUL – CANbridge Life Sciences Ltd. has inked an exclusive collaboration and license agreement with AVEO Oncology in which CANbridge will have worldwide rights, excluding the US, Canada and Mexico, to AV-203, AVEO’s clinical-stage ErbB3 (HER3) inhibitory antibody candidate.

CANbridge, a biopharmaceutical company focused on developing western drug candidates in China and North Asia, plans to develop AV-203 first in esophageal squamous cell cancer (ESCC).

“CANbridge will be expanding outside of Asia for the first time,” said James Xue, the company’s chairman and CEO. “Preclinical work shows that AV-203 has the potential to treat ESCC, the most common type of esophageal cancer in Asia, with 50% of worldwide diagnoses occurring in China. Esophageal cancer is also prevalent in other parts of the world, particularly developing countries.

“As part of our globalization strategy, we plan to develop AV-203 in Asia first, then bring it to other territories where patients with this form of disease have few treatment options,” he explained.

The latest license agreement comes after CANbridge’s deal with Germany’s Apogenix GMBH last year. In July, it acquired the rights to commercialize in China Apogenix’s APG101, a CD95-Fc fusion protein under Phase II study for glioblastoma, a brain tumor type.

Strategic Focus

The Beijing-based drug discovery company will primarily concentrate on oncology for now, Xue told PharmAsia News.

“We have strategically decided oncology will be our most focused area initially. So it is very natural for us to consider expanding our pipelines including candidates that can further address indications like glioblastoma and esophageal cancer. Both have extremely high unmet needs worldwide, not just in Asia,” he noted.

“There are also other types of cancer that have particularly high prevalence in Asia that don’t have effective treatments. It is our mission to work hard and deliver some effective treatments in these areas.”

According to the World Health Organization, esophageal cancer is the eighth most common cancer globally, with over 450,000 cases diagnosed each year.

To date, AVEO, which is dedicated to advancing a broad portfolio of targeted therapeutics for oncology and other areas of unmet medical need, has completed a Phase I, open-label, dose-escalation study of AV-203 in patients with advanced solid tumors.
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In this study, AV-203 was found to be generally safe and well-tolerated, with an early signal of activity consistent with preclinical data showing the potential for heregulin, the only known ligand for ErbB3, to serve as a biomarker predictive of AV-203 anti-tumor activity.

Deal Details, Clinical Plans

Under the terms of the agreement with AVEO, CANbridge Life Sciences is obligated to pay AVEO an upfront payment of $1m plus up to $133m in potential reimbursement and milestone payments, assuming the successful achievement of specified development, regulatory and commercialization objectives.

AVEO is also eligible for tiered royalties, with a percentage range in the low double digits, on net sales of AV-203 in the agreement’s territories.

CANbridge Life Sciences will be responsible for costs associated with the execution of a development plan that includes additional manufacturing requirements as well as preclinical and clinical studies necessary to demonstrate proof-of-concept for AV-203 as a treatment for squamous cell esophagus cancer, including a Phase IIa proof-of-concept study meeting mutually agreed upon criteria.

“Our current plan is to demonstrate initial efficacy then feel confidence in the indication. Afterward, we will consider multinational studies. Whether in Asia or beyond Asia, we haven’t decided it yet,” the CEO said. “I think the experiment is going to be in China where there is a high prevalence of ESCC. We will start the Phase I in China next year.”

“We’d like to see this product…be launched perhaps first in Asia…and then take the success beyond Asia.” – James Xue, chairman and CEO, CANbridge

The company plans to conduct Phase IIa in China in a couple of years, he added.

Following completion of the proof-of-concept studies, AVEO and CANbridge will negotiate a possible agreement under which they may co-develop AV-203, with each party bearing a percentage of the cost of global development activities based on respective geographic rights.

If the parties fail to reach such an agreement, CANbridge may continue the development of AV-203 on its own in markets outside of the United States, Canada and Mexico.

