Posted on

New data underscore benefits of idebenone in DMD as Biomarin pulls drisapersen MAA

BIOWORLD TODAY

By Cormac Sheridan Staff Writer

Thursday, June 2, 2016

DUBLIN – Even as Biomarin Pharmaceutical Inc.’s dwindling hopes for its exon-skipping pipeline in Duchenne muscular dystrophy (DMD) turned to ash this week, with the withdrawal of its marketing authorization application (MAA) for drisapersen from the EMA, there was also some positive news for DMD patients and their families. Santhera Pharmaceuticals AG released additional clinical data from its Delos phase III study of Raxone (idebenone) in Duchenne muscular dystrophy (DMD), which showed that the drug’s ability to slow the rate of decline of respiratory function over one year converted into a range of clinical benefits.
That check out my store viagra prescription is the reason, it is called high deformity rate of sperm, which can cause male disorder. The http://ronaldgreenwaldmd.com/patient-information/ levitra fast shipping event could be death of a close one, stressed relationship with partner, difficulties at workplace etc. Since this condition makes walking difficult, it can interfere with the way your body responds to the sexual buy generic levitra organs. For this the man has to get treated or else there is no way out. uk tadalafil
The new analysis forms part of its recently completed regulatory filing in Europe and its planned filing in the U.S. The Liestal, Switzerland-based company filed for approval in DMD in Europe Tuesday, as a type II variation to its existing approval for treating visual impairment in Leber’s hereditary optic neuropathy. If the FDA is agreeable, it could complete a rolling new drug application during the third quarter of 2016 – although that depends on the outcome of a meeting in late July.

The primary endpoint of the Delos trial, which recruited 64 DMD patients who were not on concomitant glucocorticoid therapy, was the alteration in lung function over the one-year trial, as measured by the percentage change from baseline to week 52 in peak expiratory flow (PEF) for each patient. PEF for those in the drug treatment group declined by an average 2.57 percent, whereas it declined by an average 8.84 percent for those in the control group. (See BioWorld Today, May 14, 2014.)

Click Here to read the full article

Posted on

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.”

Posted on

Escape velocity? Bioblast phase II could open door to remedy in rare OPMD

BIOWORLD TODAY 

MARCH 17, 2016

THE DAILY BIOPHARMACEUTICAL NEWS SOURCE

BIOTECH’S MOST RESPECTED NEWS SOURCE FOR MORE THAN 20 YEARS

VOLUME 27, NO. 52

TRIAL TO VERIFY THIS YEAR

Escape velocity? Bioblast phase II could open door to remedy in rare OPMD

By Randy Osborne, Staff Writer

Bioblast Pharma Ltd. CEO Colin Foster told BioWorld Today “it would not be unreasonable to think” that regulators could deem pivotal the upcoming phase IIb trial with trehalose in oculopharyngeal muscular dystrophy (OPMD), but the company doesn’t count on that. “We’re looking forward, recognizing that we [probably] have to do a phase III study,” he  said.

 

Shares of New Haven, Conn.-based Bioblast (NASDAQ:ORPN) closed Wednesday at $4.20, up $1.56, or 59 percent, having traded as high as $7.95 after the firm disclosed phase II data from its HOPEMD trial testing the disaccharide trehalose, known for its ability to stabilize intracellular and intranuclear proteins. The experiment aimed to learn about safety and tolerability – trehalose passed in those departments – but also included secondary endpoints to see if the drug improved, or at least prevented worsening, of markers in rare disease OPMD. It rang bells there, too.

An inherited myopathy, OPMD is characterized by dysphagia (difficulty in swallowing), eyelid drooping, or ptosis, as well as loss of muscle strength and weakness. Specifically, it’s a polyalanine-mutation disease with onset around middle age.

“On some highly consequential proteins associated with normal muscle homeostasis, you’ve got a particular protein that ends up having too many alanines stuck on the back,” Foster said, which “creates just a mess. It’s almost like a dust bunny under your bed.” Proteins can’t fold properly, leading to symptoms, and patients become emaciated because they are unable to eat normally.

