Hijar Max Pharmaceuticals Business Plan Biology Essay

Traumatic encephalon hurt ( TBI ) is one of the prima causes of decease and lasting disablement. Harmonizing to Centers for Disease Control and Prevention about 1.4 million people sustain a traumatic encephalon hurt each twelvemonth in the United States. The neural harm that is observed in patients after TBI consequences from a primary hurt and a secondary hurt that occurs over the undermentioned hours and yearss. Therefore, to better patients retrieve it critical to protect nerve cells against secondary hurt every bit shortly as possible after hurt. Unfortunately, there is presently no effectual method for forestalling neurodegeneration after TBI.

Hijar-Max Pharmaceuticals, a in private held life scientific discipline company, has a wide scope of experience in developing drugs aiming neurodegenerative diseases. Recently, our company focused on development of neuroprotective agents to handle patients after traumatic encephalon hurt ( TBI ) .

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The intent of proposed survey is to find if Talampanel ( an AMPA receptor blocker ) the new antiepileptic and neuroprotective agent is effectual in forestalling acute ictuss and better neurological recovery after TBI.

We propose to execute, randomized, double-blind II stage clinical test to measure the safety and the effectivity of Talampanel in patients after TBI. Patients with TBI will be indiscriminately assigned to two groups. Group 1 criterion attention and Group 2 criterion attention and Talampanel 35mg for 7 yearss after hurt. All topics will be followed for one twelvemonth. Serial EEGs and MRIs will be taken to measure encephalon map.

End points of this survey include:

-Decreased figure of ictuss

-Improvement in neurological appraisals

-Improvement in neurological symptoms ( concerns, etc )

-Improvement in encephalon MRI.

The entire cost of proposed survey will be about 555 $ .

We believe that Hijar-Max Pharmaceuticals has sufficiency expertise to execute proposed survey. We expect to complete this survey in 3years after registration of first patient.

2. Company description

Hijar-Max Pharmaceuticals is a in private held life scientific discipline company located in St. Louis, Missouri. Our investors include pharmaceutical-focused venture capital investors, company laminitiss and persons.

The company is focused on the find and development of fresh therapeutics for patients enduring from diseases associated with cardinal nervous system ( CNS ) .

The company is using fresh engineerings that will bring forth first-in-class therapeutics, thereby altering the criterion of attention for patients enduring from epilepsy, traumatic encephalon injures ( TBI ) ague hurting, and other upsets of the nervous system.

Hijar-Max Pharmaceuticals has been funded in 2005. Since this clip the company has identified and patented multiple development campaigners that have shown strong efficaciousness, safety and pharmacologic features. In December 2009 our company filed Investigational New Drug ( IND ) application with the U.S. Food and Drug Administration ( FDA ) for lead compound, NH555.

The company has besides on-going and planned clinical tests in CNS indicants. Recently, Hijar-Max Pharmaceuticals has successfully finished a stage II clinical survey look intoing neuroprotective consequence of N1226 compound in patients after ischaemic shot. Figure 1 nowadayss elaborate company`s grapevine.

The company is led by a strong direction squad with important drug development experience and a strong path record of success within the field of cardinal nervous system. In 2008 Hijar-Max Pharmaceuticals established coaction with Washington University in St. Louis which is one of the taking medical research establishments in the United States. In add-on, Hijar-Max has established collaborative relationships with pharmaceutical companies outside the U.S. In November 2008 Hijer- Max Pharmaceutical entered into a license understanding with Teva Pharmaceutical to develop and commercialize Talampanel for intervention patient after traumatic encephalon hurt.

We believe that our partnerships will heighten the company ‘s ability to develop and commercialize our merchandise campaigners.

Fig. 1 Hijar-Max Pharmaceuticals grapevine.