Asia First, Global Second

Speaking on the company’s global strategy, the Xue said if the company has an effective and promising candidate which has global impact beyond China and Asia, it will be happy to see the therapy utilized.

“For this particular case, we are acquiring rights including Europe and other major geographies outside Asia. Even though prevalence is not as high as in Asia for ESCC, we still think there are significant markets and significant patient populations we can address effectively,” he said.

The CEO noted that most western companies engage in their development programs for western- or Caucasian-prevalent diseases first, and then once their products are launched successfully in those geographies, they will consider developing these products in other parts of the world.

“For CANbridge, we are probably doing something in the opposite direction. We’d like to see this product generate promising data and to be launched perhaps first in Asia, for Asian-prevalent diseases. And then take the success beyond Asia. That is our global strategy,” he said.

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Canbridge nabs rights to Aveo’s ErbB3 antibody for esophageal cancer

By Shannon Ellis
Staff Writer

Tuesday, March 22, 2016

SHANGHAI – Canbridge Life Sciences Ltd., a privately held biopharma in Beijing, has in-licensed AV-203 , a clinical-stage ErbB3 (HER3) inhibitory antibody candidate from Aveo Oncology Inc., of Cambridge, Mass. While the candidate has been tested in numerous tumor models, Canbridge will develop AV-203 in esophageal squamous cell cancer (ESCC), the most prevalent form of esophageal cancer especially in China where half of all new cases arise.

A virtual biopharma with a team of 20, Canbridge has a China-focused strategy by seeking out global candidates that can meet a specific unmet need in China or Asia. The lead candidate, APG101 (aka CAN008), is a targeted CD95 therapeutic for glioblastoma in-licensed from Apogenix GmbH, of Heidelberg, Germany.

In this deal, Aveo will receive a $1 million up-front payment with the potential to receive $133 million downstream if all goes according to plan. Terms also call for Aveo to receive a tiered royalty with a percentage range in the low double digits on net sales.

In return, Canbridge has the right to develop AV-203 (aka CAN017) globally, excluding North America, for numerous indications although ESCC is the top priority.

“This is not a regional deal; it is worldwide outside of North America,” James Xue, Canbridge CEO, told BioWorld Today. “When you come to a valuation, you build in both geographies as well as indications. Because it is our decision to investigate esophageal carcinoma first, but it has potential in other types of tumors where squamous cell is dominant or has a significant presence, we feel to show our seriousness a modest up-front payment was appropriate.”

Canbridge will cover the costs for developing CAN017 for squamous cell esophagus cancer to demonstrate proof of concept including additional in-China manufacturing requirements, preclinical and clinical studies all the way to phase IIa.

The two sides leave open the option of working more closely to co-develop the candidate once Canbridge completes proof of concept in China.

“This agreement allows us to further advance AV-203 development by leveraging the resources of a motivated partner in Canbridge,” said Michael Bailey, Aveo’s president and CEO. “Importantly, it also allows us to retain North American rights for future development for a third clinical stage drug candidate, providing Aveo with a robust portfolio of oncology therapeutics.”

THE GENZYME CONNECTION

Aveo and Canbridge share an influential master connector in common: Henri Termeer, the former CEO of Genzyme, a unit of Sanofi SA, of Paris. Termeer is the chairman of Aveo and also Canbridge’s chief advisor. (Before branching out on his own, Xue was the China general manager for Genzyme.) Having Termeer on the team has been a boon for Canbridge in making ties with the U.S. and Europe.

“We talked about how Canbridge has an interest in Asian disease and whether in their pipeline there was something where we could leverage our strengths, and it came to the AV203,” said Xue. “Aveo had already completed a phase I study in the U.S. but because of their priorities, they probably will not have any immediate plans for post-phase I development. We took a closer look and saw the relationship with squamous cell type carcinoma. We moved pretty quickly after determining that since Asia has over half the world prevalence of esophageal cancer.”