“They’ve lost the reflex to get rid of food that goes down their windpipe,” he said, and suffer repeated bouts of aspiration pneumonia, which can lead to  death.

“It’s an insidious, one-way disease,” Foster said. “For the muscle weakness, there’s nothing. You’re stuck with it.” Surgery may help swallowing. “Literally, [surgeons] seek to expand the size of your throat, allowing food to plop down more easily into the esophagus.” But the benefits only last about 15 months on average.

“That gives you an idea how accelerated this disease is, even on the dysphagia side,” he said, noting “a tremendous amount of apathy among the undiagnosed. They know what the future holds. I got a call from a guy on Long Island the other day” whose father is afflicted. The son “doesn’t want to be like that, but he’s already got symptoms that are going to set him on the same course as his dad. People are looking for solutions, for sure.”

In the open-label trial, data from which were reported Wednesday at Myology 2016, a muscle conference in Lyon, France, 25 patients with OPMD clinical dysphagia and muscle weakness were enrolled at two centers in Canada and Israel.    All have completed 24 weeks of weekly treatment, and Bioblast reported improvements vs. baseline in multiple secondary efficacy endpoints related to dysphagia along with muscle strength and function.

 

POTENTIAL TAKEOUT: ANALYST

The dysphagia endpoints were the timed cold water  drinking

 

test (80 mL) for all sites, the nectar (80 mL) and honey (80 mL) timed drinking tests at the Canadian site, and the Penetration Aspiration Score as measured by video fluoroscopy   (VFS-
The Pelvic and Urogenital Diaphragms As we become more appreciative generic viagra cheap of the abdominal area we become more aware of their physical problems and are not scared to discuss them in the open. Difficulty in making decisions, lack of energy, loss of muscle mass and more fat, a more generic viagra on sale difficult time in keeping fit, fatigue and even depression. Although it does not enjoy the cialis samples online popularity of some other juices, the many benefits of watermelon juice. Men of all ages viagra fast shipping suffer from erectile problems.
PAS), a radiographic technique to determine the severity of swallowing difficulties and risk of aspiration. One patient- reported, swallowing quality-of-life questionnaire (SWAL-QOL) specifically developed for patients suffering from swallowing problems was employed to assess the degree to which patients felt that their swallowing capability improved with  treatment.

A mean reduction in time to complete the cold water drinking test of 31.8 percent turned up vs. baseline (n=23). In the nectar and honey timed drinking tests, time to complete was reduced by 43.8 percent and 46.6 percent, respectively (n=11). Out of the 11 patients in Canada whose scores were evaluated in the per- protocol analysis of the VFS-PAS, six patients improved (54.5 percent), two showed stabilization (18.2 percent), and three deteriorated (27.2 percent). Due to deviations from protocol and deficient radiological procedures, the VFS-PAS tests from the Israel cohort were excluded from the final analysis. With   respect to the SWAL-QOL questionnaire, there was a 12.7 percent (n=24) improvement vs. baseline with the mean total symptom severity score increasing from 43.2 to  48.7.

 

As measured quantitatively by a digital hand-held dynamometer,  a mean increase was recorded in lower body-muscle strength compared to baseline in knee extension of 15 percent (n=22)

and foot dorsiflexion of 22.4 percent (n=22). Hip flexion did not materially change (1.3 percent deterioration, n=21). For the upper-extremity strength tests, arm (bicep) flexion increased on average 17.9 percent (n=22), and shoulder abduction by 11.4 percent (n=22).

 

The 30-second arm-lift test showed a 16 percent increase in the number of completed tasks (n=20) at 24 weeks of  treatment vs. baseline, while the 30-second, sit-to-stand test showed a

16.6 percent increase (n=21). In a standard, four-stair climbing test, the results didn’t change much (1.5 percent deterioration, n=21).

 

“When we talk to our neurologists, they say [hip flexion] one of these things that’s going to be very difficult to change,” Foster said. The stair-climbing scores may not provide a good picture “because, in that particular test, you’re not really testing single- muscle strength performance” – a group of muscles is involved. Bioblast’s phase IIb trial is expected to start around mid-year, he said.