2. Agent and Study Plan

Talampanel { ( R ) -7-acetyl-5- ( 4-aminophenyl ) -8,9-dihydro-8-methyl-7H-1,3-dioxolo [ 4,5-h ] [ 2,3 ] benzodiazepine } ( Fig.2 ) is noncompetitive adversary of the AMPA receptors.

Fig.2 Molecular construction of Talampanel ( 4 )

AMPA receptors are activated by glutamate that mediated fast excitant neurotransmission in the cardinal nervous system ( CNS ) . Therefore, in normal synaptic operation, activation of AMPA receptors is critical in many facets of encephalon map. However, in pathophisiological conditions in which surplus of glutamine is release over-activation of AMPA receptors leads into necrotic and apoptotic neural decease. This procedure of neural decease is called excitotoxicity and involved Ca2+ influx through AMPA receptors into the nerve cell ( 1 ) . It has been suggested that excitotoxicity could be involved in the pathogenesis of several vitamin Es neurodegenerative diseases, such as ischaemia-hypoxia, epilepsy, traumatic encephalon hurt, Parkinson`s disease, ALS ( Amyotrophic sidelong induration ) and other motor nerve cell diseases, in which the activity of glutamatergic neurotransmission is elevated ( 2 ) . Therefore, AMPA receptor adversaries have a possible curative value in the intervention of chronic and acute neurodegenerative diseases. To day of the month, several compounds suppressing AMPA receptors have been developed and characterized ( 3 ) . Four of those compounds are presently undergoing clinical tests for the intervention of cardinal nervous system upsets ( Table 1 ) .

Hijer- Max, Pharmaceuticals is peculiarly interested in the usage of AMPA receptor adversaries as neuroprotectiv agents to handle patients after traumatic encephalon hurt ( TBI ) . Harmonizing to National Institute of Health, TBI is defined as a signifier of acquired encephalon hurt, occurs when a sudden injury causes harm to the encephalon. In TBI primary abuse consequences in immediate mechanical harm ( primary hurt ) . It has been shown that the degree of glutamate markedly increase early after primary hurt bring oning neural Ca2+ entry through glutamate-regulated receptors. Those biochemical and physiological events finally lead to neural decease and consequences in a secondary hurt that evolves over a period of hours to yearss, even months, after the primary abuse. Therefore, encirclement of receptors activated by glutamate such as AMPA receptors may protect patients after TBI against secondary encephalon harm and eventually better functional result of TBI patients.

We believe that Talampanel a noncompetitive adversary of the AMPA receptors may be used as a neuroprotective agent to forestall secondary encephalon harm in patients after TBI ( 5 ) . Talampanel is orally active and good tolerated by healthy human topics ( maximal tolerated dosage was 100 milligram ) . It has besides good bloodbrain incursion ( 7 ) . Presently, Talampanel is being examined in patients with amyotrophic sidelong induration, grownups with partial ictuss, and patients with perennial glioma or advanced Parkinson ‘s disease ( 6 ) .

Table 1. AMPA receptor adversaries examined for CNS diseases indicant ( 6 )

AMPA receptor

adversary

Clinical indicant

Phase of clinical trail

LY 300164

Parkinson`s disease

Phase II

Talampanel

Parkinson`s disease

Amyotrophic Lateral Sclerosis ( ALS )

Epilepsy

Brain activity

Phase II

Phase II

Phase II

Phase II

Topiramate

Parkinson`s disease

Post Traumatic Stress Disorder ( PTSD )

Alcohol and Comorbid Cocaine Dependence

Migraine

Epilepsy

Traumatic Brain Injury ( TBI )

Bipolar Disorder

Tourette Syndrome

Phase II

Phase IV

Phase II

Phase IV

Phase IV

Phase II

Phase III

Phase III

ZK 200715

Ocular system

Phase I

Talampanel was effectual in decrease of ictuss in patients with stubborn partial ictuss ( 7 ) . Furthermore, it has been shown that this drug protects primary rat hipocampal nerve cells against gluamate-mediated excitotoxicity ( 8 ) . Neuroprotective consequence of Talampanel has been besides demonstrated in vivo utilizing assorted carnal theoretical accounts ( 9 ) . It is of import to observe that, Belayev et Al. reported that talampanel therapy significantly reduces encephalon harm in rat theoretical account of TBI. In add-on, presymptomatic surveies done by our company confirmed neuroprotective consequence of talampanel in assorted carnal theoretical accounts of TBI ( manuscript in readying ) .