For its part, Aveo has had a bumpy ride after its lead candidate, tivozanib for renal cell carcinoma, ran into costly regulatory complications with the FDA during phase III trials. The company has had to cut its research team and has been monetizing its pipeline in order to refocus efforts on tivo. (See BioWorld Today, Feb. 18, 2014.)

TOO MANY PICKLED VEGETABLES

Therefore it cannot be said that levitra australia prices decreases the intimacy in the sexual act because it is associated with few acute symptoms, hypotension (hypo=low + tension=pressure) may be normal for a patient if it is without symptoms, but can be of great importance if it is associated with abnormal body function. This means that you don’t have to rush as you can hold you erection within this span of time. * Maximum gains from Kamagra cialis 5 mg are possible when you are prepared to confront the issue. He told that Sam must consume that formulation and then they must engage in the sexual activity.Martha and Sam then visited the other cities in the India for next 5 days and then cam back to their sexual youthfulness and to have more pleasure ordine cialis on line in the climax. Consuming the medicine which might get interrelate with Tadalis or may result with stern side-effects, comprises antibiotics medicine called erythromycin & rifampicin, verapamil or diltiazem for treating hypertension, ritonavir or saquinavir (for HIV), antifungals like itraconazole or ketaconazole, non-selective alpha-blockers like doxazosin for easing high blood pressure, tamsulosin and prazosin for enlarged prostate, nitrates such as glyceryl trinitrate for angina and other heart conditions. ordine cialis on line The predominant form of esophageal cancer found in Asia, mostly in China and Japan, is squamous cell. The other type, esophageal adenocarcinoma, is predominant in Europe and North America.

A China-focused statistical review published in Thoracic Cancer estimated there were 287,632 new cases of ESCC diagnosed and 208,473 deaths in 2010. Esophageal cancer incidence ranked fifth of all cancer types in China, with a rate of 21.88 per 100 000. For both incidence and mortality, men living in rural areas were most likely to be affected, peaking at the age 80 to 84.

In certain rural areas in Henan, Hebei and Shanxi, the incidence rate shoots to the highest in the world, greater than 100 cases per 100,000 according to a study in the Journal of Epidemiology. Other high incidence areas are found in the provinces of Sichuan, Anhui, Jiangsu, Hubei, Fujian, Guangdong and Xinjiang.

Studies show there is a complex interaction between genetic factors when combined with alcohol consumption, smoking and poor nutrition that can cause ESCC. It is believed diets containing a high quantity of pickled vegetables (with nitrosamine content) are also to blame.

 

ERBB3 (HER3)

ErbB3 belongs to a family of four proteins that also includes EGFR (HER1) and HER2 tyrosine kinase receptors. ErbB3 stimulates cancer growth and its overexpression generally correlates with poor prognosis.

AV-203 selectively targets the receptor ErbB3 and demonstrated preclinical activity in a number of different tumor models including breast, head and neck, lung, ovarian and pancreatic cancers. The preclinical data further showed the potential for heregulin, the only known ligand for ErbB3, to serve as a biomarker predictive of AV-203 anti-tumor activity.

Aveo completed a phase I study showing no dose-limiting toxicities at a maximum dose of 20 mg/kg.

Plans are already under way at Canbridge to make use of PDX mice models to continue testing CAN017 in tumors from Chinese squamous cell esophageal cancer patients. Company execs expect to be ready to submit an investigational new drug application next year, and take advantage of China’s new guidelines for innovative drugs.

“We are going to start a human trial in China first and hope to take advantage of the green channel approach. Because it is [CAN017 targets] a major malignant tumor, has a Chinese specificity, and we are going to manufacture the product in China, it will allow us to tap into the national guidance,” said Xue.

CHINA AS A LAUNCHPAD TO THE WEST

Meeting China’s significant unmet medical needs is the stated aim of many of China’s most promising biopharmas, in large part because there is such a gap between the drugs available in developed markets and in China – with only about 30 percent drugs available in China.

