A massive unmet demand exists globally for a safer, more effective solution than the standard of care doxorubicin. Given the severity of demand from particular cancers like glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer, CYTR could really have their hands on a serious contender here, especially if their Phase 2 clinical trial in unresectable GBM goes well. This open-label and multi-center study will look at some 28 anticipated patients every six weeks via MRI scan to validate efficacy and safety, with the patient class being comprised of individuals whose tumors have progressed following surgery, radiation and temozolomide (the standard oral chemotherapy drug for brain cancer). Success for CYTR in GBM would be a real one-two punch considering the recently reinforced Phase 2b results in STS, and the company could see a direct pathway emerge for approval of aldoxorubicin if similarly positive data is generated for GBM and then coupled with even a single positive pivotal study.
Wainwright is assuming that the planned FDA Special Protocol ... pans out, resulting in a commercial launch of aldoxorubicin in the U.S. and EU in 2017 ... punch considering the recently reinforced Phase 2b results in STS, and the company could see a direct pathway emerge for approval of aldoxorubicin if ...
Johnson & Johnson is seeking a new manufacturer for Doxil. "We continue our discussions with Ben Venue about various alternatives to ensure continued supplies of Doxil into 2014," said Vaga, on behalf of Johnson & Johnson.
Generic-Drug Failures Spur Concern as FDA Steps Up Action
By Anna Edney and Drew Armstrong Feb 27, 2014
U.S. regulators are mobilizing to shore up confidence in America’s generic-drug supply as alarm grows over the quality of products made in India, and the head of the largest U.S.-based maker of the medicines predicted more trouble lies ahead.
“It’ll get worse before it gets better,” said Mylan (MYL) Inc. Chief Executive Officer Heather Bresch, whose company has half of its more than 20,000 employees in India. As regulators boost inspections there, consumers will see “more market disruption, more companies being shut down, more bans on facilities,” she said in an interview. “I’d be shocked if there’s not.”
Food and Drug Administration officials said they plan to be more transparent on how they regulate the $30 billion industry as a way to persuade U.S. consumers that safeguards are in place. Generic drugs, which make up 84 percent of the medicine used in the U.S., helped Americans save $193 billion in 2011, an industry group has said, as health-care costs rise and insurers force more consumers to use them.
The FDA’s approval of generic Doxil has begun to ease shortages of the cancer drug
By Patrick Kenney
Over the last couple years, our healthcare system has been plagued by nationwide drug shortages that have threatened the lives of thousands of patients. The consequences of these shortages have been particularly dangerous because many of the drugs in short supply are potentially life-saving treatments for cancer.
The shortages tend to be a result of disruptions in manufacturing, in many cases due to improper practices by pharmaceutical manufacturing giants that can affect an entire supply chain.
The cancer drug Doxil (doxorubicin HCI liposome injection), which is used frequently in the treatment of recurrent ovarian cancer and relapsed multiple myeloma, has been in short supply since November 2011, when the Food and Drug Administration (FDA) intervened at a plant operated by Ben Venue Laboratories in Bedford, Ohio, where equipment had deteriorated to the point that it shed particles into injectable drugs.
In October 2011, acknowledging the urgency of the shortage crisis, President Barak Obama issued an executive order, which in part instructed the FDA to speed up efforts to get generic drugs approved and on the market. Last month, that effort bore fruit when the FDA approved the first generic form of Doxil, made by Sun Pharma Global FZE.
“Initially, there was an issue with the warehouse distributor not having the generic version available as soon as notification went out that it was available per the manufacturer and that delay was approximately one week,” Kathryn Schultz, a clinical pharmacy specialist in hematology/oncology at Rush University Medical Center, said in an email.
Schultz and her colleagues in the pharmacy department track changes in the supply of cancer drugs, and each week, they report the combined inventory for inpatient and outpatient pharmacies to their cancer center. During intense shortages, hospitals are prepared to share drugs openly
By reaching an agreement on an SPA, the FDA deems that results from this single Phase 3 clinical trial will be acceptable to support the regulatory approval of aldoxorubicin as a second-line treatment for patients with soft tissue sarcoma
Dream team never received any compensation from CYTRx
CYTR now green....come on! :CYTR Surges As Aldoxorubicin Dominates Doxorubicin In Phase IIB
Price will sustain with few shorts.
Ongoing and can join anytime.
CytRx intends to discuss a pathway for the registration of aldoxorubicin for KS with the FDA, provided that preliminary Phase 2 data are positive.
Linker Compound Offers A Promising Investment by Fusion Research for a very thorough explanation and comparison.
The competition drug for CYTR is Doxorubicin which is a highly toxic drug that can cause side effects and CYTRX offers Aldoxorubicin and that should help in this area after all it's the main reason for its development. Since doxorubicin has been known to cause heart damage in cancer patients, doxorubicin has a limit on the cumulative amount of drug the patient can receive.
If trials continue as successfully as they have, Investors should see aldoxorubicin take the place of doxorubicin. CytRx Corporation will also find an immediate market with a monstrous revenue stream.
CYTRx is a better proposition on AIDS & BRAIN CANCER Pivotal trials under US FDA - SPA actually CYTR did went up to $9 but street wanted it cheap.