Based on the scientific principle and a positive preclincal survey utilizing animas theoretical account of TBI, we hipotetized that Talampanel can 1- cut down acute ictuss and forestall the development of epilepsy following TBI and 2- improve patients neurological recovery. To prove this thought Hijer- Max, Pharmaceuticals proposes to preform II phase clinical test to find if Talampanel is effectual in forestalling acute ictuss and better neurological recovery in patients after TBI.

We believe that our company has sufficiency expertness and resources to preformed proposed survey. SWOT analysis of the company and the proposed survey is presented in Table 2.

Table 2. SWOT analysis

Strengths

– Hijar-Max Pharmaceuticals direction squad has a wide scope of expertness in developing drugs aiming diseases associated with cardinal nervous system.

– Hijar-Max Pharmaceuticals holds multiple patents covering Company ‘s drug campaigners.

– Company`s confederates. Our company establishes coaction with Washington University in St. Louis and with pharmaceutical companies outside the U.S.

– Cmpany is in a good fiscal state of affairs. Recently, we received expansive from NIH for survey the effectivity of Talampanel in patients after TBI. We besides received 250,000 from our private investors to back up this undertaking.

Failings

– Our company is entirely focused on diseases associated with cardinal nervous system. We may non hold sufficient expertness to develop our drug campaigners for different indicants.

– We rely on third-party makers for commercial production of our drug campaigners. Third-party makers may meet troubles in the production procedure that could adversely impact our ability to present drug campaigners and could do holds in survey completion.

– Many of our drug campaigners are in early phase of development.

Opportunities

– There are no sanctioned pharmaceutical therapies for either ague or post-acute TBI, so this is an country of considerable medical need.A

– Market for drugs aiming TBI.

Children at age 0-4 are in the group of highest hazard for TBI.

Military responsibilities increase the hazard of a TBI.

– Treatment of TBI is in involvement of Department of Defense and Department of Veteran Affairs. We expect to have extra support from those sections.

Menaces

– New engineerings. Our company is cognizant of rapid development of root cell therapeutics for intervention of neurodegenerative diseases.

– Drugs side effects.

– Cost of Company ‘s insurance coverage may significantly increase before study completion.

-The regulative blessing procedures.

– HMO`s, Medicare, Insurance. We can non foretell how heath attention reform affects costs of patient ‘s standard attention.

3. Market Analysis

4. Fiscal Analysis

5. Operationss program

Study Design – A stage II, multicenter, randomized, double-blind, placebo controlled test to measure the safety and efficaciousness of Talampanel in the intervention of terrible Traumatic Brain Injury ( TBI )

Objective – To find the safety and efficaciousness of acute disposal of Talampanel on recovery from terrible closed caput hurt

Puting – Degree I Trauma Centers – topics to be recruited in Emergency Department and/or Neuro ICU

Study Population – 18-80 twelvemonth old males and females who have suffered a terrible traumatic encephalon hurt as determined by the Glasgow Coma Scales.

– A sum of 30 topics will be randomized into 2 groups, with 20 topics in the intervention group and 10 in the placebo group at 2 sites. Training, monitoring and information direction will be managed through the Center for Clinical Studies squad at Washington University in St. Louis site.

Main Outcomes Measures: Improvement of encephalon axonal hurt determined by MRI utilizing DTI ( Diffusion Tensor Imaging, Improvement in impaired encephalon functional connectivity, measured by utilizing resting-state fMRI correlativity analysis, and improved neurological and cognitive map utilizing the Glasgow-Outcome Scale, and trials of attending, memory, and watchfulness.