“The big multinational companies have set their center of gravity and development capabilities mostly in the West,” explains Xue. “Many products are successfully launched with Western populations as a priority. If they happen to be able to address a disease in the Asian population then it is perfect. However, if prevalence in Asia is much greater than in the West and you are still using this algorithm to the do the global launch then it will be quite a missed opportunity for those companies. That is where companies like Canbridge can come in.”

But with Canbridge’s first foray into a global rights deal, the company is joining a small band of companies that are hoping to pull the center of gravity slowly their way.

“Once the data generated in China begins to look very promising, we have strong confidence that we can replicate the data in the West,” said Xue. “We can utilize Asia as a base to develop innovative therapies for the global patient, instead of the other way around.”

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Canbridge inks deal with Apogenix to bring targeted brain tumor treatment to China

By Shannon Ellis, Staff Writer

©2015. REPRINTED WITH PERMISSION FROM THOMSON REUTERS.

SHANGHAI – Beijing-based Canbridge Life Sciences Inc. is a
biotech that seeks to bring Western innovation to Chinese patients
who have few if any treatment options. That licensing strategy has
led it to sign a deal with Apogenix GmbH, of Heidelberg, Germany,
for lead candidate APG101, an onco-immunotherapy targeting the
CD95 ligand for a highly lethal and diffi cult to treat type of brain
cancer, glioblastoma multiforme.

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up-front payment, with the promise of milestones and royalties,
in exchange for the technology and rights to develop and
commercialize APG101 in China, Hong Kong and Macau. Canbridge
signed on for indications beyond glioblastoma as well.
“We are always actively looking for clinical-stage assets from
biotechs that hold promise for any unmet medical needs,
particularly in the oncology area,” said James Xue, chairman and
CEO of Canbridge. “Apogenix’s lead product, APG101, fi ts like a
glove.”

Click here to read the full article…

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CANbridge Life Science’s ‘portfolio’ bid aims to get cancer drugs to patients faster

Canbridge Life Science’s ‘portfolio’ bid aims to get cancer drugs to patients faster

By Shannon Ellis 

July 29, 2104

Staff Writer

SHANGHAI – Canbridge Life Sciences Inc., of Beijing, is on its way to bridging the gap that leaves many patients in China waiting anywhere from four years to six years for critical treatments approved in developed markets. With time of the essence, the firm is taking a portfolio approach to its in-licensing strategy, developing both clinical-stage and approved treatments, while mixing new drugs with treatments classified as medical devices.

In its second deal since forming last year, Canbridge will have the Chinese commercialization rights to Caphosol, an adjunct therapy for cancer patients that suffer from extreme dry mouth (oral mucositis) as a consequence of radiation or chemotherapy. According to CEO James Xue, there are no adequate treatments approved in China, even though Caphosol has been available in the U.S., Canada and the European Union.

Canbridge signed the deal with Eusa Pharma Ltd., the international division of Jazz Pharmaceutical plc, of Dublin.

“Drug development takes a lot of money capital and time,” Xue said. “If we only focus on products that are in clinical development stage . . . we have to take a lot of risks in terms of development risk.”

In the company’s inaugural deal, it did take on some of that risk. Canbridge licensed the China rights to co-develop ATI-1123, a liposomal formulation of docetaxel to treat non-small-cell lung cancer, from nanotech specialist Azaya Therapeutics Inc., of San Antonio. ATI-1123 had finished phase I in the U.S. for multiple solid tumor cancers. (See BioWorld Asia, Sept. 25, 2014.)

Developing novel therapeutics is a lengthy and costly process everywhere, but particularly so in China. And with so much unmet need, going after some low-hanging fruit can help a small start-up generate crucial income to temper the risk.

Xue said that Canbridge is hopeful Caphosol will launch in a “relatively more speedy way and with limited risk,” citing that those “products already approved by the U.S. FDA and EMEA have a pretty assured registration and approval process in China.”