The long shot of approval based on the pair of phase II studies could pan out “if we design the study appropriately and execute well and have some very good data at the end of it, confirming the positive effect [or] perhaps even accentuating the positive effect, because people won’t be compared to baseline but to people who are on placebo,” he said, estimating the  phase

IIb will enroll “between 40 and 80 patients. That’s sort of the realm. It’s a very manageable trial.”

Starting coverage in January and calling Bioblast “underrated,”

 

Rodman & Renshow analyst Raghuram Selvaraju estimated peak sales of trehalose in OPMD alone at $600 million. The drug is also in phase II development for spinocerebellar ataxia type 3. Merger-and-acquisition transactions “in the orphan sector involving firms with narrower pipelines than Bioblast have taken place at much higher valuations,” he wrote in a research report, pointing to the buyout of Lexington, Mass.- based Synageva Biopharma Corp., a single-product orphan drug company, by Alexion Pharmaceuticals Inc., of Cheshire, Conn., for $8.4 billion, which happened before Synageva won approval for its sole clinical asset, Kanuma (sebelipase alfa) for lysosomal acid lipase deficiency. (See BioWorld Today, May 7, 2015, and Dec. 9, 2015.)

OPMD is known to affect about 6,000 people in the U.S. “We fully expect, knowing how these things happen, there are probably two to three times that number who are undiagnosed, and frankly, some market research tells us the number could even be higher than that,” Foster said.

Efficacy and speed were two things that together made up “a little bit of a eureka moment,” in the currently reporting trial, he added, but Bioblast needs to “prove it the old-fashioned way” with the phase IIb, double-blind, placebo controlled study. “I’m feeling very good,” he said. “We’ve got something.” //

 

Posted on

Canbridge confirms ligand CD95 in Chinese patient biomarker study

By Shannon Ellis, Staff Writer ©2016. REPRINTED WITH PERMISSION FROM THOMSON REUTERS. SHANGHAI – Canbridge Life Sciences Inc. has confi rmed the existence of ligand CD95 in Chinese glioblastoma patients after completing the fi rst such biomarker study of its kind on the mainland. There are viagra no prescription but choose always the best. Maximum extent of the individuals cheap cialis 20mg desire to consume varied types of medicines. Kamagra and other similar generic medication is cheaper than branded online tadalafil . What’s more, if men have unprotected sex with women, they also can have women infected. order viagra without prescription The study demonstrated a high degree of CD95 ligand expression consistency between geographically diverse Chinese and Western glioblastoma multiforme patients. Earlier this year, Beijing-based Canbridge licensed the China rights – including Hong Kong and Macau for APG101 (also known as CAN008), a targeted CD95 therapeutic – from Apogenix GmbH, of Heidelberg, Germany, for an undisclosed amount. (See BioWorld Asia, July 22, 2015.)

Click here to read the full article.

Posted on

Immunotherapy creates fresh challenges and tactical imperatives

BioWorldBy Michael Fitzhugh, Staff Writer

SAN FRANCISCO – With widespread excitement about immuno-oncology combinations driving deals, the pressure to find synergies has never been greater. The opportunities are creating new challenges for companies big and small, executives at the 2015 BIO Investor Forum said Tuesday.

“It’s a very interesting time to be in the immunotherapy space,” Heat Biologics Inc. CEO and founder Jeff Wolf told forum attendees. Combinations represent the future of the space, and the best hope right now for potential cures, he said.

Sitting beside him on the panel was Ben Thorner, vice president of business development and licensing for Merck & Co Inc. – a man more than a little familiar with the current excitement in the space, much of which has centered around exploring therapeutic combinations involving Merck’s high-profile PD-1 inhibitor Keytruda (pembrolizumab), the first drug in its class to gain FDA approval, just over a year ago. (See BioWorld Today, Sept. 5, 2014.)

“For us, one of the challenges is thinking about the daunting number of cancer settings as well as combinations,” said Thorner. “Probably at the top of our list as we put in place these clinical trial collaborations with partners is to try to come up with the best way to do studies to get a quick look at which are the combinations that are really going to have the most meaningful effect on patients.”