Secondary Outcomes Measures: lessening in figure of ictuss by EEG measurings.

Study Duration – the Talampanel in TBI trail will inscribe 30 topics at 2 sites. The entire follow-up clip for patients enrolled is 48 hebdomads. It is anticipated that the appropriate figure of topics will be enrolled within 2 old ages of survey induction. All topics will be followed from the clip the capable marks consent until discontinuance or completion of all survey demands. Subjects enrolled will be evaluated at baseline, hr 12, twenty-four hours 1, twenty-four hours 2, twenty-four hours 3, twenty-four hours 4, twenty-four hours 5, twenty-four hours 6, twenty-four hours 7, and hebdomad 2, 4, 12, 24, 36, and 48.

Randomization procedure – 2-1 randomisation will be conducted by computing machine in Research Pharmacy at Barnes Jewish Hospital. Drug / placebo is initiated within 12 hours of encephalon hurt and after baseline/screening appraisals are completed. 35 mg. of IV Talampanela„? vs. placebo BID ( 0800 & A ; 1200 ) is continued for 7 yearss.

Safety – Subjects will be closely monitored with critical marks, plasma drug degrees to mensurate for toxicity, blood trials for CBC ( with derived function and thrombocytes ) , blood chemical sciences to supervise liver and kidney map, neurological appraisal, and physical tests as indicated.

Data Safety Monitoring Plan – There will be an independent Data Safety Monitoring Board ( DSMB ) . They will run into regularly and will be charged with judging inauspicious events, supervising the survey, and safeguarding the involvements of survey topics. We will follow with any extra meantime analysis deemed appropriate by the DSMB. Should an unexpected safety concern arise, the DSMB may urge that the test be stopped. A cardinal issue in both safety and efficaciousness will be pull offing informations in a timely mode and sing quality confidence through efficient and right informations entry and site monitoring. Site visit monitoring will be done by the Washington University Center for Clinical Studies as needed based on public presentation ( norm of 1 visit per site ) . Sites may necessitate more visits, depending on demand.

Patent Protection –

Payments to sites – sites to be paid start-up fees up front, and so based upon accrual and making survey mileposts

Inclusion

18 – 80 old ages old

Males and females

Severe TBI ( GCS of 8-12 )

Exclusion

History of old caput hurt

History of psychiatric unwellness

History of drug or intoxicant abuse necessitating intervention

History of ictus activity

Unstable cardiac disease

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2. Doble A. ( 1999 ) The function of excitotoxicity in neurodegenerative disease: deductions for therapy. Pharmacol Ther. Mar ; 81 ( 3 ) :163-221.

3. Gitto R, Barraca ML, De Luca L, Chimiri A. ( 2004 ) New tendencies in development of AMPA receptor adversaries. Expert. Opin. Ther. Patents. 14 ( 8 ) : 1199-1213.

4. www.chemblink.com

5. Howes JF, Bell C. ( 2007 ) Talampane. Neurotherapeutics. Jan ; 4 ( 1 ) :126-9.

6. www.clinicaltrials.gov

7. Chappell et Al ( 2002 ) A crossing over, add-on test of talampanel in patients with stubborn partial ictuss. Neurology ( 58 ) 1680-1682

8. Belayev L et Al ( 2001 ) Talampanel, a fresh noncompetitive AMPA adversary, is neuroprotective after traumatic encephalon hurt in rats. J Neurotrauma. ( 10 ) :1031-8.

9. Denes L, SzilA?agyi G, GA?al A, Nagy Z. ( 2006 ) Talampanel a non-competitive AMPA-antagonist attenuates caspase-3dependent programmed cell death in mouse encephalon after transeunt focal intellectual ischaemia. Brain Research Bulletin ( 70 ) 260-262.