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Oral mucositis is a startlingly common side effect of cancer treatment. It can lead to painful mouth sores, impede a patient’s ability to swallow or take in nutrition orally and, in some cases, cause life-threatening sepsis.

The company estimated some 40 percent of chemotherapy patients, 70 percent of bone marrow transplant patients and 97 percent of head and neck cancer patients receiving radiation therapy develop oral mucositis.

“This product has a vey attractive market potential. The number of cancer patients is at 3.5 million a year in China and most of these patients would experience a certain degree of mucositis,” Xue said. “The sheer number of patients is so large, even if we capture a small percentage of the market, it will still mean significant revenues for us.”

BUILDING A FULLY INTEGRATED COMPANY

With that deal, Canbridge is also a step closer to realizing its plans to be a fully integrated biotech company and will develop its commercial operation from the ground up. Its model is in the same mold as those of Sciclone Pharmaceutical Inc. and Hong Kong-based Lee’s Pharmaceutical Ltd., both of which have been successful in licensing the best of the West for China.

Xue brings regulatory and commercialization experience from his days as general manager at Genzyme China, and he said the current climate, with numerous pharma companies being probed for corrupt activities in their sales ranks, does not deter him. Echoing a sentiment shared by other speciality biotechs, he said, “there are ways to do it right; the precondition is the product you work with is unique enough to differentiate itself.”

Citing data from a study conducted last year by McKinsey Consulting, that 50 percent of big pharma revenues in China comes from off-patent therapies left to fight it out against cheaper generics, he said, “even big pharma has not done the proper work to bring original, patented life-saving therapies to China.”

Xue said his reception during his U.S. trips has been increasingly positive and he has seen a trend where “CEOs are taking a more active role in directing their China strategy at an earlier stage . . . to drive up the value of their equity in the face of their investors,” and, he adds, may be a little disappointed in the ability of the big pharmas to execute partnerships in China.

Canbridge may very well be on a roll. According to Xue, it has received special status from the Beijing municipality that will enable it to tap into government grants and other resources, and it has struck up a partnership with an undisclosed Chinese pharmaceutical with cash to invest. He said the company now has a very robust business development pipeline and expects to be making several announcements in the coming months

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GenSpera’s Targeted “Death Carrot” Toxin in Trials for Two Cancers

XCONOMY

Top Stories in Texas

http://www.xconomy.com/texas/

GenSpera’s Targeted “Death Carrot” Toxin in Trials for Two Cancers

http://www.xconomy.com/texas/2014/03/27/gensperas-targeted-death-carrot-toxin-in-trials-for-two-cancers/

Bernadette Tansey 3/27/14

 

Craig Dionne has a record of experience in drug development and a lot of friends in the pharmaceutical industry. But when his friends first heard about the experimental drug he started working on some years ago, he says their initial reaction was alarm—to put it mildly.

“They told me I was a fool,” Dionne says affably. Dionne is CEO of San Antonio, TX-based GenSpera, which has now started a second round of early stage clinical trials on the experimental drug he took a chance on. He’s hoping the trials are about to show his friends he was right.

Back in the early 1990s, Dionne and his collaborators at Johns Hopkins University saw potential for a cancer drug in a highly potent toxin, thapsigargin, found in a common Mediterranean weed called Thapsia Garganica. You’ll find it described as the “death carrot’’ in online accounts.

Thapsigargin kills fast-growing cells. So far, so good; that’s a routine property of chemotherapy drugs. But the relative safety of classical chemotherapy agents rests on the fact that they’re more destructive to rapidly multiplying tumor cells than they are to slow-growing normal cells.

Thapsigargin doesn’t work that way—which initially made it alarming to Dionne’s friends. It’s an equal opportunity cell-killer.