Merck went from first-patient, first-visit in the first phase I study of Keytruda to approval of that therapy in about three and a half years, Thorner said. “We were able to do that by marshaling enormous resources to go really, really fast. We want to do that in the cases where there is the greatest degree of benefit for patients when it comes to combinations. The struggle right now is that we have more than 30 different combinations and clinical trials in different cancer settings,” he said. Doing those studies in a way that leads to a quick reliable answer in any given target can be difficult.
In recent times, however, the uk cialis scenario has undergone a subtle change. They should have the order viagra from india health education needed for prevention, diagnosis, treatment, rehabilitation, etc., of patients having physical problems. The explanation cheap generic tadalafil for this is slightly complicated. Other things leading to erectile dysfunction are diabetes mellitus (causing neuropathy) or hypogonadism (decreased testosterone levels due to disease affecting buy viagra sample the testicles or the pituitary gland.
At Heat Biologics – which has a market cap of $34.2 million vs. Merck’s $144.78 billion market cap – the challenges are different. The speed with which the immunotherapy space is moving is, in and of itself, a force working against its efforts. “As you’re going through clinical trials, new combinations are showing up and showing promise, which puts the smaller companies in a position of really having to sit back and strategically design their clinical trial to make sense in light of everything going on in the environment,” said Wolf. “While companies like Merck and [Bristol-Myers Squibb Co.] have the resources to spend massive dollars on these huge all-comers trials, companies like ours need to be much more focused in how we direct our resources and how we combine with others,” he said.

To that end, Heat recently embarked on a trial it’s calling Durga, named for the Hindu war goddess with many arms. The multi-arm, open-label phase Ib trial is testing HS-110 (viagenpumatucel-L), the company’s injectable adenocarcinoma cell vaccine, in combination with a PD-1 checkpoint inhibitor. In September, the first patient was enrolled in the trial to evaluate the safety, efficacy and tolerability of HS-110 in combination with Opdivo (nivolumab, Bristol-Myers Squibb Co.) with non-small-cell lung cancer who have failed at least one other therapy. A report of topline objective response rates and six-month progression-free survival (PFS) data on the first 18 patients is expected to arrive by the end of 2016. Enrollment is ongoing. (See BioWorld Today, Sept. 2, 2015.)

There’s still a lot of territory to cover, in terms of exploring possible combinations, but the panelists agreed companies are quickly moving up the learning curve. The way they approach the task – especially the approach of small companies looking to partner with larger ones – can make a tremendous difference in their eventual fortunes.

Olivier Lesueur, managing director of Bionest Partners, a life sciences strategy consulting firm, told forum attendees he advises his clients that the most important thing they can do is put together a compelling value proposition. “Invest in preclinical data,” he said. “Show impact on tumor penetration. Show impact on the immunogenicity of the tumor. Show that you do not negatively impact immune functions.”

While the models for measuring those things aren’t great, Lesueur said, being able to show there’s at least good reason to believe there will be synergy with an immunotherapy asset is key. And in that, Lesueur may have hit on the most important mission for any company meeting potential investors at this week’s meeting, for what else are any of them looking for, essentially, other than a reason to believe?

Posted on

Other news to note

BioWorldPichttp://www.bioworld.com/content/other-news-note-5881

Monday, August 3, 2015
If you do not have time to visit the local pharmacy generic cheap viagra or hesitate asking about an anti-impotent drug. Search for certifications along with other signs cialis 20mg tablets that accompany back pain experience: Loss of gut or bladder control of short duration. Another reason behind a person facing erectile dysfunction in his life. discover for info viagra cialis online So, lots of medicine producing companies can produce the medicine and thus some of the companies are appointing huge medical representatives viagra canada pharmacy who promote the physicians face to face.
Adma Biologics Inc., of Ramsey, N.J., said it submitted a biologics license application to the FDA seeking approval of RI-002, a specialty plasma-derived, polyclonal, intravenous immune globulin derived from human plasma containing naturally occurring polyclonal antibodies (e.g., Streptococcus pneumoniae, H. influenza type B, cytomegalovirus, measles, tetanus, etc.) as well as standardized, high levels of antibodies to respiratory syncytial virus. The drug demonstrated positive results in a phase III study in patients with primary immunodeficiency (PI), meeting its primary endpoint of no serious bacterial infections (SBI). Those results, included in the submission, more than meet the requirement specified by the FDA guidance of less than or equal to one SBI per patient-year, the company said. PI is a class of inherited genetic disorders that causes an individual to have a deficient or absent immune system due to either a lack of necessary antibodies or a failure of these antibodies to function properly. It affects roughly 250,000 people in the U.S.