“It can kill cells that grow slowly,” Dionne says. That makes it a threat to normal cells, unless a drug company can successfully tweak it. And Dionne saw a reason to try.

Like most normal cells, some cancer cells also grow slowly, such as those in tumors of the prostate. And such cancer cells can resist chemotherapy drugs that target fast-growing cells. Dionne and his collaborators at Johns Hopkins reasoned that thapsigargin might be an effective weapon against slow-growing tumor cells, if it could be modified to spare normal cells. The end result of their chemical tinkering is GenSpera’s experimental drug G-202, which has now moved into a second round of early stage clinical trials.

The compound was designed to allow the powerful toxin to move through the bloodstream in an inactive form until it’s released by an enzyme, PSMA, found at higher levels on the surface of certain tumor cells, Dionne says. He compares G-202 to a grenade with a pin ready to be pulled.

A molecule of G-202 contains a modified form of thapsigargin called 12ADT, which is linked to a small peptide. The effect of that peptide—a small chain of five amino acids—is to keep 12ADT soluble in the watery environment of the blood. More importantly, he peptide keeps the toxin inactive.

But when G-202 encounters a cell with the enzyme PSMA (prostate-specific membrane antigen) on its surface, the enzyme clips the peptide off the toxic 12ADT molecule. The toxin, now insoluble in water but highly soluble in fats, can sink through the lipid-rich outer membrane of a nearby cancer cell and start its deadly work.

Dionne says G-202 is similar to the new class of targeted cancer drugs called antibody-drug conjugates, which are also designed to deliver a toxin only to particular tumor cells. These drugs combine a toxin with an antibody engineered to bind to a specific molecule on the surface of a cancer cell. However, antibodies are large proteins whose unique amino acid sequences and folding patterns can help them fit selectively only with certain cell surface receptors.

Serotonin-producing cells develop early on in the ENS, and if this buy generic levitra development is affected, the second brain cannot form properly. You will be helped to prolong your erection in a more healthy levitra online devensec.com and natural way by this medicine. Sexual dysfunction is a common concern shared by many women. generic levitra cheap This levitra 20mg canada medicine may lead to allergic reaction in some individuals. By contrast, G-202‘s targeting agent, the small peptide, could theoretically be clipped away from its toxic payload by enzymes other than PSMA, Dionne says. If that happened, the toxin could be released in the vicinity of normal cells rather than tumor cells. This is one of the reasons why GenSpera has spent years on preclinical testing and animal studies before launching its first clinical trial of G-202 in humans in 2011, he says.

Dionne says the company also took a close look at the cardiovascular effects of the experimental drug because of its molecular mechanism of action. Thapsigargin works by disrupting a molecular pump that regulates the level of calcium ions inside cells—and ion exchanges are central to the functioning of the cardiovascular system, Dionne says. Once inside any cell, whether a tumor cell or a normal one, thapsigargin causes a damaging influx of calcium, which starts a process of programmed cell death called apoptosis.

GenSpera also had to watch out for off-target effects of G-202 for another reason. Although the target enzyme PSMA appears in a higher concentration on cells of the prostate than on many other cells, it has been found as well in certain normal tissues, such as sections of the brain, small intestine, and kidney. Dionne says G-202 can’t pass through the blood-brain barrier. Studies of the drug’s action in animals and in humans so far have not turned up significant damage to the other normal cells bearing the PSMA enzyme, he added.

However, the discovery of enriched PSMA levels in yet another type of tissue has expanded the possible uses of G-202. The enzyme is more abundant on the cells of blood vessels that bring nutrients and oxygen to solid tumors than it is in normal blood vessels. Based on this finding, GenSpera began widening its views beyond prostate cancer, Dionne says. If the toxin in G-202 could be released by PSMA in tumor blood vessels, these vessels might disintegrate, and the tumor might starve and die.

“The potential applications are so much broader,” Dionne says.

In GenSpera’s first small trials in 2011 and 2012, 44 participants with a range of different cancer types received doses of G-202. Dionne says the drug appeared to have no serious effects on the liver, cardiovascular system, or bone marrow. Kidney damage could be prevented by limiting the G-202 dose and giving trial participants plenty of water, he says.

Although the main goal of the first trial was to assess the safety of G-202, GenSpera noted that a few trial participants with advanced liver cancer survived longer than expected. Encouraged by those signs, GenSpera is now conducting a Phase II trial in up to 17 adults with advanced hepatocellular carcinoma who are no longer helped by sorafenib (Nexavar), a cancer drug co-owned by Bayer and Amgen.

In March, GenSpera also began a Phase II trial in up to 34 participants with the brain cancer glioblastoma multiforme at the University of California San Diego’s Moores Cancer Center. The company may also conduct trials in prostate and kidney cancer if it can raise the funding.

GenSpera (OTC: GNSZ) is a tiny virtual company, that had $3.6 million in cash at the end of 2013—enough to fund its operations through at least nine months of this year. The company last week announced a share offering to raise as much as $7.5 million.

Dionne, a former executive at Cephalon, which was acquired by Teva Pharmaceutical Industries (NASDAQ: TEVA) in 2011, co-founded GenSpera in 2003. The firm began its preclinical studies in 2007, when it raised its first funds from outside investors. Dionne, who is GenSpera’s chief financial officer as well as CEO, is one of the company’s staff of two full-time employees. GenSpera contracts out all its other work.

“We’re virtual out of choice,” he says.

GenSpera’s scientific advisory board includes company co-founders John Isaacs and Samuel Denmeade, who are oncology professors at the Johns Hopkins University Sidney Kimmel Comprehensive Cancer Center.

GenSpera has raised $24.3 million since its inception, and the majority has come from high net worth individuals who often continue to reinvest, Dionne says. The company went public in 2009 and trades in the OTCQB tier of the Over-The-Counter Markets Group. GenSpera’s market capitalization is about $37 million.

Dionne says the company’s ideal plan is to seek a pharmaceutical company partner or buyer after conducting Phase II trials that show the potential of G-202 in solid tumors.

“We want to be valued across a range of tumor types,” Dionne says. The company has been built with the goal of making it attractive to big drug companies, he says.

“Our customer is large pharma,” Dionne says. “That’s who is ultimately going to pay us what we’re worth.”

Posted on

GenSpera registers for public offering

 

 

Mar 21, 2014, 1:15pm CDT

GenSpera registers for public offering

http://www.bizjournals.com/sanantonio/blog/2014/03/genspera-registers-for-public-offering.html

Biotech firm GenSpera has filed with the SEC for a future public offering.

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W. Scott Bailey

GenSpera Inc. has filed a registration with the U.S. Securities and Exchange Commission for a public offering.

The filing does not specify how many shares of stock the San Antonio-based biotech company plans to offer or at what price.

It does indicate that GenSpera (GNSZ: OTC) intends to use the proceeds from the sale of stock to fund Phase II clinical trials of its lead drug G-202 in patients with liver and brain cancer. The company also plans to dedicate a portion of those proceeds for working capital.

GenSpera, which is still in the research-and-development phase for its lead drug, reported a net loss of $2 million in the fourth quarter of 2013.

On Tuesday, I reported that GenSpera has launched a Phase II clinical trial for G-202 with patients who have glioblastoma multiforme, the most prevalent type of primary brain cancer. The trial will be conducted at the University of California at San Diego’s Moores Cancer Center.

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GenSpera enrolls brain cancer mid-stage trial with ‘grenade’ delivery

GenSpera enrolls brain cancer mid-stage trial with ‘grenade’ delivery

Blood-brain barrier in glioblastoma? ‘We don’t need to worry about it.’

http://www.fiercedrugdelivery.com/search/site/genspera

The weed Thapsia garganica, which provides the active ingredient thapsigargin for G-202–Courtesy of GenSpera

March 19, 2014 | By Michael Gibney

Texas cancer drug delivery specialist GenSpera is enrolling a new study for its molecular “grenade” candidate G-202. This time it’s a Phase II for the treatment of the notoriously aggressive brain cancer glioblastoma.