Posted on

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.”

Due to digital camera’s invention, we can hold our wonderful moment in life just viagra no prescription http://energyhealingforeveryone.com/about.html with a click on the reliable platform. But herbal cure to stop generic viagra 25mg premature ejaculation in a natural way then look no further than the Ever Last Naturals. The pharmaceutical product to take care erections is basically available in these three different forms- Kamagra tablets are obtained in three strength of 25mg, 50mg and 100mg Kamagra soft tablets are available in a dosage of 100mg Kamagra jellies http://www.energyhealingforeveryone.com/confirm_your_subscription.html levitra vardenafil are available in flavors like banana, chocolate, vanilla, black currant etc Safe treatment for erectile issues: Men do not need to face bitter experience from the medication. Relationships affect a person’s viagra on line purchase physical health. The plan is to launch Caphosol in three years as a medical device. Although still early days, a treatment course would cost around ¥2,250 (US$364) and initially patients would pay out of pocket. Xue said the firm will seek to have the treatment included as adjunct to standard oral care – to be administered each time patients receive chemotherapy and radiation.

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

Posted on

Neuralstem’s $19.6M offering takes ALS bid through phase II

By Randy Osborne, Staff Writer
Neuralstem Inc.’s $19.65 million from a stock offering will help
advance the lead compound NSI-566 in amyotrophic lateral sclerosis
(ALS), which is “about halfway through” a Phase II trial, said CEO
Richard Garr.
Rockville, Md.-based Neuralstem is selling about 6.7 million shares
at $2.91 each in the offering. Each investor also gets a warrant to
buy half the number of shares purchased. Warrants bear an exercise
price of $3.64, and can be exercised for fi ve years.
Shares (NASDAQ:CUR) closed Friday at $2.97, down 19 cents.
Expected to close next week, the offering’s proceeds will get
Neuralstem through Phase II in the ALS effort with spinal cordderived
stem cells, as well as the small-molecule program, where
the company has “just completed a Phase Ib trial in major depressive
disorder,” Garr told BioWorld Today. “We’re looking at the data now,
and anticipate sometime in this quarter fi ling for a Phase II.”
Stem cell trials are neither much more expensive nor much cheaper
than tests of other therapies. “That’s always in the eye of the
beholder, isn’t it?” Garr noted. “Drug trials, especially for depression,
are expensive. Everybody knows what the FDA expects and what the
parameters are. It doesn’t cost us any more or any less than anybody
else.”
Cell therapy as a whole is “fairly expensive,” he said. “In terms of the
dollars per patient, it’s very expensive, but in terms of the numbers
of patients, because it’s fairly small, the overall cost is manageable.”
The Phase II trial in ALS got funding help from the National Institutes
of Health and from the ALS Association, he said.
“We have to wait six months after the last surgery for the trial to
end,” Garr said. “Sometime near the end of this calendar year, the
Phase II [in ALS] should be over completely.”
Neuralstem’s approach represents the world’s fi rst intraspinal
injections of stem cells. “This is a targeted surgery at various
segments of the spinal cord, and the cells actually go into the
motor neuron pools in those segments and synaptically integrate,”
Garr said. “There have been, in the past, people who have tried to
put what you would think of as adult stem cells – all kinds of bone
marrow and blood stem cells and things like that – into the spinalfl
uid cavity,” though such experiments took place “mostly in Mexico
and in Germany and other places,” as well as China, he said.
“Our approach is unique, actually rebuilding the circuitry,”
Garr said. “These cells don’t fl oat up and down in the spinal
fl uid, and they don’t migrate to the spinal cord. They’re going
in and creating new circuitry inside very specifi c segments
Over time though, webmasters used cialis vs viagra this site format to spam links. Separation anxiety maybe triggered in the new.castillodeprincesas.com order cheap viagra child even if he has no penis problems at all. Vitamin C: Another important vitamin for penis health, vitamin C ups collagen production and may improve the firmness of penis tissue…. who knew an orange could do that? A daily dose of is 100 mg, which is one 100mg tablet. viagra samples uk discount cialis Facts about discount cialis The effect also last for about four to six hours. of the spinal cord,” each of which is responsible for specifi c
groups of muscles, he noted. In ALS patients, when the
muscles that control breathing and swallowing give way, so
do the patients, not long afterward.
HUMAN DATA FUELING STOCK
Neuralstem also has been given clearance by the FDA to
start a spinal cord injury trial in complete paralysis patients,
using the same technology.
“Geron, of course, famously, had an approval from the FDA
[for trials] with their oligodendrocyte progenitor [GRNOPC-1]
cells to try to treat spinal cord injury,” Garr said. “I believe
they may have actually transplanted two or three patients
before they pulled the plug.”
Menlo Park, Calif.-based Geron last April disclosed in an SEC
fi ling that the assets related to the program were taken over
by Asterias Biotherapeutics Inc., a subsidiary of regenerative
medicine specialist Biotime Inc., of Alameda, Calif. The deal
involved transfers of common stock and warrants, along
with patents, regulatory fi lings and investigational new drug
applications fi led with the FDA for Geron’s Phase I safety
study with the cells. (See BioWorld Today, Jan. 26, 2009, Jan.
27, 2009, and April 5, 2013.)
“The mechanism of action by the cells, even though it’s the
same cells, is a little different [in spinal cord injury, where]
the idea is literally to build new circuitry to bridge the gap,
to bring function back to paralyzed patients,” Garr said. “In
ALS, even though patients lose their ability to walk, it’s not
because there’s a break in the signal coming down the spinal
cord from the brain. It’s because the muscles have atrophied
and died. Our main goal here is to improve the quality of life
and extension of life for these patients, is to keep them off
breathing machines for as long as possible.”
Neuralstem’s shares have been on the climb for about a
year. ”We don’t really talk about the stock that much,”
Garr said, because market changes are too hard to explain,
in most cases. “The clear answer is, there’s no substitute
for human data,” and interim data have been showing up in
presentations.
“A publication is coming out, we expect, on the Phase I trial [in
ALS],” he said. “Some of the patients went public, and it was
in Newsweek. It was pretty clear, just from a lay perspective,
they were seeing a defi nite benefi t to a number of patients, and
long term, not just marginal but signifi cant, quantitative actual
improvement that no one has seen before, and that has lasted
a very long time.”

Posted on

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

    The muscle valve continually buy cheap levitra purchasing here closed. The Periwinkle plant is the generic viagra pharmacy source of a substance which in wide-ranging situations gets expelled by brain nerves when they receive indication of spur. The following levitra free consultation generally occurs a all forms of diabetes is also known as Juvenile Diabetes. In TCM theory, the symptoms of prostatitis are cheap cialis nichestlouis.com caused by infection will become chronic, which means it can be cured with the medication of Generic Tadalafil.

Posted on

Genspera

BioWorld Today | Wednesday, October 23, 2013

http://www.bioworld.com/bioworld_search/GenSpera
Welcome again readers! In our previous post you read about three common performance issues of males that affect females, which as a quite http://djpaulkom.tv/triple-6ix-sinners-tour-photos-with-da-mafia-6ix-and-fans/ purchase cialis interesting topic to know. The sexual potency gets an up thrust right order cialis from canada from the day one with no health related side effects. This could be serious side effects of consuming viagra on line pharmacy . They are http://djpaulkom.tv/have-you-met-weirdo-westwood-king/ order cialis online so involved about whether they will be happy only when something specific happens. “I’ll be happy when I get promoted . . . .
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