The G-202 candidate in question is the same as one that garnered GenSpera positive results in a Phase I study ending in October last year. That trial aimed at solid tumors with a subset of patients with hepatocellular carcinoma, a type of liver cancer.

Along with a research team at the University of California in San Diego, GenSpera will conduct the new study in two stages in up to 34 patients with recurrent forms of glioblastoma who have already undergone at least one major treatment–surgery or radiation. The drug is designed to be delivered via intravenous infusion for about an hour over the course of three days.

As an endpoint, GenSpera is looking for patients to be progression-free at 6 months. Historically, GenSpera CEO Craig Dionne told FierceDrugDelivery, about 15% of glioblastoma patients are progression-free by this point, and GenSpera is aiming to boost that number to 30%.
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G-202 has shown to be effective before. But there are many delivery challenges that come with getting drugs past the blood-brain barrier, and here’s where GenSpera’s drug could have an edge: it doesn’t need to cross the barrier and its drugs work from within the blood vessels in the tumor.

Since G-202 is designed to act on the blood vessels inside a tumor, constricting them so as to starve the tumor, Dionne said, it doesn’t come up against the same challenges as other drugs that need to cross the endothelial cells to get into the tumor’s mainframe.

“Our approach to the blood-brain barrier,” Dionne said, “is we don’t need to worry about it.”

Dionne compares G-202’s release mechanism to a “grenade” complete with a “pin” that’s pulled at a specific site in a tumor’s blood vessel. G-202 is the first to take advantage of the enzymatic action of the prostate-specific membrane antigen, PSMA, that exists in abundance at tumors such as glioblastoma. The PSMA enzyme pulls off a peptide cap on the drug that delivers a hefty dose of the specifically deadly toxin 12ADT.

“If you look at glioblastoma, it is highly vascularized and makes a lot of PSMA, which is perfect for us,” Dionne said. “The toxin is targeted with the antibody drug conjugate and, taking advantage of the enzymatic action, it delivers thousands of active molecules. The amplification is a huge part.”

The toxin 12ADT is the final component of the uniquely designed drug. Its active ingredient, thapsigargin, is derived from a Mediterranean wild weed called Thapsia garganica, Dionne said, which works by disrupting a pump that regulates calcium levels in the blood vessel cells. The toxin is extremely potent, more so even than common cancer drugs such as doxorubicin, and kills independently of cell division rate, which means it can affect slow-growing tumors or even cancer stem cells that can linger after a tumor is mostly eradicated. According to Dionne, once the toxin is released, it is highly lipophilic and stays there in the tumor.

GenSpera’s other Phase II trial for G-202 in hepatocellular carcinoma is also currently being enrolled, Dionne said, with 16 patients on board.

– here’s the release

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AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference: October 2013

  • AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference: October 2013
    the company started a Phase II study in patients with recurrent high-grade glioma 10/22/13 Genspera Inc. (San Antonio) G-202 A thapsigargin-based prostate-specific membrane antigen-activated prodrug Hepatocellular carcinoma Data showed that 27% of patients exhibited stable disease 10/23/13 Immunogen Inc. (Waltham, Mass.) SAR566658 An antibody-drug conjugate targeted to CA6 Ovarian, breast and other epithelial cancers Interim Phase I data showed it is generally well tolerated and can induce

    BioWorld Insight | Monday, November 11, 2013

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Genspera

BioWorld Today | Wednesday, October 23, 2013

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Genspera Inc., of San Antonio, reported Phase I data at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston showing that 27 percent of patients receiving G-202, a thapsigargin-based prostate-specific membrane antigen-activated prodrug, exhibited stable disease